cinacalcet

Generic: cinacalcet

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cinacalcet
Generic Name cinacalcet
Labeler aurobindo pharma limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

cinacalcet hydrochloride 60 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-832
Product ID 65862-832_5aadf0b6-2c49-48d4-8d22-2fbf99dbf4e6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206125
Listing Expiration 2026-12-31
Marketing Start 2019-06-25

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 65862832
Hyphenated Format 65862-832

Supplemental Identifiers

RxCUI
432400 432401 432402
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 ANDA206125 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 60 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (65862-832-01)
  • 500 TABLET, FILM COATED in 1 BOTTLE (65862-832-05)
  • 30 TABLET, FILM COATED in 1 BOTTLE (65862-832-30)
  • 90 TABLET, FILM COATED in 1 BOTTLE (65862-832-90)
source: ndc

Packages (4)

65862-832-01 100 TABLET, FILM COATED in 1 BOTTLE (65862-832-01) 65862-832-05 500 TABLET, FILM COATED in 1 BOTTLE (65862-832-05) 65862-832-30 30 TABLET, FILM COATED in 1 BOTTLE (65862-832-30) 65862-832-90 90 TABLET, FILM COATED in 1 BOTTLE (65862-832-90)

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": "5aadf0b6-2c49-48d4-8d22-2fbf99dbf4e6", "openfda": {"unii": ["1K860WSG25"], "rxcui": ["432400", "432401", "432402"], "spl_set_id": ["42e99112-c402-4662-877f-9e3a84dff9f2"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (65862-832-01)", "package_ndc": "65862-832-01", "marketing_start_date": "20190625"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (65862-832-05)", "package_ndc": "65862-832-05", "marketing_start_date": "20190625"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (65862-832-30)", "package_ndc": "65862-832-30", "marketing_start_date": "20190625"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (65862-832-90)", "package_ndc": "65862-832-90", "marketing_start_date": "20190625"}], "brand_name": "Cinacalcet", "product_id": "65862-832_5aadf0b6-2c49-48d4-8d22-2fbf99dbf4e6", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Calcium-sensing Receptor Agonist [EPC]", "Increased Calcium-sensing Receptor Sensitivity [MoA]"], "product_ndc": "65862-832", "generic_name": "Cinacalcet", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cinacalcet", "active_ingredients": [{"name": "CINACALCET HYDROCHLORIDE", "strength": "60 mg/1"}], "application_number": "ANDA206125", "marketing_category": "ANDA", "marketing_start_date": "20190625", "listing_expiration_date": "20261231"}