AZACITIDINE
- Product NDC
- 55150-393
- 11-digit product format
- 551500393
- Labeler code
- 55150
- Product ID
- 55150-393_e89b9510-86df-4095-b6d3-4eb05b613c4f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- AZACITIDINE
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS; SUBCUTANEOUS
- Labeler
- Eugia US LLC
- Application
- ANDA215066
- Marketing category
- ANDA
- Marketing start
- 2023-01-03
- Substance
- AZACITIDINE
- Active strength
- 100 mg/4mL
- 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/4mL |
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 |
|---|
| 55150-393-01 | AZACITIDINE | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 3 |
| 55150-393-01 | AZACITIDINE | 4 mL in 1 VIAL, SINGLE-DOSE | INJECTION, POWDER, LYOPHILIZED, | 4 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55150-393 | AZACITIDINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [EUGIA US LLC] | 3 | Current NDC, Legacy NDC, 2 package rows | 20240727_ecd108bd-bb5f-4b2e-ad91-210fca452e9b.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 |
|---|
| 55150-393-01 | 55150039301 | 1 VIAL, SINGLE-DOSE in 1 CARTON (55150-393-01) / 4 mL in 1 VIAL, SINGLE-DOSE | 2023-01-03 | 0000-00-00 | No | No | Current |