NDC 70518-1387

Levemir

Insulin Detemir

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

• Product ID: 70518-1387_750ae475-5c2c-0f90-e053-2991aa0afbbb
• NDC: 70518-1387
• Product Type: Human Prescription Drug
• Proprietary Name: Levemir
• Generic Name: Insulin Detemir
• Dosage Form: Injection, Solution
• Route of Administration: SUBCUTANEOUS
• Marketing Start Date: 2018-08-27
• Marketing Category: NDA / NDA
• Application Number: NDA021536
• Labeler Name: REMEDYREPACK INC.
• 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: 2019-12-31

Packaging

NDC 70518-1387-0

5 SYRINGE, PLASTIC in 1 CARTON (70518-1387-0) > 3 mL in 1 SYRINGE, PLASTIC

• Marketing Start Date: 2018-08-27
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 70518-1387-0 [70518138700]

Levemir INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA021536
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2018-08-27
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
INSULIN DETEMIR	100 [iU]/mL

OpenFDA Data

• SPL SET ID: 47039417-9621-42fa-9250-7259875d75bf
• Manufacturer:
  • REMEDYREPACK INC.
• 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]

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