Azacitidine
- Product NDC
- 16729-306
- 11-digit product format
- 167290306
- Labeler code
- 16729
- Product ID
- 16729-306_28604daf-46a3-ef6c-e063-6394a90a4b27
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Azacitidine
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS; SUBCUTANEOUS
- Labeler
- Accord Healthcare Inc.
- Application
- ANDA207475
- Marketing category
- ANDA
- Marketing start
- 2019-01-09
- Substance
- AZACITIDINE
- Active strength
- 100 mg/1
- Pharmacologic classes
- Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Azacitidine
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| AZACITIDINE | 100 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | M801H13NRU |
| Rxcui | 485246 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 16729-306-10 | Azacitidine | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 16729-306 | AZACITIDINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ACCORD HEALTHCARE INC.] | 9 | Current NDC, Legacy NDC, 1 package rows | 20241206_70140e11-33f1-2240-e053-2991aa0a0480.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 |
|---|
| 16729-306-10 | 16729030610 | 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (16729-306-10) | 2019-01-09 | 0000-00-00 | No | No | Current |