insulin glargine

Generic: insulin glargine

Labeler: winthrop u.s.
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name insulin glargine
Generic Name insulin glargine
Labeler winthrop u.s.
Dosage Form INJECTION, SOLUTION
Routes
SUBCUTANEOUS
Active Ingredients

insulin glargine 100 [iU]/mL

Manufacturer
Winthrop U.S.

Identifiers & Regulatory

Product NDC 0955-1729
Product ID 0955-1729_81a7552c-6a2e-4c54-9bf7-56e15f7d166d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA021081
Marketing Start 2022-05-02
Marketing End 2026-03-31

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 09551729
Hyphenated Format 0955-1729

Supplemental Identifiers

RxCUI
311041 847230
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 insulin glargine (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 (0955-1729-01) / 10 mL in 1 VIAL, GLASS
source: ndc

Packages (1)

0955-1729-01 1 VIAL, GLASS in 1 CARTON (0955-1729-01) / 10 mL in 1 VIAL, GLASS

Ingredients (1)

insulin glargine (100 [iU]/mL)

Linked Drug Pages (1)

Insulin Glargine Solostar, Insulin Glargine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "81a7552c-6a2e-4c54-9bf7-56e15f7d166d", "openfda": {"nui": ["M0011417", "N0000175453"], "unii": ["2ZM8CX04RZ"], "rxcui": ["311041", "847230"], "spl_set_id": ["406883ea-7f97-4eff-8d43-0bab004654f1"], "pharm_class_cs": ["Insulin [CS]"], "pharm_class_epc": ["Insulin Analog [EPC]"], "manufacturer_name": ["Winthrop U.S."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, GLASS in 1 CARTON (0955-1729-01)  / 10 mL in 1 VIAL, GLASS", "package_ndc": "0955-1729-01", "marketing_end_date": "20260331", "marketing_start_date": "20220502"}], "brand_name": "Insulin Glargine", "product_id": "0955-1729_81a7552c-6a2e-4c54-9bf7-56e15f7d166d", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Insulin Analog [EPC]", "Insulin [CS]"], "product_ndc": "0955-1729", "generic_name": "insulin glargine", "labeler_name": "Winthrop U.S.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Insulin Glargine", "active_ingredients": [{"name": "INSULIN GLARGINE", "strength": "100 [iU]/mL"}], "application_number": "BLA021081", "marketing_category": "BLA", "marketing_end_date": "20260331", "marketing_start_date": "20220502"}