FDA.reportPublic FDA data

ARMLUPEG

Product NDC
70748-273
Requested package NDC
70748-273-01
11-digit product format
707480273
Labeler code
70748
Product ID
70748-273_78db760d-9070-450f-8245-bd72e0e54d7a
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

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761212Armlupegpegfilgrastim-unne351(k) BiosimilarRx2026-10-01

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