magnesium sulfate

Generic: magnesium sulfate heptahydrate

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name magnesium sulfate
Generic Name magnesium sulfate heptahydrate
Labeler sun pharmaceutical industries, inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

magnesium sulfate heptahydrate 40 mg/mL

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 47335-992
Product ID 47335-992_e4305694-0997-4791-a459-92e741b58130
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213917
Listing Expiration 2027-12-31
Marketing Start 2021-08-01

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 47335992
Hyphenated Format 47335-992

Supplemental Identifiers

RxCUI
1658259 1658262
UPC
0347335992021 0347335992014
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 ANDA213917 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 40 mg/mL
source: ndc
Packaging
  • 24 POUCH in 1 CASE (47335-992-01) / 1 BAG in 1 POUCH / 50 mL in 1 BAG
  • 24 POUCH in 1 CASE (47335-992-02) / 1 BAG in 1 POUCH / 100 mL in 1 BAG
source: ndc

Packages (2)

47335-992-01 24 POUCH in 1 CASE (47335-992-01) / 1 BAG in 1 POUCH / 50 mL in 1 BAG 47335-992-02 24 POUCH in 1 CASE (47335-992-02) / 1 BAG in 1 POUCH / 100 mL in 1 BAG

Ingredients (1)

magnesium sulfate heptahydrate (40 mg/mL)

Linked Drug Pages (1)

MAGNESIUM SULFATE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "e4305694-0997-4791-a459-92e741b58130", "openfda": {"upc": ["0347335992021", "0347335992014"], "unii": ["SK47B8698T"], "rxcui": ["1658259", "1658262"], "spl_set_id": ["efadcb55-f935-4c60-b2e2-0a76b9194b50"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "24 POUCH in 1 CASE (47335-992-01)  / 1 BAG in 1 POUCH / 50 mL in 1 BAG", "package_ndc": "47335-992-01", "marketing_start_date": "20210801"}, {"sample": false, "description": "24 POUCH in 1 CASE (47335-992-02)  / 1 BAG in 1 POUCH / 100 mL in 1 BAG", "package_ndc": "47335-992-02", "marketing_start_date": "20210801"}], "brand_name": "MAGNESIUM SULFATE", "product_id": "47335-992_e4305694-0997-4791-a459-92e741b58130", "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": "47335-992", "generic_name": "magnesium sulfate heptahydrate", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "MAGNESIUM SULFATE", "active_ingredients": [{"name": "MAGNESIUM SULFATE HEPTAHYDRATE", "strength": "40 mg/mL"}], "application_number": "ANDA213917", "marketing_category": "ANDA", "marketing_start_date": "20210801", "listing_expiration_date": "20271231"}