magnesium sulfate

Generic: magnesium sulfate heptahydrate

Labeler: camber pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name magnesium sulfate
Generic Name magnesium sulfate heptahydrate
Labeler camber pharmaceuticals, inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

magnesium sulfate heptahydrate 500 mg/mL

Manufacturer
Camber Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 31722-394
Product ID 31722-394_36bf495e-3966-8317-e063-6294a90a055f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA219777
Listing Expiration 2026-12-31
Marketing Start 2025-05-28

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 31722394
Hyphenated Format 31722-394

Supplemental Identifiers

RxCUI
1658221 1658236 1658244 1658245
UPC
0331722394505 0331722394208 0331722394109 0331722394314
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 (source: ndc)
Generic Name magnesium sulfate heptahydrate (source: ndc)
Application Number ANDA219777 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 500 mg/mL
source: ndc
Packaging
  • 25 VIAL, SINGLE-DOSE in 1 CARTON (31722-394-32) / 2 mL in 1 VIAL, SINGLE-DOSE (31722-394-31)
  • 25 VIAL, SINGLE-DOSE in 1 CARTON (31722-394-33) / 10 mL in 1 VIAL, SINGLE-DOSE (31722-394-10)
  • 25 VIAL, SINGLE-DOSE in 1 CARTON (31722-394-34) / 20 mL in 1 VIAL, SINGLE-DOSE (31722-394-20)
  • 25 VIAL, SINGLE-DOSE in 1 CARTON (31722-394-35) / 50 mL in 1 VIAL, SINGLE-DOSE (31722-394-50)
source: ndc

Packages (4)

31722-394-32 25 VIAL, SINGLE-DOSE in 1 CARTON (31722-394-32) / 2 mL in 1 VIAL, SINGLE-DOSE (31722-394-31) 31722-394-33 25 VIAL, SINGLE-DOSE in 1 CARTON (31722-394-33) / 10 mL in 1 VIAL, SINGLE-DOSE (31722-394-10) 31722-394-34 25 VIAL, SINGLE-DOSE in 1 CARTON (31722-394-34) / 20 mL in 1 VIAL, SINGLE-DOSE (31722-394-20) 31722-394-35 25 VIAL, SINGLE-DOSE in 1 CARTON (31722-394-35) / 50 mL in 1 VIAL, SINGLE-DOSE (31722-394-50)

Ingredients (1)

magnesium sulfate heptahydrate (500 mg/mL)

Linked Drug Pages (1)

Magnesium Sulfate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "INTRAVENOUS"], "spl_id": "36bf495e-3966-8317-e063-6294a90a055f", "openfda": {"upc": ["0331722394505", "0331722394208", "0331722394109", "0331722394314"], "unii": ["SK47B8698T"], "rxcui": ["1658221", "1658236", "1658244", "1658245"], "spl_set_id": ["647ca293-9e68-4773-947a-0fb064aa6fd1"], "manufacturer_name": ["Camber Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL, SINGLE-DOSE in 1 CARTON (31722-394-32)  / 2 mL in 1 VIAL, SINGLE-DOSE (31722-394-31)", "package_ndc": "31722-394-32", "marketing_start_date": "20250528"}, {"sample": false, "description": "25 VIAL, SINGLE-DOSE in 1 CARTON (31722-394-33)  / 10 mL in 1 VIAL, SINGLE-DOSE (31722-394-10)", "package_ndc": "31722-394-33", "marketing_start_date": "20250528"}, {"sample": false, "description": "25 VIAL, SINGLE-DOSE in 1 CARTON (31722-394-34)  / 20 mL in 1 VIAL, SINGLE-DOSE (31722-394-20)", "package_ndc": "31722-394-34", "marketing_start_date": "20250528"}, {"sample": false, "description": "25 VIAL, SINGLE-DOSE in 1 CARTON (31722-394-35)  / 50 mL in 1 VIAL, SINGLE-DOSE (31722-394-50)", "package_ndc": "31722-394-35", "marketing_start_date": "20250528"}], "brand_name": "Magnesium Sulfate", "product_id": "31722-394_36bf495e-3966-8317-e063-6294a90a055f", "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": "31722-394", "generic_name": "Magnesium sulfate heptahydrate", "labeler_name": "Camber Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Magnesium Sulfate", "active_ingredients": [{"name": "MAGNESIUM SULFATE HEPTAHYDRATE", "strength": "500 mg/mL"}], "application_number": "ANDA219777", "marketing_category": "ANDA", "marketing_start_date": "20250528", "listing_expiration_date": "20261231"}