Decitabine
- Product NDC
- 68001-642
- 11-digit product format
- 680010642
- Labeler code
- 68001
- Product ID
- 68001-642_3ff1337b-204f-2c46-e063-6394a90a4ebe
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Decitabine
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- BluePoint Laboratories
- Application
- ANDA215355
- Marketing category
- ANDA
- Marketing start
- 2025-05-01
- 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
- 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/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 |
|---|
| 68001-642-41 | Decitabine | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 2 |
| 68001-642-41 | Decitabine | 10 mL in 1 VIAL, SINGLE-DOSE | INJECTION, POWDER, LYOPHILIZED, | 10 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68001-642 | DECITABINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [BLUEPOINT LABORATORIES] | 1 | Current NDC, 2 package rows | 20250503_de303068-589e-4e0a-90ed-e60b2c1a2b56.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 68001-642-41 | 68001064241 | 1 VIAL, SINGLE-DOSE in 1 CARTON (68001-642-41) / 10 mL in 1 VIAL, SINGLE-DOSE | 2025-05-01 | No | No | Current |