paricalcitol 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| Vitamin D analogues/derivatives | 2066 | 131918-61-1 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
suppressed immunoglobulin production & thymic lymphocyte proliferation in vivo
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
| Dose | Unit | Route |
|---|---|---|
| 2 | mcg | O |
| 2 | mcg | P |
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| BDDCS (Biopharmaceutical Drug Disposition Classification System) | 2 | Benet LZ, Broccatelli F, Oprea TI |
| EoM (Fraction excreted unchanged in urine) | 0 % | Benet LZ, Broccatelli F, Oprea TI |
| MRTD (Maximum Recommended Therapeutic Daily Dose) | 0.00 µM/kg/day | Contrera JF, Matthews EJ, Kruhlak NL, Benz RD |
| BA (Bioavailability) | 72 % | Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H |
| Vd (Volume of distribution) | 0.41 L/kg | Lombardo F, Berellini G, Obach RS |
| CL (Clearance) | 0.89 mL/min/kg | Lombardo F, Berellini G, Obach RS |
| fu (Fraction unbound in plasma) | 0.00 % | Lombardo F, Berellini G, Obach RS |
| t_half (Half-life) | 5.30 hours | Lombardo F, Berellini G, Obach RS |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| April 17, 1998 | FDA | ABBVIE |
FDA Adverse Event Reporting System (Female)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Death | 3102.63 | 25.89 | 1256 | 5638 | 324123 | 50274107 |
| Cardiac disorder | 451.61 | 25.89 | 182 | 6712 | 42797 | 50555433 |
| Infarction | 324.74 | 25.89 | 73 | 6821 | 2255 | 50595975 |
| Sepsis | 223.74 | 25.89 | 167 | 6727 | 132758 | 50465472 |
| Adverse event | 163.51 | 25.89 | 91 | 6803 | 43672 | 50554558 |
| Myocardial infarction | 154.32 | 25.89 | 114 | 6780 | 88913 | 50509317 |
| Cardiac failure | 153.88 | 25.89 | 107 | 6787 | 75933 | 50522297 |
| Calciphylaxis | 144.26 | 25.89 | 39 | 6855 | 2599 | 50595631 |
| Cardiovascular disorder | 143.94 | 25.89 | 54 | 6840 | 10400 | 50587830 |
| Cardio-respiratory arrest | 138.39 | 25.89 | 88 | 6806 | 53804 | 50544426 |
| Respiratory arrest | 121.95 | 25.89 | 66 | 6828 | 29943 | 50568287 |
| Nephrogenic systemic fibrosis | 108.65 | 25.89 | 35 | 6859 | 4287 | 50593943 |
| Cerebrovascular disorder | 82.03 | 25.89 | 25 | 6869 | 2553 | 50595677 |
| Blood parathyroid hormone increased | 75.38 | 25.89 | 24 | 6870 | 2830 | 50595400 |
| Skin induration | 74.91 | 25.89 | 24 | 6870 | 2887 | 50595343 |
| Renal transplant | 71.25 | 25.89 | 19 | 6875 | 1200 | 50597030 |
| Acute myocardial infarction | 68.16 | 25.89 | 45 | 6849 | 29228 | 50569002 |
| Skin hypertrophy | 61.52 | 25.89 | 21 | 6873 | 3074 | 50595156 |
| Skin tightness | 61.25 | 25.89 | 22 | 6872 | 3741 | 50594489 |
| Chronic kidney disease | 55.79 | 25.89 | 45 | 6849 | 39726 | 50558504 |
| Drug ineffective | 52.87 | 25.89 | 23 | 6871 | 819310 | 49778920 |
| Cerebrovascular accident | 50.00 | 25.89 | 63 | 6831 | 94617 | 50503613 |
| Peritonitis bacterial | 46.23 | 25.89 | 19 | 6875 | 4642 | 50593588 |
