NDC 68258-8977

Levemir

Insulin Detemir

Levemir is a Soft Tissue Implant in the Human Prescription Drug category. It is labeled and distributed by Dispensing Solutions, Inc.. The primary component is Insulin Detemir.

• Product ID: 68258-8977_082bc713-cea6-4af8-b2be-65622cb897d0
• NDC: 68258-8977
• Product Type: Human Prescription Drug
• Proprietary Name: Levemir
• Generic Name: Insulin Detemir
• Dosage Form: Implant
• Route of Administration: SOFT TISSUE
• Marketing Start Date: 2006-03-27
• Marketing Category: NDA / NDA
• Application Number: NDA021536
• Labeler Name: Dispensing Solutions, Inc.
• Substance Name: INSULIN DETEMIR
• Active Ingredient Strength: 14 mg/mL
• Pharm Classes: Insulin [Chemical/Ingredient],Insulin Analog [EPC]
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 68258-8977-1

1 VIAL in 1 CARTON (68258-8977-1) > 10 mL in 1 VIAL

• Marketing Start Date: 2006-03-27
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 68258-8977-1 [68258897701]

Levemir IMPLANT

• Marketing Category: NDA
• Application Number: NDA021536
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2006-03-27
• Inactivation Date: 2019-10-29

Drug Details

Active Ingredients

Ingredient	Strength
INSULIN DETEMIR	14.2 mg/mL

OpenFDA Data

• SPL SET ID: 2b8d9730-686b-444b-9941-7b5877255924
• Manufacturer:
  • Dispensing Solutions, Inc.
• UNII:
  • 4FT78T86XV
• RxNorm Concept Unique ID - RxCUI:
  • 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