sajazir

Generic: icatibant

Labeler: cycle pharmaceuticals ltd-uk
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sajazir
Generic Name icatibant
Labeler cycle pharmaceuticals ltd-uk
Dosage Form INJECTION
Routes
SUBCUTANEOUS
Active Ingredients

icatibant acetate 30 mg/3mL

Manufacturer
Cycle Pharmaceuticals Ltd-Uk

Identifiers & Regulatory

Product NDC 70709-013
Product ID 70709-013_98f58ca8-04a0-4453-adf0-b000d3bcfae1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212446
Listing Expiration 2026-12-31
Marketing Start 2021-06-03

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 70709013
Hyphenated Format 70709-013

Supplemental Identifiers

RxCUI
1148141 2569480
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 sajazir (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 (70709-013-01) / 3 mL in 1 SYRINGE, GLASS
  • 3 SYRINGE, GLASS in 1 CARTON (70709-013-03) / 3 mL in 1 SYRINGE, GLASS
source: ndc

Packages (2)

70709-013-01 1 SYRINGE, GLASS in 1 CARTON (70709-013-01) / 3 mL in 1 SYRINGE, GLASS 70709-013-03 3 SYRINGE, GLASS in 1 CARTON (70709-013-03) / 3 mL in 1 SYRINGE, GLASS

Ingredients (1)

icatibant acetate (30 mg/3mL)

Linked Drug Pages (1)

SAJAZIR ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "98f58ca8-04a0-4453-adf0-b000d3bcfae1", "openfda": {"unii": ["325O8467XK"], "rxcui": ["1148141", "2569480"], "spl_set_id": ["1756aca0-21a1-4898-8d6c-9666738db45c"], "manufacturer_name": ["Cycle Pharmaceuticals Ltd-Uk"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 SYRINGE, GLASS in 1 CARTON (70709-013-01)  / 3 mL in 1 SYRINGE, GLASS", "package_ndc": "70709-013-01", "marketing_start_date": "20210603"}, {"sample": false, "description": "3 SYRINGE, GLASS in 1 CARTON (70709-013-03)  / 3 mL in 1 SYRINGE, GLASS", "package_ndc": "70709-013-03", "marketing_start_date": "20210603"}], "brand_name": "SAJAZIR", "product_id": "70709-013_98f58ca8-04a0-4453-adf0-b000d3bcfae1", "dosage_form": "INJECTION", "pharm_class": ["Bradykinin B2 Receptor Antagonist [EPC]", "Bradykinin B2 Receptor Antagonists [MoA]"], "product_ndc": "70709-013", "generic_name": "ICATIBANT", "labeler_name": "Cycle Pharmaceuticals Ltd-Uk", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "SAJAZIR", "active_ingredients": [{"name": "ICATIBANT ACETATE", "strength": "30 mg/3mL"}], "application_number": "ANDA212446", "marketing_category": "ANDA", "marketing_start_date": "20210603", "listing_expiration_date": "20261231"}