Cinacalcet

Orange BookUNIISPLATC H05BX01

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

Identification

ManufacturerREMEDYREPACK INC.

CountryUS (United States)

ATC codeH05BX01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7051846150
50 POUCH in 1 BOX (70518-4615-0) / 1 TABLET, FILM COATED in 1 POUCH (70518-4615-1)

Annotations

UNII (FDA Substance ID)

1K860WSG25

CINACALCET HYDROCHLORIDE

RxCUI 384379

Orange Book

A209226

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": "70518-4615_50343b7d-69e1-ea69-e063-6294a90abe0a",
  "productndc": "70518-4615",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "209226",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 30MG BASE",
        "product_no": "001",
        "approval_date": "Apr 30, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 60MG BASE",
        "product_no": "002",
        "approval_date": "Apr 30, 2018"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 90MG BASE",
        "product_no": "003",
        "approval_date": "Apr 30, 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": "ANDA209226",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Cinacalcet",
  "start_marketing_date": "20260423",
  "active_numerator_strength": "30"
}

Related drugs

Other records sharing ATC code H05BX01.

Access this data programmatically

Query Cinacalcet and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs