AZACITIDINE
- Product NDC
- 43598-678
- 11-digit product format
- 435980678
- Labeler code
- 43598
- Product ID
- 43598-678_b7d42845-1888-66b9-77a0-c6f4902e21ac
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- AZACITIDINE
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS; SUBCUTANEOUS
- Labeler
- Dr. Reddy's Laboratories Inc.
- Application
- ANDA207518
- Marketing category
- ANDA
- Marketing start
- 2017-12-13
- 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
- Brand name suffix
- 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 |
|---|
| 43598-678-11 | AZACITIDINE AZACITIDINE | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43598-678 | AZACITIDINE AZACITIDINE (AZACITIDINE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [DR. REDDY'S LABORATORIES INC.] | 2 | Current NDC, Legacy NDC, 1 package rows | 20181206_d38a1247-28c8-a911-e691-a983a2f9a6e3.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 |
|---|
| 43598-678-11 | 43598067811 | 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (43598-678-11) | 2017-12-13 | 0000-00-00 | No | No | Current |