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desipramine ๐ถ Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| substances of the imipramine group | 812 | 50-47-5 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
A tricyclic dibenzazepine compound that potentiates neurotransmission. Desipramine selectively blocks reuptake of norepinephrine from the neural synapse, and also appears to impair serotonin transport. This compound also possesses minor anticholinergic activity, through its affinity to muscarinic receptors.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
| Dose | Unit | Route |
|---|---|---|
| 0.10 | g | O |
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| BDDCS (Biopharmaceutical Drug Disposition Classification System) | 1 | Benet LZ, Broccatelli F, Oprea TI |
| EoM (Fraction excreted unchanged in urine) | 2 % | Benet LZ, Broccatelli F, Oprea TI |
| MRTD (Maximum Recommended Therapeutic Daily Dose) | 16.09 ยตM/kg/day | Contrera JF, Matthews EJ, Kruhlak NL, Benz RD |
| BA (Bioavailability) | 70 % | Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H |
| Vd (Volume of distribution) | 15 L/kg | Lombardo F, Berellini G, Obach RS |
| CL (Clearance) | 11 mL/min/kg | Lombardo F, Berellini G, Obach RS |
| fu (Fraction unbound in plasma) | 0.16 % | Lombardo F, Berellini G, Obach RS |
| t_half (Half-life) | 22 hours | Lombardo F, Berellini G, Obach RS |
| S (Water solubility) | 30.28 mg/mL | Bocci G, Oprea TI, Benet LZ |
Predicted pharmacokinetic/toxicological properties (PK-AZ):
| Property | Description | Value | Unit | Confidence | Similarity |
|---|---|---|---|---|---|
| azlogd74 | LogD at pH 7.4 | 1.268 | High | 1 | |
| caco2-efflux | Caco-2 efflux ratio (BA/AB) | 0.776 | High | 1 | |
| caco2-intrinsic-papp | Caco-2 intrinsic apparent permeability | 29.992 | 10^-6 cm/s | High | 1 |
| dh-clint | Dog hepatocyte intrinsic clearance | 40.738 | uL/min/10^6 cells | High | 1 |
| dppb | Dog plasma protein binding (% unbound) | 4.600 | % | High | 1 |
| fcs-ppb | Fetal calf serum protein binding (% unbound) | 18.460 | % | High | 1 |
| herg | hERG pIC50 | 5.391 | pIC50 | High | 1 |
| hh-clint | Human hepatocyte intrinsic clearance | 7.015 | uL/min/10^6 cells | High | 1 |
| hlm-clint | Human liver microsomal intrinsic clearance | 9.886 | uL/min/mg protein | High | 1 |
| hppb | Human plasma protein binding (% unbound) | 14.780 | % | High | 1 |
| kinase-safety-class | ACVR2A,ACVR2B,AKT1,AKT2,AKT3,AURKA,AXL,BRAF,BTK,CAMK2B,CAMK2D,CDK4,CDK5,CDK9,CHEK1,DDR1,DYRK1B,EIF2AK3,EPHB4,ERBB2,FLT3,GRK2,ITK,JAK2,JAK3,MAP2K6,MAP3K21,MAP3K7,MAPK10,MAPK12,MAPK7,MAPKAPK2,MET,MTOR,NTRK2,PDK2,PDK4,PDPK1,PIK3CB,PIM2,PRKCD,PRKDC,SIK2,SIK3,STK33,SYK,TEK,TGFBR1,TTK | 49 | |||
| kinase-selectivity-class | AXL,PDK4,STK33 | 3 | |||
| mdck-mdr1-bcrp-efflux | MDCK-MDR1-BCRP efflux ratio | 1.042 | High | 1 | |
| mdck-mdr1-efflux | MDCK-MDR1 efflux ratio | 1.002 | High | 1 | |
| mh-clint | Mouse hepatocyte intrinsic clearance | 118.577 | High | 1 | |
| mppb | Mouse plasma protein binding (% unbound) | 6.140 | High | 1 | |
| nih-mdck-mdr1-efflux | NIH MDCK-MDR1 efflux ratio | 5.200 | High | 1 | |
| pfas-class | PFAS structural alert (1 = True, 0 = False) | 0 | |||
| pld-class | Phospholipidosis risk class (1 = positive, 0 = negative) | 1 | High | 1 | |
| pppb | Pig plasma protein binding (% unbound) | 17.780 | % | High | 1 |
| rat-kpuu-brain | Rat brain Kpuu | 0.153 | % | High | 1 |
