toujeo

Generic: insulin glargine

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

Drug Facts

Product Profile

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

insulin glargine 300 U/mL

Manufacturer
Sanofi-Aventis U.S. LLC

Identifiers & Regulatory

Product NDC 0024-5869
Product ID 0024-5869_49201ad7-68f7-407c-959f-852591703f96
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA206538
Listing Expiration 2026-12-31
Marketing Start 2015-02-15

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00245869
Hyphenated Format 0024-5869

Supplemental Identifiers

RxCUI
1604539 1604544 2002419 2002420
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 toujeo (source: ndc)
Generic Name insulin glargine (source: ndc)
Application Number BLA206538 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 300 U/mL
source: ndc
Packaging
  • 1 SYRINGE in 1 CARTON (0024-5869-00) / 1.5 mL in 1 SYRINGE
  • 3 SYRINGE in 1 CARTON (0024-5869-03) / 1.5 mL in 1 SYRINGE (0024-5869-01)
source: ndc

Packages (2)

0024-5869-00 1 SYRINGE in 1 CARTON (0024-5869-00) / 1.5 mL in 1 SYRINGE 0024-5869-03 3 SYRINGE in 1 CARTON (0024-5869-03) / 1.5 mL in 1 SYRINGE (0024-5869-01)

Ingredients (1)

insulin glargine (300 U/mL)

Linked Drug Pages (1)

TOUJEO, TOUJEO Max ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "49201ad7-68f7-407c-959f-852591703f96", "openfda": {"nui": ["M0011417", "N0000175453"], "unii": ["2ZM8CX04RZ"], "rxcui": ["1604539", "1604544", "2002419", "2002420"], "spl_set_id": ["c9561d96-124d-48ca-982f-0aa1575bff36"], "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": true, "description": "1 SYRINGE in 1 CARTON (0024-5869-00)  / 1.5 mL in 1 SYRINGE", "package_ndc": "0024-5869-00", "marketing_start_date": "20150215"}, {"sample": false, "description": "3 SYRINGE in 1 CARTON (0024-5869-03)  / 1.5 mL in 1 SYRINGE (0024-5869-01)", "package_ndc": "0024-5869-03", "marketing_start_date": "20150215"}], "brand_name": "TOUJEO", "product_id": "0024-5869_49201ad7-68f7-407c-959f-852591703f96", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Insulin Analog [EPC]", "Insulin [CS]"], "product_ndc": "0024-5869", "generic_name": "insulin glargine", "labeler_name": "Sanofi-Aventis U.S. LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "TOUJEO", "active_ingredients": [{"name": "INSULIN GLARGINE", "strength": "300 U/mL"}], "application_number": "BLA206538", "marketing_category": "BLA", "marketing_start_date": "20150215", "listing_expiration_date": "20261231"}