Methotrexate
- Product NDC
- 48433-065
- 11-digit product format
- 484330065
- Labeler code
- 48433
- Product ID
- 48433-065_49a1fdee-5587-e05a-e063-6294a90aebc5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- methotrexate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Safecor Health LLC
- Application
- ANDA081235
- Marketing category
- ANDA
- Marketing start
- 2026-01-19
- 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
- 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 | 2.5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 3IG1E710ZN |
| Rxcui | 105585 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 48433-065-01 | Methotrexate | 1 in 1 BLISTER PACK | TABLET | 1 | | 2 |
| 48433-065-05 | Methotrexate | 20 in 1 CARTON | TABLET | 20 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 48433-065-01 | 48433006501 | 1 in 1 BLISTER PACK | | | | | Historical |
| 48433-065-05 | 48433006505 | 20 BLISTER PACK in 1 CARTON (48433-065-05) / 1 TABLET in 1 BLISTER PACK (48433-065-01) | 20 blister pack | 2026-01-19 | No | No | Historical |