| Skin fibrosis | 39.10 | 25.89 | 11 | 6883 | 848 | 50597382 |
| Hyperphosphataemia | 38.38 | 25.89 | 13 | 6881 | 1858 | 50596372 |
| Transplant | 37.36 | 25.89 | 10 | 6884 | 640 | 50597590 |
| Blood parathyroid hormone abnormal | 36.91 | 25.89 | 8 | 6886 | 207 | 50598023 |
| Parathyroidectomy | 35.81 | 25.89 | 8 | 6886 | 239 | 50597991 |
| Shunt occlusion | 34.75 | 25.89 | 9 | 6885 | 507 | 50597723 |
| Cardiac arrest | 33.97 | 25.89 | 49 | 6845 | 83602 | 50514628 |
| Arteriovenous fistula thrombosis | 31.87 | 25.89 | 7 | 6887 | 193 | 50598037 |
| Peritoneal dialysis complication | 31.46 | 25.89 | 10 | 6884 | 1171 | 50597059 |
| Haemorrhagic stroke | 31.44 | 25.89 | 15 | 6879 | 5213 | 50593017 |
| Device related sepsis | 30.55 | 25.89 | 13 | 6881 | 3462 | 50594768 |
| Device related infection | 30.21 | 25.89 | 24 | 6870 | 20711 | 50577519 |
| Fibrosis | 29.61 | 25.89 | 13 | 6881 | 3734 | 50594496 |
| Acute pulmonary oedema | 29.53 | 25.89 | 16 | 6878 | 7251 | 50590979 |
| Off label use | 29.40 | 25.89 | 14 | 6880 | 474412 | 50123818 |
| Azotaemia | 28.77 | 25.89 | 13 | 6881 | 3995 | 50594235 |
| Joint contracture | 27.98 | 25.89 | 10 | 6884 | 1674 | 50596556 |
| Pulmonary sepsis | 26.41 | 25.89 | 9 | 6885 | 1310 | 50596920 |
FDA Adverse Event Reporting System (Male)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Death | 3883.41 | 26.58 | 1851 | 6624 | 340233 | 29225819 |
| Cardiac disorder | 699.54 | 26.58 | 295 | 8180 | 36968 | 29529084 |
| Infarction | 484.21 | 26.58 | 117 | 8358 | 2309 | 29563743 |
| Myocardial infarction | 295.21 | 26.58 | 247 | 8228 | 110049 | 29456003 |
| Cardiovascular disorder | 233.38 | 26.58 | 90 | 8385 | 8845 | 29557207 |
| Adverse event | 217.69 | 26.58 | 100 | 8375 | 15191 | 29550861 |
| Sepsis | 176.21 | 26.58 | 210 | 8265 | 142472 | 29423580 |
| Cardiac failure | 160.61 | 26.58 | 152 | 8323 | 79135 | 29486917 |
| Respiratory arrest | 142.62 | 26.58 | 90 | 8385 | 25743 | 29540309 |
| Cardio-respiratory arrest | 134.09 | 26.58 | 113 | 8362 | 50488 | 29515564 |
| Transplant | 130.71 | 26.58 | 32 | 8443 | 665 | 29565387 |
| Renal transplant | 121.22 | 26.58 | 36 | 8439 | 1582 | 29564470 |
| Cerebrovascular accident | 94.23 | 26.58 | 113 | 8362 | 76798 | 29489254 |
| Calciphylaxis | 91.22 | 26.58 | 26 | 8449 | 986 | 29565066 |
| Cerebrovascular disorder | 89.20 | 26.58 | 29 | 8446 | 1722 | 29564330 |
| Infection | 76.86 | 26.58 | 102 | 8373 | 76649 | 29489403 |
| Shunt thrombosis | 69.79 | 26.58 | 13 | 8462 | 65 | 29565987 |
| Parathyroidectomy | 67.51 | 26.58 | 13 | 8462 | 80 | 29565972 |
| Nephrogenic systemic fibrosis | 66.29 | 26.58 | 29 | 8446 | 3913 | 29562139 |
| Cardiac arrest | 63.99 | 26.58 | 99 | 8376 | 85492 | 29480560 |
| Skin induration | 54.68 | 26.58 | 21 | 8454 | 2033 | 29564019 |
| Shunt occlusion | 53.49 | 26.58 | 16 | 8459 | 720 | 29565332 |
| Blood parathyroid hormone increased | 51.46 | 26.58 | 18 | 8457 | 1337 | 29564715 |
