Methotrexate
- Product NDC
- 63323-123
- 11-digit product format
- 633230123
- Labeler code
- 63323
- Product ID
- 63323-123_880c2caa-1b11-45ce-a54e-a3733da367f0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- METHOTREXATE SODIUM
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRA-ARTERIAL; INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Fresenius Kabi USA, LLC
- Application
- ANDA040263
- Marketing category
- ANDA
- Marketing start
- 2001-09-10
- 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 | 1946772 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63323-123-10 | Methotrexate | 10 mL in 1 VIAL | INJECTION, SOLUTION | 10 | | 6 |
| 63323-123-10 | Methotrexate | 1 in 1 CARTON | INJECTION, SOLUTION | 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, SOLUTION [FRESENIUS KABI USA, LLC] | 3 | |
| METHOTREXATE | ACTIVE MOIETY | YL5FZ2Y5U1 | METHOTREXATE (METHOTREXATE SODIUM) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 3 | |
| BENZYL ALCOHOL | INACTIVE INGREDIENT | LKG8494WBH | METHOTREXATE (METHOTREXATE SODIUM) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 3 | |
| HYDROCHLORIC ACID | INACTIVE INGREDIENT | QTT17582CB | METHOTREXATE (METHOTREXATE SODIUM) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 3 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | METHOTREXATE (METHOTREXATE SODIUM) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 3 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | METHOTREXATE (METHOTREXATE SODIUM) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63323-123 | METHOTREXATE (METHOTREXATE SODIUM) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 6 | Current NDC, Legacy NDC, 2 package rows | 20210326_b585f621-f6c9-4735-ab61-bd1b401f3df0.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 |
|---|
| 63323-123-10 | 63323012310 | 1 VIAL in 1 CARTON (63323-123-10) / 10 mL in 1 VIAL | 1 vial | 2001-09-10 | 0000-00-00 | No | No | Current |