| rh-clint | Rat hepatocyte intrinsic clearance | 287.078 | uL/min/10^6 cells | High | 1 |
| rh-fuinc | Rat hepatocyte fraction unbound in incubation | 34.730 | % | High | 1 |
| rppb | Rat plasma protein binding (% unbound) | 14.290 | % | High | 1 |
| solubility-dd | Solubility at pH 7.4 in DMSO | 893.305 | uM | High | 1 |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Nov. 20, 1964 | FDA | SANOFI AVENTIS US |
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 |
|---|---|---|---|---|---|---|
| Completed suicide | 188.43 | 33.11 | 76 | 1472 | 144982 | 90481917 |
| Hyperkeratosis | 114.54 | 33.11 | 26 | 1522 | 6902 | 90619997 |
| Immune thrombocytopenia | 107.22 | 33.11 | 28 | 1520 | 13298 | 90613601 |
| Cardiac murmur | 89.62 | 33.11 | 26 | 1522 | 18168 | 90608731 |
| Antidepressant drug level above therapeutic | 75.27 | 33.11 | 12 | 1536 | 478 | 90626421 |
| Angina pectoris | 70.04 | 33.11 | 26 | 1522 | 39134 | 90587765 |
| Dyspnoea exertional | 64.02 | 33.11 | 29 | 1519 | 72259 | 90554640 |
| Toxicity to various agents | 60.07 | 33.11 | 45 | 1503 | 287801 | 90339098 |
| Intestinal obstruction | 49.78 | 33.11 | 20 | 1528 | 37111 | 90589788 |
| Urinary retention | 46.04 | 33.11 | 19 | 1529 | 37725 | 90589174 |
| Ileus | 44.93 | 33.11 | 15 | 1533 | 16531 | 90610368 |
| Therapy non-responder | 44.11 | 33.11 | 28 | 1520 | 136676 | 90490223 |
| Autoimmune hepatitis | 34.65 | 33.11 | 11 | 1537 | 10340 | 90616559 |
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 |
|---|---|---|---|---|---|---|
| Completed suicide | 74.23 | 30.59 | 33 | 572 | 96432 | 42524298 |
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 |
|---|---|---|---|---|---|---|
| Completed suicide | 250.02 | 28.82 | 111 | 1982 | 242270 | 110344936 |
| Immune thrombocytopenia | 89.82 | 28.82 | 28 | 2065 | 22466 | 110564740 |
| Hyperkeratosis | 75.06 | 28.82 | 20 | 2073 | 9219 | 110577987 |
| Toxicity to various agents | 70.70 | 28.82 | 64 | 2029 | 480491 | 110106715 |
| Antidepressant drug level above therapeutic | 68.82 | 28.82 | 12 | 2081 | 745 | 110586461 |
| Cardiac murmur | 55.74 | 28.82 | 20 | 2073 | 24608 | 110562598 |
| Intestinal obstruction | 43.88 | 28.82 | 21 | 2072 | 53206 | 110534000 |
| Therapy non-responder | 42.46 | 28.82 | 30 | 2063 | 157277 | 110429929 |
| Angina pectoris | 40.75 | 28.82 | 21 | 2072 | 62274 | 110524932 |
| Dyspnoea exertional | 40.63 | 28.82 | 25 | 2068 | 104035 | 110483171 |
| Ileus | 34.38 | 28.82 | 15 | 2078 | 30714 | 110556492 |
| Urinary retention | 33.08 | 28.82 | 19 | 2074 | 69664 | 110517542 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | N06AA01 | NERVOUS SYSTEM PSYCHOANALEPTICS ANTIDEPRESSANTS Non-selective monoamine reuptake inhibitors |
| MeSH PA | D000928 | Antidepressive Agents |
| MeSH PA | D000929 | Antidepressive Agents, Tricyclic |
| MeSH PA | D004791 | Enzyme Inhibitors |
| MeSH PA | D011619 | Psychotropic Drugs |
| MeSH PA | D014179 | Neurotransmitter Uptake Inhibitors |
| MeSH PA | D018377 | Neurotransmitter Agents |
| MeSH PA | D018663 | Adrenergic Agents |
| MeSH PA | D018759 | Adrenergic Uptake Inhibitors |
| MeSH PA | D049990 | Membrane Transport Modulators |
| CHEBI has role | CHEBI:88188 | drug allergen |
| FDA EPC | N0000175752 | Tricyclic Antidepressant |
| CHEBI has role | CHEBI:35469 | antidepressant |
| CHEBI has role | CHEBI:35480 | analgesic |
| CHEBI has role | CHEBI:35610 | antineoplastic agent |
