NDC 0169-6438

Levemir

Insulin Detemir

Levemir is a Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Novo Nordisk. The primary component is Insulin Detemir.

• Product ID: 0169-6438_18faddbd-0bc0-48d1-a16f-f4939de3d0a3
• NDC: 0169-6438
• Product Type: Human Prescription Drug
• Proprietary Name: Levemir
• Generic Name: Insulin Detemir
• Dosage Form: Injection, Solution
• Route of Administration: SUBCUTANEOUS
• Marketing Start Date: 2013-10-31
• Marketing Category: BLA / NDA
• Application Number: BLA021536
• Labeler Name: Novo Nordisk
• Substance Name: INSULIN DETEMIR
• Active Ingredient Strength: 100 [iU]/mL
• Pharm Classes: Insulin [Chemical/Ingredient],Insulin Analog [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 0169-6438-10

5 SYRINGE, PLASTIC in 1 CARTON (0169-6438-10) > 3 mL in 1 SYRINGE, PLASTIC

• Marketing Start Date: 2013-10-31
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0169-6438-90 [00169643890]

Levemir INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA021536
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2013-10-31

NDC 0169-6438-98 [00169643898]

Levemir INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA021536
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2013-10-31

NDC 0169-6438-10 [00169643810]

Levemir INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA021536
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2013-10-31

NDC 0169-6438-97 [00169643897]

Levemir INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA021536
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2013-10-31
• Marketing End Date: 2016-12-31

Drug Details

Active Ingredients

Ingredient	Strength
INSULIN DETEMIR	100 [iU]/mL

OpenFDA Data

• SPL SET ID: d38d65c1-25bf-401d-9c7e-a2c3222da8af
• Manufacturer:
  • Novo Nordisk
• UNII:
  • 4FT78T86XV
• RxNorm Concept Unique ID - RxCUI:
  • 847241
  • 847239
  • 616238
  • 484322
• PHarm Class EPC:
  • Insulin Analog [EPC]
• NUI Code:
  • N0000175453
  • N0000004931

Pharmacological Class

• Insulin [Chemical/Ingredient]
• Insulin Analog [EPC]

NDC Crossover Matching brand name "Levemir" or generic name "Insulin Detemir"

NDC	Brand Name	Generic Name
0169-3687	Levemir	insulin detemir
0169-6432	Levemir	insulin detemir
0169-6438	Levemir	insulin detemir
50090-1276	Levemir	insulin detemir
50090-1475	Levemir	insulin detemir
50090-4501	Levemir	insulin detemir
68258-8977	Levemir	insulin detemir
70518-1387	Levemir	insulin detemir
70518-1462	Levemir	insulin detemir