FDA.reportPublic FDA data

Novolin

Product NDC
64725-1834
11-digit product format
647251834
Labeler code
64725
Product ID
64725-1834_88240c8b-10c5-43b4-8a36-020380cea930
Type
HUMAN OTC DRUG
Nonproprietary name
Human Insulin
Dosage form
INJECTION, SUSPENSION
Route
SUBCUTANEOUS
Labeler
TYA Pharmaceuticals
Application
NDA019959
Marketing category
NDA
Marketing start
1991-07-01
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
64725-1834-12019-11-27C16284748780-19855e2a2-4122-60a7-e053-dbdaa90a05bdNovolin N NPH, Human Insulin Isophane Suspension (recombinant DNA origin) 100 units/mL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64725-1834-1Novolin N10 mL in 1 VIALINJECTION, SUSPENSION102

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
INSULIN HUMANACTIVE INGREDIENT1Y17CTI5SRNOVOLIN N (HUMAN INSULIN) INJECTION, SUSPENSION [TYA PHARMACEUTICALS]2
INSULIN HUMANACTIVE MOIETY1Y17CTI5SRNOVOLIN N (HUMAN INSULIN) INJECTION, SUSPENSION [TYA PHARMACEUTICALS]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXNOVOLIN N (HUMAN INSULIN) INJECTION, SUSPENSION [TYA PHARMACEUTICALS]2
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBNOVOLIN N (HUMAN INSULIN) INJECTION, SUSPENSION [TYA PHARMACEUTICALS]2
METACRESOLINACTIVE INGREDIENTGGO4Y809LONOVOLIN N (HUMAN INSULIN) INJECTION, SUSPENSION [TYA PHARMACEUTICALS]2
PHENOLINACTIVE INGREDIENT339NCG44TVNOVOLIN N (HUMAN INSULIN) INJECTION, SUSPENSION [TYA PHARMACEUTICALS]2
PROTAMINE SULFATEINACTIVE INGREDIENT0DE9724IHCNOVOLIN N (HUMAN INSULIN) INJECTION, SUSPENSION [TYA PHARMACEUTICALS]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32INOVOLIN N (HUMAN INSULIN) INJECTION, SUSPENSION [TYA PHARMACEUTICALS]2
SODIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENT94255I6E2TNOVOLIN N (HUMAN INSULIN) INJECTION, SUSPENSION [TYA PHARMACEUTICALS]2
WATERINACTIVE INGREDIENT059QF0KO0RNOVOLIN N (HUMAN INSULIN) INJECTION, SUSPENSION [TYA PHARMACEUTICALS]2
ZINC CHLORIDEINACTIVE INGREDIENT86Q357L16BNOVOLIN N (HUMAN INSULIN) INJECTION, SUSPENSION [TYA PHARMACEUTICALS]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64725-1834NOVOLIN N (HUMAN INSULIN) INJECTION, SUSPENSION [TYA PHARMACEUTICALS]2Legacy NDC, 1 package rows20140928_99c995f1-522e-42aa-b45a-117e0af77d81.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311028insulin isophane (NPH), human 100 UNT/mL Injectable SuspensionPSN99c995f1-522e-42aa-b45a-117e0af77d812
311027NovoLIN N 100 UNT/ML Injectable SuspensionPSN99c995f1-522e-42aa-b45a-117e0af77d812
311027insulin isophane, human 100 UNT/ML Injectable Suspension [Novolin N]SBD99c995f1-522e-42aa-b45a-117e0af77d812
311028insulin isophane, human 100 UNT/ML Injectable SuspensionSCD99c995f1-522e-42aa-b45a-117e0af77d812
311028insulin isophane (NPH), human 100 UNT/ML Injectable SuspensionSY99c995f1-522e-42aa-b45a-117e0af77d812
311027Novolin N 100 UNT/ML Injectable SuspensionSY99c995f1-522e-42aa-b45a-117e0af77d812
311027ReliOn Novolin N 100 UNT/ML Injectable SuspensionSY99c995f1-522e-42aa-b45a-117e0af77d812

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
64725-1834-16472518340110 mL in 1 VIAL10 mlHistorical