Decitabine
- Product NDC
- 67457-316
- 11-digit product format
- 674570316
- Labeler code
- 67457
- Product ID
- 67457-316_b47bee52-7718-749c-e053-2a95a90a0f38
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- decitabine
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Mylan Institutional LLC
- Application
- ANDA204607
- Marketing category
- ANDA
- Marketing start
- 2018-10-10
- 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 |
|---|
| 67457-316-25 | Decitabine | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 7 |
| 67457-316-25 | Decitabine | 20 mL in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 20 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 67457-316 | DECITABINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MYLAN INSTITUTIONAL LLC] | 7 | Current NDC, Legacy NDC, 2 package rows | 20201120_447a9fbd-106d-4ff6-8fd0-bb38a8c90e17.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 67457-316-25 | 67457031625 | 1 VIAL in 1 CARTON (67457-316-25) / 20 mL in 1 VIAL | 1 vial | 2018-10-10 | 0000-00-00 | No | No | Current |