IMURAN
- Product NDC
- 54766-590
- 11-digit product format
- 547660590
- Labeler code
- 54766
- Product ID
- 54766-590_431426e8-80d4-a4e2-e063-6394a90af918
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- azathioprine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Sebela Pharmaceuticals Inc.
- Application
- NDA016324
- Marketing category
- NDA
- Marketing start
- 2017-12-01
- Marketing end
- 2028-04-30
- 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
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- IMURAN
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| AZATHIOPRINE | 50 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | MRK240IY2L |
| Rxcui | 105611, 197388 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 54766-590-10 | IMURAN | 100 in 1 BOTTLE | TABLET | 100 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 54766-590 | IMURAN (AZATHIOPRINE) TABLET [SEBELA PHARMACEUTICALS INC.] | 4 | Current NDC, Legacy NDC, 1 package rows | 20240721_606101a0-6244-7eff-e053-2a91aa0acadd.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 |
|---|
| 54766-590-10 | 54766059010 | 100 TABLET in 1 BOTTLE (54766-590-10) | 100 tablet | 2017-12-01 | 2028-04-30 | No | No | Current |