Sodium Chloride

In shortageOrange BookUNIISPLATC A12CA01

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

Identification

ManufacturerSpectra Medical Deviecs, LLC

CountryUS (United States)

ATC codeA12CA01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6528215051
5 TRAY in 1 CARTON (65282-1505-1) / 5 AMPULE in 1 TRAY / 5 mL in 1 AMPULE

Annotations

UNII (FDA Substance ID)

451W47IQ8X

SODIUM CHLORIDE

RxCUI 9863

Orange Book

A206171

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": "INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS",
  "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": "65282-1505_447bf261-1a3a-2da1-e063-6394a90a7537",
  "productndc": "65282-1505",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "206171",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "45MG/5ML (9MG/ML)",
        "product_no": "001",
        "approval_date": "Jul 21, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "90MG/10ML (9MG/ML)",
        "product_no": "002",
        "approval_date": "Jul 21, 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": "ANDA206171",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Sodium Chloride",
  "start_marketing_date": "20170721",
  "active_numerator_strength": "9"
}

Related drugs

Other records sharing ATC code A12CA01.

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