insulin glargine u-300 max (0955-2900)

Drug Facts

Product Profile

Brand Name insulin glargine u-300 max

Generic Name insulin glargine

Labeler sanofi-aventis u.s. llc

Dosage Form INJECTION, SOLUTION

Routes

SUBCUTANEOUS

Active Ingredients

insulin glargine 300 [iU]/mL

Manufacturer

Sanofi-Aventis U.S. LLC

Identifiers & Regulatory

Product NDC 0955-2900

Product ID 0955-2900_63c52b96-0bdf-42f0-9c6c-e439846e6926

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category BLA

Application Number BLA206538

Listing Expiration 2026-12-31

Marketing Start 2023-04-01

Pharmacologic Class

Established (EPC)

insulin analog [epc]

Chemical Structure

insulin [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 09552900

Hyphenated Format 0955-2900

Supplemental Identifiers

RxCUI

1604539 2002419

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 u-300 max (source: ndc)

Generic Name insulin glargine (source: ndc)

Application Number BLA206538 (source: ndc)

Routes

SUBCUTANEOUS

source: ndc

Resolved Composition

Strengths

300 [iU]/mL

source: ndc

Packaging

2 SYRINGE in 1 CARTON (0955-2900-02) / 3 mL in 1 SYRINGE (0955-2900-01)

source: ndc

Packages (1)

0955-2900-02 2 SYRINGE in 1 CARTON (0955-2900-02) / 3 mL in 1 SYRINGE (0955-2900-01)

Ingredients (1)

insulin glargine (300 [iU]/mL)

Linked Drug Pages (1)

Insulin glargine U-300 Max, Insulin glargine U-300 ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["SUBCUTANEOUS"], "spl_id": "63c52b96-0bdf-42f0-9c6c-e439846e6926", "openfda": {"nui": ["M0011417", "N0000175453"], "unii": ["2ZM8CX04RZ"], "rxcui": ["1604539", "2002419"], "spl_set_id": ["99ea856d-9562-443a-9422-1006a3cff2f4"], "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": "2 SYRINGE in 1 CARTON (0955-2900-02)  / 3 mL in 1 SYRINGE (0955-2900-01)", "package_ndc": "0955-2900-02", "marketing_start_date": "20230401"}], "brand_name": "Insulin glargine U-300 Max", "product_id": "0955-2900_63c52b96-0bdf-42f0-9c6c-e439846e6926", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Insulin Analog [EPC]", "Insulin [CS]"], "product_ndc": "0955-2900", "generic_name": "insulin glargine", "labeler_name": "Sanofi-Aventis U.S. LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Insulin glargine U-300 Max", "active_ingredients": [{"name": "INSULIN GLARGINE", "strength": "300 [iU]/mL"}], "application_number": "BLA206538", "marketing_category": "BLA", "marketing_start_date": "20230401", "listing_expiration_date": "20261231"}