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levocarnitine 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| 513 | 541-15-1 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
A constituent of STRIATED MUSCLE and LIVER. It is an amino acid derivative and an essential cofactor for fatty acid metabolism.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
| Dose | Unit | Route |
|---|---|---|
| 2 | g | O |
| 2 | g | P |
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| MRTD (Maximum Recommended Therapeutic Daily Dose) | 305.16 µM/kg/day | Contrera JF, Matthews EJ, Kruhlak NL, Benz RD |
| BA (Bioavailability) | 15 % | Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H |
| Vd (Volume of distribution) | 0.40 L/kg | Lombardo F, Berellini G, Obach RS |
| CL (Clearance) | 1.60 mL/min/kg | Lombardo F, Berellini G, Obach RS |
| fu (Fraction unbound in plasma) | 1 % | Lombardo F, Berellini G, Obach RS |
| t_half (Half-life) | 5 hours | Lombardo F, Berellini G, Obach RS |
| S (Water solubility) | 32 mg/mL | Bocci G, Oprea TI, Benet LZ |
| BDDCS (Biopharmaceutical Drug Disposition Classification System) | 1 | Bocci G, Oprea TI, Benet LZ |
Predicted pharmacokinetic/toxicological properties (PK-AZ):
| Property | Description | Value | Unit | Confidence | Similarity |
|---|---|---|---|---|---|
| azlogd74 | LogD at pH 7.4 | -4.389 | High | 1 | |
| caco2-efflux | Caco-2 efflux ratio (BA/AB) | 0.152 | High | 1 | |
| caco2-intrinsic-papp | Caco-2 intrinsic apparent permeability | 0.593 | 10^-6 cm/s | High | 1 |
| dh-clint | Dog hepatocyte intrinsic clearance | 1.175 | uL/min/10^6 cells | High | 1 |
| dppb | Dog plasma protein binding (% unbound) | 93.990 | % | High | 1 |
| fcs-ppb | Fetal calf serum protein binding (% unbound) | 64.480 | % | High | 1 |
| herg | hERG pIC50 | 4.509 | pIC50 | High | 1 |
| hh-clint | Human hepatocyte intrinsic clearance | 1.459 | uL/min/10^6 cells | High | 1 |
| hlm-clint | Human liver microsomal intrinsic clearance | 3.908 | uL/min/mg protein | High | 1 |
| hppb | Human plasma protein binding (% unbound) | 93.080 | % | High | 1 |
| kinase-safety-class | ACVR2A,ACVR2B,ACVRL1,AKT2,AKT3,ALK,AURKA,AXL,BRAF,BTK,CAMK2B,CAMK2D,CDK4,CDK5,CDK9,DDR1,DYRK1B,EGFR,EIF2AK3,EPHB4,ERBB2,FLT3,GRK2,GSK3B,ITK,JAK1,JAK2,JAK3,MAP2K6,MAP3K21,MAP3K7,MAPK10,MAPK7,MAPK9,MAPKAPK2,MET,MTOR,NTRK2,PDK1,PDK2,PDK4,PDPK1,PIK3CB,PIK3CD,PIK3CG,PIM2,PLK1,PRKCD,PRKDC,SIK2,SIK3,STK33,SYK,TEK,TGFBR1,TTK,ULK1,ZAP70 | 58 | |||
| kinase-selectivity-class | AXL,BRAF,CAMK2D,CDK4,GRK2,MAPK7 | 6 | |||
| mdck-mdr1-efflux | MDCK-MDR1 efflux ratio | 0.198 | High | 1 | |
| mh-clint | Mouse hepatocyte intrinsic clearance | 0.521 | High | 1 | |
| mppb | Mouse plasma protein binding (% unbound) | 98.140 | High | 1 | |
| nih-mdck-mdr1-efflux | NIH MDCK-MDR1 efflux ratio | 0.716 | High | 1 | |
| pfas-class | PFAS structural alert (1 = True, 0 = False) | 0 | |||
| pppb | Pig plasma protein binding (% unbound) | 97.350 | % | High | 1 |
| rh-clint | Rat hepatocyte intrinsic clearance | 2.421 | uL/min/10^6 cells | High | 1 |
| rh-fuinc | Rat hepatocyte fraction unbound in incubation | 90.600 | % | High | 1 |
| rppb | Rat plasma protein binding (% unbound) | 97.640 | % | High | 1 |
