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United States · US · US:69452-428_4e58e598-c8fd-a692-e063-6394a90ae564

sodium sulfate, potassium sulfate, and magnesium sulfate

Orange BookUNIISPLATC C03CB

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

Identification

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

Packs · 1

  • ndc11
    6945242862
    2 BOTTLE, PLASTIC in 1 KIT (69452-428-62) / 177 mL in 1 BOTTLE, PLASTIC

Annotations

UNII (FDA Substance ID)
ML30MJ2U7I
MAGNESIUM SULFATE ANHYDROUS
RxCUI 1311625
Orange Book
A204135
AA
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "ML30MJ2U7I",
    "rxcui": "1311625",
    "inchikey": "CSNNHWWHGAXBCP-UHFFFAOYSA-L",
    "display_name": "MAGNESIUM SULFATE ANHYDROUS",
    "substance_type": "chemical",
    "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": "69452-428_4e58e598-c8fd-a692-e063-6394a90ae564",
  "productndc": "69452-428",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "204135",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "1.6GM/BOT;3.13GM/BOT;17.5GM/BOT",
        "product_no": "001",
        "approval_date": "Jun 24, 2024"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "MAGNESIUM SULFATE ANHYDROUS; POTASSIUM SULFATE; SODIUM SULFATE",
  "proprietary_name": "sodium sulfate, potassium sulfate, and magnesium sulfate",
  "active_ingred_unit": "g/177mL; g/177mL; g/177mL",
  "application_number": "ANDA204135",
  "marketing_category": "ANDA",
  "nonproprietary_name": "sodium sulfate, potassium sulfate, and magnesium sulfate",
  "start_marketing_date": "20250415",
  "active_numerator_strength": "1.6; 3.13; 17.5"
}

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