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United States · US · US:84386-112_200390f2-7dad-4ecc-a086-c29e18525c01
Cinacalcet
Orange BookUNIISPLATC H05BX01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAurobindo Pharma Limited
CountryUS (United States)
ATC codeH05BX01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc118438611201100 TABLET, FILM COATED in 1 BOTTLE (84386-112-01)
- ndc118438611205500 TABLET, FILM COATED in 1 BOTTLE (84386-112-05)
- ndc11843861123030 TABLET, FILM COATED in 1 BOTTLE (84386-112-30)
- ndc11843861129090 TABLET, FILM COATED in 1 BOTTLE (84386-112-90)
Annotations
UNII (FDA Substance ID)
1K860WSG25
CINACALCET HYDROCHLORIDE
RxCUI 384379
Orange Book
A206125
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": "84386-112_200390f2-7dad-4ecc-a086-c29e18525c01",
"productndc": "84386-112",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "206125",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 30MG BASE",
"product_no": "001",
"approval_date": "Mar 8, 2018"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 60MG BASE",
"product_no": "002",
"approval_date": "Mar 8, 2018"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 90MG BASE",
"product_no": "003",
"approval_date": "Mar 8, 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": "ANDA206125",
"marketing_category": "ANDA",
"nonproprietary_name": "Cinacalcet",
"start_marketing_date": "20260323",
"active_numerator_strength": "60"
}Related drugs
Other records sharing ATC code H05BX01.
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