NDC 50090-4501

Levemir

Insulin Detemir

Levemir is a Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by A-s Medication Solutions. The primary component is Insulin Detemir.

• Product ID: 50090-4501_826ae8d7-38e5-4686-84ae-4a698a8d86b7
• NDC: 50090-4501
• 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: A-S Medication Solutions
• 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 50090-4501-0

5 SYRINGE, PLASTIC in 1 CARTON (50090-4501-0) > 3 mL in 1 SYRINGE, PLASTIC

• Marketing Start Date: 2019-09-04
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50090-4501-0 [50090450100]

Levemir INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA021536
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-09-04

Drug Details

Active Ingredients

Ingredient	Strength
INSULIN DETEMIR	100 [iU]/mL

OpenFDA Data

• SPL SET ID: 80967086-8161-4ff7-ab17-f03d8319f651
• Manufacturer:
  • A-S Medication Solutions
• UNII:
  • 4FT78T86XV
• RxNorm Concept Unique ID - RxCUI:
  • 847241
  • 847239
• PHarm Class EPC:
  • Insulin Analog [EPC]
• NUI Code:
  • N0000175453
  • N0000004931

Pharmacological Class

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