FDA.reportPublic FDA data

INSULIN GLARGINE

Product NDC
72572-422
Requested package NDC
72572-422-05
11-digit product format
725720422
Labeler code
72572
Product ID
72572-422_83f8663d-cb21-9b78-e315-e0db15befb18
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
insulin glargine-yfgn
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
Civica, Inc.
Application
BLA761201
Marketing category
BLA
Marketing start
2025-10-30
Substance
INSULIN GLARGINE
Active strength
100 [iU]/mL
Pharmacologic classes
Insulin Analog [EPC], Insulin [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
INSULIN GLARGINE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
INSULIN GLARGINE100 [iU]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2ZM8CX04RZInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2563971Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
72cfe377-52f6-0348-fc71-5d4ac1992ffbAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
a9e2da77-dd6b-4b0e-9065-a13f87955fe1Product name120220720
5f5c996a-6aad-4f9a-86a2-e09dc8b634cbProduct name120220207
1c45812e-8815-4d17-83e9-a18ac8df9badProduct name120210105
256d5b66-c6d0-4302-bcdf-00cf53e72c3bProduct name220200323
2e66a9ce-feca-49d1-97e2-3bec86a60bd8Product name220200323
e43198b7-315b-480b-8517-8809d5ca232aProduct name220200323

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72572-422-01INSULIN GLARGINE1 in 1 CARTONINJECTION, SOLUTION11
72572-422-01INSULIN GLARGINE3 mL in 1 SYRINGEINJECTION, SOLUTION31
72572-422-05INSULIN GLARGINE5 in 1 CARTONINJECTION, SOLUTION51
72572-422-05INSULIN GLARGINE3 mL in 1 SYRINGEINJECTION, SOLUTION31

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72572-422-01ML - Milliliter72572-42272444446-23e2-457b-9275-800001fa24f112026-01-08
72572-422-05ML - Milliliter72572-42209d5d73f-b6cf-4ae2-ad0e-705f726a971912025-12-16

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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
INSULIN GLARGINEINSULIN GLARGINE-YFGNCivica, Inc.72cfe377-52f6-0348-fc71-5d4ac1992ffb2025-07-24Warnings, Adverse reactionsExact identifier
application number: BLA761201
ndc (package): 72572-422-05
ndc (product): 72572-422
ndc11 (package): 72572042205
INSULIN GLARGINEINSULIN GLARGINE-YFGNCivica, Inc.216f2167-c201-76fe-81ed-0d51fe53832f2025-07-03Warnings, Adverse reactionsExact identifier
application number: BLA761201
SEMGLEEINSULIN GLARGINE-YFGNBiocon Biologics Inc.8cf5544f-87d6-468b-f6ae-898b1fdb5d802025-03-03Warnings, Adverse reactionsExact identifier
application number: BLA761201
Insulin GlargineINSULIN GLARGINE-YFGNBiocon Biologics Inc.3ac85ebb-5594-59c8-77fd-df254329d1512025-03-03Warnings, Adverse reactionsExact identifier
application number: BLA761201

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761201Semgleeinsulin glargine-yfgn351(k) InterchangeableRx2026-06-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2563971insulin glargine-yfgn 300 UNT in 3 ML Pen InjectorPSN72cfe377-52f6-0348-fc71-5d4ac1992ffb1
25639713 ML insulin glargine-yfgn 100 UNT/ML Pen InjectorSCD72cfe377-52f6-0348-fc71-5d4ac1992ffb1
2563971insulin glargine-yfgn 100 UNT/ML per 3 ML Pen InjectorSY72cfe377-52f6-0348-fc71-5d4ac1992ffb1
2563971insulin glargine-yfgn 300 UNT per 3 ML Pen InjectorSY72cfe377-52f6-0348-fc71-5d4ac1992ffb1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72572-422-05725720422055 SYRINGE in 1 CARTON (72572-422-05) / 3 mL in 1 SYRINGE5 syringe2025-10-30NoNoCurrent