Sodium Chloride

In shortageOrange BookUNIISPLATC A12CA01

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

Identification

ManufacturerB. Braun Medical Inc.

CountryUS (United States)

ATC codeA12CA01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0264937588
10 mL in 1 AMPULE (0264-9375-88)

Annotations

UNII (FDA Substance ID)

451W47IQ8X

SODIUM CHLORIDE

RxCUI 9863

Orange Book

N019635

APAPAPAP

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": "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": "0264-9375_7a6642e8-d304-47fc-acd9-0dcac4650f88",
  "productndc": "0264-9375",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "019635",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AP",
        "strength": "450MG/100ML",
        "product_no": "001",
        "approval_date": "Mar 9, 1988"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "900MG/100ML",
        "product_no": "002",
        "approval_date": "Mar 9, 1988"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "3GM/100ML",
        "product_no": "003",
        "approval_date": "Mar 9, 1988"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "5GM/100ML",
        "product_no": "004",
        "approval_date": "Mar 9, 1988"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "90MG/10ML (9MG/ML)",
        "product_no": "005",
        "approval_date": "Aug 8, 2016"
      }
    ],
    "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/mL",
  "application_number": "NDA019635",
  "marketing_category": "NDA",
  "nonproprietary_name": "Sodium Chloride",
  "start_marketing_date": "20160809",
  "active_numerator_strength": "9"
}

Related drugs

Other records sharing ATC code A12CA01.

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