FDA.reportPublic FDA data

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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct67457-833DDiscontinued by firm2026-08-17
excluded packagepackage67457-83367457-833-06DDiscontinued by firm2026-08-17

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7979a9c8-e75a-40a9-87cc-a5f08355aaefProduct name120230626
c3bb58c9-5c71-4b39-a70d-70acbffd3efeProduct name120230127
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
4217ae0d-ff4c-46f5-9e69-8cb4b72b3e37Product name120150402
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67457-833-06Fulphila1 in 1 CARTONINJECTION113
67457-833-06Fulphila0.6 mL in 1 SYRINGEINJECTION0.613

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67457-833-06ML - Milliliter67457-83394f39530-c787-4375-ab79-02955304f67912018-08-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67457-833FULPHILA (PEGFILGRASTIM-JMDB) INJECTION [MYLAN INSTITUTIONAL LLC]13Current NDC, Legacy NDC, 2 package rows20240110_3ea915d7-2feb-4e75-91f7-913c965b7d8a.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FulphilaPEGFILGRASTIM-JMDBBiocon Biologics Inc.9bfc4d3e-6120-7fec-f1d6-0b37437520342026-01-30Warnings, Adverse reactionsExact identifier
application number: BLA761075

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761075Fulphilapegfilgrastim-jmdb351(k) BiosimilarRx2026-08-01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67457-833-06674570833061 SYRINGE in 1 CARTON (67457-833-06) / .6 mL in 1 SYRINGE1 syringe2018-07-092026-05-31NoNoCurrent