Azacitidine
- Product NDC
- 68001-620
- 11-digit product format
- 680010620
- Labeler code
- 68001
- Product ID
- 68001-620_4df05823-5b8c-e6c0-e063-6294a90a8d1b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Azacitidine
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS; SUBCUTANEOUS
- Labeler
- BluePoint Laboratories.
- Application
- ANDA201537
- Marketing category
- ANDA
- Marketing start
- 2025-01-10
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Azacitidine
- Listing expiration
- 2027-12-31
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 |
|---|
| 68001-620-54 | 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 |
|---|
| 68001-620 | AZACITIDINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [BLUEPOINT LABORATORIES.] | 2 | Current NDC, 1 package rows | 20250209_cd9db533-8a49-4d01-99e2-b2db8db1ed38.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 68001-620-54 | 68001062054 | 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (68001-620-54) | 2025-01-10 | No | No | Current |