SODIUM CHLORIDE

In shortageOrange BookUNIISPLATC A12CA01

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerBaxter Healthcare Corporation

CountryUS (United States)

ATC codeA12CA01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 7

ndc11
0338954301
250 mL in 1 BAG (0338-9543-01)
ndc11
0338954302
250 mL in 1 BAG (0338-9543-02)
ndc11
0338954303
500 mL in 1 BAG (0338-9543-03)
ndc11
0338954304
500 mL in 1 BAG (0338-9543-04)
ndc11
0338954305
1000 mL in 1 BAG (0338-9543-05)
ndc11
0338954306
1000 mL in 1 BAG (0338-9543-06)
ndc11
0338954312
1000 mL in 1 BAG (0338-9543-12)

Annotations

UNII (FDA Substance ID)

451W47IQ8X

SODIUM CHLORIDE

RxCUI 9863

Orange Book

N016677

APAP

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": "0338-9543_ba9e58a5-60c5-4aab-9cef-36320d052091",
  "productndc": "0338-9543",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "016677",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "900MG/100ML",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "450MG/50ML (9MG/ML)",
        "product_no": "003",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "225MG/25ML (9MG/ML)",
        "product_no": "004",
        "approval_date": "Oct 30, 1985"
      }
    ],
    "appl_type": "N"
  },
  "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": "g/1000mL",
  "application_number": "NDA016677",
  "marketing_category": "NDA",
  "nonproprietary_name": "sodium chloride",
  "start_marketing_date": "19701209",
  "active_numerator_strength": "9"
}

Related drugs

Other records sharing ATC code A12CA01.

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