| CHEBI has role | CHEBI:35620 | vasodilator agent |
| CHEBI has role | CHEBI:35640 | adrenergic uptake inhibitor |
| CHEBI has role | CHEBI:37890 | ฮฑ-adrenergic antagonist |
| CHEBI has role | CHEBI:37955 | H<small><sub>1</sub></small>-receptor antagonist |
| CHEBI has role | CHEBI:48873 | cholinergic antagonist |
| CHEBI has role | CHEBI:50949 | serotonin uptake inhibitor |
| CHEBI has role | CHEBI:76779 | EC 3.4.21.26 (prolyl oligopeptidase) inhibitor |
| CHEBI has role | CHEBI:76811 | EC 3.1.4.12 (sphingomyelin phosphodiesterase) inhibitor |
Related Drugs by ATC class:
N06AA Non-selective monoamine reuptake inhibitors 20 drugs
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Depressive disorder | indication | 35489007 | |
| Cataplexy | off-label use | 46263000 | |
| Anxiety | off-label use | 48694002 | |
| Bulimia nervosa | off-label use | 78004001 | |
| Neuropathic pain | off-label use | 247398009 | |
| Chronic idiopathic urticaria | off-label use | 302162004 | |
| Panic disorder | off-label use | 371631005 | DOID:594 |
| Attention deficit hyperactivity disorder | off-label use | 406506008 | |
| Depressive Disorder following Traumatic Brain Injury | off-label use | ||
| Suicidal thoughts | contraindication | 6471006 | |
| Alcoholism | contraindication | 7200002 | |
| Bipolar disorder | contraindication | 13746004 | DOID:3312 |
| Lowered convulsive threshold | contraindication | 19260006 | |
| Glaucoma | contraindication | 23986001 | DOID:1686 |
| Torsades de pointes | contraindication | 31722008 | |
| Hyperthyroidism | contraindication | 34486009 | DOID:7998 |
| Conduction disorder of the heart | contraindication | 44808001 | |
| Schizophrenia | contraindication | 58214004 | DOID:5419 |
| Epilepsy | contraindication | 84757009 | DOID:1826 |
| Kidney disease | contraindication | 90708001 | DOID:557 |
| Prolonged QT interval | contraindication | 111975006 | |
| Seizure disorder | contraindication | 128613002 | |
| Cerebrovascular accident | contraindication | 230690007 | |
| Disease of liver | contraindication | 235856003 | DOID:409 |
| Benign prostatic hyperplasia | contraindication | 266569009 | |
| Retention of urine | contraindication | 267064002 | |
| Angle-closure glaucoma | contraindication | 392291006 | DOID:13550 |
| Myocardial infarction in recovery phase | contraindication | 418044006 | |
| Congenital long QT syndrome | contraindication | 442917000 |
๐ถ Veterinary Drug Use
None
๐ถ Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 9.83 | Basic |
| pKa2 | 5.01 | Basic |
Orange Book patent data (new drug applications)
None
Orange Book exclusivity data (new drug applications)
None
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Sodium-dependent noradrenaline transporter | Transporter | INHIBITOR | Kd | 9.08 | WOMBAT-PK | CHEMBL | |||
| D(2) dopamine receptor | GPCR | Ki | 5.63 | PDSP | |||||
| Alpha-2A adrenergic receptor | GPCR | Ki | 5.86 | PDSP | |||||
| Potassium voltage-gated channel subfamily H member 2 | Ion channel | Ki | 5.86 | WOMBAT-PK | |||||
| Sodium-dependent serotonin transporter | Transporter | Kd | 7.76 | WOMBAT-PK | |||||
| 5-hydroxytryptamine receptor 1A | GPCR | Ki | 5.19 | PDSP | |||||
| 5-hydroxytryptamine receptor 2A | GPCR | Ki | 6.80 | WOMBAT-PK | |||||
| 5-hydroxytryptamine receptor 2B | GPCR | EC50 | 6.50 | WOMBAT-PK | |||||
| 5-hydroxytryptamine receptor 2C | GPCR | EC50 | 6.50 | WOMBAT-PK | |||||
| Alpha-1A adrenergic receptor | GPCR | Ki | 7 | WOMBAT-PK | |||||
