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United States · US · US:16729-440_40aa0834-3fd8-c230-e063-6294a90a800d
CINACALCET
Orange BookUNIISPLATC H05BX01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAccord Healthcare, Inc.
CountryUS (United States)
ATC codeH05BX01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11167294401030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (16729-440-10)
- ndc11167294401590 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (16729-440-15)
Annotations
UNII (FDA Substance ID)
1K860WSG25
CINACALCET HYDROCHLORIDE
RxCUI 384379
Orange Book
A211892
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": "16729-440_40aa0834-3fd8-c230-e063-6294a90a800d",
"productndc": "16729-440",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "211892",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 30MG BASE",
"product_no": "001",
"approval_date": "May 15, 2020"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 60MG BASE",
"product_no": "002",
"approval_date": "May 15, 2020"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 90MG BASE",
"product_no": "003",
"approval_date": "May 15, 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": "ANDA211892",
"marketing_category": "ANDA",
"nonproprietary_name": "Cinacalcet",
"start_marketing_date": "20200616",
"active_numerator_strength": "30"
}Related drugs
Other records sharing ATC code H05BX01.
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