cinacalcet hydrochloride

Generic: cinacalcet

Labeler: amneal pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cinacalcet hydrochloride
Generic Name cinacalcet
Labeler amneal pharmaceuticals llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

cinacalcet hydrochloride 90 mg/1

Manufacturer
Amneal Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 65162-213
Product ID 65162-213_4d63252a-b953-4066-b38c-a468580dc407
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204364
Listing Expiration 2026-12-31
Marketing Start 2021-12-06

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 65162213
Hyphenated Format 65162-213

Supplemental Identifiers

RxCUI
432400 432401 432402
UPC
0365162155105 0365162157109 0365162213102
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 hydrochloride (source: ndc)
Generic Name cinacalcet (source: ndc)
Application Number ANDA204364 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 90 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (65162-213-03)
  • 100 TABLET in 1 BOTTLE (65162-213-10)
  • 250 TABLET in 1 BOTTLE (65162-213-25)
source: ndc

Packages (3)

65162-213-03 30 TABLET in 1 BOTTLE (65162-213-03) 65162-213-10 100 TABLET in 1 BOTTLE (65162-213-10) 65162-213-25 250 TABLET in 1 BOTTLE (65162-213-25)

Ingredients (1)

cinacalcet hydrochloride (90 mg/1)

Linked Drug Pages (1)

Cinacalcet Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4d63252a-b953-4066-b38c-a468580dc407", "openfda": {"upc": ["0365162155105", "0365162157109", "0365162213102"], "unii": ["1K860WSG25"], "rxcui": ["432400", "432401", "432402"], "spl_set_id": ["28262843-b0a8-4ca7-8b92-41b7f0e896b4"], "manufacturer_name": ["Amneal Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (65162-213-03)", "package_ndc": "65162-213-03", "marketing_start_date": "20211206"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE (65162-213-10)", "package_ndc": "65162-213-10", "marketing_start_date": "20211206"}, {"sample": false, "description": "250 TABLET in 1 BOTTLE (65162-213-25)", "package_ndc": "65162-213-25", "marketing_start_date": "20211206"}], "brand_name": "Cinacalcet Hydrochloride", "product_id": "65162-213_4d63252a-b953-4066-b38c-a468580dc407", "dosage_form": "TABLET", "pharm_class": ["Calcium-sensing Receptor Agonist [EPC]", "Increased Calcium-sensing Receptor Sensitivity [MoA]"], "product_ndc": "65162-213", "generic_name": "Cinacalcet", "labeler_name": "Amneal Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cinacalcet Hydrochloride", "active_ingredients": [{"name": "CINACALCET HYDROCHLORIDE", "strength": "90 mg/1"}], "application_number": "ANDA204364", "marketing_category": "ANDA", "marketing_start_date": "20211206", "listing_expiration_date": "20261231"}