METHOTREXATE
- Product NDC
- 46708-730
- 11-digit product format
- 467080730
- Labeler code
- 46708
- Product ID
- 46708-730_ff55c573-dc84-4ff3-9d10-2b24c47dd679
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- METHOTREXATE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Alembic Pharmaceuticals Limited
- Application
- ANDA217552
- Marketing category
- ANDA
- Marketing start
- 2024-06-04
- 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 |
|---|
| 46708-730-31 | 46708073031 | 100 TABLET in 1 BOTTLE (46708-730-31) | 100 tablet | 2024-06-04 | No | No | Historical |
| 46708-730-36 | 46708073036 | 36 TABLET in 1 BOTTLE (46708-730-36) | 36 tablet | 2024-06-04 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| METHOTREXATE | Alembic Pharmaceuticals Limited | 2024-06-07 | Human Prescription Drug Label | 1 |