Methotrexate Sodium
- Product NDC
- 0054-8550
- 11-digit product format
- 000548550
- Labeler code
- 0054
- Product ID
- 0054-8550_d72fc36a-3aee-493b-9fa1-5ce69d35b39d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Methotrexate Sodium
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- West-Ward Pharmaceuticals Corp.
- Application
- ANDA040054
- Marketing category
- ANDA
- Marketing start
- 1994-08-01
- Marketing end
- 0000-00-00
- Substance
- METHOTREXATE SODIUM
- Active strength
- 3 mg/1
- Pharmacologic classes
- Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0054-8550-25 | Methotrexate Sodium | 10 in 1 CARTON | TABLET | 10 | | 20 |
| 0054-8550-25 | Methotrexate Sodium | 10 in 1 BLISTER PACK | TABLET | 10 | | 20 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| METHOTREXATE SODIUM | ACTIVE INGREDIENT | 3IG1E710ZN | METHOTREXATE SODIUM TABLET [ROXANE LABORATORIES, INC] | 8 | |
| METHOTREXATE | ACTIVE MOIETY | YL5FZ2Y5U1 | METHOTREXATE SODIUM TABLET [ROXANE LABORATORIES, INC] | 8 | |
| LACTOSE | INACTIVE INGREDIENT | J2B2A4N98G | METHOTREXATE SODIUM TABLET [ROXANE LABORATORIES, INC] | 8 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | METHOTREXATE SODIUM TABLET [ROXANE LABORATORIES, INC] | 8 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | METHOTREXATE SODIUM TABLET [ROXANE LABORATORIES, INC] | 8 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | METHOTREXATE SODIUM TABLET [ROXANE LABORATORIES, INC] | 8 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | METHOTREXATE SODIUM TABLET [ROXANE LABORATORIES, INC] | 8 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0054-8550 | METHOTREXATE SODIUM TABLET [HIKMA PHARMACEUTICALS USA INC.] | 17 | Legacy NDC, 2 package rows | 20240302_d71b1856-99d8-4a9e-9189-f87b6675f80a.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 |
|---|
| 0054-8550-25 | 00054855025 | 10 BLISTER PACK in 1 CARTON (0054-8550-25) > 10 TABLET in 1 BLISTER PACK | 10 blister pack | 1994-08-01 | 0000-00-00 | No | No | Current |