Azathioprine
- Product NDC
- 68462-502
- 11-digit product format
- 684620502
- Labeler code
- 68462
- Product ID
- 68462-502_26e47a7e-a3b4-036a-e063-6394a90ae208
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Azathioprine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Glenmark Pharmaceuticals, Inc
- Application
- ANDA075252
- Marketing category
- ANDA
- Marketing start
- 1999-08-01
- 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 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68462-502-01 | Azathioprine | 100 in 1 BOTTLE | TABLET | 100 | | 36 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| AZATHIOPRINE | ACTIVE INGREDIENT | MRK240IY2L | AZATHIOPRINE TABLET [GLENMARK PHARMACEUTICALS, INC] | 1 | |
| AZATHIOPRINE | ACTIVE MOIETY | MRK240IY2L | AZATHIOPRINE TABLET [GLENMARK PHARMACEUTICALS, INC] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | AZATHIOPRINE TABLET [GLENMARK PHARMACEUTICALS, INC] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | AZATHIOPRINE TABLET [GLENMARK PHARMACEUTICALS, INC] | 1 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | AZATHIOPRINE TABLET [GLENMARK PHARMACEUTICALS, INC] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | AZATHIOPRINE TABLET [GLENMARK PHARMACEUTICALS, INC] | 1 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | AZATHIOPRINE TABLET [GLENMARK PHARMACEUTICALS, INC] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68462-502 | AZATHIOPRINE TABLET [GLENMARK PHARMACEUTICALS, INC] | 36 | Current NDC, Legacy NDC, 1 package rows | 20241208_ceab8e8b-d022-4d0c-a552-cc5782446248.zip |
| 68462-502 | AZATHIOPRINE TABLET [GLENMARK PHARMACEUTICALS, INC] | 11 | Current NDC, Legacy NDC | 20220922_200ce996-da00-5be7-e054-00144ff8d46c.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 |
|---|
| 68462-502-01 | 68462050201 | 100 TABLET in 1 BOTTLE (68462-502-01) | 100 tablet | 1999-08-01 | 2023-07-01 | No | No | Current |
| 68462-502-10 | 68462050210 | 100 TABLET in 1 BOTTLE (68462-502-10) | 100 tablet | 1999-08-01 | 2023-07-01 | No | No | Current |