Magnesium Sulfate in Water

Orange BookUNIISPLATC D11AX05

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

Identification

ManufacturerAvenacy, LLC

CountryUS (United States)

ATC codeD11AX05

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
8363450081
24 POUCH in 1 CARTON (83634-500-81) / 1 BAG in 1 POUCH (83634-500-41) / 50 mL in 1 BAG
ndc11
8363450082
24 POUCH in 1 CARTON (83634-500-82) / 1 BAG in 1 POUCH (83634-500-42) / 100 mL in 1 BAG
ndc11
8363450083
30 POUCH in 1 CARTON (83634-500-83) / 1 BAG in 1 POUCH (83634-500-41) / 50 mL in 1 BAG

Annotations

UNII (FDA Substance ID)

SK47B8698T

MAGNESIUM SULFATE HEPTAHYDRATE

RxCUI 236741

Orange Book

A209642

APAPAP

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": "83634-500_74a0488c-befd-4f6b-af07-d06834e8202a",
  "productndc": "83634-500",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "209642",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "2GM/50ML (40MG/ML)",
        "product_no": "001",
        "approval_date": "Nov 8, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "4GM/100ML (40MG/ML)",
        "product_no": "002",
        "approval_date": "Nov 8, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "4GM/50ML (80MG/ML)",
        "product_no": "003",
        "approval_date": "Nov 8, 2021"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "MAGNESIUM SULFATE HEPTAHYDRATE",
  "proprietary_name": "Magnesium Sulfate in Water",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA209642",
  "marketing_category": "ANDA",
  "nonproprietary_name": "magnesium sulfate in water",
  "start_marketing_date": "20240422",
  "active_numerator_strength": "40"
}

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