Methotrexate
- Product NDC
- 68382-775
- 11-digit product format
- 683820775
- Labeler code
- 68382
- Product ID
- 68382-775_5d9b7269-19d4-4d2c-b252-f3ff759dffa5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Methotrexate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Zydus Pharmaceuticals USA Inc.
- Application
- ANDA207812
- Marketing category
- ANDA
- Marketing start
- 2017-02-09
- Substance
- METHOTREXATE
- Active strength
- 2.5 mg/1
- Pharmacologic classes
- Folate Analog Metabolic Inhibitor [EPC], Folic Acid Metabolism Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Methotrexate
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| METHOTREXATE | 2.5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | YL5FZ2Y5U1 |
| Rxcui | 105585 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68382-775 | METHOTREXATE TABLET [ZYDUS PHARMACEUTICALS USA INC.] | 7 | Current NDC, Legacy NDC, 7 package rows | 20231110_948e0bab-6524-4b87-9853-1799d4415558.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 |
|---|
| 68382-775-01 | 68382077501 | 100 TABLET in 1 BOTTLE (68382-775-01) | 100 tablet | 2017-02-09 | 0000-00-00 | No | No | Current |
| 68382-775-05 | 68382077505 | 500 TABLET in 1 BOTTLE (68382-775-05) | 500 tablet | 2017-02-09 | 0000-00-00 | No | No | Current |
| 68382-775-10 | 68382077510 | 1000 TABLET in 1 BOTTLE (68382-775-10) | 1000 tablet | 2017-02-09 | 0000-00-00 | No | No | Current |
| 68382-775-16 | 68382077516 | 90 TABLET in 1 BOTTLE (68382-775-16) | 90 tablet | 2017-02-09 | 0000-00-00 | No | No | Current |
| 68382-775-60 | 68382077560 | 36 TABLET in 1 BOTTLE (68382-775-60) | 36 tablet | 2017-02-09 | 0000-00-00 | No | No | Current |
| 68382-775-77 | 68382077577 | 100 BLISTER PACK in 1 CARTON (68382-775-77) / 1 TABLET in 1 BLISTER PACK | 100 blister pack | 2017-02-09 | 0000-00-00 | No | No | Current |