Decitabine
- Product NDC
- 67184-0535
- 11-digit product format
- 671840535
- Labeler code
- 67184
- Product ID
- 67184-0535_0afb3dc7-6072-4a53-acc4-59589fb8491e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- decitabine
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Qilu Pharmaceutical Co., Ltd.
- Application
- ANDA212826
- Marketing category
- ANDA
- Marketing start
- 2021-04-12
- 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 |
|---|
| 67184-0535-1 | Decitabine | 20 mL in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 20 | | 2 |
| 67184-0535-1 | Decitabine | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 67184-0535 | DECITABINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [QILU PHARMACEUTICAL CO., LTD.] | 2 | Current NDC, Legacy NDC, 2 package rows | 20211020_5b2dce6f-c715-47dc-971e-06244ccd7548.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 |
|---|
| 67184-0535-1 | 67184053501 | 1 VIAL in 1 CARTON (67184-0535-1) / 20 mL in 1 VIAL | 1 vial | 2021-04-12 | 0000-00-00 | No | No | Current |