Azacitidine
- Product NDC
- 0781-3491
- 11-digit product format
- 007813491
- Labeler code
- 0781
- Product ID
- 0781-3491_bf6cb4b7-d4ec-4124-862c-aaa6a32da511
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Azacitidine
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS; SUBCUTANEOUS
- Labeler
- Sandoz Inc
- Application
- ANDA212580
- Marketing category
- ANDA
- Marketing start
- 2024-05-16
- 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 |
|---|
| 0781-3491-94 | Azacitidine | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0781-3491 | AZACITIDINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SANDOZ INC] | 3 | Current NDC, 1 package rows | 20241025_7f89fcbd-d3f4-4112-8733-69baea41255e.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 0781-3491-94 | 00781349194 | 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (0781-3491-94) | 2024-11-01 | No | No | Current |