Rolvedon
- Product NDC
- 76961-101
- 11-digit product format
- 769610101
- Labeler code
- 76961
- Product ID
- 76961-101_9209fc63-aee3-43dc-9bc6-16c5ed73d858
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- eflapegrastim-xnst
- Dosage form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Labeler
- Spectrum Pharmaceuticals, Inc.
- Application
- BLA761148
- Marketing category
- BLA
- Marketing start
- 2022-10-18
- Marketing end
- 2027-08-31
- 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
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Rolvedon
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 |
|---|
| 76961-101-01 | Rolvedon | 0.6 mL in 1 SYRINGE, GLASS | INJECTION, SOLUTION | 0.6 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 76961-101 | ROLVEDON (EFLAPEGRASTIM-XNST) INJECTION, SOLUTION [SPECTRUM PHARMACEUTICALS, INC.] | 4 | Current NDC, Legacy NDC, 1 package rows | 20240316_6e436115-62e7-4729-aeb0-ff78ea685206.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 |
|---|
| 76961-101-01 | 76961010101 | .6 mL in 1 SYRINGE, GLASS (76961-101-01) | 2022-10-18 | 2027-08-31 | No | No | Current |