Methotrexate
- Product NDC
- 67046-1524
- 11-digit product format
- 670461524
- Labeler code
- 67046
- Product ID
- 67046-1524_2f20d43e-a477-a839-e063-6394a90ace38
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Methotrexate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Coupler LLC
- Application
- ANDA213343
- Marketing category
- ANDA
- Marketing start
- 2025-02-27
- 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 |
|---|
| 67046-1524-3 | 67046152403 | 30 TABLET in 1 BLISTER PACK (67046-1524-3) | 30 tablet | 2025-02-27 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Methotrexate | Coupler LLC | 2025-02-27 | HUMAN PRESCRIPTION DRUG LABEL | 1 |