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United States · US · US:13267-542_2e4dae7b-58ec-4b60-bff5-a1ecf6147d18

Sodium Fluoride

In shortageOrange BookUNIISPLATC V09IX06

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

Identification

ManufacturerTHE FEINSTEIN INSTITUTES FOR MEDICAL RESEARCH
CountryUS (United States)
ATC codeV09IX06
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    1326754242
    20 mL in 1 VIAL, GLASS (13267-542-42)

Annotations

UNII (FDA Substance ID)
9L75099X6R
SODIUM FLUORIDE F-18
RxCUI 1311495
Orange Book
A204328
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Sodium Bicarbonate 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": "13267-542_2e4dae7b-58ec-4b60-bff5-a1ecf6147d18",
  "productndc": "13267-542",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "204328",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "20-600mCi/ML",
        "product_no": "001",
        "approval_date": "Nov 19, 2014"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "SODIUM FLUORIDE F-18",
  "shortage_reason": "Sodium Bicarbonate Injection",
  "shortage_status": "current",
  "proprietary_name": "Sodium Fluoride",
  "active_ingred_unit": "mCi/mL",
  "application_number": "ANDA204328",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Sodium Fluoride F 18",
  "start_marketing_date": "20141119",
  "active_numerator_strength": "600"
}

Related drugs

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