| Unevaluable event | 50.52 | 26.58 | 52 | 8423 | 29799 | 29536253 |
| Drug ineffective | 45.25 | 26.58 | 24 | 8451 | 363146 | 29202906 |
| Acute myocardial infarction | 44.81 | 26.58 | 62 | 8413 | 48376 | 29517676 |
| Off label use | 40.28 | 26.58 | 18 | 8457 | 300782 | 29265270 |
| Skin hypertrophy | 38.21 | 26.58 | 17 | 8458 | 2386 | 29563666 |
| Chronic kidney disease | 35.77 | 26.58 | 48 | 8427 | 36368 | 29529684 |
| Skin tightness | 31.57 | 26.58 | 14 | 8461 | 1950 | 29564102 |
| Peritoneal dialysis complication | 30.97 | 26.58 | 13 | 8462 | 1584 | 29564468 |
| Toxicity to various agents | 27.25 | 26.58 | 8 | 8467 | 173653 | 29392399 |
FDA Adverse Event Reporting System (Geriatric)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Myocardial infarction | 340.83 | 22.25 | 229 | 7977 | 165592 | 64324934 |
| Death | 323.92 | 22.25 | 349 | 7857 | 482356 | 64008170 |
| Cardio-respiratory arrest | 266.68 | 22.25 | 162 | 8044 | 98231 | 64392295 |
| Cardiac disorder | 244.34 | 22.25 | 126 | 8080 | 55690 | 64434836 |
| Calciphylaxis | 213.54 | 22.25 | 55 | 8151 | 3257 | 64487269 |
| Infarction | 203.79 | 22.25 | 55 | 8151 | 3905 | 64486621 |
| Sepsis | 190.41 | 22.25 | 187 | 8019 | 230154 | 64260372 |
| Cardiac failure | 157.44 | 22.25 | 132 | 8074 | 132241 | 64358285 |
| Respiratory arrest | 150.41 | 22.25 | 90 | 8116 | 52895 | 64437631 |
| Nephrogenic systemic fibrosis | 148.38 | 22.25 | 47 | 8159 | 5845 | 64484681 |
| Skin induration | 120.63 | 22.25 | 37 | 8169 | 4138 | 64486388 |
| Renal transplant | 96.11 | 22.25 | 27 | 8179 | 2221 | 64488305 |
| Acute myocardial infarction | 94.25 | 22.25 | 75 | 8131 | 69643 | 64420883 |
| Skin hypertrophy | 93.18 | 22.25 | 31 | 8175 | 4498 | 64486028 |
| Skin tightness | 82.68 | 22.25 | 29 | 8177 | 4932 | 64485594 |
| Blood parathyroid hormone increased | 74.77 | 22.25 | 24 | 8182 | 3110 | 64487416 |
| Parathyroidectomy | 74.38 | 22.25 | 14 | 8192 | 186 | 64490340 |
| Peritonitis bacterial | 72.31 | 22.25 | 31 | 8175 | 9012 | 64481514 |
| Peritoneal dialysis complication | 65.44 | 22.25 | 20 | 8186 | 2208 | 64488318 |
| Chronic kidney disease | 65.09 | 22.25 | 56 | 8150 | 57863 | 64432663 |
| Cerebrovascular disorder | 56.48 | 22.25 | 20 | 8186 | 3495 | 64487031 |
| Skin fibrosis | 55.51 | 22.25 | 16 | 8190 | 1443 | 64489083 |
| Cardiac arrest | 55.19 | 22.25 | 82 | 8124 | 153982 | 64336544 |
| Shunt thrombosis | 54.46 | 22.25 | 10 | 8196 | 115 | 64490411 |
| Shunt occlusion | 53.65 | 22.25 | 15 | 8191 | 1212 | 64489314 |
| Cardiovascular disorder | 53.00 | 22.25 | 30 | 8176 | 15851 | 64474675 |
| Joint range of motion decreased | 45.04 | 22.25 | 29 | 8177 | 19314 | 64471212 |
| Joint contracture | 44.24 | 22.25 | 15 | 8191 | 2304 | 64488222 |
| Fibrosis | 40.42 | 22.25 | 17 | 8189 | 4711 | 64485815 |
| Transplant | 39.61 | 22.25 | 11 | 8195 | 867 | 64489659 |
| Scar | 38.58 | 22.25 | 23 | 8183 | 13375 | 64477151 |
