Methotrexate
- Product NDC
- 0143-9517
- 11-digit product format
- 001439517
- Labeler code
- 0143
- Product ID
- 0143-9517_3046ff78-3565-46d1-a88b-283e5ff6e7c3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Methotrexate
- Dosage form
- SOLUTION
- Route
- INTRA-ARTERIAL; INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- ANDA089342
- Marketing category
- ANDA
- Marketing start
- 2018-01-05
- Substance
- METHOTREXATE
- Active strength
- 25 mg/mL
- 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 | 25 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | YL5FZ2Y5U1 |
| Rxcui | 1655959, 1655960, 1655967, 1655968 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0143-9517-01 | Methotrexate | 1 in 1 BOX | SOLUTION | 1 | | 9 |
| 0143-9517-01 | Methotrexate | 8 mL in 1 VIAL | SOLUTION | 8 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0143-9517 | METHOTREXATE SOLUTION [HIKMA PHARMACEUTICALS USA INC.] | 9 | Current NDC, Legacy NDC, 2 package rows | 20230420_3989d30d-56e5-4e8d-9379-c30fecc894f2.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0143-9517-01 | 00143951701 | 1 VIAL in 1 BOX (0143-9517-01) / 8 mL in 1 VIAL | 1 vial | 2018-01-05 | 0000-00-00 | No | No | Current |