FDA.reportPublic FDA data

ARMLUPEG

Product NDC
70748-273
11-digit product format
707480273
Labeler code
70748
Product ID
70748-273_967f202f-090e-4c23-8c20-73e2e6af571d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
pegfilgrastim-unne
Dosage form
INJECTION
Route
SUBCUTANEOUS
Labeler
Lupin Pharmaceuticals, Inc.
Application
BLA761212
Marketing category
BLA
Marketing start
2026-04-01
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ARMLUPEG
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
2737548Internal RxNorm lookup
2737555Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
c48fe1a7-63d7-4dce-bb53-a913cb0ade83Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a21a21e5-f36d-4c1f-8918-def921b8f7e3Product name320250124
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
70748-273-01ARMLUPEG0.6 mL in 1 SYRINGEINJECTION0.65
70748-273-01ARMLUPEG1 in 1 CARTONINJECTION15

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
ARMLUPEGPEGFILGRASTIM-UNNELupin Pharmaceuticals, Inc.c48fe1a7-63d7-4dce-bb53-a913cb0ade832026-07-23Warnings, Adverse reactionsExact identifier
application number: BLA761212
ndc (product): 70748-273

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761212Armlupegpegfilgrastim-unne351(k) BiosimilarRx2026-08-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2737555Armlupeg 6 MG in 0.6 ML Prefilled SyringePSNc48fe1a7-63d7-4dce-bb53-a913cb0ade835
2737548pegfilgrastim-unne 6 MG in 0.6 ML Prefilled SyringePSNc48fe1a7-63d7-4dce-bb53-a913cb0ade835
27375550.6 ML pegfilgrastim-unne 10 MG/ML Prefilled Syringe [Armlupeg]SBDc48fe1a7-63d7-4dce-bb53-a913cb0ade835
27375480.6 ML pegfilgrastim-unne 10 MG/ML Prefilled SyringeSCDc48fe1a7-63d7-4dce-bb53-a913cb0ade835
27375550.6 ML Armlupeg 10 MG/ML Prefilled SyringeSYc48fe1a7-63d7-4dce-bb53-a913cb0ade835
2737555Armlupeg 6 MG per 0.6 ML Prefilled SyringeSYc48fe1a7-63d7-4dce-bb53-a913cb0ade835
2737548pegfilgrastim-unne 6 MG per 0.6 ML Prefilled SyringeSYc48fe1a7-63d7-4dce-bb53-a913cb0ade835

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70748-273-01707480273011 SYRINGE in 1 CARTON (70748-273-01) / .6 mL in 1 SYRINGE1 syringe2026-04-01NoNoCurrent