Fulphila
- Product NDC
- 67457-833
- 11-digit product format
- 674570833
- Labeler code
- 67457
- Product ID
- 67457-833_85a107b2-3583-48e8-a205-79e4bbd3b2a5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- pegfilgrastim
- Dosage form
- INJECTION
- Route
- SUBCUTANEOUS
- Labeler
- Mylan Institutional LLC
- Application
- BLA761075
- Marketing category
- BLA
- Marketing start
- 2018-07-09
- Marketing end
- 2026-05-31
- 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
- Current FDA listing
- Yes
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 67457-833-06 | Fulphila | 1 in 1 CARTON | INJECTION | 1 | | 13 |
| 67457-833-06 | Fulphila | 0.6 mL in 1 SYRINGE | INJECTION | 0.6 | | 13 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 67457-833 | FULPHILA (PEGFILGRASTIM-JMDB) INJECTION [MYLAN INSTITUTIONAL LLC] | 13 | Current NDC, Legacy NDC, 2 package rows | 20240110_3ea915d7-2feb-4e75-91f7-913c965b7d8a.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 67457-833-06 | 67457083306 | 1 SYRINGE in 1 CARTON (67457-833-06) / .6 mL in 1 SYRINGE | 1 syringe | 2018-07-09 | 2026-05-31 | No | No | Current |