FDA.reportPublic FDA data

ADMELOG

Product NDC
70518-4275
11-digit product format
705184275
Labeler code
70518
Product ID
70518-4275_4019335a-c21f-ab29-e063-6394a90a1c8a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
insulin lispro
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
REMEDYREPACK INC.
Application
BLA209196
Marketing category
BLA
Marketing start
2025-02-04
Substance
INSULIN LISPRO
Active strength
100 U/mL
Pharmacologic classes
Insulin Analog [EPC], Insulin [Chemical/Ingredient]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
INSULIN LISPRO100 U/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
GFX7QIS1IIInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1652639Internal RxNorm lookup
1992171Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
12ec9e3f-e2ac-43a1-b334-8b6538cf2bb0Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a42609d2-d76b-4c21-bc65-ace5fa0da69dProduct name120210105
0c5ba5d1-c81f-5bcc-49a8-b8e264edfb14Product name320200325
4477e8cc-8057-4880-8829-dfea528a2efaProduct name220200325

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-4275-0ADMELOG3 mL in 1 SYRINGEINJECTION, SOLUTION33
70518-4275-0ADMELOG5 in 1 CARTONINJECTION, SOLUTION53

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-4275ADMELOG (INSULIN LISPRO) INJECTION, SOLUTION [REMEDYREPACK INC.]1Current NDC, 2 package rows20250209_12ec9e3f-e2ac-43a1-b334-8b6538cf2bb0.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ADMELOGINSULIN LISPROREMEDYREPACK INC.12ec9e3f-e2ac-43a1-b334-8b6538cf2bb02025-10-01Warnings, Adverse reactionsExact identifier
application number: BLA209196
ndc (product): 70518-4275
ADMELOGINSULIN LISPROSanofi-Aventis U.S. LLC0691def8-4a7b-4de3-866f-a280989f47f12025-06-04Warnings, Adverse reactionsExact identifier
application number: BLA209196

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
209196Admeloginsulin lispro351(a)Rx2026-07-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1992171Admelog 100 UNT/ML in 3 ML Pen InjectorPSN12ec9e3f-e2ac-43a1-b334-8b6538cf2bb03
1652639insulin lispro 100 UNT/ML in 3 ML Pen InjectorPSN12ec9e3f-e2ac-43a1-b334-8b6538cf2bb03
19921713 ML insulin lispro 100 UNT/ML Pen Injector [Admelog]SBD12ec9e3f-e2ac-43a1-b334-8b6538cf2bb03
16526393 ML insulin lispro 100 UNT/ML Pen InjectorSCD12ec9e3f-e2ac-43a1-b334-8b6538cf2bb03
1992171Admelog 100 UNT/ML per 3 ML Pen InjectorSY12ec9e3f-e2ac-43a1-b334-8b6538cf2bb03
1652639insulin lispro 100 UNT/ML per 3 ML Pen InjectorSY12ec9e3f-e2ac-43a1-b334-8b6538cf2bb03

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-4275-0705184275005 SYRINGE in 1 CARTON (70518-4275-0) / 3 mL in 1 SYRINGE5 syringe2025-02-04NoNoCurrent