Cinacalcet

Orange BookUNIISPLATC H05BX01

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerBryant Ranch Prepack

CountryUS (United States)

ATC codeH05BX01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6362987651
30 TABLET, FILM COATED in 1 BOTTLE (63629-8765-1)

Annotations

UNII (FDA Substance ID)

1K860WSG25

CINACALCET HYDROCHLORIDE

RxCUI 384379

Orange Book

A210570

ABABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "1K860WSG25",
    "rxcui": "384379",
    "inchikey": "QANQWUQOEJZMLL-PKLMIRHRSA-N",
    "display_name": "CINACALCET HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "b71d56b8-9c03-4347-8752-8a04825a1add": {
      "match": "brand_token",
      "title": "CINACALCET TABLET, FILM COATED [BRYANT RANCH PREPACK]",
      "spl_version": "105",
      "published_date": "2026-06-01"
    }
  },
  "productid": "63629-8765_196b9b04-245b-4196-87c3-4c2a6f95e4e3",
  "productndc": "63629-8765",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "210570",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 30MG BASE",
        "product_no": "001",
        "approval_date": "May 17, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 60MG BASE",
        "product_no": "002",
        "approval_date": "May 17, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 90MG BASE",
        "product_no": "003",
        "approval_date": "May 17, 2019"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CINACALCET HYDROCHLORIDE",
  "proprietary_name": "Cinacalcet",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA210570",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Cinacalcet",
  "start_marketing_date": "20190518",
  "active_numerator_strength": "90"
}

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