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United States · US · US:0264-7636_ed62bbc9-60b1-41c1-ae42-846cb79daa11

Potassium Chloride in Dextrose and Sodium Chloride

Orange BookUNIISPLATC C03CB

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

Identification

ManufacturerB. Braun Medical Inc.
CountryUS (United States)
ATC codeC03CB
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0264763600
    12 CONTAINER in 1 CASE (0264-7636-00) / 1000 mL in 1 CONTAINER

Annotations

UNII (FDA Substance ID)
IY9XDZ35W2
DEXTROSE, UNSPECIFIED FORM
RxCUI 4850
Orange Book
N019630
AP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "IY9XDZ35W2",
    "rxcui": "4850",
    "inchikey": null,
    "display_name": "DEXTROSE, UNSPECIFIED FORM",
    "substance_type": "mixture",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "ff67f638-5b53-406a-962a-87773a91fc48": {
      "match": "brand_token",
      "title": "POTASSIUM CITRATE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]",
      "spl_version": "104",
      "published_date": "2026-05-28"
    }
  },
  "productid": "0264-7636_ed62bbc9-60b1-41c1-ae42-846cb79daa11",
  "productndc": "0264-7636",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "019630",
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        "approval_date": "Feb 17, 1988"
      },
      {
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        "product_no": "002",
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      },
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        "rs": false,
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      },
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        "rs": false,
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      {
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        "product_no": "013",
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      },
      {
        "rs": false,
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        "product_no": "014",
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        "product_no": "053",
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      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DEXTROSE, UNSPECIFIED FORM; POTASSIUM CHLORIDE; SODIUM CHLORIDE",
  "proprietary_name": "Potassium Chloride in Dextrose and Sodium Chloride",
  "active_ingred_unit": "g/100mL; g/100mL; g/100mL",
  "application_number": "NDA019630",
  "marketing_category": "NDA",
  "nonproprietary_name": "DEXTROSE, SODIUM CHLORIDE, and POTASSIUM CHLORIDE",
  "start_marketing_date": "19880217",
  "active_numerator_strength": "5; .22; .45"
}

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