lantus

Generic: insulin glargine

Labeler: sanofi-aventis u.s. llc
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name lantus
Generic Name insulin glargine
Labeler sanofi-aventis u.s. llc
Dosage Form INJECTION, SOLUTION
Routes
SUBCUTANEOUS
Active Ingredients

insulin glargine 100 [iU]/mL

Manufacturer
sanofi-aventis U.S. LLC

Identifiers & Regulatory

Product NDC 0088-2220
Product ID 0088-2220_4e220385-b760-4a64-a1ca-84bd2bebe448
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA021081
Listing Expiration 2026-12-31
Marketing Start 2009-09-23

Pharmacologic Class

Established (EPC)
insulin analog [epc]
Chemical Structure
insulin [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00882220
Hyphenated Format 0088-2220

Supplemental Identifiers

RxCUI
285018 311041 847230 847232
UNII
2ZM8CX04RZ
NUI
M0011417 N0000175453

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name lantus (source: ndc)
Generic Name insulin glargine (source: ndc)
Application Number BLA021081 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 100 [iU]/mL
source: ndc
Packaging
  • 1 VIAL, GLASS in 1 CARTON (0088-2220-33) / 10 mL in 1 VIAL, GLASS
  • 1 VIAL, GLASS in 1 CARTON (0088-2220-34) / 10 mL in 1 VIAL, GLASS
source: ndc

Packages (2)

0088-2220-33 1 VIAL, GLASS in 1 CARTON (0088-2220-33) / 10 mL in 1 VIAL, GLASS 0088-2220-34 1 VIAL, GLASS in 1 CARTON (0088-2220-34) / 10 mL in 1 VIAL, GLASS

Ingredients (1)

insulin glargine (100 [iU]/mL)

Linked Drug Pages (1)

Lantus Solostar, Lantus ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "4e220385-b760-4a64-a1ca-84bd2bebe448", "openfda": {"nui": ["M0011417", "N0000175453"], "unii": ["2ZM8CX04RZ"], "rxcui": ["285018", "311041", "847230", "847232"], "spl_set_id": ["d5e07a0c-7e14-4756-9152-9fea485d654a"], "pharm_class_cs": ["Insulin [CS]"], "pharm_class_epc": ["Insulin Analog [EPC]"], "manufacturer_name": ["sanofi-aventis U.S. LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, GLASS in 1 CARTON (0088-2220-33)  / 10 mL in 1 VIAL, GLASS", "package_ndc": "0088-2220-33", "marketing_start_date": "20090923"}, {"sample": true, "description": "1 VIAL, GLASS in 1 CARTON (0088-2220-34)  / 10 mL in 1 VIAL, GLASS", "package_ndc": "0088-2220-34", "marketing_start_date": "20090923"}], "brand_name": "Lantus", "product_id": "0088-2220_4e220385-b760-4a64-a1ca-84bd2bebe448", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Insulin Analog [EPC]", "Insulin [CS]"], "product_ndc": "0088-2220", "generic_name": "insulin glargine", "labeler_name": "sanofi-aventis U.S. LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lantus", "active_ingredients": [{"name": "INSULIN GLARGINE", "strength": "100 [iU]/mL"}], "application_number": "BLA021081", "marketing_category": "BLA", "marketing_start_date": "20090923", "listing_expiration_date": "20261231"}