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United States · US · US:0338-0048_1fe43459-21c4-4243-81bf-9674c1428f1e

SODIUM CHLORIDE

In shortageOrange BookUNIISPLATC A12CA01

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

Identification

ManufacturerBaxter Healthcare Corporation
CountryUS (United States)
ATC codeA12CA01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    0338004802
    24 BOTTLE, PLASTIC in 1 CARTON (0338-0048-02) / 250 mL in 1 BOTTLE, PLASTIC
  • ndc11
    0338004803
    18 BOTTLE, PLASTIC in 1 CARTON (0338-0048-03) / 500 mL in 1 BOTTLE, PLASTIC
  • ndc11
    0338004804
    12 BOTTLE, PLASTIC in 1 CARTON (0338-0048-04) / 1000 mL in 1 BOTTLE, PLASTIC

Annotations

UNII (FDA Substance ID)
451W47IQ8X
SODIUM CHLORIDE
RxCUI 9863
Orange Book
N017427
AT
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Sodium Chloride 0.9% 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": "IRRIGATION",
  "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": "0338-0048_1fe43459-21c4-4243-81bf-9674c1428f1e",
  "productndc": "0338-0048",
  "dosage_form": "IRRIGANT",
  "orange_book": {
    "appl_no": "017427",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AT",
        "strength": "900MG/100ML",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "SODIUM CHLORIDE",
  "shortage_reason": "Sodium Chloride 0.9% Injection",
  "shortage_status": "current",
  "proprietary_name": "SODIUM CHLORIDE",
  "active_ingred_unit": "mg/100mL",
  "application_number": "NDA017427",
  "marketing_category": "NDA",
  "nonproprietary_name": "sodium chloride",
  "start_marketing_date": "19741231",
  "active_numerator_strength": "900"
}

Related drugs

Other records sharing ATC code A12CA01.

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