cinacalcet

Generic: cinacalcet

Labeler: accord healthcare, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

cinacalcet hydrochloride 60 mg/1

Manufacturer
Accord Healthcare, Inc.

Identifiers & Regulatory

Product NDC 16729-441
Product ID 16729-441_40aa0834-3fd8-c230-e063-6294a90a800d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211892
Listing Expiration 2026-12-31
Marketing Start 2020-06-16

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 16729441
Hyphenated Format 16729-441

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 ANDA211892 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 60 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (16729-441-10)
  • 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (16729-441-15)
source: ndc

Packages (2)

16729-441-10 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (16729-441-10) 16729-441-15 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (16729-441-15)

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": "40aa0834-3fd8-c230-e063-6294a90a800d", "openfda": {"unii": ["1K860WSG25"], "rxcui": ["432400", "432401", "432402"], "spl_set_id": ["6bad4e06-c0a1-4123-83c2-67d3b081e8a9"], "manufacturer_name": ["Accord Healthcare, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (16729-441-10)", "package_ndc": "16729-441-10", "marketing_start_date": "20200616"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (16729-441-15)", "package_ndc": "16729-441-15", "marketing_start_date": "20200619"}], "brand_name": "CINACALCET", "product_id": "16729-441_40aa0834-3fd8-c230-e063-6294a90a800d", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Calcium-sensing Receptor Agonist [EPC]", "Increased Calcium-sensing Receptor Sensitivity [MoA]"], "product_ndc": "16729-441", "generic_name": "Cinacalcet", "labeler_name": "Accord Healthcare, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "CINACALCET", "active_ingredients": [{"name": "CINACALCET HYDROCHLORIDE", "strength": "60 mg/1"}], "application_number": "ANDA211892", "marketing_category": "ANDA", "marketing_start_date": "20200616", "listing_expiration_date": "20261231"}