apidra solostar

Generic: insulin glulisine

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

Drug Facts

Product Profile

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

insulin glulisine 100 [iU]/mL

Manufacturer
sanofi-aventis U.S. LLC

Identifiers & Regulatory

Product NDC 0088-2502
Product ID 0088-2502_6be54063-6912-4810-b1c7-dfca969224d8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA021629
Listing Expiration 2026-12-31
Marketing Start 2009-02-24

Pharmacologic Class

Established (EPC)
insulin analog [epc]
Chemical Structure
insulin [chemical/ingredient]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00882502
Hyphenated Format 0088-2502

Supplemental Identifiers

RxCUI
485210 803194 847259 847261
UNII
7XIY785AZD
NUI
N0000004931 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 apidra solostar (source: ndc)
Generic Name insulin glulisine (source: ndc)
Application Number BLA021629 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 100 [iU]/mL
source: ndc
Packaging
  • 1 SYRINGE, PLASTIC in 1 CARTON (0088-2502-01) / 3 mL in 1 SYRINGE, PLASTIC
  • 5 SYRINGE, PLASTIC in 1 CARTON (0088-2502-05) / 3 mL in 1 SYRINGE, PLASTIC (0088-2502-00)
source: ndc

Packages (2)

0088-2502-01 1 SYRINGE, PLASTIC in 1 CARTON (0088-2502-01) / 3 mL in 1 SYRINGE, PLASTIC 0088-2502-05 5 SYRINGE, PLASTIC in 1 CARTON (0088-2502-05) / 3 mL in 1 SYRINGE, PLASTIC (0088-2502-00)

Ingredients (1)

insulin glulisine (100 [iU]/mL)

Linked Drug Pages (1)

Apidra, Apidra SoloStar ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "6be54063-6912-4810-b1c7-dfca969224d8", "openfda": {"nui": ["N0000004931", "N0000175453"], "unii": ["7XIY785AZD"], "rxcui": ["485210", "803194", "847259", "847261"], "spl_set_id": ["e7af6a7a-8046-4fb4-9979-4ec4230b23aa"], "pharm_class_cs": ["Insulin [Chemical/Ingredient]"], "pharm_class_epc": ["Insulin Analog [EPC]"], "manufacturer_name": ["sanofi-aventis U.S. LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 SYRINGE, PLASTIC in 1 CARTON (0088-2502-01)  / 3 mL in 1 SYRINGE, PLASTIC", "package_ndc": "0088-2502-01", "marketing_start_date": "20090224"}, {"sample": false, "description": "5 SYRINGE, PLASTIC in 1 CARTON (0088-2502-05)  / 3 mL in 1 SYRINGE, PLASTIC (0088-2502-00)", "package_ndc": "0088-2502-05", "marketing_start_date": "20090224"}], "brand_name": "Apidra SoloStar", "product_id": "0088-2502_6be54063-6912-4810-b1c7-dfca969224d8", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Insulin Analog [EPC]", "Insulin [Chemical/Ingredient]"], "product_ndc": "0088-2502", "generic_name": "insulin glulisine", "labeler_name": "sanofi-aventis U.S. LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Apidra SoloStar", "active_ingredients": [{"name": "INSULIN GLULISINE", "strength": "100 [iU]/mL"}], "application_number": "BLA021629", "marketing_category": "BLA", "marketing_start_date": "20090224", "listing_expiration_date": "20261231"}