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United States · US · US:71770-210_4072f3df-e754-4c2e-be0c-af3c8edb9211
PHEBURANE
In shortageOrange BookUNIISPLATC A16AX03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMedunik USA
CountryUS (United States)
ATC codeA16AX03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc117177021010174 g in 1 BOTTLE (71770-210-10)
Annotations
UNII (FDA Substance ID)
NT6K61736T
SODIUM PHENYLBUTYRATE
RxCUI 214837
Orange Book
N216513
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": {
"d15f2cbf-4d22-40b5-8ef9-16b9d323a7f9": {
"match": "brand_token",
"title": "PHEBURANE (SODIUM PHENYLBUTYRATE) PELLET PHEBURANE (SODIUM PHENYLBUTYRATE) KIT [MEDUNIK USA]",
"spl_version": "6",
"published_date": "2025-11-28"
}
},
"productid": "71770-210_4072f3df-e754-4c2e-be0c-af3c8edb9211",
"productndc": "71770-210",
"dosage_form": "PELLET",
"orange_book": {
"appl_no": "216513",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "84GM/BOT",
"product_no": "001",
"approval_date": "Jun 17, 2022"
}
],
"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": "PHEBURANE",
"active_ingred_unit": "mg/g",
"application_number": "NDA216513",
"marketing_category": "NDA",
"nonproprietary_name": "Sodium phenylbutyrate",
"start_marketing_date": "20220914",
"active_numerator_strength": "483"
}Related drugs
Other records sharing ATC code A16AX03.
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