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United States · US · US:40028-512_53cdbece-6719-47f1-8bc0-da2d326f5802

Sodium Fluoride F 18

In shortageOrange BookUNIISPLATC V09IX06

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

Identification

ManufacturerPETNET Solutions, Inc.
CountryUS (United States)
ATC codeV09IX06
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    4002851230
    1 VIAL, MULTI-DOSE in 1 CAN (40028-512-30) / 30 mL in 1 VIAL, MULTI-DOSE

Annotations

UNII (FDA Substance ID)
9L75099X6R
SODIUM FLUORIDE F-18
RxCUI 1311495
Orange Book
A203890
AP
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Sodium Chloride 0.9% 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": "40028-512_53cdbece-6719-47f1-8bc0-da2d326f5802",
  "productndc": "40028-512",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "203890",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AP",
        "strength": "10-200mCi/ML",
        "product_no": "001",
        "approval_date": "Sep 28, 2015"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "SODIUM FLUORIDE F-18",
  "shortage_reason": "Sodium Chloride 0.9% Injection",
  "shortage_status": "current",
  "proprietary_name": "Sodium Fluoride F 18",
  "active_ingred_unit": "mCi/mL",
  "application_number": "ANDA203890",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Sodium Fluoride F 18",
  "start_marketing_date": "20110126",
  "active_numerator_strength": "200"
}

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