icatibant

Generic: icatibant

Labeler: alembic pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name icatibant
Generic Name icatibant
Labeler alembic pharmaceuticals limited
Dosage Form INJECTION
Routes
SUBCUTANEOUS
Active Ingredients

icatibant acetate 30 mg/3mL

Manufacturer
Alembic Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 46708-654
Product ID 46708-654_8c149392-d281-4311-880f-3be2b4752f40
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213773
Listing Expiration 2026-12-31
Marketing Start 2024-06-14

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 46708654
Hyphenated Format 46708-654

Supplemental Identifiers

RxCUI
1148141
UNII
325O8467XK

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 icatibant (source: ndc)
Generic Name icatibant (source: ndc)
Application Number ANDA213773 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 30 mg/3mL
source: ndc
Packaging
  • 1 SYRINGE, GLASS in 1 CARTON (46708-654-03) / 3 mL in 1 SYRINGE, GLASS
  • 3 SYRINGE, GLASS in 1 CARTON (46708-654-09) / 3 mL in 1 SYRINGE, GLASS
source: ndc

Packages (2)

46708-654-03 1 SYRINGE, GLASS in 1 CARTON (46708-654-03) / 3 mL in 1 SYRINGE, GLASS 46708-654-09 3 SYRINGE, GLASS in 1 CARTON (46708-654-09) / 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": "8c149392-d281-4311-880f-3be2b4752f40", "openfda": {"unii": ["325O8467XK"], "rxcui": ["1148141"], "spl_set_id": ["8c149392-d281-4311-880f-3be2b4752f40"], "manufacturer_name": ["Alembic Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 SYRINGE, GLASS in 1 CARTON (46708-654-03)  / 3 mL in 1 SYRINGE, GLASS", "package_ndc": "46708-654-03", "marketing_start_date": "20240614"}, {"sample": false, "description": "3 SYRINGE, GLASS in 1 CARTON (46708-654-09)  / 3 mL in 1 SYRINGE, GLASS", "package_ndc": "46708-654-09", "marketing_start_date": "20240614"}], "brand_name": "Icatibant", "product_id": "46708-654_8c149392-d281-4311-880f-3be2b4752f40", "dosage_form": "INJECTION", "pharm_class": ["Bradykinin B2 Receptor Antagonist [EPC]", "Bradykinin B2 Receptor Antagonists [MoA]"], "product_ndc": "46708-654", "generic_name": "Icatibant", "labeler_name": "Alembic Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Icatibant", "active_ingredients": [{"name": "ICATIBANT ACETATE", "strength": "30 mg/3mL"}], "application_number": "ANDA213773", "marketing_category": "ANDA", "marketing_start_date": "20240614", "listing_expiration_date": "20261231"}