cinacalcet

Generic: cinacalcet

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

Drug Facts

Product Profile

Brand Name cinacalcet
Generic Name cinacalcet
Labeler exelan pharmaceuticals inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

cinacalcet hydrochloride 60 mg/1

Manufacturer
EXELAN PHARMACEUTICALS INC.

Identifiers & Regulatory

Product NDC 76282-675
Product ID 76282-675_d4eda09a-6371-49ea-bc20-054b55e432e4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208915
Listing Expiration 2026-12-31
Marketing Start 2020-04-14

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 76282675
Hyphenated Format 76282-675

Supplemental Identifiers

RxCUI
432400 432401 432402
UPC
0376282674308 0376282675305 0376282676302
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 ANDA208915 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 60 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (76282-675-30)
source: ndc

Packages (1)

76282-675-30 30 TABLET in 1 BOTTLE (76282-675-30)

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": "d4eda09a-6371-49ea-bc20-054b55e432e4", "openfda": {"upc": ["0376282674308", "0376282675305", "0376282676302"], "unii": ["1K860WSG25"], "rxcui": ["432400", "432401", "432402"], "spl_set_id": ["04a978cb-d57b-4f1e-ba14-316b6f9abe33"], "manufacturer_name": ["EXELAN PHARMACEUTICALS INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (76282-675-30)", "package_ndc": "76282-675-30", "marketing_start_date": "20200414"}], "brand_name": "CINACALCET", "product_id": "76282-675_d4eda09a-6371-49ea-bc20-054b55e432e4", "dosage_form": "TABLET", "pharm_class": ["Calcium-sensing Receptor Agonist [EPC]", "Increased Calcium-sensing Receptor Sensitivity [MoA]"], "product_ndc": "76282-675", "generic_name": "CINACALCET", "labeler_name": "EXELAN PHARMACEUTICALS INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "CINACALCET", "active_ingredients": [{"name": "CINACALCET HYDROCHLORIDE", "strength": "60 mg/1"}], "application_number": "ANDA208915", "marketing_category": "ANDA", "marketing_start_date": "20200414", "listing_expiration_date": "20261231"}