FDA.reportPublic FDA data

ADMELOG

Product NDC
0024-5926
11-digit product format
000245926
Labeler code
0024
Product ID
0024-5926_9631cc90-ea8d-42bb-ba01-ed8f09b8a6c5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
insulin lispro
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS; SUBCUTANEOUS
Labeler
Sanofi-Aventis U.S. LLC
Application
BLA209196
Marketing category
BLA
Marketing start
2018-10-19
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 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
242120Internal RxNorm lookup
1652639Internal RxNorm lookup
1992169Internal 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
0691def8-4a7b-4de3-866f-a280989f47f1Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
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
0024-5926-05ADMELOG1 in 1 CARTONINJECTION, SOLUTION114
0024-5926-05ADMELOG3 mL in 1 VIALINJECTION, SOLUTION314

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0024-5926-05ML - Milliliter0024-592682b9070b-d708-4a60-a4d4-95f190acfc9612019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0024-5926ADMELOG (INSULIN LISPRO) INJECTION, SOLUTION [SANOFI-AVENTIS U.S. LLC]13Current NDC, Legacy NDC, 2 package rows20230921_0691def8-4a7b-4de3-866f-a280989f47f1.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
ADMELOGINSULIN LISPROSanofi-Aventis U.S. LLC0691def8-4a7b-4de3-866f-a280989f47f12025-06-04Warnings, Adverse reactionsExact identifier
application number: BLA209196
ndc (product): 0024-5926

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
209196Admeloginsulin lispro351(a)Rx2026-06-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1992171Admelog 100 UNT/ML in 3 ML Pen InjectorPSN0691def8-4a7b-4de3-866f-a280989f47f114
1992169Admelog 100 UNT/ML Injectable SolutionPSN0691def8-4a7b-4de3-866f-a280989f47f114
1652639insulin lispro 100 UNT/ML in 3 ML Pen InjectorPSN0691def8-4a7b-4de3-866f-a280989f47f114
242120insulin lispro 100 UNT/ML Injectable SolutionPSN0691def8-4a7b-4de3-866f-a280989f47f114
19921713 ML insulin lispro 100 UNT/ML Pen Injector [Admelog]SBD0691def8-4a7b-4de3-866f-a280989f47f114
1992169insulin lispro 100 UNT/ML Injectable Solution [Admelog]SBD0691def8-4a7b-4de3-866f-a280989f47f114
16526393 ML insulin lispro 100 UNT/ML Pen InjectorSCD0691def8-4a7b-4de3-866f-a280989f47f114
242120insulin lispro 100 UNT/ML Injectable SolutionSCD0691def8-4a7b-4de3-866f-a280989f47f114
1992169Admelog 100 UNT/ML Injectable SolutionSY0691def8-4a7b-4de3-866f-a280989f47f114
1992171Admelog 100 UNT/ML per 3 ML Pen InjectorSY0691def8-4a7b-4de3-866f-a280989f47f114
1652639insulin lispro 100 UNT/ML per 3 ML Pen InjectorSY0691def8-4a7b-4de3-866f-a280989f47f114
242120insulin, analog lispro 100 UNT/ML Injectable SolutionSY0691def8-4a7b-4de3-866f-a280989f47f114

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0024-5926-05000245926051 VIAL in 1 CARTON (0024-5926-05) / 3 mL in 1 VIAL1 vial2018-10-190000-00-00NoNoCurrent