Reblozyl
- Product NDC
- 59572-775
- 11-digit product format
- 595720775
- Labeler code
- 59572
- Product ID
- 59572-775_769ec39a-61bd-4726-b14a-9594897baa67
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Luspatercept
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- SUBCUTANEOUS
- Labeler
- Celgene Corporation
- Application
- BLA761136
- Marketing category
- BLA
- Marketing start
- 2019-11-08
- Substance
- LUSPATERCEPT
- Active strength
- 75 mg/1
- Pharmacologic classes
- Erythroid Maturation Agent [EPC], Increased Erythroid Cell Production [PE]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Reblozyl
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LUSPATERCEPT | 75 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | AQK7UBA1LS |
| Rxcui | 2262906, 2262911, 2262913, 2262915 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 59572-775-01 | Reblozyl | 1 in 1 VIAL, GLASS | INJECTION, POWDER, LYOPHILIZED, | 1 | | 20 |
| 59572-775-01 | Reblozyl | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 20 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 59572-775 | REBLOZYL (LUSPATERCEPT) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [CELGENE CORPORATION] | 19 | Current NDC, Legacy NDC, 2 package rows | 20240530_82f4d266-3f52-41eb-86ba-0abf3cf468e8.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 |
|---|
| 59572-775-01 | 59572077501 | 1 VIAL, GLASS in 1 CARTON (59572-775-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS | 2019-11-08 | 0000-00-00 | No | No | Current |