| Drug ineffective | 37.88 | 22.25 | 31 | 8175 | 840216 | 63650310 |
| Azotaemia | 35.84 | 22.25 | 18 | 8188 | 7484 | 64483042 |
| Device related sepsis | 35.78 | 22.25 | 16 | 8190 | 5139 | 64485387 |
| Arteriovenous fistula thrombosis | 35.13 | 22.25 | 9 | 8197 | 520 | 64490006 |
| Cerebrovascular accident | 34.04 | 22.25 | 62 | 8144 | 137521 | 64353005 |
| Blood parathyroid hormone abnormal | 33.22 | 22.25 | 8 | 8198 | 358 | 64490168 |
| Device related infection | 33.14 | 22.25 | 29 | 8177 | 30597 | 64459929 |
| Peritonitis | 31.82 | 22.25 | 26 | 8180 | 24997 | 64465529 |
| Hypercalcaemia | 30.54 | 22.25 | 28 | 8178 | 31388 | 64459138 |
| Cardiopulmonary failure | 30.05 | 22.25 | 15 | 8191 | 6155 | 64484371 |
| Skin hyperpigmentation | 29.20 | 22.25 | 15 | 8191 | 6536 | 64483990 |
| Sudden death | 27.93 | 22.25 | 22 | 8184 | 20074 | 64470452 |
| Hyperphosphataemia | 26.50 | 22.25 | 12 | 8194 | 3969 | 64486557 |
| General physical health deterioration | 26.44 | 22.25 | 71 | 8135 | 204354 | 64286172 |
| Shunt malfunction | 25.87 | 22.25 | 6 | 8200 | 228 | 64490298 |
| Haemorrhagic stroke | 25.87 | 22.25 | 16 | 8190 | 9935 | 64480591 |
| Nephropathy | 25.73 | 22.25 | 15 | 8191 | 8371 | 64482155 |
| Hypocalcaemia | 25.57 | 22.25 | 29 | 8177 | 41724 | 64448802 |
| Hypertensive crisis | 25.41 | 22.25 | 20 | 8186 | 18228 | 64472298 |
| Arrhythmia | 24.64 | 22.25 | 32 | 8174 | 52912 | 64437614 |
| Toxicity to various agents | 24.30 | 22.25 | 8 | 8198 | 363505 | 64127021 |
| Off label use | 23.11 | 22.25 | 28 | 8178 | 632778 | 63857748 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | H05BX02 | SYSTEMIC HORMONAL PREPARATIONS, EXCL. SEX HORMONES AND INSULINS CALCIUM HOMEOSTASIS ANTI-PARATHYROID AGENTS Other anti-parathyroid agents |
| FDA CS | M0007651 | Ergocalciferols |
| CHEBI has role | CHEBI:50827 | antiparathyroid drugs |
| FDA EPC | N0000175907 | Vitamin D2 Analog |
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Hyperparathyroidism Secondary to Chronic Renal Failure | indication | ||
| Poisoning by digitalis glycoside | contraindication | 12876009 | |
| Hyperphosphatemia | contraindication | 20165001 | DOID:0050459 |
| Hypervitaminosis D | contraindication | 27712000 | DOID:9971 |
| Hypercalcemia | contraindication | 66931009 | DOID:12678 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
None
Orange Book patent data (new drug applications)
None
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 0.002MG/ML (0.002MG/ML) | ZEMPLAR | ABBVIE | N020819 | Feb. 1, 2000 | RX | SOLUTION | INTRAVENOUS | Oct. 18, 2023 | FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S). AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S) |
| 0.005MG/ML (0.005MG/ML) | ZEMPLAR | ABBVIE | N020819 | April 17, 1998 | RX | SOLUTION | INTRAVENOUS | Oct. 18, 2023 | FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S). AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S) |
