cinacalcet

Generic: cinacalcet

Labeler: dr. reddys laboratories inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cinacalcet
Generic Name cinacalcet
Labeler dr. reddys laboratories inc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

cinacalcet hydrochloride 60 mg/1

Manufacturer
Dr. Reddys Laboratories Inc

Identifiers & Regulatory

Product NDC 43598-368
Product ID 43598-368_b6dbd55a-a71d-0cf8-2c73-7ebbfc032906
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208368
Marketing Start 2020-09-18
Marketing End 2026-11-30

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 43598368
Hyphenated Format 43598-368

Supplemental Identifiers

RxCUI
432400 432401 432402
UPC
0343598369303
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 ANDA208368 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 60 mg/1
source: ndc
Packaging
  • 500 TABLET in 1 BOTTLE (43598-368-05)
  • 30 TABLET in 1 BOTTLE (43598-368-30)
source: ndc

Packages (2)

43598-368-05 500 TABLET in 1 BOTTLE (43598-368-05) 43598-368-30 30 TABLET in 1 BOTTLE (43598-368-30)

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": "b6dbd55a-a71d-0cf8-2c73-7ebbfc032906", "openfda": {"upc": ["0343598369303"], "unii": ["1K860WSG25"], "rxcui": ["432400", "432401", "432402"], "spl_set_id": ["0837aabc-e796-0e07-8958-71f1ff6e89bf"], "manufacturer_name": ["Dr. Reddys Laboratories Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET in 1 BOTTLE (43598-368-05)", "package_ndc": "43598-368-05", "marketing_end_date": "20261130", "marketing_start_date": "20200918"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (43598-368-30)", "package_ndc": "43598-368-30", "marketing_end_date": "20261130", "marketing_start_date": "20200918"}], "brand_name": "Cinacalcet", "product_id": "43598-368_b6dbd55a-a71d-0cf8-2c73-7ebbfc032906", "dosage_form": "TABLET", "pharm_class": ["Calcium-sensing Receptor Agonist [EPC]", "Increased Calcium-sensing Receptor Sensitivity [MoA]"], "product_ndc": "43598-368", "generic_name": "Cinacalcet", "labeler_name": "Dr. Reddys Laboratories Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cinacalcet", "active_ingredients": [{"name": "CINACALCET HYDROCHLORIDE", "strength": "60 mg/1"}], "application_number": "ANDA208368", "marketing_category": "ANDA", "marketing_end_date": "20261130", "marketing_start_date": "20200918"}