Methotrexate
- Product NDC
- 0143-9367
- 11-digit product format
- 001439367
- Labeler code
- 0143
- Product ID
- 0143-9367_7950579c-084b-472b-a7ce-f342691aff97
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Methotrexate
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRA-ARTERIAL; INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- ANDA040632
- Marketing category
- ANDA
- Marketing start
- 2005-09-06
- Substance
- METHOTREXATE
- Active strength
- 1 g/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 | 1 g/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | YL5FZ2Y5U1 |
| Rxcui | 311625 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0143-9367-01 | Methotrexate | 1 in 1 BOX | INJECTION, POWDER, LYOPHILIZED, | 1 | | 2 |
| 0143-9367-01 | Methotrexate | 1 in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 1 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0143-9367 | METHOTREXATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HIKMA PHARMACEUTICALS USA INC.] | 2 | Current NDC, Legacy NDC, 2 package rows | 20240906_8593f7fc-eabe-44ae-bb05-b3d7d408e4f7.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 |
|---|
| 0143-9367-01 | 00143936701 | 1 VIAL in 1 BOX (0143-9367-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL | 1 vial | 2005-09-06 | 0000-00-00 | No | No | Current |