cinacalcet

Generic: cinacalcet

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

Drug Facts

Product Profile

Brand Name cinacalcet
Generic Name cinacalcet
Labeler camber pharmaceuticals, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

cinacalcet hydrochloride 60 mg/1

Manufacturer
Camber Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 31722-104
Product ID 31722-104_5480ebd3-5b39-4f8b-bb03-05617f6f519f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209403
Listing Expiration 2026-12-31
Marketing Start 2020-10-07

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 31722104
Hyphenated Format 31722-104

Supplemental Identifiers

RxCUI
432400 432401 432402
UPC
0331722103305 0331722104302 0331722105309
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 cinacalcet (source: ndc)
Generic Name cinacalcet (source: ndc)
Application Number ANDA209403 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 60 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (31722-104-30)
  • 3 BLISTER PACK in 1 CARTON (31722-104-31) / 10 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (2)

31722-104-30 30 TABLET, FILM COATED in 1 BOTTLE (31722-104-30) 31722-104-31 3 BLISTER PACK in 1 CARTON (31722-104-31) / 10 TABLET, FILM COATED in 1 BLISTER PACK

Ingredients (1)

cinacalcet hydrochloride (60 mg/1)

Linked Drug Pages (1)

Cinacalcet ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "5480ebd3-5b39-4f8b-bb03-05617f6f519f", "openfda": {"upc": ["0331722103305", "0331722104302", "0331722105309"], "unii": ["1K860WSG25"], "rxcui": ["432400", "432401", "432402"], "spl_set_id": ["5480ebd3-5b39-4f8b-bb03-05617f6f519f"], "manufacturer_name": ["Camber Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (31722-104-30)", "package_ndc": "31722-104-30", "marketing_start_date": "20201007"}, {"sample": false, "description": "3 BLISTER PACK in 1 CARTON (31722-104-31)  / 10 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "31722-104-31", "marketing_start_date": "20201007"}], "brand_name": "Cinacalcet", "product_id": "31722-104_5480ebd3-5b39-4f8b-bb03-05617f6f519f", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Calcium-sensing Receptor Agonist [EPC]", "Increased Calcium-sensing Receptor Sensitivity [MoA]"], "product_ndc": "31722-104", "generic_name": "Cinacalcet", "labeler_name": "Camber Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cinacalcet", "active_ingredients": [{"name": "CINACALCET HYDROCHLORIDE", "strength": "60 mg/1"}], "application_number": "ANDA209403", "marketing_category": "ANDA", "marketing_start_date": "20201007", "listing_expiration_date": "20261231"}