Decitabine
- Product NDC
- 72205-036
- 11-digit product format
- 722050036
- Labeler code
- 72205
- Product ID
- 72205-036_2ca9d834-97c7-48db-a6ad-cdf530063b05
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Decitabine
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Novadoz Pharmaceuticals LLC
- Application
- ANDA212265
- Marketing category
- ANDA
- Marketing start
- 2020-03-02
- 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 |
|---|
| 72205-036-01 | Decitabine | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 2 |
| 72205-036-01 | 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 |
|---|
| 72205-036 | DECITABINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [NOVADOZ PHARMACEUTICALS LLC] | 2 | Current NDC, Legacy NDC, 2 package rows | 20210616_a1b43089-bc88-4ac6-bdee-9cc38ec30f4e.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 72205-036-01 | 72205003601 | 1 VIAL, SINGLE-DOSE in 1 CARTON (72205-036-01) / 10 mL in 1 VIAL, SINGLE-DOSE | 2020-03-02 | 0000-00-00 | No | No | Current |