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United States · US · US:71335-2762_fc31ff9c-7242-4dfe-8bb9-c70e66fc03ba

CINACALCET

Orange BookUNIISPLATC H05BX01

Last synced from FDA National Drug Code directory (United States) on

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
    7133527621
    30 TABLET in 1 BOTTLE (71335-2762-1)

Annotations

UNII (FDA Substance ID)
1K860WSG25
CINACALCET HYDROCHLORIDE
RxCUI 384379
Orange Book
A208915
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": "71335-2762_fc31ff9c-7242-4dfe-8bb9-c70e66fc03ba",
  "productndc": "71335-2762",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "208915",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 30MG BASE",
        "product_no": "001",
        "approval_date": "Mar 8, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 60MG BASE",
        "product_no": "002",
        "approval_date": "Mar 8, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 90MG BASE",
        "product_no": "003",
        "approval_date": "Mar 8, 2018"
      }
    ],
    "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": "ANDA208915",
  "marketing_category": "ANDA",
  "nonproprietary_name": "CINACALCET",
  "start_marketing_date": "20180308",
  "active_numerator_strength": "60"
}

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