METHOTREXATE
- Product NDC
- 46708-711
- 11-digit product format
- 467080711
- Labeler code
- 46708
- Product ID
- 46708-711_e98b2abd-8068-482e-9ce3-1ab262f0838e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- methotrexate
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
- Labeler
- Alembic Pharmaceuticals Limited
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- METHOTREXATE
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| METHOTREXATE SODIUM | 25 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 3IG1E710ZN |
| Rxcui | 1655956, 1946772 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 46708-711-01 | METHOTREXATE | 2 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 2 | | 1 |
| 46708-711-05 | METHOTREXATE | 5 in 1 CARTON | INJECTION, SOLUTION | 5 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 46708-711-01 | 46708071101 | 2 mL in 1 VIAL, MULTI-DOSE | 2 ml | | | | Historical |
| 46708-711-05 | 46708071105 | 5 VIAL, MULTI-DOSE in 1 CARTON (46708-711-05) / 2 mL in 1 VIAL, MULTI-DOSE (46708-711-01) | | 2026-04-15 | No | No | Current |