Azacitidine
- Product NDC
- 16714-927
- 11-digit product format
- 167140927
- Labeler code
- 16714
- Product ID
- 16714-927_946ea9fe-07aa-b87b-d702-482df4bd4afe
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Azacitidine
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS; SUBCUTANEOUS
- Labeler
- NorthStar RxLLC
- Application
- ANDA201537
- Marketing category
- ANDA
- Marketing start
- 2019-05-08
- 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 |
|---|
| 16714-927-01 | Azacitidine | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 16714-927 | AZACITIDINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [NORTHSTAR RXLLC] | 6 | Current NDC, Legacy NDC, 1 package rows | 20240810_81366ec1-9689-4857-ded6-3d6342fe5132.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 |
|---|
| 16714-927-01 | 16714092701 | 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (16714-927-01) | 2019-05-08 | 0000-00-00 | No | No | Current |