Decitabine
- Product NDC
- 43598-348
- 11-digit product format
- 435980348
- Labeler code
- 43598
- Product ID
- 43598-348_86ae5ec4-f9af-4eff-ae01-e817fe1e8890
- 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
- 2013-07-11
- Marketing end
- 0000-00-00
- 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
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
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] | 2 | |
| Decitabine | ACTIVE MOIETY | 776B62CQ27 | DECITABINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [DR.REDDY'S LABORATORIES INC] | 2 | |
| potassium phosphate, monobasic | INACTIVE INGREDIENT | 4J9FJ0HL51 | DECITABINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [DR.REDDY'S LABORATORIES INC] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43598-348 | DECITABINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [DR. REDDY'S LABORATORIES INC.] | 6 | Legacy NDC | 20201006_99cea19b-cabf-8a6d-b2ef-f04920952b93.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 43598-348-37 | 43598034837 | 1 VIAL, SINGLE-USE in 1 CARTON (43598-348-37) > 10 mL in 1 VIAL, SINGLE-USE | 2013-07-11 | 0000-00-00 | No | No | Current |