| solubility-dd | Solubility at pH 7.4 in DMSO | 1018.591 | uM | High | 1 |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Dec. 27, 1985 | FDA | SIGMA TAU |
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 |
|---|---|---|---|---|---|---|
| Seizure | 119.37 | 18.13 | 80 | 4259 | 152549 | 90471559 |
| Fanconi syndrome | 87.55 | 18.13 | 20 | 4319 | 1923 | 90622185 |
| Status epilepticus | 69.13 | 18.13 | 28 | 4311 | 18846 | 90605262 |
| Hyperammonaemia | 63.69 | 18.13 | 20 | 4319 | 6455 | 90617653 |
| Hypophosphataemic osteomalacia | 57.26 | 18.13 | 10 | 4329 | 241 | 90623867 |
| Nephrocalcinosis | 51.86 | 18.13 | 12 | 4327 | 1220 | 90622888 |
| Mitochondrial cytopathy | 44.06 | 18.13 | 8 | 4331 | 242 | 90623866 |
| Insulin-like growth factor increased | 38.42 | 18.13 | 9 | 4330 | 965 | 90623143 |
| Ventricular hypokinesia | 38.35 | 18.13 | 13 | 4326 | 5328 | 90618780 |
| Congestive cardiomyopathy | 37.94 | 18.13 | 14 | 4325 | 7340 | 90616768 |
| Cardiac failure chronic | 37.64 | 18.13 | 13 | 4326 | 5633 | 90618475 |
| Sudden infant death syndrome | 35.59 | 18.13 | 7 | 4332 | 327 | 90623781 |
| Urine calcium/creatinine ratio increased | 35.57 | 18.13 | 6 | 4333 | 117 | 90623991 |
| Epilepsy | 34.95 | 18.13 | 30 | 4309 | 82176 | 90541932 |
| Orthopnoea | 31.57 | 18.13 | 12 | 4327 | 6823 | 90617285 |
| Ammonia increased | 27.60 | 18.13 | 10 | 4329 | 4976 | 90619132 |
| Product preparation issue | 26.25 | 18.13 | 8 | 4331 | 2338 | 90621770 |
| Upper respiratory tract inflammation | 25.22 | 18.13 | 8 | 4331 | 2664 | 90621444 |
| Tachypnoea | 23.71 | 18.13 | 14 | 4325 | 21295 | 90602813 |
| Metabolic disorder | 23.68 | 18.13 | 10 | 4329 | 7460 | 90616648 |
| Hypophosphataemia | 22.64 | 18.13 | 12 | 4327 | 14842 | 90609266 |
| Pharyngeal abscess | 22.60 | 18.13 | 5 | 4334 | 415 | 90623693 |
| Pulmonary congestion | 22.23 | 18.13 | 13 | 4326 | 19420 | 90604688 |
| Femur fracture | 22.02 | 18.13 | 18 | 4321 | 46064 | 90578044 |
| Spinal pain | 21.96 | 18.13 | 12 | 4327 | 15755 | 90608353 |
| Device related infection | 21.25 | 18.13 | 14 | 4325 | 25772 | 90598336 |
| Starvation | 20.98 | 18.13 | 5 | 4334 | 577 | 90623531 |
| Glycosuria | 20.86 | 18.13 | 6 | 4333 | 1436 | 90622672 |
| Rhabdomyolysis | 20.35 | 18.13 | 18 | 4321 | 51238 | 90572870 |
| Myoclonic epilepsy | 20.15 | 18.13 | 6 | 4333 | 1621 | 90622487 |
| Multiple organ dysfunction syndrome | 19.51 | 18.13 | 20 | 4319 | 68316 | 90555792 |
| Infantile spasms | 19.26 | 18.13 | 4 | 4335 | 246 | 90623862 |
| Metabolic acidosis | 19.07 | 18.13 | 18 | 4321 | 55658 | 90568450 |
| Off label use | 18.95 | 18.13 | 103 | 4236 | 1102149 | 89521959 |
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 |
|---|---|---|---|---|---|---|
| Seizure | 104.21 | 18.23 | 91 | 4253 | 120470 | 42496521 |
| Hyperammonaemia | 65.33 | 18.23 | 26 | 4318 | 7840 | 42609151 |
| Dyschromatopsia | 41.93 | 18.23 | 10 | 4334 | 539 | 42616452 |
| Status epilepticus | 34.86 | 18.23 | 21 | 4323 | 15557 | 42601434 |
| Ammonia increased | 27.25 | 18.23 | 12 | 4332 | 4647 | 42612344 |
| Keratouveitis | 23.87 | 18.23 | 4 | 4340 | 33 | 42616958 |
| Retinogram abnormal | 23.71 | 18.23 | 5 | 4339 | 153 | 42616838 |
| Product preparation issue | 22.22 | 18.23 | 7 | 4337 | 1068 | 42615923 |
