NDC 64725-1834

Novolin N

Human Insulin

Novolin N is a Subcutaneous Injection, Suspension in the Human Otc Drug category. It is labeled and distributed by Tya Pharmaceuticals. The primary component is Insulin Human.

Product ID64725-1834_88240c8b-10c5-43b4-8a36-020380cea930
NDC64725-1834
Product TypeHuman Otc Drug
Proprietary NameNovolin N
Generic NameHuman Insulin
Dosage FormInjection, Suspension
Route of AdministrationSUBCUTANEOUS
Marketing Start Date1991-07-01
Marketing CategoryNDA / NDA
Application NumberNDA019959
Labeler NameTYA Pharmaceuticals
Substance NameINSULIN HUMAN
Active Ingredient Strength100 [iU]/mL
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 64725-1834-1

10 mL in 1 VIAL (64725-1834-1)
Marketing Start Date1991-07-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 64725-1834-1 [64725183401]

Novolin N INJECTION, SUSPENSION
Marketing CategoryNDA
Application NumberNDA019959
Product TypeHUMAN OTC DRUG
Marketing Start Date1991-07-01
Inactivation Date2019-11-27

Drug Details

Active Ingredients

IngredientStrength
INSULIN HUMAN100 [iU]/mL

OpenFDA Data

SPL SET ID:99c995f1-522e-42aa-b45a-117e0af77d81
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 311027
  • 311028
  • NDC Crossover Matching brand name "Novolin N" or generic name "Human Insulin"

    NDCBrand NameGeneric Name
    0169-1833NovolinHuman Insulin
    0169-1834NovolinHuman Insulin
    0169-1837NovolinHuman Insulin
    0169-3003NovolinHuman Insulin
    0169-3004NovolinHuman Insulin
    0169-3007NovolinHuman Insulin
    50090-0403NovolinHuman Insulin
    50090-0497NovolinHuman Insulin
    50090-0498NovolinHuman Insulin
    64725-1833NovolinHuman Insulin
    64725-1834NovolinHuman Insulin
    64725-1837NovolinHuman Insulin
    68071-1701NovolinHuman Insulin

    Trademark Results [Novolin]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    NOVOLIN
    NOVOLIN
    73498651 1384926 Live/Registered
    NOVO INDUSTRI A/S
    1984-09-10

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.