🇺🇸
United States · US · US:64380-116_2c66ebff-4389-49f9-a6ed-39d7de46dcb5
Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral
Orange BookUNIISPLATC C03CB
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerStrides Pharma Science Limited
CountryUS (United States)
ATC codeC03CB
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1164380116012 BOTTLE in 1 CARTON (64380-116-01) / 177 mL in 1 BOTTLE (64380-116-02)
Annotations
UNII (FDA Substance ID)
DE08037SAB
MAGNESIUM SULFATE, UNSPECIFIED FORM
RxCUI 6585
Orange Book
A215469
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": "64380-116_2c66ebff-4389-49f9-a6ed-39d7de46dcb5",
"productndc": "64380-116",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "215469",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "1.6GM/BOT;3.13GM/BOT;17.5GM/BOT",
"product_no": "001",
"approval_date": "Nov 22, 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 Oral",
"active_ingred_unit": "g/177mL; g/177mL; g/177mL",
"application_number": "ANDA215469",
"marketing_category": "ANDA",
"nonproprietary_name": "Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral",
"start_marketing_date": "20240117",
"active_numerator_strength": "1.6; 3.13; 17.5"
}Related drugs
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