icatibant

Generic: icatibant acetate

Labeler: bryant ranch prepack
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name icatibant
Generic Name icatibant acetate
Labeler bryant ranch prepack
Dosage Form INJECTION, SOLUTION
Routes
SUBCUTANEOUS
Active Ingredients

icatibant acetate 30 mg/3mL

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 72162-2106
Product ID 72162-2106_a6550ebb-f39e-4def-96d9-cb6a86f288d2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212081
Listing Expiration 2026-12-31
Marketing Start 2021-04-15

Pharmacologic Class

Classes
bradykinin b2 receptor antagonist [epc] bradykinin b2 receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 721622106
Hyphenated Format 72162-2106

Supplemental Identifiers

RxCUI
1148141
UNII
325O8467XK

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 icatibant (source: ndc)
Generic Name icatibant acetate (source: ndc)
Application Number ANDA212081 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 30 mg/3mL
source: ndc
Packaging
  • 1 SYRINGE, GLASS in 1 CARTON (72162-2106-2) / 3 mL in 1 SYRINGE, GLASS
source: ndc

Packages (1)

72162-2106-2 1 SYRINGE, GLASS in 1 CARTON (72162-2106-2) / 3 mL in 1 SYRINGE, GLASS

Ingredients (1)

icatibant acetate (30 mg/3mL)

Linked Drug Pages (1)

ICATIBANT ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "a6550ebb-f39e-4def-96d9-cb6a86f288d2", "openfda": {"unii": ["325O8467XK"], "rxcui": ["1148141"], "spl_set_id": ["a6550ebb-f39e-4def-96d9-cb6a86f288d2"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "1 SYRINGE, GLASS in 1 CARTON (72162-2106-2)  / 3 mL in 1 SYRINGE, GLASS", "package_ndc": "72162-2106-2", "marketing_start_date": "20210415"}], "brand_name": "ICATIBANT", "product_id": "72162-2106_a6550ebb-f39e-4def-96d9-cb6a86f288d2", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Bradykinin B2 Receptor Antagonist [EPC]", "Bradykinin B2 Receptor Antagonists [MoA]"], "product_ndc": "72162-2106", "generic_name": "icatibant acetate", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ICATIBANT", "active_ingredients": [{"name": "ICATIBANT ACETATE", "strength": "30 mg/3mL"}], "application_number": "ANDA212081", "marketing_category": "ANDA", "marketing_start_date": "20210415", "listing_expiration_date": "20261231"}