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United States · US · US:43598-368_b6dbd55a-a71d-0cf8-2c73-7ebbfc032906

Cinacalcet

Orange BookUNIISPLATC H05BX01

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

Identification

ManufacturerDr. Reddys Laboratories Inc
CountryUS (United States)
ATC codeH05BX01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    4359836805
    500 TABLET in 1 BOTTLE (43598-368-05)
  • ndc11
    4359836830
    30 TABLET in 1 BOTTLE (43598-368-30)

Annotations

UNII (FDA Substance ID)
1K860WSG25
CINACALCET HYDROCHLORIDE
RxCUI 384379
Orange Book
A208368
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": "43598-368_b6dbd55a-a71d-0cf8-2c73-7ebbfc032906",
  "productndc": "43598-368",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "208368",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 30MG BASE",
        "product_no": "001",
        "approval_date": "Sep 18, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 60MG BASE",
        "product_no": "002",
        "approval_date": "Sep 18, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 90MG BASE",
        "product_no": "003",
        "approval_date": "Sep 18, 2020"
      }
    ],
    "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": "ANDA208368",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Cinacalcet",
  "start_marketing_date": "20200918",
  "active_numerator_strength": "60"
}

Related drugs

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