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United States · US · US:51672-4170_494f52da-8ae6-6ec4-e063-6294a90a73a6

Sodium Sulfate, Potassium Sulfate, and Magnesium Sulfate Bowel Prep kit

Orange BookUNIISPLATC C03CB

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

Identification

ManufacturerSun Pharmaceutical Industries, Inc.
CountryUS (United States)
ATC codeC03CB
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5167241705
    2 BOTTLE in 1 CARTON (51672-4170-5) / 177 mL in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
DE08037SAB
MAGNESIUM SULFATE, UNSPECIFIED FORM
RxCUI 6585
Orange Book
A206431
AA
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "DE08037SAB",
    "rxcui": "6585",
    "inchikey": null,
    "display_name": "MAGNESIUM SULFATE, UNSPECIFIED FORM",
    "substance_type": "mixture",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "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": "51672-4170_494f52da-8ae6-6ec4-e063-6294a90a73a6",
  "productndc": "51672-4170",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "206431",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "1.6GM/BOT;3.13GM/BOT;17.5GM/BOT",
        "product_no": "001",
        "approval_date": "Mar 19, 2024"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "MAGNESIUM SULFATE, UNSPECIFIED FORM; POTASSIUM SULFATE; SODIUM SULFATE ANHYDROUS",
  "proprietary_name": "Sodium Sulfate, Potassium Sulfate, and Magnesium Sulfate Bowel Prep kit",
  "active_ingred_unit": "g/177mL; g/177mL; g/177mL",
  "application_number": "ANDA206431",
  "marketing_category": "ANDA",
  "nonproprietary_name": "sodium sulfate anhydrous, potassium sulfate, and magnesium sulfate",
  "start_marketing_date": "20240327",
  "active_numerator_strength": "1.6; 3.13; 17.5"
}

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