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United States · US · US:68382-396_6ad04728-e1b6-4851-9614-1322607ce238
SODIUM PHENYLACETATE AND SODIUM BENZOATE
In shortageOrange BookUNIISPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerZydus Pharmaceuticals USA Inc.
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1168382396011 VIAL in 1 CARTON (68382-396-01) / 50 mL in 1 VIAL
Annotations
UNII (FDA Substance ID)
OJ245FE5EU
SODIUM BENZOATE
RxCUI 56455
Orange Book
A205880
AP
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Sodium Chloride 0.9% Injection
Raw payload (JSON)
{
"unii": {
"unii": "OJ245FE5EU",
"rxcui": "56455",
"inchikey": "WXMKPNITSTVMEF-UHFFFAOYSA-M",
"display_name": "SODIUM BENZOATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAVENOUS",
"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": "68382-396_6ad04728-e1b6-4851-9614-1322607ce238",
"productndc": "68382-396",
"dosage_form": "INJECTION, SOLUTION, CONCENTRATE",
"orange_book": {
"appl_no": "205880",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "10%;10% (5GM/50ML;5GM/50ML)",
"product_no": "001",
"approval_date": "Aug 4, 2016"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "SODIUM BENZOATE; SODIUM PHENYLACETATE",
"shortage_reason": "Sodium Chloride 0.9% Injection",
"shortage_status": "current",
"proprietary_name": "SODIUM PHENYLACETATE AND SODIUM BENZOATE",
"active_ingred_unit": "mg/mL; mg/mL",
"application_number": "ANDA205880",
"marketing_category": "ANDA",
"nonproprietary_name": "sodium phenylacetate and sodium benzoate",
"start_marketing_date": "20210208",
"active_numerator_strength": "100; 100"
}Access this data programmatically
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