insulin glargine

Generic: insulin glargine-yfgn

Labeler: civica, inc.
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name insulin glargine
Generic Name insulin glargine-yfgn
Labeler civica, inc.
Dosage Form INJECTION, SOLUTION
Routes
SUBCUTANEOUS
Active Ingredients

insulin glargine 100 [iU]/mL

Manufacturer
Civica, Inc.

Identifiers & Regulatory

Product NDC 72572-424
Product ID 72572-424_40be8473-6e6e-3d64-cb3d-5f8060a262f3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761201
Listing Expiration 2026-12-31
Marketing Start 2025-10-30

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72572424
Hyphenated Format 72572-424

Supplemental Identifiers

RxCUI
2563971
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-yfgn (source: ndc)
Application Number BLA761201 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 100 [iU]/mL
source: ndc
Packaging
  • 1 SYRINGE in 1 CARTON (72572-424-01) / 3 mL in 1 SYRINGE
  • 5 SYRINGE in 1 CARTON (72572-424-05) / 3 mL in 1 SYRINGE
source: ndc

Packages (2)

72572-424-01 1 SYRINGE in 1 CARTON (72572-424-01) / 3 mL in 1 SYRINGE 72572-424-05 5 SYRINGE in 1 CARTON (72572-424-05) / 3 mL in 1 SYRINGE

Ingredients (1)

insulin glargine (100 [iU]/mL)

Linked Drug Pages (1)

INSULIN GLARGINE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "40be8473-6e6e-3d64-cb3d-5f8060a262f3", "openfda": {"nui": ["M0011417", "N0000175453"], "unii": ["2ZM8CX04RZ"], "rxcui": ["2563971"], "spl_set_id": ["216f2167-c201-76fe-81ed-0d51fe53832f"], "pharm_class_cs": ["Insulin [CS]"], "pharm_class_epc": ["Insulin Analog [EPC]"], "manufacturer_name": ["Civica, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 SYRINGE in 1 CARTON (72572-424-01)  / 3 mL in 1 SYRINGE", "package_ndc": "72572-424-01", "marketing_start_date": "20251030"}, {"sample": false, "description": "5 SYRINGE in 1 CARTON (72572-424-05)  / 3 mL in 1 SYRINGE", "package_ndc": "72572-424-05", "marketing_start_date": "20251030"}], "brand_name": "INSULIN GLARGINE", "product_id": "72572-424_40be8473-6e6e-3d64-cb3d-5f8060a262f3", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Insulin Analog [EPC]", "Insulin [CS]"], "product_ndc": "72572-424", "generic_name": "insulin glargine-yfgn", "labeler_name": "Civica, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "INSULIN GLARGINE", "active_ingredients": [{"name": "INSULIN GLARGINE", "strength": "100 [iU]/mL"}], "application_number": "BLA761201", "marketing_category": "BLA", "marketing_start_date": "20251030", "listing_expiration_date": "20261231"}