NDC 0088-5021

Lantus

Insulin Glargine

Lantus is a Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Sanofi-aventis U.s. Llc. The primary component is Insulin Glargine.

• Product ID: 0088-5021_2c27943b-b9d7-4838-8b39-618aab8b54fa
• NDC: 0088-5021
• Product Type: Human Prescription Drug
• Proprietary Name: Lantus
• Generic Name: Insulin Glargine
• Dosage Form: Injection, Solution
• Route of Administration: SUBCUTANEOUS
• Marketing Start Date: 2017-06-04
• Marketing Category: BLA / NDA
• Application Number: BLA021081
• Labeler Name: sanofi-aventis U.S. LLC
• Substance Name: INSULIN GLARGINE
• Active Ingredient Strength: 100 [iU]/mL
• Pharm Classes: Insulin [Chemical/Ingredient],Insulin Analog [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 0088-5021-01

1 VIAL, GLASS in 1 PACKAGE (0088-5021-01) > 10 mL in 1 VIAL, GLASS

• Marketing Start Date: 2017-06-04
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0088-5021-01 [00088502101]

Lantus INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA021081
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2017-06-04

Drug Details

Active Ingredients

Ingredient	Strength
INSULIN GLARGINE	100 [iU]/mL

OpenFDA Data

• SPL SET ID: 6328c99d-d75f-43ef-b19e-7e71f91e57f6
• Manufacturer:
  • sanofi-aventis U.S. LLC
• UNII:
  • 2ZM8CX04RZ
• RxNorm Concept Unique ID - RxCUI:
  • 311041
  • 847230
  • 847232
  • 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