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United States · US · US:67877-725_a55745d9-2b54-474d-9250-0447cbee6668

Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate

Orange BookUNIISPLATC C03CB

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

Identification

ManufacturerAscend Laboratories, LLC
CountryUS (United States)
ATC codeC03CB
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6787772592
    2 BOTTLE, PLASTIC in 1 CARTON (67877-725-92) / 177 mL in 1 BOTTLE, PLASTIC

Annotations

UNII (FDA Substance ID)
DE08037SAB
MAGNESIUM SULFATE, UNSPECIFIED FORM
RxCUI 6585
Orange Book
A213924
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": "67877-725_a55745d9-2b54-474d-9250-0447cbee6668",
  "productndc": "67877-725",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "213924",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "1.6GM/BOT;3.13GM/BOT;17.5GM/BOT",
        "product_no": "001",
        "approval_date": "Dec 29, 2023"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "MAGNESIUM SULFATE, UNSPECIFIED FORM; POTASSIUM SULFATE; SODIUM SULFATE",
  "proprietary_name": "Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate",
  "active_ingred_unit": "g/177mL; g/177mL; g/177mL",
  "application_number": "ANDA213924",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate",
  "start_marketing_date": "20240329",
  "active_numerator_strength": "1.6; 3.13; 17.5"
}

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