FDA.reportPublic FDA data

Novolin

Product NDC
64725-1833
11-digit product format
647251833
Labeler code
64725
Product ID
64725-1833_a2c745d7-1b63-4064-b6a1-e18e43b318ad
Type
HUMAN OTC DRUG
Nonproprietary name
Human Insulin
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
TYA Pharmaceuticals
Application
NDA019938
Marketing category
NDA
Marketing start
1991-06-25
Marketing end
0000-00-00
Substance
INSULIN HUMAN
Active strength
100 [iU]/mL
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
d1997359-a049-4781-b04b-084a7f3cb039Product name220200325
aa12d3c0-d2b4-4c50-9af0-cb08b230ec20Product name220200323

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64725-1833-12020-01-31C16284748780-19d75b9cf-e1dd-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Novolin R safely and effectively. See full prescribing information for Novolin R. Initial U.S. Approval: 1991 Novolin R (Regular, Human Insulin [rDNA origin] USP) solution for subcutaneous or intravenous use ®

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64725-1833-1Novolin R10 mL in 1 VIALINJECTION, SOLUTION102

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
INSULIN HUMANACTIVE INGREDIENT1Y17CTI5SRNOVOLIN R (HUMAN INSULIN) INJECTION, SOLUTION [TYA PHARMACEUTICALS]2
INSULIN HUMANACTIVE MOIETY1Y17CTI5SRNOVOLIN R (HUMAN INSULIN) INJECTION, SOLUTION [TYA PHARMACEUTICALS]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXNOVOLIN R (HUMAN INSULIN) INJECTION, SOLUTION [TYA PHARMACEUTICALS]2
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBNOVOLIN R (HUMAN INSULIN) INJECTION, SOLUTION [TYA PHARMACEUTICALS]2
METACRESOLINACTIVE INGREDIENTGGO4Y809LONOVOLIN R (HUMAN INSULIN) INJECTION, SOLUTION [TYA PHARMACEUTICALS]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32INOVOLIN R (HUMAN INSULIN) INJECTION, SOLUTION [TYA PHARMACEUTICALS]2
WATERINACTIVE INGREDIENT059QF0KO0RNOVOLIN R (HUMAN INSULIN) INJECTION, SOLUTION [TYA PHARMACEUTICALS]2
ZINC CHLORIDEINACTIVE INGREDIENT86Q357L16BNOVOLIN R (HUMAN INSULIN) INJECTION, SOLUTION [TYA PHARMACEUTICALS]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64725-1833NOVOLIN R (HUMAN INSULIN) INJECTION, SOLUTION [TYA PHARMACEUTICALS]2Legacy NDC, 1 package rows20141031_78dadbee-c3b6-4d62-a338-731b24cc7ef0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311033NovoLIN R 100 UNT/ML Injectable SolutionPSN78dadbee-c3b6-4d62-a338-731b24cc7ef02
311034regular insulin, human 100 UNT/ML Injectable SolutionPSN78dadbee-c3b6-4d62-a338-731b24cc7ef02
311033insulin, regular, human 100 UNT/ML Injectable Solution [Novolin R]SBD78dadbee-c3b6-4d62-a338-731b24cc7ef02
311034insulin, regular, human 100 UNT/ML Injectable SolutionSCD78dadbee-c3b6-4d62-a338-731b24cc7ef02
311034insulin, human regular 100 UNT/ML Injectable SolutionSY78dadbee-c3b6-4d62-a338-731b24cc7ef02
311033Novolin R 100 UNT/ML Injectable SolutionSY78dadbee-c3b6-4d62-a338-731b24cc7ef02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
64725-1833-16472518330110 mL in 1 VIAL10 mlHistorical