cinacalcet

Generic: cinacalcet

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cinacalcet
Generic Name cinacalcet
Labeler sun pharmaceutical industries, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

cinacalcet hydrochloride 30 mg/1

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 47335-379
Product ID 47335-379_fb601aec-aba6-4bec-a98d-51e556fef95c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207008
Listing Expiration 2026-12-31
Marketing Start 2019-05-15

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 47335379
Hyphenated Format 47335-379

Supplemental Identifiers

RxCUI
432400 432401 432402
UPC
0347335600834
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 ANDA207008 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 30 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (47335-379-83)
source: ndc

Packages (1)

47335-379-83 30 TABLET, FILM COATED in 1 BOTTLE (47335-379-83)

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": "fb601aec-aba6-4bec-a98d-51e556fef95c", "openfda": {"upc": ["0347335600834"], "unii": ["1K860WSG25"], "rxcui": ["432400", "432401", "432402"], "spl_set_id": ["092553cf-1bcd-4c19-9adf-b46f2bda5c9e"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (47335-379-83)", "package_ndc": "47335-379-83", "marketing_start_date": "20190515"}], "brand_name": "Cinacalcet", "product_id": "47335-379_fb601aec-aba6-4bec-a98d-51e556fef95c", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Calcium-sensing Receptor Agonist [EPC]", "Increased Calcium-sensing Receptor Sensitivity [MoA]"], "product_ndc": "47335-379", "generic_name": "Cinacalcet", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cinacalcet", "active_ingredients": [{"name": "CINACALCET HYDROCHLORIDE", "strength": "30 mg/1"}], "application_number": "ANDA207008", "marketing_category": "ANDA", "marketing_start_date": "20190515", "listing_expiration_date": "20261231"}