MAGNESIUM SULFATE

Orange BookUNIISPLATC D11AX05

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerGland Pharma Limited

CountryUS (United States)

ATC codeD11AX05

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6808339601
24 POUCH in 1 CASE (68083-396-01) / 1 BAG in 1 POUCH / 50 mL in 1 BAG

Annotations

UNII (FDA Substance ID)

SK47B8698T

MAGNESIUM SULFATE HEPTAHYDRATE

RxCUI 236741

Orange Book

A213917

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": "68083-396_4166c4fd-2951-4ab0-ab2a-6da9dd39927e",
  "productndc": "68083-396",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "213917",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "2GM/50ML (40MG/ML)",
        "product_no": "001",
        "approval_date": "Jul 10, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "4GM/100ML (40MG/ML)",
        "product_no": "002",
        "approval_date": "Jul 10, 2020"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "MAGNESIUM SULFATE HEPTAHYDRATE",
  "proprietary_name": "MAGNESIUM SULFATE",
  "active_ingred_unit": "g/50mL",
  "application_number": "ANDA213917",
  "marketing_category": "ANDA",
  "nonproprietary_name": "MAGNESIUM SULFATE HEPTAHYDRATE",
  "start_marketing_date": "20200710",
  "active_numerator_strength": "2"
}

Related drugs

Other records sharing ATC code D11AX05.

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