icatibant

Generic: icatibant

Labeler: teva pharmaceuticals usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name icatibant
Generic Name icatibant
Labeler teva pharmaceuticals usa, inc.
Dosage Form INJECTION, SOLUTION
Routes
SUBCUTANEOUS
Active Ingredients

icatibant acetate 10 mg/mL

Manufacturer
Teva Pharmaceuticals USA, Inc.

Identifiers & Regulatory

Product NDC 0093-3066
Product ID 0093-3066_56c3b3d7-5c66-422c-a72d-30b3599d71db
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210118
Listing Expiration 2026-12-31
Marketing Start 2019-07-15

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 00933066
Hyphenated Format 0093-3066

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 ANDA210118 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 1 SYRINGE in 1 CARTON (0093-3066-34) / 3 mL in 1 SYRINGE
  • 3 CARTON in 1 BOX (0093-3066-93) / 1 SYRINGE in 1 CARTON (0093-3066-19) / 3 mL in 1 SYRINGE
source: ndc

Packages (2)

0093-3066-34 1 SYRINGE in 1 CARTON (0093-3066-34) / 3 mL in 1 SYRINGE 0093-3066-93 3 CARTON in 1 BOX (0093-3066-93) / 1 SYRINGE in 1 CARTON (0093-3066-19) / 3 mL in 1 SYRINGE

Ingredients (1)

icatibant acetate (10 mg/mL)

Linked Drug Pages (1)

Icatibant ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "56c3b3d7-5c66-422c-a72d-30b3599d71db", "openfda": {"unii": ["325O8467XK"], "rxcui": ["1148141"], "spl_set_id": ["402a20e0-d1e2-4a24-ae1d-f2ff6d8fa7b3"], "manufacturer_name": ["Teva Pharmaceuticals USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 SYRINGE in 1 CARTON (0093-3066-34)  / 3 mL in 1 SYRINGE", "package_ndc": "0093-3066-34", "marketing_start_date": "20190715"}, {"sample": false, "description": "3 CARTON in 1 BOX (0093-3066-93)  / 1 SYRINGE in 1 CARTON (0093-3066-19)  / 3 mL in 1 SYRINGE", "package_ndc": "0093-3066-93", "marketing_start_date": "20190715"}], "brand_name": "Icatibant", "product_id": "0093-3066_56c3b3d7-5c66-422c-a72d-30b3599d71db", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Bradykinin B2 Receptor Antagonist [EPC]", "Bradykinin B2 Receptor Antagonists [MoA]"], "product_ndc": "0093-3066", "generic_name": "Icatibant", "labeler_name": "Teva Pharmaceuticals USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Icatibant", "active_ingredients": [{"name": "ICATIBANT ACETATE", "strength": "10 mg/mL"}], "application_number": "ANDA210118", "marketing_category": "ANDA", "marketing_start_date": "20190715", "listing_expiration_date": "20261231"}