cinacalcet

Generic: cinacalcet

Labeler: ascend laboratories, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cinacalcet
Generic Name cinacalcet
Labeler ascend laboratories, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

cinacalcet hydrochloride 30 mg/1

Manufacturer
Ascend Laboratories, LLC

Identifiers & Regulatory

Product NDC 67877-503
Product ID 67877-503_7dc83b54-a624-48db-ad2d-ee000a6d9c47
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210570
Listing Expiration 2027-12-31
Marketing Start 2019-05-18

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 67877503
Hyphenated Format 67877-503

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 ANDA210570 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 30 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (67877-503-01)
  • 30 TABLET, FILM COATED in 1 BOTTLE (67877-503-30)
  • 10 BLISTER PACK in 1 CARTON (67877-503-33) / 10 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (3)

67877-503-01 100 TABLET, FILM COATED in 1 BOTTLE (67877-503-01) 67877-503-30 30 TABLET, FILM COATED in 1 BOTTLE (67877-503-30) 67877-503-33 10 BLISTER PACK in 1 CARTON (67877-503-33) / 10 TABLET, FILM COATED in 1 BLISTER PACK

Ingredients (1)

cinacalcet hydrochloride (30 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": "7dc83b54-a624-48db-ad2d-ee000a6d9c47", "openfda": {"unii": ["1K860WSG25"], "rxcui": ["432400", "432401", "432402"], "spl_set_id": ["55f95ae0-84ac-4ae4-b7a0-7590ab919ae1"], "manufacturer_name": ["Ascend Laboratories, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (67877-503-01)", "package_ndc": "67877-503-01", "marketing_start_date": "20190518"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (67877-503-30)", "package_ndc": "67877-503-30", "marketing_start_date": "20190518"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (67877-503-33)  / 10 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "67877-503-33", "marketing_start_date": "20190518"}], "brand_name": "Cinacalcet", "product_id": "67877-503_7dc83b54-a624-48db-ad2d-ee000a6d9c47", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Calcium-sensing Receptor Agonist [EPC]", "Increased Calcium-sensing Receptor Sensitivity [MoA]"], "product_ndc": "67877-503", "generic_name": "Cinacalcet", "labeler_name": "Ascend Laboratories, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cinacalcet", "active_ingredients": [{"name": "CINACALCET HYDROCHLORIDE", "strength": "30 mg/1"}], "application_number": "ANDA210570", "marketing_category": "ANDA", "marketing_start_date": "20190518", "listing_expiration_date": "20271231"}