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United States · US · US:0904-7502_fba26c92-e029-462f-871b-c639228c59f9
Cinacalcet
Orange BookUNIISPLATC H05BX01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMajor Pharmaceuticals
CountryUS (United States)
ATC codeH05BX01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11090475020430 BLISTER PACK in 1 CARTON (0904-7502-04) / 1 TABLET, FILM COATED in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
1K860WSG25
CINACALCET HYDROCHLORIDE
RxCUI 384379
Orange Book
A209226
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": "0904-7502_fba26c92-e029-462f-871b-c639228c59f9",
"productndc": "0904-7502",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "209226",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 30MG BASE",
"product_no": "001",
"approval_date": "Apr 30, 2018"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 60MG BASE",
"product_no": "002",
"approval_date": "Apr 30, 2018"
},
{
"rs": true,
"rld": false,
"te_code": "AB",
"strength": "EQ 90MG BASE",
"product_no": "003",
"approval_date": "Apr 30, 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": "ANDA209226",
"marketing_category": "ANDA",
"nonproprietary_name": "Cinacalcet",
"start_marketing_date": "20250129",
"active_numerator_strength": "30"
}Related drugs
Other records sharing ATC code H05BX01.
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