| Upper respiratory tract inflammation | 21.99 | 18.23 | 8 | 4336 | 1888 | 42615103 |
| Multiple epiphyseal dysplasia | 21.28 | 18.23 | 3 | 4341 | 6 | 42616985 |
| Epilepsy | 21.00 | 18.23 | 19 | 4325 | 26152 | 42590839 |
| Pyrexia | 20.67 | 18.23 | 87 | 4257 | 393955 | 42223036 |
| Rhinovirus infection | 20.51 | 18.23 | 11 | 4333 | 6537 | 42610454 |
| Basal ganglia stroke | 19.94 | 18.23 | 4 | 4340 | 95 | 42616896 |
| Metabolic encephalopathy | 19.80 | 18.23 | 10 | 4334 | 5255 | 42611736 |
| Metabolic acidosis | 19.18 | 18.23 | 25 | 4319 | 51833 | 42565158 |
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 |
|---|---|---|---|---|---|---|
| Seizure | 172.64 | 16.30 | 137 | 7960 | 221048 | 110360154 |
| Hyperammonaemia | 119.61 | 16.30 | 43 | 8054 | 13689 | 110567513 |
| Status epilepticus | 91.02 | 16.30 | 45 | 8052 | 31526 | 110549676 |
| Fanconi syndrome | 80.60 | 16.30 | 23 | 8074 | 3496 | 110577706 |
| Ammonia increased | 54.15 | 16.30 | 21 | 8076 | 8229 | 110572973 |
| Epilepsy | 53.40 | 16.30 | 50 | 8047 | 100159 | 110481043 |
| Hypophosphataemic osteomalacia | 47.49 | 16.30 | 10 | 8087 | 427 | 110580775 |
| Upper respiratory tract inflammation | 46.93 | 16.30 | 16 | 8081 | 4355 | 110576847 |
| Nephrocalcinosis | 42.19 | 16.30 | 12 | 8085 | 1802 | 110579400 |
| Product preparation issue | 41.26 | 16.30 | 13 | 8084 | 2766 | 110578436 |
| Mitochondrial cytopathy | 37.01 | 16.30 | 8 | 8089 | 387 | 110580815 |
| Dyschromatopsia | 36.69 | 16.30 | 10 | 8087 | 1284 | 110579918 |
| Seizure cluster | 36.01 | 16.30 | 9 | 8088 | 824 | 110580378 |
| Urine calcium/creatinine ratio increased | 31.64 | 16.30 | 6 | 8091 | 149 | 110581053 |
| Retinogram abnormal | 31.62 | 16.30 | 7 | 8090 | 379 | 110580823 |
| Prescribed underdose | 29.97 | 16.30 | 30 | 8067 | 65144 | 110516058 |
| Metabolic acidosis | 28.78 | 16.30 | 36 | 8061 | 99708 | 110481494 |
| Congestive cardiomyopathy | 28.77 | 16.30 | 16 | 8081 | 14203 | 110566999 |
| Tachypnoea | 27.66 | 16.30 | 23 | 8074 | 39372 | 110541830 |
| Device related infection | 27.60 | 16.30 | 23 | 8074 | 39496 | 110541706 |
| Hepatic failure | 26.86 | 16.30 | 29 | 8068 | 68710 | 110512492 |
| Somnolence | 25.80 | 16.30 | 63 | 8034 | 297386 | 110283816 |
| Keratouveitis | 25.09 | 16.30 | 4 | 8093 | 34 | 110581168 |
| Generalised tonic-clonic seizure | 24.82 | 16.30 | 25 | 8072 | 54655 | 110526547 |
| Cardiac failure chronic | 23.81 | 16.30 | 14 | 8083 | 13797 | 110567405 |
| Multiple epiphyseal dysplasia | 23.49 | 16.30 | 3 | 8094 | 3 | 110581199 |
| Rhinovirus infection | 23.13 | 16.30 | 13 | 8084 | 11776 | 110569426 |
| Insulin-like growth factor increased | 23.07 | 16.30 | 8 | 8089 | 2288 | 110578914 |
| Carnitine deficiency | 22.06 | 16.30 | 5 | 8092 | 301 | 110580901 |
| Myoclonic epilepsy | 21.83 | 16.30 | 8 | 8089 | 2683 | 110578519 |
| Zinc deficiency | 21.27 | 16.30 | 5 | 8092 | 354 | 110580848 |
| Orthopnoea | 21.21 | 16.30 | 12 | 8085 | 11009 | 110570193 |
| Ventricular hypokinesia | 21.01 | 16.30 | 12 | 8085 | 11202 | 110570000 |
| Hepatic encephalopathy | 20.89 | 16.30 | 17 | 8080 | 28239 | 110552963 |
| Enterocolitis | 19.76 | 16.30 | 14 | 8083 | 18935 | 110562267 |
| Femur fracture | 19.58 | 16.30 | 20 | 8077 | 44449 | 110536753 |
| Metabolic encephalopathy | 18.51 | 16.30 | 11 | 8086 | 11049 | 110570153 |
