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United States · US · US:42794-086_d70f7f7c-f27a-db94-e053-2995a90a6937
Sodium Phenylbutyrate
In shortageOrange BookUNIISPLATC A16AX03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSigmapharm Laboratories, LLC
CountryUS (United States)
ATC codeA16AX03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1142794086141 BOTTLE in 1 CARTON (42794-086-14) / 250 g in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
NT6K61736T
SODIUM PHENYLBUTYRATE
RxCUI 214837
Orange Book
A202819
AB
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": {
"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": "42794-086_d70f7f7c-f27a-db94-e053-2995a90a6937",
"productndc": "42794-086",
"dosage_form": "POWDER",
"orange_book": {
"appl_no": "202819",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "3GM/TEASPOONFUL",
"product_no": "001",
"approval_date": "Mar 22, 2013"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "SODIUM PHENYLBUTYRATE",
"shortage_reason": "Sodium Chloride 0.9% Injection",
"shortage_status": "current",
"proprietary_name": "Sodium Phenylbutyrate",
"active_ingred_unit": "g/g",
"application_number": "ANDA202819",
"marketing_category": "ANDA",
"nonproprietary_name": "Sodium Phenylbutyrate",
"start_marketing_date": "20130408",
"active_numerator_strength": ".94"
}Related drugs
Other records sharing ATC code A16AX03.
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