| 0.01MG/2ML (0.005MG/ML) | ZEMPLAR | ABBVIE | N020819 | Feb. 1, 2000 | RX | SOLUTION | INTRAVENOUS | Oct. 18, 2023 | FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S). AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S) |
| 1MCG | ZEMPLAR | ABBVIE | N021606 | May 26, 2005 | RX | CAPSULE | ORAL | Oct. 18, 2023 | INDICATED IN PEDIATRIC PATIENTS 10 YEARS AND OLDER FOR THE PREVENTION AND TREATMENT OF SECONDARY HYPERPARATHYROIDISM ASSOCIATED WITH CHRONIC KIDNEY DISEASE (CKD) STAGES 3 AND 4 AND CKD STAGE 5 IN PATIENTS ON HEMODIALYSIS OR PERITONEAL DIALYSIS |
| 2MCG | ZEMPLAR | ABBVIE | N021606 | May 26, 2005 | RX | CAPSULE | ORAL | Oct. 18, 2023 | INDICATED IN PEDIATRIC PATIENTS 10 YEARS AND OLDER FOR THE PREVENTION AND TREATMENT OF SECONDARY HYPERPARATHYROIDISM ASSOCIATED WITH CHRONIC KIDNEY DISEASE (CKD) STAGES 3 AND 4 AND CKD STAGE 5 IN PATIENTS ON HEMODIALYSIS OR PERITONEAL DIALYSIS |
| 4MCG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ZEMPLAR | ABBVIE | N021606 | May 26, 2005 | DISCN | CAPSULE | ORAL | Oct. 18, 2023 | INDICATED IN PEDIATRIC PATIENTS 10 YEARS AND OLDER FOR THE PREVENTION AND TREATMENT OF SECONDARY HYPERPARATHYROIDISM ASSOCIATED WITH CHRONIC KIDNEY DISEASE (CKD) STAGES 3 AND 4 AND CKD STAGE 5 IN PATIENTS ON HEMODIALYSIS OR PERITONEAL DIALYSIS |
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Vitamin D3 receptor | Nuclear hormone receptor | AGONIST | EC50 | 8.70 | WOMBAT-PK | CHEMBL |
External reference:
| ID | Source |
|---|---|
| 4021107 | VUID |
| N0000148562 | NUI |
| D00930 | KEGG_DRUG |
| 4021107 | VANDF |
| C0249582 | UMLSCUI |
| CHEBI:7931 | CHEBI |
| CHEMBL1200622 | ChEMBL_ID |
| DB00910 | DRUGBANK_ID |
| C084656 | MESH_SUPPLEMENTAL_RECORD_UI |
| 5281104 | PUBCHEM_CID |
| 2791 | IUPHAR_LIGAND_ID |
| 7688 | INN_ID |
| 6702D36OG5 | UNII |
| 221005 | RXNORM |
| 11702 | MMSL |
| 206206 | MMSL |
| 5234 | MMSL |
| d04312 | MMSL |
| 007498 | NDDF |
| 108946001 | SNOMEDCT_US |
| 126233000 | SNOMEDCT_US |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Zemplar | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0074-1658 | INJECTION, SOLUTION | 5 ug | INTRAVENOUS | NDA | 26 sections |
| Zemplar | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0074-4314 | CAPSULE, LIQUID FILLED | 2 ug | ORAL | NDA | 28 sections |
| Zemplar | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0074-4317 | CAPSULE, LIQUID FILLED | 1 ug | ORAL | NDA | 28 sections |
| Zemplar | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0074-4637 | INJECTION, SOLUTION | 2 ug | INTRAVENOUS | NDA | 26 sections |
| Zemplar | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0074-9036 | CAPSULE, LIQUID FILLED | 1 ug | ORAL | NDA | 28 sections |
| Zemplar | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0074-9037 | CAPSULE, LIQUID FILLED | 2 ug | ORAL | NDA | 28 sections |
| Paricalcitol | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0143-9596 | INJECTION | 5 ug | INTRAVENOUS | NDA | 24 sections |
