Beleodaq
- Product NDC
- 72893-002
- 11-digit product format
- 728930002
- Labeler code
- 72893
- Product ID
- 72893-002_0af69daf-c3eb-436a-b8d9-8ae89c5f0c85
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Belinostat
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Acrotech Biopharma Inc
- Application
- NDA206256
- Marketing category
- NDA
- Marketing start
- 2014-07-21
- Substance
- BELINOSTAT
- Active strength
- 500 mg/10mL
- Pharmacologic classes
- Histone Deacetylase Inhibitor [EPC], Histone Deacetylase Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Beleodaq
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BELINOSTAT | 500 mg/10mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | F4H96P17NZ |
| Rxcui | 1543547, 1543552 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72893-002-01 | Beleodaq | 10 mL in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 10 | | 10 |
| 72893-002-01 | Beleodaq | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 10 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72893-002 | BELEODAQ (BELINOSTAT) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ACROTECH BIOPHARMA INC] | 10 | Current NDC, Legacy NDC, 2 package rows | 20250409_2e8ef36b-71fa-4492-a16f-577d5f7d111d.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 |
|---|
| 72893-002-01 | 72893000201 | 1 VIAL in 1 CARTON (72893-002-01) / 10 mL in 1 VIAL | 1 vial | 2014-07-21 | 0000-00-00 | No | No | Current |