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United States · US · US:49884-170_2bf2608e-f953-4123-98f8-05122fd6e10d
Sodium Phenylbutyrate
In shortageOrange BookUNIISPLATC A16AX03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPar Health USA, LLC
CountryUS (United States)
ATC codeA16AX03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1149884170041 BOTTLE in 1 CARTON (49884-170-04) / 250 TABLET in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
NT6K61736T
SODIUM PHENYLBUTYRATE
RxCUI 214837
Orange Book
A204395
AB
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Sodium Acetate 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": {
"52430b12-4d5f-d1e1-e063-6394a90abd64": {
"match": "brand_token",
"title": "SODIUM FLUORIDE RINSE LIQUID [ROCKLAND COSMETICS, INC.]",
"spl_version": "1",
"published_date": "2026-05-21"
}
},
"productid": "49884-170_2bf2608e-f953-4123-98f8-05122fd6e10d",
"productndc": "49884-170",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "204395",
"products": [
{
"rs": true,
"rld": false,
"te_code": "AB",
"strength": "500MG",
"product_no": "001",
"approval_date": "Apr 15, 2016"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "SODIUM PHENYLBUTYRATE",
"shortage_reason": "Sodium Acetate Injection",
"shortage_status": "current",
"proprietary_name": "Sodium Phenylbutyrate",
"active_ingred_unit": "mg/1",
"application_number": "ANDA204395",
"marketing_category": "ANDA",
"nonproprietary_name": "Sodium Phenylbutyrate Tablets, 500 mg",
"start_marketing_date": "20160429",
"active_numerator_strength": "500"
}Related drugs
Other records sharing ATC code A16AX03.
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