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United States · US · US:65162-213_4d63252a-b953-4066-b38c-a468580dc407
Cinacalcet Hydrochloride
Orange BookUNIISPLATC H05BX01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAmneal Pharmaceuticals LLC
CountryUS (United States)
ATC codeH05BX01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11651622130330 TABLET in 1 BOTTLE (65162-213-03)
- ndc116516221310100 TABLET in 1 BOTTLE (65162-213-10)
- ndc116516221325250 TABLET in 1 BOTTLE (65162-213-25)
Annotations
UNII (FDA Substance ID)
1K860WSG25
CINACALCET HYDROCHLORIDE
RxCUI 384379
Orange Book
A204364
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": "65162-213_4d63252a-b953-4066-b38c-a468580dc407",
"productndc": "65162-213",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "204364",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "EQ 30MG BASE",
"product_no": "001",
"approval_date": "Dec 2, 2021"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "EQ 60MG BASE",
"product_no": "002",
"approval_date": "Dec 2, 2021"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "EQ 90MG BASE",
"product_no": "003",
"approval_date": "Dec 2, 2021"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "CINACALCET HYDROCHLORIDE",
"proprietary_name": "Cinacalcet Hydrochloride",
"active_ingred_unit": "mg/1",
"application_number": "ANDA204364",
"marketing_category": "ANDA",
"nonproprietary_name": "Cinacalcet",
"start_marketing_date": "20211206",
"active_numerator_strength": "90"
}Related drugs
Other records sharing ATC code H05BX01.
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