| Alpha-2B adrenergic receptor | GPCR | WOMBAT-PK | |||||||
| Histamine H1 receptor | GPCR | Ki | 7.12 | WOMBAT-PK | |||||
| Muscarinic acetylcholine receptor M1 | GPCR | Ki | 6.76 | WOMBAT-PK | |||||
| Muscarinic acetylcholine receptor M2 | GPCR | Ki | 6.27 | WOMBAT-PK | |||||
| Muscarinic acetylcholine receptor M3 | GPCR | Ki | 6.68 | WOMBAT-PK | |||||
| Muscarinic acetylcholine receptor M4 | GPCR | Ki | 6.80 | WOMBAT-PK | |||||
| Muscarinic acetylcholine receptor M5 | GPCR | Ki | 6.84 | WOMBAT-PK | |||||
| 5-hydroxytryptamine receptor 1B | GPCR | Ki | 6.98 | PDSP | |||||
| Sodium-dependent dopamine transporter | Transporter | Ki | 9.31 | CHEMBL | |||||
| Voltage-dependent calcium channel gamma-1 subunit | Ion channel | WOMBAT-PK | |||||||
| Voltage-dependent N-type calcium channel subunit alpha-1B | Ion channel | IC50 | 4.96 | CHEMBL | |||||
| Solute carrier family 22 member 1 | Transporter | IC50 | 4.25 | CHEMBL | |||||
| Sodium channel alpha subunits; brain (Types I, II, III) | Ion channel | IC50 | 5.62 | CHEMBL | |||||
| Equilibrative nucleoside transporter 4 | Transporter | INHIBITOR | Ki | 4.49 | IUPHAR | ||||
| D(1A) dopamine receptor | GPCR | Ki | 5.26 | PDSP | |||||
| Alpha-1A adrenergic receptor | GPCR | IC50 | 9.60 | CHEMBL | |||||
| Sodium-dependent serotonin transporter | Transporter | Ki | 6.79 | CHEMBL | |||||
| Sodium-dependent dopamine transporter | Transporter | Ki | 5.19 | CHEMBL | |||||
| Transporter | Transporter | Ki | 9.19 | CHEMBL | |||||
| Sodium-dependent noradrenaline transporter | Transporter | IC50 | 5.80 | CHEMBL | |||||
| Sodium-dependent serotonin transporter | Transporter | IC50 | 5.03 | CHEMBL | |||||
| Histamine H1 receptor | GPCR | IC50 | 9.10 | CHEMBL | |||||
| Transporter | Transporter | Ki | 9.11 | CHEMBL | |||||
| Serotonin (5-HT) receptor | GPCR | IC50 | 6.46 | CHEMBL | |||||
| G protein-activated inward rectifier potassium channel 4 | Ion channel | BLOCKER | IC50 | 4.30 | IUPHAR | ||||
| G protein-activated inward rectifier potassium channel 2 | Ion channel | BLOCKER | IC50 | 4.40 | IUPHAR |
External reference:
| ID | Source |
|---|---|
| 4019708 | VUID |
| N0000147800 | NUI |
| D00812 | KEGG_DRUG |
| 58-28-6 | SECONDARY_CAS_RN |
| 203174 | RXNORM |
| 4018608 | VANDF |
| 4019708 | VANDF |
| C0011685 | UMLSCUI |
| CHEBI:47781 | CHEBI |
| DSM | PDB_CHEM_ID |
| CHEMBL72 | ChEMBL_ID |
| DB01151 | DRUGBANK_ID |
| CHEMBL1696 | ChEMBL_ID |
| D003891 | MESH_DESCRIPTOR_UI |
| 2995 | PUBCHEM_CID |
| 2399 | IUPHAR_LIGAND_ID |
| 1500 | INN_ID |
| TG537D343B | UNII |
| 1064 | MMSL |
| 4547 | MMSL |
| d00145 | MMSL |
| 001503 | NDDF |
| 004602 | NDDF |
| 26120001 | SNOMEDCT_US |
| 33378002 | SNOMEDCT_US |
| 372705002 | SNOMEDCT_US |
| TG537D343B | INXIGHT DRUGS |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| DESIPRAMINE HYDROCHLORIDE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 16590-586 | TABLET, FILM COATED | 100 mg | ORAL | ANDA | 20 sections |
| DESIPRAMINE HYDROCHLORIDE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 16590-830 | TABLET, FILM COATED | 10 mg | ORAL | ANDA | 20 sections |
| Desipramine Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 21695-428 | TABLET, FILM COATED | 25 mg | ORAL | ANDA | 20 sections |
| Desipramine Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 21695-845 | TABLET | 10 mg | ORAL | ANDA | 15 sections |
