FDA.reportPublic FDA data

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
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PEGFILGRASTIM6 mg/.6mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3A58010674Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2048020Internal RxNorm lookup
2048025Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9bfc4d3e-6120-7fec-f1d6-0b3743752034Available on FDA.report

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
83257-005-41Fulphila0.6 mL in 1 SYRINGEINJECTION0.610
83257-005-41Fulphila1 in 1 CARTONINJECTION110

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83257-005-41ML - Milliliter83257-00570938b99-c329-4d38-92d5-7e9a8098a55712023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83257-005FULPHILA (PEGFILGRASTIM-JMDB) INJECTION [BIOCON BIOLOGICS INC.]10Current NDC, 2 package rows20250122_9bfc4d3e-6120-7fec-f1d6-0b3743752034.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
ndc (product): 83257-005

Purple Book Biologic Products#

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2048025Fulphila 6 MG in 0.6 ML Prefilled SyringePSN9bfc4d3e-6120-7fec-f1d6-0b374375203410
2048020pegfilgrastim-jmdb 6 MG in 0.6 ML Prefilled SyringePSN9bfc4d3e-6120-7fec-f1d6-0b374375203410
20480250.6 ML pegfilgrastim-jmdb 10 MG/ML Prefilled Syringe [Fulphila]SBD9bfc4d3e-6120-7fec-f1d6-0b374375203410
20480200.6 ML pegfilgrastim-jmdb 10 MG/ML Prefilled SyringeSCD9bfc4d3e-6120-7fec-f1d6-0b374375203410
20480250.6 ML Fulphila 10 MG/ML Prefilled SyringeSY9bfc4d3e-6120-7fec-f1d6-0b374375203410
2048025Fulphila 6 MG per 0.6 ML Prefilled SyringeSY9bfc4d3e-6120-7fec-f1d6-0b374375203410
2048020pegfilgrastim-jmdb 6 MG per 0.6 ML Prefilled SyringeSY9bfc4d3e-6120-7fec-f1d6-0b374375203410

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83257-005-41832570005411 SYRINGE in 1 CARTON (83257-005-41) / .6 mL in 1 SYRINGE1 syringe2023-10-01NoNoCurrent