Azathioprine
- Product NDC
- 68382-003
- 11-digit product format
- 683820003
- Labeler code
- 68382
- Product ID
- 68382-003_64e1751f-fdf5-45e7-ac57-6499c0b5aa91
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Azathioprine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Zydus Pharmaceuticals USA Inc.
- Application
- ANDA077621
- Marketing category
- ANDA
- Marketing start
- 2007-07-11
- Substance
- AZATHIOPRINE
- Active strength
- 50 mg/1
- Pharmacologic classes
- Nucleic Acid Synthesis Inhibitors [MoA], Nucleosides [CS], Purine Antimetabolite [EPC], Purines [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Azathioprine
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| AZATHIOPRINE | 50 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | MRK240IY2L |
| Rxcui | 197388, 199310, 359228, 359229 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68382-003-01 | Azathioprine | 100 in 1 BOTTLE | TABLET | 100 | | 11 |
| 68382-003-05 | Azathioprine | 500 in 1 BOTTLE | TABLET | 500 | | 11 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| AZATHIOPRINE | ACTIVE INGREDIENT | MRK240IY2L | AZATHIOPRINE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.] | 5 | |
| AZATHIOPRINE | ACTIVE MOIETY | MRK240IY2L | AZATHIOPRINE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.] | 5 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | AZATHIOPRINE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.] | 5 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | AZATHIOPRINE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.] | 5 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | AZATHIOPRINE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.] | 5 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | AZATHIOPRINE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.] | 5 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | AZATHIOPRINE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.] | 5 | |
| AZATHIOPRINE | ACTIVE INGREDIENT | MRK240IY2L | AZATHIOPRINE TABLET [PHYSICIANS TOTAL CARE, INC.] | 4 | |
| AZATHIOPRINE | ACTIVE INGREDIENT | MRK240IY2L | AZATHIOPRINE TABLET [AMERICAN HEALTH PACKAGING] | 4 | |
| AZATHIOPRINE | ACTIVE MOIETY | MRK240IY2L | AZATHIOPRINE TABLET [AMERICAN HEALTH PACKAGING] | 4 | |
| AZATHIOPRINE | ACTIVE MOIETY | MRK240IY2L | AZATHIOPRINE TABLET [PHYSICIANS TOTAL CARE, INC.] | 4 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | AZATHIOPRINE TABLET [AMERICAN HEALTH PACKAGING] | 4 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | AZATHIOPRINE TABLET [PHYSICIANS TOTAL CARE, INC.] | 4 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | AZATHIOPRINE TABLET [PHYSICIANS TOTAL CARE, INC.] | 4 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | AZATHIOPRINE TABLET [AMERICAN HEALTH PACKAGING] | 4 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | AZATHIOPRINE TABLET [AMERICAN HEALTH PACKAGING] | 4 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | AZATHIOPRINE TABLET [PHYSICIANS TOTAL CARE, INC.] | 4 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | AZATHIOPRINE TABLET [PHYSICIANS TOTAL CARE, INC.] | 4 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | AZATHIOPRINE TABLET [AMERICAN HEALTH PACKAGING] | 4 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | AZATHIOPRINE TABLET [PHYSICIANS TOTAL CARE, INC.] | 4 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | AZATHIOPRINE TABLET [AMERICAN HEALTH PACKAGING] | 4 | |
| AZATHIOPRINE | ACTIVE INGREDIENT | MRK240IY2L | AZATHIOPRINE TABLET [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| AZATHIOPRINE | ACTIVE MOIETY | MRK240IY2L | AZATHIOPRINE TABLET [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | AZATHIOPRINE TABLET [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | AZATHIOPRINE TABLET [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | AZATHIOPRINE TABLET [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | AZATHIOPRINE TABLET [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | AZATHIOPRINE TABLET [AIDAREX PHARMACEUTICALS LLC] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68382-003 | AZATHIOPRINE TABLET [ZYDUS PHARMACEUTICALS USA INC.] | 11 | Current NDC, Legacy NDC, 2 package rows | 20240811_b1b0fa3e-11c3-46d0-9537-6b372c2a1b56.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 |
|---|
| 68382-003-01 | 68382000301 | 100 TABLET in 1 BOTTLE (68382-003-01) | 100 tablet | 2007-07-11 | 0000-00-00 | No | No | Current |
| 68382-003-05 | 68382000305 | 500 TABLET in 1 BOTTLE (68382-003-05) | 500 tablet | 2007-07-11 | 0000-00-00 | No | No | Current |