Methotrexate
- Product NDC
- 0703-3678
- 11-digit product format
- 007033678
- Labeler code
- 0703
- Product ID
- 0703-3678_e81074cc-12b4-4ac9-a5bb-749188989b2c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Methotrexate
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRA-ARTERIAL; INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS
- Labeler
- Teva Parenteral Medicines, Inc.
- Application
- ANDA040843
- Marketing category
- ANDA
- Marketing start
- 2012-08-01
- 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
- 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 | 25 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 3IG1E710ZN |
| Rxcui | 1655956, 1655959, 1655960 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0703-3678-01 | Methotrexate | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 11 |
| 0703-3678-01 | Methotrexate | 40 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 40 | | 11 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0703-3678 | METHOTREXATE INJECTION, SOLUTION [TEVA PARENTERAL MEDICINES, INC.] | 10 | Current NDC, Legacy NDC, 2 package rows | 20240616_346ec9ce-dc98-4a55-b55e-d3af11f2d703.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0703-3678-01 | 00703367801 | 1 VIAL, SINGLE-DOSE in 1 CARTON (0703-3678-01) / 40 mL in 1 VIAL, SINGLE-DOSE | 2012-08-01 | 0000-00-00 | No | No | Current |
| 0703-3678-81 | 00703367881 | 1 VIAL, SINGLE-DOSE in 1 CARTON (0703-3678-81) > 40 mL in 1 VIAL, SINGLE-DOSE | 2015-12-14 | 0000-00-00 | No | No | Current |