🇺🇸
United States · US · US:70710-2180_47ef97e0-8853-4254-b969-1a489764cec1
Sodium phenylbutyrate
In shortageOrange BookUNIISPLATC A16AX03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerZydus Pharmaceuticals USA Inc.
CountryUS (United States)
ATC codeA16AX03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1170710218081 BOTTLE in 1 CARTON (70710-2180-8) / 250 TABLET in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
NT6K61736T
SODIUM PHENYLBUTYRATE
RxCUI 214837
Orange Book
A220418
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": "70710-2180_47ef97e0-8853-4254-b969-1a489764cec1",
"productndc": "70710-2180",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "220418",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "500MG",
"product_no": "001",
"approval_date": "Feb 17, 2026"
}
],
"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": "ANDA220418",
"marketing_category": "ANDA",
"nonproprietary_name": "Sodium phenylbutyrate",
"start_marketing_date": "20260323",
"active_numerator_strength": "500"
}Related drugs
Other records sharing ATC code A16AX03.
Access this data programmatically
Query Sodium phenylbutyrate and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.