Decitabine
- Product NDC
- 25021-219
- 11-digit product format
- 250210219
- Labeler code
- 25021
- Product ID
- 25021-219_350e175f-f66a-4707-a35a-c7460c3bd3d9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Decitabine
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Sagent Pharmaceuticals
- Application
- ANDA212826
- Marketing category
- ANDA
- Marketing start
- 2023-11-01
- Substance
- DECITABINE
- Active strength
- 50 mg/20mL
- 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
- Decitabine
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DECITABINE | 50 mg/20mL |
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 |
|---|
| 25021-219-20 | Decitabine | 20 mL in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 20 | | 1 |
| 25021-219-20 | Decitabine | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 25021-219 | DECITABINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SAGENT PHARMACEUTICALS] | 1 | Current NDC, 2 package rows | 20231108_749f8d8c-e378-42a1-b94a-136b606dadb4.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 25021-219-20 | 25021021920 | 1 VIAL in 1 CARTON (25021-219-20) / 20 mL in 1 VIAL | 1 vial | 2023-11-01 | No | No | Historical |