Rolvedon
- Product NDC
- 82497-132
- 11-digit product format
- 824970132
- Labeler code
- 82497
- Product ID
- 82497-132_ef8eef01-b278-484e-b4d4-85905e756674
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- eflapegrastim-xnst
- Dosage form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Labeler
- Assertio Specialty Pharmaceuticals, LLC
- Application
- BLA761148
- Marketing category
- BLA
- Marketing start
- 2025-12-11
- Substance
- EFLAPEGRASTIM
- Active strength
- 13.2 mg/.6mL
- Pharmacologic classes
- Granulocyte Colony-Stimulating Factor [CS], Increased Myeloid Cell Production [PE], Leukocyte Growth Factor [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Rolvedon
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| EFLAPEGRASTIM | 13.2 mg/.6mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | UT99UG9QJX |
| Rxcui | 2612541, 2612547 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 82497-132-01 | Rolvedon | 0.6 mL in 1 SYRINGE, GLASS | INJECTION, SOLUTION | 0.6 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 82497-132-01 | 82497013201 | .6 mL in 1 SYRINGE, GLASS (82497-132-01) | 2025-12-11 | No | No | Historical |