NDC 55045-3685

Lantus

Insulin Glargine

Lantus is a Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Dispensing Solutions, Inc.. The primary component is Insulin Glargine.

• Product ID: 55045-3685_71907ed5-ee95-471a-8d7d-f72dcbbdfb60
• NDC: 55045-3685
• Product Type: Human Prescription Drug
• Proprietary Name: Lantus
• Generic Name: Insulin Glargine
• Dosage Form: Injection, Solution
• Route of Administration: SUBCUTANEOUS
• Marketing Start Date: 2009-09-23
• Marketing Category: NDA / NDA
• Application Number: NDA021081
• Labeler Name: Dispensing Solutions, Inc.
• Substance Name: INSULIN GLARGINE
• Active Ingredient Strength: 100 [iU]/mL
• Pharm Classes: Insulin [Chemical/Ingredient],Insulin Analog [EPC]
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 55045-3685-1

10 mL in 1 VIAL, GLASS (55045-3685-1)

• Marketing Start Date: 2009-09-23
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 55045-3685-1 [55045368501]

Lantus INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA021081
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2009-09-23
• Inactivation Date: 2019-10-29

Drug Details

Active Ingredients

Ingredient	Strength
INSULIN GLARGINE	100 [iU]/mL

OpenFDA Data

• SPL SET ID: f2149727-c2df-41b0-97f1-45ea75e0aa1a
• Manufacturer:
  • Dispensing Solutions, Inc.
• UNII:
  • 2ZM8CX04RZ
• RxNorm Concept Unique ID - RxCUI:
  • 311041
  • 285018
• PHarm Class EPC:
  • Insulin Analog [EPC]
• NUI Code:
  • N0000175453
  • N0000004931

Pharmacological Class

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

NDC Crossover Matching brand name "Lantus" or generic name "Insulin Glargine"

NDC	Brand Name	Generic Name
0088-2220	Lantus	insulin glargine
70518-1865	Lantus	Lantus
0088-5021	Lantus	Lantus
50090-0876	Lantus	Lantus
55045-3685	Lantus	Lantus
64725-2220	Lantus	Lantus
0002-7715	BASAGLAR	Insulin glargine
0002-8214	BASAGLAR	Insulin glargine
0088-2219	Lantus Solostar	insulin glargine
0024-5869	TOUJEO	insulin glargine
0024-5871	TOUJEO Max	insulin glargine