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United States · US · US:51662-1352_100d196c-c851-3cf7-e063-6294a90ad8c2

MAGNESIUM SULFATE

Orange BookUNIISPLATC D11AX05

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

Identification

ManufacturerHF Acquisition Co LLC, DBA HealthFirst
CountryUS (United States)
ATC codeD11AX05
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    5166213521
    50 mL in 1 BAG (51662-1352-1)
  • ndc11
    5166213523
    24 POUCH in 1 CASE (51662-1352-3) / 1 BAG in 1 POUCH (51662-1352-2) / 50 mL in 1 BAG

Annotations

UNII (FDA Substance ID)
SK47B8698T
MAGNESIUM SULFATE HEPTAHYDRATE
RxCUI 236741
Orange Book
N020309
APAPAPAPAP
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": "51662-1352_100d196c-c851-3cf7-e063-6294a90ad8c2",
  "productndc": "51662-1352",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "020309",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "4GM/100ML (40MG/ML)",
        "product_no": "001",
        "approval_date": "Jun 24, 1994"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "4GM/50ML (80MG/ML)",
        "product_no": "002",
        "approval_date": "Jun 24, 1994"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AP",
        "strength": "2GM/50ML (40MG/ML)",
        "product_no": "003",
        "approval_date": "Jan 26, 2007"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AP",
        "strength": "20GM/500ML (40MG/ML)",
        "product_no": "004",
        "approval_date": "Jan 18, 1995"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AP",
        "strength": "40GM/1000ML (40MG/ML)",
        "product_no": "005",
        "approval_date": "Jan 18, 1995"
      }
    ],
    "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": "NDA020309",
  "marketing_category": "NDA",
  "nonproprietary_name": "MAGNESIUM SULFATE",
  "start_marketing_date": "20181221",
  "active_numerator_strength": "40"
}

Related drugs

Other records sharing ATC code D11AX05.

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