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 ID: 0169-3003_46700b71-3f26-4aaa-8eb7-6ceeeb515c79
• NDC: 0169-3003
• Product Type: Human Otc Drug
• Proprietary Name: Novolin R
• Generic Name: Human Insulin
• Dosage Form: Injection, Solution
• Route of Administration: SUBCUTANEOUS
• Marketing Start Date: 2019-09-06
• Marketing Category: BLA / NDA
• Application Number: BLA019938
• Labeler Name: Novo Nordisk
• Substance Name: INSULIN HUMAN
• Active Ingredient Strength: 100 [iU]/mL
• Pharm Classes: Insulin [CS], Insulin [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

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 Date: 2019-09-06
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0169-3003-01 [00169300301]

Novolin R INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA019938
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2019-09-06

NDC 0169-3003-15 [00169300315]

Novolin R INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA019938
• Product Type: HUMAN OTC DRUG
• Billing Unit: ML
• Marketing Start Date: 2019-09-06

NDC 0169-3003-25 [00169300325]

Novolin R INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA019938
• Product Type: HUMAN OTC DRUG
• Billing Unit: ML
• Marketing Start Date: 2019-09-06

NDC 0169-3003-12 [00169300312]

Novolin R INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA019938
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2019-09-06

Drug Details

Active Ingredients

Ingredient	Strength
INSULIN HUMAN	100 [iU]/mL

NDC Crossover Matching brand name "Novolin R" or generic name "Human Insulin"

NDC	Brand Name	Generic Name
0169-1833	Novolin	Human Insulin
0169-1834	Novolin	Human Insulin
0169-1837	Novolin	Human Insulin
0169-3003	Novolin	Human Insulin
0169-3004	Novolin	Human Insulin
0169-3007	Novolin	Human Insulin
50090-0403	Novolin	Human Insulin
50090-0497	Novolin	Human Insulin
50090-0498	Novolin	Human Insulin
64725-1833	Novolin	Human Insulin
64725-1834	Novolin	Human Insulin
64725-1837	Novolin	Human Insulin
68071-1701	Novolin	Human Insulin