🇺🇸
United States · US · US:0054-9628_599719a1-b644-4ece-b0c0-ce8d85378e01
sodium oxybate
In shortageOrange BookUNIISPLATC N01AX11
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerHikma Pharmaceuticals USA Inc.
CountryUS (United States)
ATC codeN01AX11
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc110054962857180 mL in 1 BOTTLE, PLASTIC (0054-9628-57)
Annotations
UNII (FDA Substance ID)
7G33012534
SODIUM OXYBATE
RxCUI 9899
Orange Book
N021196
AA
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Sodium Chloride 0.9% Injection
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": "0054-9628_599719a1-b644-4ece-b0c0-ce8d85378e01",
"productndc": "0054-9628",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "021196",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AA",
"strength": "0.5GM/ML",
"product_no": "001",
"approval_date": "Jul 17, 2002"
}
],
"appl_type": "N"
},
"dea_schedule": "CIII",
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "SODIUM OXYBATE",
"shortage_reason": "Sodium Chloride 0.9% Injection",
"shortage_status": "current",
"proprietary_name": "sodium oxybate",
"active_ingred_unit": "g/mL",
"application_number": "NDA021196",
"marketing_category": "NDA AUTHORIZED GENERIC",
"nonproprietary_name": "sodium oxybate",
"start_marketing_date": "20230103",
"active_numerator_strength": ".5"
}Related drugs
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