polyethylene glycol 3350, nf powder for solution, laxative

Generic: polyethylene glycol 3350, nf powder for solution, laxative

Labeler: lgm pharma solutions, llc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name polyethylene glycol 3350, nf powder for solution, laxative
Generic Name polyethylene glycol 3350, nf powder for solution, laxative
Labeler lgm pharma solutions, llc
Dosage Form POWDER, FOR SOLUTION
Routes
ORAL
Active Ingredients

polyethylene glycol 3350 17 g/d

Manufacturer
LGM PHARMA SOLUTIONS, LLC

Identifiers & Regulatory

Product NDC 79739-7116
Product ID 79739-7116_fc3454ec-7729-4327-90f7-9e12dddb19d6
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA090812
Listing Expiration 2026-12-31
Marketing Start 2009-10-07

Pharmacologic Class

Established (EPC)
osmotic laxative [epc]
Mechanism of Action
osmotic activity [moa]
Physiologic Effect
stimulation large intestine fluid/electrolyte secretion [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 797397116
Hyphenated Format 79739-7116

Supplemental Identifiers

RxCUI
876193
UNII
G2M7P15E5P
NUI
N0000010288 N0000175811 N0000009871

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 polyethylene glycol 3350, nf powder for solution, laxative (source: ndc)
Generic Name polyethylene glycol 3350, nf powder for solution, laxative (source: ndc)
Application Number ANDA090812 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 17 g/d
source: ndc
Packaging
  • 7 d in 1 BOTTLE (79739-7116-1)
  • 14 d in 1 BOTTLE (79739-7116-2)
  • 30 d in 1 BOTTLE (79739-7116-3)
source: ndc

Packages (3)

79739-7116-1 7 d in 1 BOTTLE (79739-7116-1) 79739-7116-2 14 d in 1 BOTTLE (79739-7116-2) 79739-7116-3 30 d in 1 BOTTLE (79739-7116-3)

Ingredients (1)

polyethylene glycol 3350 (17 g/d)

Linked Drug Pages (1)

Polyethylene Glycol 3350, NF Powder for Solution, Laxative ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "fc3454ec-7729-4327-90f7-9e12dddb19d6", "openfda": {"nui": ["N0000010288", "N0000175811", "N0000009871"], "unii": ["G2M7P15E5P"], "rxcui": ["876193"], "spl_set_id": ["d78bead5-ff19-4d45-9003-ec131f1f5a13"], "pharm_class_pe": ["Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]"], "pharm_class_epc": ["Osmotic Laxative [EPC]"], "pharm_class_moa": ["Osmotic Activity [MoA]"], "manufacturer_name": ["LGM PHARMA SOLUTIONS, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "7 d in 1 BOTTLE (79739-7116-1)", "package_ndc": "79739-7116-1", "marketing_start_date": "20091007"}, {"sample": false, "description": "14 d in 1 BOTTLE (79739-7116-2)", "package_ndc": "79739-7116-2", "marketing_start_date": "20091007"}, {"sample": false, "description": "30 d in 1 BOTTLE (79739-7116-3)", "package_ndc": "79739-7116-3", "marketing_start_date": "20091007"}], "brand_name": "Polyethylene Glycol 3350, NF Powder for Solution, Laxative", "product_id": "79739-7116_fc3454ec-7729-4327-90f7-9e12dddb19d6", "dosage_form": "POWDER, FOR SOLUTION", "pharm_class": ["Osmotic Activity [MoA]", "Osmotic Laxative [EPC]", "Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]"], "product_ndc": "79739-7116", "generic_name": "Polyethylene Glycol 3350, NF Powder for Solution, Laxative", "labeler_name": "LGM PHARMA SOLUTIONS, LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Polyethylene Glycol 3350, NF Powder for Solution, Laxative", "active_ingredients": [{"name": "POLYETHYLENE GLYCOL 3350", "strength": "17 g/d"}], "application_number": "ANDA090812", "marketing_category": "ANDA", "marketing_start_date": "20091007", "listing_expiration_date": "20261231"}