NYVEPRIA
- Product NDC
- 0069-0324
- 11-digit product format
- 000690324
- Labeler code
- 0069
- Product ID
- 0069-0324_a89f35d2-46e6-457b-a617-3c7537e6f709
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- pegfilgrastim-apgf
- Dosage form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Labeler
- Pfizer Laboratories Div Pfizer Inc
- Application
- BLA761111
- Marketing category
- BLA
- Marketing start
- 2020-12-15
- Substance
- PEGFILGRASTIM
- Active strength
- 6 mg/.6mL
- Pharmacologic classes
- Granulocyte Colony-Stimulating Factor [CS], Granulocyte-Macrophage Colony-Stimulating Factor [CS], Increased Myeloid Cell Production [PE], Leukocyte Growth Factor [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- NYVEPRIA
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PEGFILGRASTIM | 6 mg/.6mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 3A58010674 |
| Rxcui | 2469335, 2469340 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0069-0324-01 | NYVEPRIA | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0069-0324 | NYVEPRIA (PEGFILGRASTIM-APGF) INJECTION, SOLUTION [PFIZER LABORATORIES DIV PFIZER INC] | 8 | Current NDC, Legacy NDC, 1 package rows | 20230630_99d30b99-2743-446b-98f3-0430bf4ea869.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0069-0324-01 | 00069032401 | 1 CARTON in 1 CARTON (0069-0324-01) / 1 SYRINGE in 1 CARTON / .6 mL in 1 SYRINGE | 1 carton | 2020-12-15 | 0000-00-00 | No | No | Current |