Methotrexate
- Product NDC
- 0378-0014
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- methotrexate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA081235
- Marketing category
- ANDA
- Substance
- METHOTREXATE SODIUM
- Current FDA listing
- Yes
Packages
| Package NDC | Description | Marketing start | Marketing end | Sample | Status |
|---|
| 0378-0014-01 | 100 TABLET in 1 BOTTLE, PLASTIC (0378-0014-01) | 19920518 | | No | Historical |
Related DailyMed Labels
| Set ID | Title | Manufacturer | Effective date | Type | Version |
|---|
| 70c09984-2b36-424f-8b27-3fd0cd4e833d | These highlights do not include all the information needed to use METHOTREXATE TABLETS safely and effectively. See full prescribing information for METHOTREXATE TABLETS. METHOTREXATE tablets, for oral use Initial U.S. Approval: 1953 | Mylan Pharmaceuticals Inc. | 2026-05-07 | HUMAN PRESCRIPTION DRUG LABEL | 19 |
| 6f14ced9-c16b-905a-e053-2a91aa0a031e | METHOTREXATE TABLETS. These highlights do not include all the information needed to use METHOTREXATE TABLETS safely and effectively. See full prescribing information for METHOTREXATE TABLETS. METHOTREXATE tablets, for oral use Initial U.S. Approval: 1953 | Golden State Medical Supply, Inc. | 2026-04-15 | HUMAN PRESCRIPTION DRUG LABEL | 10 |
| f177e6fa-c482-432d-8208-937468ab3f10 | These highlights do not include all the information needed to use METHOTREXATE TABLETS safely and effectively. See full prescribing information for METHOTREXATE TABLETS. METHOTREXATE tablets, for oral use Initial U.S. Approval: 1953 | Safecor Health LLC | 2026-01-30 | HUMAN PRESCRIPTION DRUG LABEL | 2 |
| 8df0780e-0fbd-4ab8-80b0-7a5eaa08ec0a | These highlights do not include all the information needed to use METHOTREXATE TABLETS safely and effectively. See full prescribing information for METHOTREXATE TABLETS. METHOTREXATE tablets, for oral use Initial U.S. Approval: 1953 | Mylan Institutional Inc. | 2025-07-22 | HUMAN PRESCRIPTION DRUG LABEL | 20 |
| 0b54b5c4-2466-4f85-b9a0-ad93ec4a06a1 | These highlights do not include all the information needed to use METHOTREXATE TABLETS safely and effectively. See full prescribing information for METHOTREXATE TABLETS. METHOTREXATE tablets, for oral use Initial U.S. Approval: 1953 | Bryant Ranch Prepack | 2024-05-17 | HUMAN PRESCRIPTION DRUG LABEL | 5 |