Azacitidine
- Product NDC
- 43817-906
- 11-digit product format
- 438170906
- Labeler code
- 43817
- Product ID
- 43817-906_dcfb97f4-4218-4d97-ba28-4f97dabe4ac0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Azacitidine
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- SUBCUTANEOUS
- Labeler
- Panacea Biotec Limited
- Application
- ANDA207234
- Marketing category
- ANDA
- Marketing start
- 2019-05-06
- Substance
- AZACITIDINE
- Active strength
- 100 mg/50mL
- 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/50mL |
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 |
|---|
| 43817-906-01 | Azacitidine | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 2 |
| 43817-906-01 | Azacitidine | 50 mL in 1 VIAL, SINGLE-DOSE | INJECTION, POWDER, LYOPHILIZED, | 50 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43817-906 | AZACITIDINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [PANACEA BIOTEC LIMITED] | 2 | Current NDC, Legacy NDC, 2 package rows | 20201201_9abb489d-ce54-4140-83f6-b756f00b0967.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 |
|---|
| 43817-906-01 | 43817090601 | 1 VIAL, SINGLE-DOSE in 1 CARTON (43817-906-01) / 50 mL in 1 VIAL, SINGLE-DOSE | 2019-05-06 | 0000-00-00 | No | No | Current |