FDA.reportPublic FDA data

LYUMJEV

Product NDC
50090-7433
11-digit product format
500907433
Labeler code
50090
Product ID
50090-7433_d1450e12-abc4-424d-be20-f1fc96a4a212
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Insulin lispro-aabc
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS; SUBCUTANEOUS
Labeler
A-S Medication Solutions
Application
BLA761109
Marketing category
BLA
Marketing start
2020-06-15
Substance
INSULIN LISPRO
Active strength
100 [iU]/mL
Pharmacologic classes
Insulin Analog [EPC], Insulin [Chemical/Ingredient]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
LYUMJEV
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
INSULIN LISPRO100 [iU]/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
2380231Internal RxNorm lookup
2380236Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
616daea1-0b79-4970-a141-6f99f2072f02Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d31d7280-9cbd-4e8c-ad8c-a830d9d6c4bfProduct name120260309
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
a42609d2-d76b-4c21-bc65-ace5fa0da69dProduct name120210105
0c5ba5d1-c81f-5bcc-49a8-b8e264edfb14Product name320200325
4477e8cc-8057-4880-8829-dfea528a2efaProduct name220200325
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-7433-0LYUMJEV1 in 1 CARTONINJECTION, SOLUTION13
50090-7433-0LYUMJEV10 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7433-0ML - Milliliter50090-74337f9d20c3-a18a-4fd6-9a40-e1900f9e0cb412024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-7433LYUMJEV (INSULIN LISPRO-AABC) INJECTION, SOLUTION [A-S MEDICATION SOLUTIONS]1Current NDC, 2 package rows20241107_616daea1-0b79-4970-a141-6f99f2072f02.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
LYUMJEVINSULIN LISPRO-AABCA-S Medication Solutions616daea1-0b79-4970-a141-6f99f2072f022026-04-13Warnings, Adverse reactionsExact identifier
application number: BLA761109
ndc (product): 50090-7433
LYUMJEVINSULIN LISPRO-AABCEli Lilly and Companyc5a056e2-b568-4ca6-9ed8-79c010942d002025-12-30Warnings, Adverse reactionsExact identifier
application number: BLA761109

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761109Lyumjevinsulin lispro-aabc351(a)Rx2026-07-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2380231insulin lispro-aabc 100 UNT/ML Injectable SolutionPSN616daea1-0b79-4970-a141-6f99f2072f023
2380236LYUMJEV 100 UNT/ML Injectable SolutionPSN616daea1-0b79-4970-a141-6f99f2072f023
2380236insulin lispro-aabc 100 UNT/ML Injectable Solution [Lyumjev]SBD616daea1-0b79-4970-a141-6f99f2072f023
2380231insulin lispro-aabc 100 UNT/ML Injectable SolutionSCD616daea1-0b79-4970-a141-6f99f2072f023
2380236Lyumjev 100 UNT/ML Injectable SolutionSY616daea1-0b79-4970-a141-6f99f2072f023

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-7433-0500907433001 VIAL, MULTI-DOSE in 1 CARTON (50090-7433-0) / 10 mL in 1 VIAL, MULTI-DOSE2024-11-04NoNoCurrent