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United States · US · US:52768-125_2d6a7d5c-cf38-4ef7-b70b-86b58d37b905

Sodium Fluoride

In shortageOrange BookUNIISPLATC V09IX06

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

Identification

ManufacturerPrecision Nuclear LLC
CountryUS (United States)
ATC codeV09IX06
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    5276812530
    30 mL in 1 VIAL, MULTI-DOSE (52768-125-30)
  • ndc11
    5276812550
    50 mL in 1 VIAL, MULTI-DOSE (52768-125-50)

Annotations

UNII (FDA Substance ID)
9L75099X6R
SODIUM FLUORIDE F-18
RxCUI 1311495
Orange Book
A204542
AP
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Sodium Acetate Injection
Raw payload (JSON)
{
  "unii": {
    "unii": "9L75099X6R",
    "rxcui": "1311495",
    "inchikey": "PUZPDOWCWNUUKD-ULWFUOSBSA-M",
    "display_name": "SODIUM FLUORIDE F-18",
    "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": "52768-125_2d6a7d5c-cf38-4ef7-b70b-86b58d37b905",
  "productndc": "52768-125",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "204542",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "10-200mCi/ML",
        "product_no": "001",
        "approval_date": "Feb 27, 2015"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "SODIUM FLUORIDE F-18",
  "shortage_reason": "Sodium Acetate Injection",
  "shortage_status": "current",
  "proprietary_name": "Sodium Fluoride",
  "active_ingred_unit": "mCi/mL",
  "application_number": "ANDA204542",
  "marketing_category": "ANDA",
  "nonproprietary_name": "SODIUM FLUORIDE F-18",
  "start_marketing_date": "20110101",
  "active_numerator_strength": "200"
}

Related drugs

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