Methotrexate
- Product NDC
- 63323-122
- 11-digit product format
- 633230122
- Labeler code
- 63323
- Product ID
- 63323-122_3d21237a-ef53-4592-bf06-0c739696203d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- METHOTREXATE SODIUM
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRA-ARTERIAL; INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS
- Labeler
- Fresenius Kabi USA, LLC
- Application
- ANDA040266
- Marketing category
- ANDA
- Marketing start
- 2000-01-22
- Substance
- METHOTREXATE SODIUM
- 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 SODIUM | 1 g/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 3IG1E710ZN |
| Rxcui | 311625 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63323-122-50 | Methotrexate | 1 in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 1 | | 6 |
| 63323-122-50 | Methotrexate | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 6 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| METHOTREXATE SODIUM | ACTIVE INGREDIENT | 3IG1E710ZN | METHOTREXATE (METHOTREXATE SODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] | 2 | |
| METHOTREXATE | ACTIVE MOIETY | YL5FZ2Y5U1 | METHOTREXATE (METHOTREXATE SODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] | 2 | |
| HYDROCHLORIC ACID | INACTIVE INGREDIENT | QTT17582CB | METHOTREXATE (METHOTREXATE SODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] | 2 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | METHOTREXATE (METHOTREXATE SODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63323-122 | METHOTREXATE (METHOTREXATE SODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] | 5 | Current NDC, Legacy NDC, 2 package rows | 20210407_ec476b11-0b3c-4139-b1eb-a3daa76bc271.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 |
|---|
| 63323-122-50 | 63323012250 | 1 VIAL in 1 CARTON (63323-122-50) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL | 1 vial | 2000-01-22 | 0000-00-00 | No | No | Current |