magnesium sulfate in water (83634-501)

Drug Facts

Product Profile

Brand Name magnesium sulfate in water

Generic Name magnesium sulfate in water

Labeler avenacy, llc

Dosage Form INJECTION, SOLUTION

Routes

INTRAVENOUS

Active Ingredients

magnesium sulfate heptahydrate 80 mg/mL

Manufacturer

Avenacy, LLC

Identifiers & Regulatory

Product NDC 83634-501

Product ID 83634-501_74a0488c-befd-4f6b-af07-d06834e8202a

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA209642

Listing Expiration 2026-12-31

Marketing Start 2024-04-22

Pharmacologic Class

Classes

calculi dissolution agent [epc] increased large intestinal motility [pe] inhibition large intestine fluid/electrolyte absorption [pe] inhibition small intestine fluid/electrolyte absorption [pe] magnesium ion exchange activity [moa] osmotic activity [moa] osmotic laxative [epc] stimulation large intestine fluid/electrolyte secretion [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 83634501

Hyphenated Format 83634-501

Supplemental Identifiers

RxCUI

829734 1658259 1658262

UNII

SK47B8698T

Packaging Origin

Original Packager

true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name magnesium sulfate in water (source: ndc)

Generic Name magnesium sulfate in water (source: ndc)

Application Number ANDA209642 (source: ndc)

Routes

INTRAVENOUS

source: ndc

Resolved Composition

Strengths

80 mg/mL

source: ndc

Packaging

24 POUCH in 1 CARTON (83634-501-81) / 1 BAG in 1 POUCH (83634-501-41) / 50 mL in 1 BAG
30 POUCH in 1 CARTON (83634-501-82) / 1 BAG in 1 POUCH (83634-501-41) / 50 mL in 1 BAG

source: ndc

Packages (2)

83634-501-81 24 POUCH in 1 CARTON (83634-501-81) / 1 BAG in 1 POUCH (83634-501-41) / 50 mL in 1 BAG 83634-501-82 30 POUCH in 1 CARTON (83634-501-82) / 1 BAG in 1 POUCH (83634-501-41) / 50 mL in 1 BAG

Ingredients (1)

magnesium sulfate heptahydrate (80 mg/mL)

Linked Drug Pages (1)

Magnesium Sulfate in Water ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["INTRAVENOUS"], "spl_id": "74a0488c-befd-4f6b-af07-d06834e8202a", "openfda": {"unii": ["SK47B8698T"], "rxcui": ["829734", "1658259", "1658262"], "spl_set_id": ["f50f4e06-288c-4b5e-9260-f3fe0a210c0c"], "manufacturer_name": ["Avenacy, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "24 POUCH in 1 CARTON (83634-501-81)  / 1 BAG in 1 POUCH (83634-501-41)  / 50 mL in 1 BAG", "package_ndc": "83634-501-81", "marketing_start_date": "20240422"}, {"sample": false, "description": "30 POUCH in 1 CARTON (83634-501-82)  / 1 BAG in 1 POUCH (83634-501-41)  / 50 mL in 1 BAG", "package_ndc": "83634-501-82", "marketing_start_date": "20250915"}], "brand_name": "Magnesium Sulfate in Water", "product_id": "83634-501_74a0488c-befd-4f6b-af07-d06834e8202a", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Calculi Dissolution Agent [EPC]", "Increased Large Intestinal Motility [PE]", "Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]", "Inhibition Small Intestine Fluid/Electrolyte Absorption [PE]", "Magnesium Ion Exchange Activity [MoA]", "Osmotic Activity [MoA]", "Osmotic Laxative [EPC]", "Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]"], "product_ndc": "83634-501", "generic_name": "magnesium sulfate in water", "labeler_name": "Avenacy, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Magnesium Sulfate in Water", "active_ingredients": [{"name": "MAGNESIUM SULFATE HEPTAHYDRATE", "strength": "80 mg/mL"}], "application_number": "ANDA209642", "marketing_category": "ANDA", "marketing_start_date": "20240422", "listing_expiration_date": "20261231"}