🇺🇸
United States · US · US:65162-065_fb0e7d54-bf58-46d7-8561-9a270771f0d2
Sodium Oxybate
In shortageOrange BookUNIISPLATC N01AX11
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAmneal Pharmaceuticals LLC
CountryUS (United States)
ATC codeN01AX11
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1165162065871 BOTTLE in 1 CARTON (65162-065-87) / 180 mL in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
7G33012534
SODIUM OXYBATE
RxCUI 9899
Orange Book
A203631
AA
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Sodium Oxybate Solution
Raw payload (JSON)
{
"unii": {
"unii": "7G33012534",
"rxcui": "9899",
"inchikey": "XYGBKMMCQDZQOZ-UHFFFAOYSA-M",
"display_name": "SODIUM OXYBATE",
"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": "65162-065_fb0e7d54-bf58-46d7-8561-9a270771f0d2",
"productndc": "65162-065",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "203631",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "0.5GM/ML",
"product_no": "001",
"approval_date": "Sep 10, 2025"
}
],
"appl_type": "A"
},
"dea_schedule": "CIII",
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "SODIUM OXYBATE",
"shortage_reason": "Sodium Oxybate Solution",
"shortage_status": "current",
"proprietary_name": "Sodium Oxybate",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA203631",
"marketing_category": "ANDA",
"nonproprietary_name": "Sodium Oxybate",
"start_marketing_date": "20250912",
"active_numerator_strength": "500"
}Related drugs
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