Azacitidine
- Product NDC
- 63323-771
- 11-digit product format
- 633230771
- Labeler code
- 63323
- Product ID
- 63323-771_4becda8d-8042-4cf1-bef3-c0ec3c23eebe
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Azacitidine
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS; SUBCUTANEOUS
- Labeler
- Fresenius Kabi USA, LLC
- Application
- ANDA207518
- Marketing category
- ANDA
- Marketing start
- 2017-03-16
- Substance
- AZACITIDINE
- Active strength
- 100 mg/30mL
- 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/30mL |
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 |
|---|
| 63323-771-39 | Azacitidine | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 6 |
| 63323-771-39 | Azacitidine | 30 mL in 1 VIAL, SINGLE-DOSE | INJECTION, POWDER, LYOPHILIZED, | 30 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63323-771 | AZACITIDINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC
] | 5 | Current NDC, Legacy NDC, 2 package rows | 20210116_3b594aba-e798-4105-b801-0b0d970747c1.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 |
|---|
| 63323-771-39 | 63323077139 | 1 VIAL, SINGLE-DOSE in 1 CARTON (63323-771-39) / 30 mL in 1 VIAL, SINGLE-DOSE | 2017-03-16 | 0000-00-00 | No | No | Current |