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United States · US · US:75987-060_3178e0bc-ebb7-4ddd-be43-630ff87eeb02
BUPHENYL
In shortageOrange BookUNIISPLATC A16AX03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerHorizon Therapeutics USA, Inc.
CountryUS (United States)
ATC codeA16AX03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1175987060081 BOTTLE in 1 CARTON (75987-060-08) / 250 TABLET in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
NT6K61736T
SODIUM PHENYLBUTYRATE
RxCUI 214837
Orange Book
N020572
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Sodium Chloride 0.9% Injection
Raw payload (JSON)
{
"unii": {
"unii": "NT6K61736T",
"rxcui": "214837",
"inchikey": "VPZRWNZGLKXFOE-UHFFFAOYSA-M",
"display_name": "SODIUM PHENYLBUTYRATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"463a36fa-3eb2-4326-8bd0-c8c7a11bca3a": {
"match": "brand_token",
"title": "BUPHENYL (SODIUM PHENYLBUTYRATE) TABLET BUPHENYL (SODIUM PHENYLBUTYRATE) POWDER [HORIZON THERAPEUTICS USA, INC.]",
"spl_version": "9",
"published_date": "2024-11-14"
}
},
"productid": "75987-060_3178e0bc-ebb7-4ddd-be43-630ff87eeb02",
"productndc": "75987-060",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "020572",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "500MG",
"product_no": "001",
"approval_date": "May 13, 1996"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "SODIUM PHENYLBUTYRATE",
"shortage_reason": "Sodium Chloride 0.9% Injection",
"shortage_status": "current",
"proprietary_name": "BUPHENYL",
"active_ingred_unit": "mg/1",
"application_number": "NDA020572",
"marketing_category": "NDA",
"nonproprietary_name": "sodium phenylbutyrate",
"start_marketing_date": "19960513",
"active_numerator_strength": "500"
}Related drugs
Other records sharing ATC code A16AX03.
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