| Glycosuria | 18.35 | 16.30 | 7 | 8090 | 2623 | 110578579 |
| Pneumonia aspiration | 18.33 | 16.30 | 26 | 8071 | 81207 | 110499995 |
| Epileptic encephalopathy | 18.06 | 16.30 | 5 | 8092 | 680 | 110580522 |
| Ureaplasma infection | 17.94 | 16.30 | 6 | 8091 | 1540 | 110579662 |
| Basal ganglia stroke | 17.76 | 16.30 | 4 | 8093 | 234 | 110580968 |
| Pneumonia | 17.60 | 16.30 | 117 | 7980 | 876597 | 109704605 |
| Pharyngeal abscess | 16.86 | 16.30 | 5 | 8092 | 868 | 110580334 |
| Blood citric acid increased | 16.69 | 16.30 | 3 | 8094 | 55 | 110581147 |
| Blood bilirubin increased | 16.67 | 16.30 | 24 | 8073 | 75948 | 110505254 |
| Metabolic disorder | 16.42 | 16.30 | 10 | 8087 | 10500 | 110570702 |
| Pain | 16.40 | 16.30 | 28 | 8069 | 954927 | 109626275 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | A16AA01 | ALIMENTARY TRACT AND METABOLISM OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS Amino acids and derivatives |
| FDA CS | M0003493 | Carnitine |
| FDA EPC | N0000175903 | Carnitine Analog |
| CHEBI has role | CHEBI:22587 | antiviral agent |
| CHEBI has role | CHEBI:27314 | water-soluble vitamin (role) |
| CHEBI has role | CHEBI:33282 | antibacterial agent |
| CHEBI has role | CHEBI:35526 | hypoglycemic agent |
| CHEBI has role | CHEBI:35554 | cardiovascular drug |
| CHEBI has role | CHEBI:35610 | antineoplastic agent |
| CHEBI has role | CHEBI:35679 | antilipemic drug |
| CHEBI has role | CHEBI:35705 | immunosuppressive agent |
| CHEBI has role | CHEBI:35842 | antirheumatic drug |
| CHEBI has role | CHEBI:38070 | anti-arrhythmia drug |
| CHEBI has role | CHEBI:50247 | antidote |
| CHEBI has role | CHEBI:50733 | nutraceutical |
| CHEBI has role | CHEBI:64946 | anti-HIV agent |
| CHEBI has role | CHEBI:65023 | anti-asthmatic agent |
| CHEBI has role | CHEBI:66980 | nootropic agent |
| CHEBI has role | CHEBI:75772 | <em>Saccharomyces cerevisiae </em> metabolite |
| CHEBI has role | CHEBI:231911 | renoprotective agent |
| CHEBI has role | CHEBI:75771 | mouse metabolite |
| CHEBI has role | CHEBI:77746 | human metabolite |
Related Drugs by ATC class:
A16AA Amino acids and derivatives 6 drugs
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Carnitine deficiency | indication | 421784001 | |
| Recovery during viral myocarditis | off-label use | 89141000 | |
| Obstruction of bile duct | contraindication | 30144000 | |
| Low blood pressure | contraindication | 45007003 | |
| Blood coagulation disorder | contraindication | 64779008 | DOID:1247 |
| Kidney disease | contraindication | 90708001 | DOID:557 |
| Seizure disorder | contraindication | 128613002 | |
| Disease of liver | contraindication | 235856003 | DOID:409 |
| Vitamin K Deficiency Induced Hypoprothrombinemia | contraindication |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 3.86 | acidic |
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 |
|---|---|---|---|---|---|---|---|---|---|
| Carnitine O-palmitoyltransferase 1, liver isoform | Enzyme | WOMBAT-PK | |||||||
| Carnitine O-palmitoyltransferase 1, muscle isoform | Enzyme | Ki | 4 | CHEMBL | |||||
| Carnitine palmitoyltransferase 2 | Enzyme | Ki | 4 | CHEMBL |
External reference:
| ID | Source |
|---|---|
| 4020953 | VUID |
| N0000148430 | NUI |
