sensipar

Generic: cinacalcet hydrochloride

Labeler: amgen inc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name sensipar
Generic Name cinacalcet hydrochloride
Labeler amgen inc
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

cinacalcet hydrochloride 90 mg/1

Manufacturer
Amgen Inc

Identifiers & Regulatory

Product NDC 55513-075
Product ID 55513-075_42c2c9c2-6929-4952-b559-a57a1d75424e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021688
Marketing Start 2004-04-04
Marketing End 2028-02-28

Pharmacologic Class

Classes
calcium-sensing receptor agonist [epc] increased calcium-sensing receptor sensitivity [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 55513075
Hyphenated Format 55513-075

Supplemental Identifiers

RxCUI
432400 432401 432402 656137 706958 706960
UNII
1K860WSG25

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 sensipar (source: ndc)
Generic Name cinacalcet hydrochloride (source: ndc)
Application Number NDA021688 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 90 mg/1
source: ndc
Packaging
  • 30 TABLET, COATED in 1 BOTTLE, PLASTIC (55513-075-30)
source: ndc

Packages (1)

55513-075-30 30 TABLET, COATED in 1 BOTTLE, PLASTIC (55513-075-30)

Ingredients (1)

cinacalcet hydrochloride (90 mg/1)

Linked Drug Pages (1)

Sensipar ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "42c2c9c2-6929-4952-b559-a57a1d75424e", "openfda": {"unii": ["1K860WSG25"], "rxcui": ["432400", "432401", "432402", "656137", "706958", "706960"], "spl_set_id": ["45028573-13c4-4c8b-ae62-6c75bba97c81"], "manufacturer_name": ["Amgen Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, COATED in 1 BOTTLE, PLASTIC (55513-075-30)", "package_ndc": "55513-075-30", "marketing_end_date": "20280228", "marketing_start_date": "20040404"}], "brand_name": "Sensipar", "product_id": "55513-075_42c2c9c2-6929-4952-b559-a57a1d75424e", "dosage_form": "TABLET, COATED", "pharm_class": ["Calcium-sensing Receptor Agonist [EPC]", "Increased Calcium-sensing Receptor Sensitivity [MoA]"], "product_ndc": "55513-075", "generic_name": "cinacalcet hydrochloride", "labeler_name": "Amgen Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sensipar", "active_ingredients": [{"name": "CINACALCET HYDROCHLORIDE", "strength": "90 mg/1"}], "application_number": "NDA021688", "marketing_category": "NDA", "marketing_end_date": "20280228", "marketing_start_date": "20040404"}