Neulasta
- Product NDC
- 55513-099
- 11-digit product format
- 555130099
- Labeler code
- 55513
- Product ID
- 55513-099_0a35b49f-339b-4651-829a-4e84fb3a0759
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- pegfilgrastim
- Dosage form
- SOLUTION
- Route
- SUBCUTANEOUS
- Labeler
- Amgen, Inc
- Application
- BLA125031
- Marketing category
- BLA
- Marketing start
- 2026-03-31
- Substance
- PEGFILGRASTIM
- Active strength
- 4 mg/.4mL
- 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
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 3A58010674 | PEGFILGRASTIM | 208265-92-3 | PEGFILGRASTIM |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 55513-099-01 | 55513009901 | 1 VIAL in 1 CARTON (55513-099-01) / .4 mL in 1 VIAL | 1 vial | 2026-03-31 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Neulasta | Amgen, Inc | Amgen Manufacturing Limited LLC | 2026-03-10 | HUMAN PRESCRIPTION DRUG LABEL | 159 |