FDA.reportPublic FDA data

HUMULIN R

Product NDC
50090-0353
11-digit product format
500900353
Labeler code
50090
Product ID
50090-0353_87a75165-353b-4c21-b82d-4ccbd893f881
Type
HUMAN OTC DRUG
Nonproprietary name
Insulin human
Dosage form
INJECTION, SOLUTION
Route
PARENTERAL
Labeler
A-S Medication Solutions
Application
BLA018780
Marketing category
BLA
Marketing start
1983-06-27
Substance
INSULIN HUMAN
Active strength
100 [iU]/mL
Pharmacologic classes
Insulin [CS], Insulin [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
INSULIN HUMAN100 [iU]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1Y17CTI5SR
Rxcui311034, 311036

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d1997359-a049-4781-b04b-084a7f3cb039Product name220200325
aa12d3c0-d2b4-4c50-9af0-cb08b230ec20Product name220200323

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-0353-02021-09-11C16284748780-19d75b9d0-e4d3-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use HUMULIN R safely and effectively. See full prescribing information for HUMULIN R. HUMULIN R (insulin human) injection, for subcutaneous or intravenous use Initial U.S. Approval: 1982
50090-0353-02020-01-31C16284748780-19d75b9d0-e4d3-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use HUMULIN R safely and effectively. See full prescribing information for HUMULIN R. HUMULIN R (insulin human) injection, for subcutaneous or intravenous use Initial U.S. Approval: 1982

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-0353-0HUMULIN R10 mL in 1 VIALINJECTION, SOLUTION1025
50090-0353-0HUMULIN R1 in 1 CARTONINJECTION, SOLUTION125

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0353-0ML - Milliliter50090-0353edacdce2-49d0-463f-b612-c6ead3fcb6f912021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0353HUMULIN R (INSULIN HUMAN) INJECTION, SOLUTION [A-S MEDICATION SOLUTIONS]25Current NDC, Legacy NDC, 2 package rows20240103_81199e55-ade9-46de-a5a3-c0415acee403.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311036HumuLIN R 100 UNT/ML Injectable SolutionPSN81199e55-ade9-46de-a5a3-c0415acee40325
311034regular insulin, human 100 UNT/ML Injectable SolutionPSN81199e55-ade9-46de-a5a3-c0415acee40325
311036insulin, regular, human 100 UNT/ML Injectable Solution [Humulin R]SBD81199e55-ade9-46de-a5a3-c0415acee40325
311034insulin, regular, human 100 UNT/ML Injectable SolutionSCD81199e55-ade9-46de-a5a3-c0415acee40325
311036Humulin R 100 UNT/ML Injectable SolutionSY81199e55-ade9-46de-a5a3-c0415acee40325
311034insulin, human regular 100 UNT/ML Injectable SolutionSY81199e55-ade9-46de-a5a3-c0415acee40325

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-0353-0500900353001 VIAL in 1 CARTON (50090-0353-0) / 10 mL in 1 VIAL1 vial2019-04-30NoNoHistorical