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United States · US · US:47335-380_fb601aec-aba6-4bec-a98d-51e556fef95c
Cinacalcet
Orange BookUNIISPLATC H05BX01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSun Pharmaceutical Industries, Inc.
CountryUS (United States)
ATC codeH05BX01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11473353808330 TABLET, FILM COATED in 1 BOTTLE (47335-380-83)
Annotations
UNII (FDA Substance ID)
1K860WSG25
CINACALCET HYDROCHLORIDE
RxCUI 384379
Orange Book
A207008
AB
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": "47335-380_fb601aec-aba6-4bec-a98d-51e556fef95c",
"productndc": "47335-380",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "207008",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "EQ 30MG BASE",
"product_no": "001",
"approval_date": "Oct 11, 2018"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 60MG BASE",
"product_no": "002",
"approval_date": "Oct 11, 2018"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "EQ 90MG BASE",
"product_no": "003",
"approval_date": "Oct 11, 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": "ANDA207008",
"marketing_category": "ANDA",
"nonproprietary_name": "Cinacalcet",
"start_marketing_date": "20190515",
"active_numerator_strength": "60"
}Related drugs
Other records sharing ATC code H05BX01.
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