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United States · US · US:63323-623_b9f9ae0e-b72d-480a-b1cc-41d817aa83be

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 · 5

  • ndc11
    6332362376
    1000 mL in 1 BAG (63323-623-76)
  • ndc11
    6332362353
    50 mL in 1 BAG (63323-623-53)
  • ndc11
    6332362361
    100 mL in 1 BAG (63323-623-61)
  • ndc11
    6332362374
    250 mL in 1 BAG (63323-623-74)
  • ndc11
    6332362375
    500 mL in 1 BAG (63323-623-75)

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 Bicarbonate Injection
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": "63323-623_b9f9ae0e-b72d-480a-b1cc-41d817aa83be",
  "productndc": "63323-623",
  "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 Bicarbonate Injection",
  "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": "20170919",
  "active_numerator_strength": "9"
}

Related drugs

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