Sodium Chloride

In shortageOrange BookUNIISPLATC A12CA01

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

Identification

ManufacturerHikma Pharmaceuticals USA Inc.

CountryUS (United States)

ATC codeA12CA01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0641049725
25 VIAL in 1 CARTON (0641-0497-25) / 2 mL in 1 VIAL (0641-0497-17)

Annotations

UNII (FDA Substance ID)

451W47IQ8X

SODIUM CHLORIDE

RxCUI 9863

Orange Book

A201833

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": "0641-0497_0950e98d-bfec-40e8-9f56-ba90e0d6e8c8",
  "productndc": "0641-0497",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "201833",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "18MG/2ML (9MG/ML)",
        "product_no": "001",
        "approval_date": "Sep 24, 2013"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "90MG/10ML (9MG/ML)",
        "product_no": "002",
        "approval_date": "Jan 7, 2015"
      }
    ],
    "appl_type": "A"
  },
  "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": "ANDA201833",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Sodium Chloride",
  "start_marketing_date": "20130924",
  "active_numerator_strength": "9"
}

Related drugs

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