NDC 0169-3003

Novolin R

Human Insulin

Novolin R is a Subcutaneous Injection, Solution in the Human Otc Drug category. It is labeled and distributed by Novo Nordisk. The primary component is Insulin Human.

Product ID0169-3003_46700b71-3f26-4aaa-8eb7-6ceeeb515c79
NDC0169-3003
Product TypeHuman Otc Drug
Proprietary NameNovolin R
Generic NameHuman Insulin
Dosage FormInjection, Solution
Route of AdministrationSUBCUTANEOUS
Marketing Start Date2019-09-06
Marketing CategoryBLA / NDA
Application NumberBLA019938
Labeler NameNovo Nordisk
Substance NameINSULIN HUMAN
Active Ingredient Strength100 [iU]/mL
Pharm ClassesInsulin [CS], Insulin [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 0169-3003-15

5 SYRINGE, PLASTIC in 1 CARTON (0169-3003-15) > 3 mL in 1 SYRINGE, PLASTIC (0169-3003-01)
Marketing Start Date2019-09-06
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0169-3003-01 [00169300301]

Novolin R INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA019938
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-09-06

NDC 0169-3003-15 [00169300315]

Novolin R INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA019938
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2019-09-06

NDC 0169-3003-25 [00169300325]

Novolin R INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA019938
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2019-09-06

NDC 0169-3003-12 [00169300312]

Novolin R INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA019938
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-09-06

Drug Details

Active Ingredients

IngredientStrength
INSULIN HUMAN100 [iU]/mL

NDC Crossover Matching brand name "Novolin R" 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.