Sensipar

Orange BookUNIISPLATC H05BX01

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

Identification

ManufacturerAmgen Inc

CountryUS (United States)

ATC codeH05BX01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5551307430
30 TABLET, COATED in 1 BOTTLE, PLASTIC (55513-074-30)

Annotations

UNII (FDA Substance ID)

1K860WSG25

CINACALCET HYDROCHLORIDE

RxCUI 384379

Orange Book

N021688

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": {
    "45028573-13c4-4c8b-ae62-6c75bba97c81": {
      "match": "brand_token",
      "title": "SENSIPAR (CINACALCET HYDROCHLORIDE) TABLET, COATED [AMGEN INC]",
      "spl_version": "136",
      "published_date": "2025-12-09"
    }
  },
  "productid": "55513-074_42c2c9c2-6929-4952-b559-a57a1d75424e",
  "productndc": "55513-074",
  "dosage_form": "TABLET, COATED",
  "orange_book": {
    "appl_no": "021688",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 30MG BASE",
        "product_no": "001",
        "approval_date": "Mar 8, 2004"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 60MG BASE",
        "product_no": "002",
        "approval_date": "Mar 8, 2004"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 90MG BASE",
        "product_no": "003",
        "approval_date": "Mar 8, 2004"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CINACALCET HYDROCHLORIDE",
  "proprietary_name": "Sensipar",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA021688",
  "marketing_category": "NDA",
  "nonproprietary_name": "cinacalcet hydrochloride",
  "start_marketing_date": "20040404",
  "active_numerator_strength": "60"
}

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