Methotrexate
- Product NDC
- 68071-3765
- 11-digit product format
- 680713765
- Labeler code
- 68071
- Product ID
- 68071-3765_2bae0372-8ccb-0028-e063-6294a90a889f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Methotrexate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals, Inc.
- Application
- ANDA210454
- Marketing category
- ANDA
- Marketing start
- 2020-01-30
- Substance
- METHOTREXATE SODIUM
- Active strength
- 2.5 mg/1
- Pharmacologic classes
- Folate Analog Metabolic Inhibitor [EPC], Folic Acid Metabolism Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 3IG1E710ZN | METHOTREXATE SODIUM | 7413-34-5 | METHOTREXATE SODIUM |
| YL5FZ2Y5U1 | METHOTREXATE | 59-05-2 | Methotrexate |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 68071-3765-6 | 68071376506 | 60 TABLET in 1 BOTTLE (68071-3765-6) | 60 tablet | 2025-01-14 | No | No | Historical |
| 68071-3765-9 | 68071376509 | 90 TABLET in 1 BOTTLE (68071-3765-9) | 90 tablet | 2025-01-10 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Methotrexate | NuCare Pharmaceuticals, Inc. | 2025-01-14 | HUMAN PRESCRIPTION DRUG LABEL | 2 |