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United States · US · US:68462-853_060b5266-8881-4270-b62d-df8e49ecfd4b
sodium phenylbutyrate
In shortageOrange BookUNIISPLATC A16AX03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerGLENMARK PHARMACEUTICALS INC., USA
CountryUS (United States)
ATC codeA16AX03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc116846285320250 TABLET in 1 BOTTLE (68462-853-20)
Annotations
UNII (FDA Substance ID)
NT6K61736T
SODIUM PHENYLBUTYRATE
RxCUI 214837
Orange Book
A216462
AB
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Sodium Bicarbonate 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": "68462-853_060b5266-8881-4270-b62d-df8e49ecfd4b",
"productndc": "68462-853",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "216462",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "500MG",
"product_no": "001",
"approval_date": "Nov 1, 2022"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "SODIUM PHENYLBUTYRATE",
"shortage_reason": "Sodium Bicarbonate Injection",
"shortage_status": "current",
"proprietary_name": "sodium phenylbutyrate",
"active_ingred_unit": "mg/1",
"application_number": "ANDA216462",
"marketing_category": "ANDA",
"nonproprietary_name": "sodium phenylbutyrate",
"start_marketing_date": "20221101",
"active_numerator_strength": "500"
}Related drugs
Other records sharing ATC code A16AX03.
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