| DESIPRAMINE HYDROCHLORIDE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 23155-578 | TABLET | 10 mg | ORAL | ANDA | 13 sections |
| DESIPRAMINE HYDROCHLORIDE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 23155-579 | TABLET | 25 mg | ORAL | ANDA | 13 sections |
| DESIPRAMINE HYDROCHLORIDE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 23155-580 | TABLET | 50 mg | ORAL | ANDA | 13 sections |
| DESIPRAMINE HYDROCHLORIDE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 23155-581 | TABLET | 75 mg | ORAL | ANDA | 13 sections |
| DESIPRAMINE HYDROCHLORIDE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 23155-582 | TABLET | 100 mg | ORAL | ANDA | 13 sections |
| DESIPRAMINE HYDROCHLORIDE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 23155-583 | TABLET | 150 mg | ORAL | ANDA | 13 sections |
| Norpramin | HUMAN PRESCRIPTION DRUG LABEL | 1 | 30698-007 | TABLET, SUGAR COATED | 10 mg | ORAL | NDA | 21 sections |
| Norpramin | HUMAN PRESCRIPTION DRUG LABEL | 1 | 30698-011 | TABLET, SUGAR COATED | 25 mg | ORAL | NDA | 21 sections |
| Norpramin | HUMAN PRESCRIPTION DRUG LABEL | 1 | 30698-015 | TABLET, SUGAR COATED | 50 mg | ORAL | NDA | 21 sections |
| Norpramin | HUMAN PRESCRIPTION DRUG LABEL | 1 | 30698-019 | TABLET, SUGAR COATED | 75 mg | ORAL | NDA | 21 sections |
| Norpramin | HUMAN PRESCRIPTION DRUG LABEL | 1 | 30698-020 | TABLET, SUGAR COATED | 100 mg | ORAL | NDA | 21 sections |
| Norpramin | HUMAN PRESCRIPTION DRUG LABEL | 1 | 30698-021 | TABLET, SUGAR COATED | 150 mg | ORAL | NDA | 21 sections |
| Desipramine Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 45963-341 | TABLET, FILM COATED | 10 mg | ORAL | ANDA | 16 sections |
| Desipramine Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 45963-342 | TABLET, FILM COATED | 25 mg | ORAL | ANDA | 16 sections |
| Desipramine Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 45963-343 | TABLET, FILM COATED | 50 mg | ORAL | ANDA | 16 sections |
| Desipramine Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 45963-344 | TABLET, FILM COATED | 75 mg | ORAL | ANDA | 16 sections |
| Desipramine Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 45963-345 | TABLET, FILM COATED | 100 mg | ORAL | ANDA | 16 sections |
| Desipramine Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 45963-346 | TABLET, FILM COATED | 150 mg | ORAL | ANDA | 16 sections |
| DESIPRAMINE HYDROCHLORIDE | Human Prescription Drug Label | 1 | 46708-315 | TABLET, FILM COATED | 10 mg | ORAL | ANDA | 16 sections |
| DESIPRAMINE HYDROCHLORIDE | Human Prescription Drug Label | 1 | 46708-316 | TABLET, FILM COATED | 25 mg | ORAL | ANDA | 16 sections |
| DESIPRAMINE HYDROCHLORIDE | Human Prescription Drug Label | 1 | 46708-317 | TABLET, FILM COATED | 50 mg | ORAL | ANDA | 16 sections |
| DESIPRAMINE HYDROCHLORIDE | Human Prescription Drug Label | 1 | 46708-318 | TABLET, FILM COATED | 75 mg | ORAL | ANDA | 16 sections |
| DESIPRAMINE HYDROCHLORIDE | Human Prescription Drug Label | 1 | 46708-319 | TABLET, FILM COATED | 100 mg | ORAL | ANDA | 16 sections |
| DESIPRAMINE HYDROCHLORIDE | Human Prescription Drug Label | 1 | 46708-320 | TABLET, FILM COATED | 150 mg | ORAL | ANDA | 16 sections |
| DESIPRAMINE HYDROCHLORIDE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 50742-112 | TABLET | 10 mg | ORAL | ANDA | 23 sections |
| DESIPRAMINE HYDROCHLORIDE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 50742-112 | TABLET | 10 mg | ORAL | ANDA | 23 sections |