icatibant

Generic: icatibant

Labeler: cipla usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name icatibant
Generic Name icatibant
Labeler cipla usa inc.
Dosage Form INJECTION
Routes
SUBCUTANEOUS
Active Ingredients

icatibant acetate 30 mg/3mL

Manufacturer
Cipla USA Inc.

Identifiers & Regulatory

Product NDC 69097-664
Product ID 69097-664_430ca904-a971-4233-a98b-46ca19275dab
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212446
Listing Expiration 2026-12-31
Marketing Start 2020-07-13

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 69097664
Hyphenated Format 69097-664

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 ANDA212446 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 30 mg/3mL
source: ndc
Packaging
  • 1 SYRINGE, GLASS in 1 CARTON (69097-664-34) / 3 mL in 1 SYRINGE, GLASS
  • 3 SYRINGE, GLASS in 1 CARTON (69097-664-68) / 3 mL in 1 SYRINGE, GLASS
source: ndc

Packages (2)

69097-664-34 1 SYRINGE, GLASS in 1 CARTON (69097-664-34) / 3 mL in 1 SYRINGE, GLASS 69097-664-68 3 SYRINGE, GLASS in 1 CARTON (69097-664-68) / 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": "430ca904-a971-4233-a98b-46ca19275dab", "openfda": {"unii": ["325O8467XK"], "rxcui": ["1148141"], "spl_set_id": ["ccbb5e50-ce56-4898-aa1a-f1c1f3d312f6"], "manufacturer_name": ["Cipla USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 SYRINGE, GLASS in 1 CARTON (69097-664-34)  / 3 mL in 1 SYRINGE, GLASS", "package_ndc": "69097-664-34", "marketing_start_date": "20200713"}, {"sample": false, "description": "3 SYRINGE, GLASS in 1 CARTON (69097-664-68)  / 3 mL in 1 SYRINGE, GLASS", "package_ndc": "69097-664-68", "marketing_start_date": "20200713"}], "brand_name": "ICATIBANT", "product_id": "69097-664_430ca904-a971-4233-a98b-46ca19275dab", "dosage_form": "INJECTION", "pharm_class": ["Bradykinin B2 Receptor Antagonist [EPC]", "Bradykinin B2 Receptor Antagonists [MoA]"], "product_ndc": "69097-664", "generic_name": "ICATIBANT", "labeler_name": "Cipla USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ICATIBANT", "active_ingredients": [{"name": "ICATIBANT ACETATE", "strength": "30 mg/3mL"}], "application_number": "ANDA212446", "marketing_category": "ANDA", "marketing_start_date": "20200713", "listing_expiration_date": "20261231"}