Magnesium Sulfate

Orange BookUNIISPLATC D11AX05

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

Identification

ManufacturerFresenius Kabi USA, LLC

CountryUS (United States)

ATC codeD11AX05

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
6332306403
25 VIAL, SINGLE-DOSE in 1 CARTON (63323-064-03) / 2 mL in 1 VIAL, SINGLE-DOSE (63323-064-01)
ndc11
6332306411
25 VIAL, SINGLE-DOSE in 1 TRAY (63323-064-11) / 10 mL in 1 VIAL, SINGLE-DOSE (63323-064-04)

Annotations

UNII (FDA Substance ID)

SK47B8698T

MAGNESIUM SULFATE HEPTAHYDRATE

RxCUI 236741

Orange Book

N019316

APAPAPAP

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": "INTRAMUSCULAR; 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": "63323-064_f603fb8c-08d1-44ce-843f-181b5468a7ce",
  "productndc": "63323-064",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "019316",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "5GM/10ML (500MG/ML)",
        "product_no": "001",
        "approval_date": "Sep 8, 1986"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "1GM/2ML (500MG/ML)",
        "product_no": "002",
        "approval_date": "Sep 8, 1986"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "10GM/20ML (500MG/ML)",
        "product_no": "003",
        "approval_date": "Jan 29, 2016"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "25GM/50ML (500MG/ML)",
        "product_no": "004",
        "approval_date": "Jan 29, 2016"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "MAGNESIUM SULFATE HEPTAHYDRATE",
  "proprietary_name": "Magnesium Sulfate",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA019316",
  "marketing_category": "NDA",
  "nonproprietary_name": "MAGNESIUM SULFATE HEPTAHYDRATE",
  "start_marketing_date": "20000808",
  "active_numerator_strength": "500"
}

Related drugs

Other records sharing ATC code D11AX05.

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