FDA.reportPublic FDA data

ADMELOG

Product NDC
0024-5925
11-digit product format
000245925
Labeler code
0024
Product ID
0024-5925_9631cc90-ea8d-42bb-ba01-ed8f09b8a6c5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
insulin lispro
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
Sanofi-Aventis U.S. LLC
Application
BLA209196
Marketing category
BLA
Marketing start
2017-12-11
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 Identifiers#

Field, Values table
FieldValues
UniiGFX7QIS1II
Rxcui242120, 1652639, 1992169, 1992171

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
0024-5925-00ADMELOG1 in 1 CARTONINJECTION, SOLUTION114
0024-5925-00ADMELOG3 mL in 1 SYRINGEINJECTION, SOLUTION314
0024-5925-01ADMELOG3 mL in 1 SYRINGEINJECTION, SOLUTION314
0024-5925-05ADMELOG5 in 1 CARTONINJECTION, SOLUTION514

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0024-5925-00ML - Milliliter0024-59258c39b012-5617-40f0-bcd2-e07f0140ec5912020-04-20
0024-5925-01ML - Milliliter0024-592572fed583-7567-415e-a702-c2b89021b02012019-03-12
0024-5925-05ML - Milliliter0024-59251d7ebf55-7777-43b7-900e-fd509deef83912018-02-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0024-5925ADMELOG (INSULIN LISPRO) INJECTION, SOLUTION [SANOFI-AVENTIS U.S. LLC]13Current NDC, Legacy NDC, 4 package rows20230921_0691def8-4a7b-4de3-866f-a280989f47f1.zip

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
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 startMarketing endSampleExclude flagStatus
0024-5925-00000245925001 SYRINGE in 1 CARTON (0024-5925-00) / 3 mL in 1 SYRINGE1 syringe2017-12-110000-00-00YesNoCurrent
0024-5925-01000245925013 mL in 1 SYRINGE3 mlHistorical
0024-5925-05000245925055 SYRINGE in 1 CARTON (0024-5925-05) / 3 mL in 1 SYRINGE (0024-5925-01) 5 syringe2017-12-110000-00-00NoNoCurrent