METHOTREXATE
- Product NDC
- 62332-711
- 11-digit product format
- 623320711
- Labeler code
- 62332
- Product ID
- 62332-711_91ce9c78-370f-49a1-ae22-428bdddb389f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- methotrexate
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
- Labeler
- Alembic Pharmaceuticals Inc.
- Application
- ANDA220225
- Marketing category
- ANDA
- Marketing start
- 2026-04-15
- Substance
- METHOTREXATE SODIUM
- Active strength
- 25 mg/mL
- Pharmacologic classes
- Folate Analog Metabolic Inhibitor [EPC], Folic Acid Metabolism Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 2eb9a854-4fbc-9bbe-3199-41fc1018a1f0 | Product name | 9 | 20250224 |
| 3082de91-569a-4d57-b379-acbf37f1d5c3 | Product name | 1 | 20210312 |
| f76135bc-a210-42d9-851b-1b73cbaccdb3 | Product name | 1 | 20200511 |
| 423544b2-e325-49ee-8910-4c5dfe41906f | Product name | 1 | 20181120 |
| c9fd924b-0a8d-4d53-bf70-11070e24e4dd | Product name | 2 | 20181120 |
| ce1e7cc6-4850-4cb1-8dde-8010b2fbc359 | Product name | 1 | 20181120 |
| eb454f54-2806-4c31-a08b-8dcb08261099 | Product name | 2 | 20181120 |
| d9cebc09-c68d-46f5-bdcd-fd82e945cc27 | Product name | 1 | 20170705 |
| 16ba0c1e-2371-48a4-8b4c-a9a338dfe1f3 | Product name | 2 | 20160504 |
| 88514aea-9d58-4ed2-b135-9811fb14c8fb | Product name | 1 | 20141209 |
| 0eba90a2-1cca-7e7b-28a5-85a09e2bc9a4 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 62332-711-01 | METHOTREXATE | 2 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 2 | 4 | |
| 62332-711-05 | METHOTREXATE | 5 in 1 CARTON | INJECTION, SOLUTION | 5 | 4 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1655956 | methotrexate 1 GM in 40 ML Injection | PSN | a63364d5-4dfa-49d7-8a5e-c8959ae1d37a | 4 |
| 1946772 | methotrexate 25 MG/mL Injectable Solution | PSN | a63364d5-4dfa-49d7-8a5e-c8959ae1d37a | 4 |
| 1655956 | 40 ML methotrexate 25 MG/ML Injection | SCD | a63364d5-4dfa-49d7-8a5e-c8959ae1d37a | 4 |
| 1946772 | methotrexate 25 MG/ML Injectable Solution | SCD | a63364d5-4dfa-49d7-8a5e-c8959ae1d37a | 4 |
| 1946772 | methotrexate (as methotrexate sodium) 25 MG/ML Injectable Solution | SY | a63364d5-4dfa-49d7-8a5e-c8959ae1d37a | 4 |
| 1655956 | methotrexate 1 GM per 40 ML Injection | SY | a63364d5-4dfa-49d7-8a5e-c8959ae1d37a | 4 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 62332-711-01 | 62332071101 | 2 mL in 1 VIAL, MULTI-DOSE | 2 ml | Historical | |||
| 62332-711-05 | 62332071105 | 5 VIAL, MULTI-DOSE in 1 CARTON (62332-711-05) / 2 mL in 1 VIAL, MULTI-DOSE (62332-711-01) | 2026-04-15 | No | No | Historical |