Decitabine
- Product NDC
- 72162-2634
- 11-digit product format
- 721622634
- Labeler code
- 72162
- Product ID
- 72162-2634_65cf8205-fdd2-4b24-ab56-ffd03eca0ae2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Decitabine
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA212265
- Marketing category
- ANDA
- Marketing start
- 2019-08-28
- 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 |
|---|
| 72162-2634-2 | Decitabine | 20 mL in 1 VIAL, SINGLE-USE | INJECTION, POWDER, LYOPHILIZED, | 20 | | 100 |
| 72162-2634-2 | Decitabine | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 100 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 72162-2634-2 | 72162263402 | 1 VIAL, SINGLE-USE in 1 CARTON (72162-2634-2) / 20 mL in 1 VIAL, SINGLE-USE | 2026-05-06 | No | No | Current |