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United States · US · US:70121-1720_8ec55093-e97e-4389-b992-36a61608bf5a

Magnesium Sulfate

Orange BookUNIISPLATC D11AX05

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

Identification

ManufacturerAmneal Pharmaceuticals LLC
CountryUS (United States)
ATC codeD11AX05
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    7012117203
    12 POUCH in 1 CARTON (70121-1720-3) / 1 BAG in 1 POUCH / 100 mL in 1 BAG
  • ndc11
    7012117209
    24 POUCH in 1 CARTON (70121-1720-9) / 1 BAG in 1 POUCH / 100 mL in 1 BAG

Annotations

UNII (FDA Substance ID)
SK47B8698T
MAGNESIUM SULFATE HEPTAHYDRATE
RxCUI 236741
Orange Book
A216597
APAP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "SK47B8698T",
    "rxcui": "236741",
    "inchikey": "WRUGWIBCXHJTDG-UHFFFAOYSA-L",
    "display_name": "MAGNESIUM SULFATE HEPTAHYDRATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "9875ae6b-2d91-49a3-9512-60a2b8bbccda": {
      "match": "brand_token",
      "title": "MAGNESIUM OXIDE TABLET [BRYANT RANCH PREPACK]",
      "spl_version": "103",
      "published_date": "2026-05-25"
    }
  },
  "productid": "70121-1720_8ec55093-e97e-4389-b992-36a61608bf5a",
  "productndc": "70121-1720",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "216597",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "2GM/50ML (40MG/ML)",
        "product_no": "001",
        "approval_date": "Feb 15, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "4GM/100ML (40MG/ML)",
        "product_no": "002",
        "approval_date": "Feb 15, 2023"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "MAGNESIUM SULFATE HEPTAHYDRATE",
  "proprietary_name": "Magnesium Sulfate",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA216597",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Magnesium Sulfate In Water For",
  "start_marketing_date": "20230220",
  "active_numerator_strength": "40"
}

Related drugs

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