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United States · US · US:65219-282_2ad355c8-4420-42d5-8ea8-b4cc3ccc1c0e

Sodium chloride

In shortageOrange BookUNIISPLATC A12CA01

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

Identification

ManufacturerFresenius Kabi USA, LLC
CountryUS (United States)
ATC codeA12CA01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6521928210
    10 BAG in 1 CASE (65219-282-10) / 1000 mL in 1 BAG (65219-282-01)

Annotations

UNII (FDA Substance ID)
451W47IQ8X
SODIUM CHLORIDE
RxCUI 9863
Orange Book
A207310
AP
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Sodium Oxybate Solution
Raw payload (JSON)
{
  "unii": {
    "unii": "451W47IQ8X",
    "rxcui": "9863",
    "inchikey": "FAPWRFPIFSIZLT-UHFFFAOYSA-M",
    "display_name": "SODIUM CHLORIDE",
    "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": "65219-282_2ad355c8-4420-42d5-8ea8-b4cc3ccc1c0e",
  "productndc": "65219-282",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "207310",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "900MG/100ML",
        "product_no": "001",
        "approval_date": "Sep 19, 2017"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "SODIUM CHLORIDE",
  "shortage_reason": "Sodium Oxybate Solution",
  "shortage_status": "current",
  "proprietary_name": "Sodium chloride",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA207310",
  "marketing_category": "ANDA",
  "nonproprietary_name": "SODIUM CHLORIDE",
  "start_marketing_date": "20230630",
  "active_numerator_strength": "9"
}

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