cinacalcet

Generic: cinacalcet

Labeler: cipla usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cinacalcet
Generic Name cinacalcet
Labeler cipla usa inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

cinacalcet hydrochloride 90 mg/1

Manufacturer
Cipla USA Inc.

Identifiers & Regulatory

Product NDC 69097-412
Product ID 69097-412_383a7dc8-b195-4868-8774-f16a5558771e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208915
Listing Expiration 2026-12-31
Marketing Start 2018-03-08

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 69097412
Hyphenated Format 69097-412

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 ANDA208915 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 90 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (69097-412-02)
source: ndc

Packages (1)

69097-412-02 30 TABLET in 1 BOTTLE (69097-412-02)

Ingredients (1)

cinacalcet hydrochloride (90 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": "383a7dc8-b195-4868-8774-f16a5558771e", "openfda": {"unii": ["1K860WSG25"], "rxcui": ["432400", "432401", "432402"], "spl_set_id": ["02b8c11b-99e8-4039-b6fa-a9c38d2f48fa"], "manufacturer_name": ["Cipla USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (69097-412-02)", "package_ndc": "69097-412-02", "marketing_start_date": "20180308"}], "brand_name": "CINACALCET", "product_id": "69097-412_383a7dc8-b195-4868-8774-f16a5558771e", "dosage_form": "TABLET", "pharm_class": ["Calcium-sensing Receptor Agonist [EPC]", "Increased Calcium-sensing Receptor Sensitivity [MoA]"], "product_ndc": "69097-412", "generic_name": "CINACALCET", "labeler_name": "Cipla USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "CINACALCET", "active_ingredients": [{"name": "CINACALCET HYDROCHLORIDE", "strength": "90 mg/1"}], "application_number": "ANDA208915", "marketing_category": "ANDA", "marketing_start_date": "20180308", "listing_expiration_date": "20261231"}