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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
- ndc114359836805500 TABLET in 1 BOTTLE (43598-368-05)
- ndc11435983683030 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
Other records sharing ATC code H05BX01.
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