| D02176 | KEGG_DRUG |
| 6645-46-1 | SECONDARY_CAS_RN |
| 1426681 | RXNORM |
| C0087163 | UMLSCUI |
| CHEBI:16347 | CHEBI |
| 152 | PDB_CHEM_ID |
| CHEMBL1149 | ChEMBL_ID |
| CHEMBL172513 | ChEMBL_ID |
| D002331 | MESH_DESCRIPTOR_UI |
| DB00583 | DRUGBANK_ID |
| 6098 | INN_ID |
| 0G389FZZ9M | UNII |
| 10917 | PUBCHEM_CID |
| 10540 | MMSL |
| 147388 | MMSL |
| 4970 | MMSL |
| d00491 | MMSL |
| 329486002 | SNOMEDCT_US |
| 372601001 | SNOMEDCT_US |
| 4780 | IUPHAR_LIGAND_ID |
| 4018934 | VANDF |
| 4020870 | VANDF |
| 4020953 | VANDF |
| 000932 | NDDF |
| 003576 | NDDF |
| 005071 | NDDF |
| 0G389FZZ9M | INXIGHT DRUGS |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Levocarnitine | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0143-9852 | INJECTION | 1 g | INTRAVENOUS | ANDA | 17 sections |
| Levocarnitine | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0517-1045 | INJECTION, SOLUTION | 200 mg | INTRAVENOUS | ANDA | 20 sections |
| Levocarnitine | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0517-1075 | INJECTION, SOLUTION | 200 mg | INTRAVENOUS | ANDA | 20 sections |
| Levocarnitine | Human Prescription Drug Label | 1 | 16571-762 | TABLET | 330 mg | ORAL | ANDA | 19 sections |
| LEVOCARNITINE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 36000-368 | INJECTION, SOLUTION | 1 g | INTRAVENOUS | ANDA | 20 sections |
| Levocarnitine | HUMAN PRESCRIPTION DRUG LABEL | 1 | 50383-171 | SOLUTION | 1 g | ORAL | NDA | 19 sections |
| Levocarnitine | HUMAN PRESCRIPTION DRUG LABEL | 1 | 50383-172 | TABLET | 330 mg | ORAL | NDA | 20 sections |
| Levocarnitine | HUMAN PRESCRIPTION DRUG LABEL | 1 | 52817-830 | SOLUTION | 1 g | ORAL | ANDA | 20 sections |
| CARNITOR | HUMAN PRESCRIPTION DRUG LABEL | 1 | 54482-144 | TABLET | 330 mg | ORAL | NDA | 20 sections |
| Carnitor | HUMAN PRESCRIPTION DRUG LABEL | 1 | 54482-145 | SOLUTION | 1 g | ORAL | NDA | 20 sections |
| Carnitor | HUMAN PRESCRIPTION DRUG LABEL | 1 | 54482-147 | INJECTION, SOLUTION | 1 g | INTRAVENOUS | NDA | 20 sections |
| Carnitor SF | HUMAN PRESCRIPTION DRUG LABEL | 1 | 54482-148 | SOLUTION | 1 g | ORAL | NDA | 21 sections |
| Levocarnitine | Human Prescription Drug Label | 1 | 64980-503 | SOLUTION | 1 g | ORAL | ANDA | 19 sections |
| Lipovite | HUMAN PRESCRIPTION DRUG LABEL | 13 | 70104-128 | INJECTION | 1 mg | INTRAMUSCULAR | unapproved drug other | 1 sections |
| Levocarnitine | Human Prescription Drug Label | 1 | 70954-139 | SOLUTION | 1 g | ORAL | ANDA | 19 sections |
| Levocarnitine | Human Prescription Drug Label | 1 | 70954-140 | SOLUTION | 1 g | ORAL | ANDA | 19 sections |
| Levocarnitine | Human Prescription Drug Label | 1 | 70954-492 | TABLET | 330 mg | ORAL | ANDA | 19 sections |
| Levocarnitine | HUMAN PRESCRIPTION DRUG LABEL | 1 | 71656-016 | SOLUTION | 1 g | ORAL | ANDA | 20 sections |
| levocarnitine | HUMAN PRESCRIPTION DRUG LABEL | 1 | 73043-034 | INJECTION, SOLUTION | 1 g | INTRAVENOUS | ANDA | 20 sections |
| Beautyturess Slimming Lifting Firming Cream | HUMAN OTC DRUG LABEL | 2 | 84753-002 | EMULSION | 30 mg | CUTANEOUS | OTC Monograph Drug | 9 sections |
| Non-proprietary name | HUMAN PRESCRIPTION DRUG LABEL | 1 | 85551-122 | INJECTION | 500 mg | INTRAMUSCULAR | unapproved drug other | 6 sections |