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United States · US · US:72865-349_978891be-92e4-4aa0-9e01-6733b1148bc3

sodium oxybate

In shortageOrange BookUNIISPLATC N01AX11

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerXLCare Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeN01AX11
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7286534918
    1 BOTTLE in 1 CARTON (72865-349-18) / 180 mL in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
7G33012534
SODIUM OXYBATE
RxCUI 9899
Orange Book
A210523
AA
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Sodium Bicarbonate 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": "72865-349_978891be-92e4-4aa0-9e01-6733b1148bc3",
  "productndc": "72865-349",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "210523",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "0.5GM/ML",
        "product_no": "001",
        "approval_date": "Nov 5, 2025"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": "CIII",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "SODIUM OXYBATE",
  "shortage_reason": "Sodium Bicarbonate Injection",
  "shortage_status": "current",
  "proprietary_name": "sodium oxybate",
  "active_ingred_unit": "g/mL",
  "application_number": "ANDA210523",
  "marketing_category": "ANDA",
  "nonproprietary_name": "sodium oxybate",
  "start_marketing_date": "20260101",
  "active_numerator_strength": ".5"
}

Related drugs

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