Fulphila
- Product NDC
- 83257-005
- 11-digit product format
- 832570005
- Labeler code
- 83257
- Product ID
- 83257-005_9c225ff4-d153-535d-98c2-7b2eaec81e12
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- pegfilgrastim-jmdb
- Dosage form
- INJECTION
- Route
- SUBCUTANEOUS
- Labeler
- Biocon Biologics Inc.
- Application
- BLA761075
- Marketing category
- BLA
- Marketing start
- 2023-10-01
- Substance
- PEGFILGRASTIM
- Active strength
- 6 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Fulphila
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PEGFILGRASTIM | 6 mg/.6mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 3A58010674 |
| Rxcui | 2048020, 2048025 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 83257-005-41 | Fulphila | 0.6 mL in 1 SYRINGE | INJECTION | 0.6 | | 10 |
| 83257-005-41 | Fulphila | 1 in 1 CARTON | INJECTION | 1 | | 10 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 83257-005 | FULPHILA (PEGFILGRASTIM-JMDB) INJECTION [BIOCON BIOLOGICS INC.] | 10 | Current NDC, 2 package rows | 20250122_9bfc4d3e-6120-7fec-f1d6-0b3743752034.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 83257-005-41 | 83257000541 | 1 SYRINGE in 1 CARTON (83257-005-41) / .6 mL in 1 SYRINGE | 1 syringe | 2023-10-01 | No | No | Current |