NDC 64725-1833

Novolin R

Human Insulin

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

• Product ID: 64725-1833_a2c745d7-1b63-4064-b6a1-e18e43b318ad
• NDC: 64725-1833
• Product Type: Human Otc Drug
• Proprietary Name: Novolin R
• Generic Name: Human Insulin
• Dosage Form: Injection, Solution
• Route of Administration: SUBCUTANEOUS
• Marketing Start Date: 1991-06-25
• Marketing Category: NDA / NDA
• Application Number: NDA019938
• Labeler Name: TYA Pharmaceuticals
• Substance Name: INSULIN HUMAN
• Active Ingredient Strength: 100 [iU]/mL
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 64725-1833-1

10 mL in 1 VIAL (64725-1833-1)

• Marketing Start Date: 1991-06-25
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 64725-1833-1 [64725183301]

Novolin R INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA019938
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 1991-06-25
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
INSULIN HUMAN	100 [iU]/mL

OpenFDA Data

• SPL SET ID: 78dadbee-c3b6-4d62-a338-731b24cc7ef0
• Manufacturer:
  • TYA Pharmaceuticals
• UNII:
  • 1Y17CTI5SR
• RxNorm Concept Unique ID - RxCUI:
  • 311033
  • 311034

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