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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- METHOTREXATE
- Listing expiration
- 2026-12-31
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 |
|---|
| 46708-730-31 | METHOTREXATE | 100 in 1 BOTTLE | TABLET | 100 | | 1 |
| 46708-730-36 | METHOTREXATE | 36 in 1 BOTTLE | TABLET | 36 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 46708-730 | METHOTREXATE TABLET [ALEMBIC PHARMACEUTICALS LIMITED] | 1 | Current NDC, 2 package rows | 20240608_ff55c573-dc84-4ff3-9d10-2b24c47dd679.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 46708-730-31 | 46708073031 | 100 TABLET in 1 BOTTLE (46708-730-31) | 100 tablet | 2024-06-04 | No | No | Current |
| 46708-730-36 | 46708073036 | 36 TABLET in 1 BOTTLE (46708-730-36) | 36 tablet | 2024-06-04 | No | No | Current |