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United States · US · US:0404-9954_82fec5d4-5c84-487c-b59a-ed8fab299d2b

Sodium Chloride

In shortageOrange BookUNIISPLATC A12CA01

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

Identification

ManufacturerHenry Schein, Inc.
CountryUS (United States)
ATC codeA12CA01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    0404995420
    1 VIAL, SINGLE-DOSE in 1 BAG (0404-9954-20) / 20 mL in 1 VIAL, SINGLE-DOSE
  • ndc11
    0404995450
    1 VIAL, SINGLE-DOSE in 1 BAG (0404-9954-50) / 50 mL in 1 VIAL, SINGLE-DOSE

Annotations

UNII (FDA Substance ID)
451W47IQ8X
SODIUM CHLORIDE
RxCUI 9863
Orange Book
N018803
APAPAP
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": "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": "0404-9954_82fec5d4-5c84-487c-b59a-ed8fab299d2b",
  "productndc": "0404-9954",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "018803",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "90MG/10ML (9MG/ML)",
        "product_no": "001",
        "approval_date": "Oct 29, 1982"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "180MG/20ML (9MG/ML)",
        "product_no": "002",
        "approval_date": "Oct 29, 1982"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "450MG/50ML (9MG/ML)",
        "product_no": "003",
        "approval_date": "Oct 29, 1982"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "18MG/2ML (9MG/ML)",
        "product_no": "004",
        "approval_date": "Jan 22, 2015"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "27MG/3ML (9MG/ML)",
        "product_no": "005",
        "approval_date": "Jan 22, 2015"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "45MG/5ML (9MG/ML)",
        "product_no": "006",
        "approval_date": "Jan 22, 2015"
      }
    ],
    "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": "NDA018803",
  "marketing_category": "NDA",
  "nonproprietary_name": "Sodium Chloride",
  "start_marketing_date": "20220112",
  "active_numerator_strength": "9"
}

Related drugs

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