Decitabine
- Product NDC
- 63323-825
- 11-digit product format
- 633230825
- Labeler code
- 63323
- Product ID
- 63323-825_9597df32-1230-63c3-e053-2995a90a3acf
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Decitabine
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Fresenius Kabi USA, LLC
- Application
- ANDA210756
- Marketing category
- ANDA
- Marketing start
- 2019-12-02
- Marketing end
- 0000-00-00
- 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
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63323-825 | DECITABINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] | 3 | Legacy NDC | 20241018_4d568777-0946-489c-99bf-57e1f562e285.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 63323-825-20 | 63323082520 | 1 VIAL, SINGLE-DOSE in 1 CARTON (63323-825-20) > 20 mL in 1 VIAL, SINGLE-DOSE | 2019-12-02 | 0000-00-00 | No | No | Current |