| Paricalcitol | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0143-9624 | INJECTION | 5 ug | INTRAVENOUS | NDA | 24 sections |
| Paricalcitol | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0143-9625 | INJECTION | 2 ug | INTRAVENOUS | NDA | 24 sections |
| Paricalcitol | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0409-1007 | INJECTION, SOLUTION | 2 ug | INTRAVENOUS | NDA | 29 sections |
| Paricalcitol | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0409-1008 | INJECTION, SOLUTION | 5 ug | INTRAVENOUS | NDA | 29 sections |
| Paricalcitol | HUMAN PRESCRIPTION DRUG LABEL | 1 | 10888-5001 | CAPSULE, LIQUID FILLED | 1 ug | ORAL | ANDA | 26 sections |
| Paricalcitol | HUMAN PRESCRIPTION DRUG LABEL | 1 | 10888-5002 | CAPSULE, LIQUID FILLED | 2 ug | ORAL | ANDA | 26 sections |
| Paricalcitol | HUMAN PRESCRIPTION DRUG LABEL | 1 | 10888-5003 | CAPSULE, LIQUID FILLED | 4 ug | ORAL | ANDA | 26 sections |
| Paricalcitol | HUMAN PRESCRIPTION DRUG LABEL | 1 | 16729-310 | INJECTION, SOLUTION | 2 ug | INTRAVENOUS | NDA | 24 sections |
| Paricalcitol | HUMAN PRESCRIPTION DRUG LABEL | 1 | 16729-311 | INJECTION, SOLUTION | 5 ug | INTRAVENOUS | NDA | 24 sections |
| Paricalcitol | HUMAN PRESCRIPTION DRUG LABEL | 1 | 17478-033 | INJECTION, SOLUTION | 5 ug | INTRAVENOUS | ANDA | 26 sections |
| Paricalcitol | Human Prescription Drug Label | 1 | 25000-012 | CAPSULE, LIQUID FILLED | 1 ug | ORAL | ANDA | 24 sections |
| Paricalcitol | Human Prescription Drug Label | 1 | 25000-014 | CAPSULE, LIQUID FILLED | 2 ug | ORAL | ANDA | 24 sections |
| Paricalcitol | Human Prescription Drug Label | 1 | 25000-017 | CAPSULE, LIQUID FILLED | 4 ug | ORAL | ANDA | 24 sections |
| PARICALCITOL | HUMAN PRESCRIPTION DRUG LABEL | 1 | 40051-612 | CAPSULE | 1 ug | ORAL | ANDA | 18 sections |
| PARICALCITOL | HUMAN PRESCRIPTION DRUG LABEL | 1 | 40051-613 | CAPSULE | 2 ug | ORAL | ANDA | 18 sections |
| PARICALCITOL | HUMAN PRESCRIPTION DRUG LABEL | 1 | 40051-614 | CAPSULE | 4 ug | ORAL | ANDA | 18 sections |
| Paricalcitol | HUMAN PRESCRIPTION DRUG LABEL | 1 | 43598-562 | INJECTION, SOLUTION | 5 ug | INTRAVENOUS | ANDA | 21 sections |
| Paricalcitol | HUMAN PRESCRIPTION DRUG LABEL | 1 | 43598-563 | INJECTION, SOLUTION | 2 ug | INTRAVENOUS | ANDA | 21 sections |
| Paricalcitol | HUMAN PRESCRIPTION DRUG LABEL | 1 | 43598-564 | INJECTION, SOLUTION | 5 ug | INTRAVENOUS | ANDA | 21 sections |
| Paricalcitol | HUMAN PRESCRIPTION DRUG LABEL | 1 | 43598-565 | INJECTION, SOLUTION | 5 ug | INTRAVENOUS | ANDA | 21 sections |
| PARICALCITOL | HUMAN PRESCRIPTION DRUG LABEL | 1 | 47781-476 | CAPSULE | 1 ug | ORAL | ANDA | 17 sections |
| PARICALCITOL | HUMAN PRESCRIPTION DRUG LABEL | 1 | 47781-477 | CAPSULE | 2 ug | ORAL | ANDA | 17 sections |
| PARICALCITOL | HUMAN PRESCRIPTION DRUG LABEL | 1 | 47781-478 | CAPSULE | 4 ug | ORAL | ANDA | 17 sections |