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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage50090-0353-0e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage50090-0353-09bebd1f3094a…5416666fcb17…

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1Y17CTI5SRInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
311034Internal RxNorm lookup
311036Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
81199e55-ade9-46de-a5a3-c0415acee403Available on FDA.report

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

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Humulin RINSULIN HUMANEli Lilly and Companyb519bd83-038c-4ec5-a231-a51ec5cc291f2025-05-27Warnings, Adverse reactionsExact identifier
application number: BLA018780
Humulin R U-500INSULIN HUMANEli Lilly and Companyb60e8dd0-1d48-4dc9-87fd-e14675255e8c2024-02-22Warnings, Adverse reactionsExact identifier
application number: BLA018780
HUMULIN RINSULIN HUMANA-S Medication Solutions81199e55-ade9-46de-a5a3-c0415acee4032023-10-31Warnings, Adverse reactionsExact identifier
application number: BLA018780
ndc (product): 50090-0353

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
018780Humulin R U-100insulin human351(a)OTC2026-07-01

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 vial2019-04-30NoNoCurrent