ONUREG
- Product NDC
- 59572-730
- 11-digit product format
- 595720730
- Labeler code
- 59572
- Product ID
- 59572-730_6981b224-73db-4a2a-b901-ed7e5bffd5ea
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- azacitidine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Celgene Corporation
- Application
- NDA214120
- Marketing category
- NDA
- Marketing start
- 2020-09-01
- Substance
- AZACITIDINE
- Active strength
- 200 mg/1
- Pharmacologic classes
- Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- ONUREG
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| AZACITIDINE | 200 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | M801H13NRU |
| Rxcui | 2396764, 2396770, 2396772, 2396774 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 59572-730-07 | ONUREG | 7 in 1 BLISTER PACK | TABLET, FILM COATED | 7 | | 13 |
| 59572-730-14 | ONUREG | 14 in 1 BOTTLE | TABLET, FILM COATED | 14 | | 13 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 59572-730 | ONUREG (AZACITIDINE) TABLET, FILM COATED [CELGENE CORPORATION] | 11 | Current NDC, Legacy NDC, 2 package rows | 20221102_0e95e33f-8aba-4f19-b332-2416580d358b.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 59572-730-07 | 59572073007 | 7 TABLET, FILM COATED in 1 BLISTER PACK (59572-730-07) | 2020-12-18 | 0000-00-00 | No | No | Current |
| 59572-730-14 | 59572073014 | 14 TABLET, FILM COATED in 1 BOTTLE (59572-730-14) | 2020-09-01 | 0000-00-00 | No | No | Current |