Decitabine
- Product NDC
- 43598-427
- 11-digit product format
- 435980427
- Labeler code
- 43598
- Product ID
- 43598-427_8911775c-4f88-acf0-5084-e879da9d1cd4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Decitabine
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Dr. Reddy's Laboratories Inc.
- Application
- ANDA203131
- Marketing category
- ANDA
- Marketing start
- 2014-12-05
- Substance
- DECITABINE
- Active strength
- 50 mg/10mL
- 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
- Decitabine
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DECITABINE | 50 mg/10mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 776B62CQ27 |
| Rxcui | 636631 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 43598-427-37 | Decitabine | 10 mL in 1 VIAL, SINGLE-USE | INJECTION, POWDER, LYOPHILIZED, | 10 | | 9 |
| 43598-427-37 | Decitabine | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 9 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Decitabine | ACTIVE INGREDIENT | 776B62CQ27 | DECITABINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [DR.REDDY'S LABORATORIES INC] | 1 | |
| Decitabine | ACTIVE MOIETY | 776B62CQ27 | DECITABINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [DR.REDDY'S LABORATORIES INC] | 1 | |
| potassium phosphate, monobasic | INACTIVE INGREDIENT | 4J9FJ0HL51 | DECITABINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [DR.REDDY'S LABORATORIES INC] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43598-427 | DECITABINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [DR. REDDY'S LABORATORIES INC.] | 8 | Current NDC, Legacy NDC, 2 package rows | 20240907_358764ca-4c69-d516-af0c-bf8a348d26ca.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 |
|---|
| 43598-427-37 | 43598042737 | 1 VIAL, SINGLE-USE in 1 CARTON (43598-427-37) / 10 mL in 1 VIAL, SINGLE-USE | 2014-12-05 | 0000-00-00 | No | No | Current |