gavilyte g tm
Generic: polyethylene glycol-3350 and electrolytes
Labeler: lupin pharmaceuticals,inc.Drug Facts
Product Profile
Brand Name
gavilyte g tm
Generic Name
polyethylene glycol-3350 and electrolytes
Labeler
lupin pharmaceuticals,inc.
Dosage Form
POWDER, FOR SOLUTION
Routes
Active Ingredients
polyethylene glycol 3350 236 g/274.31g, potassium chloride 2.97 g/274.31g, sodium bicarbonate 6.74 g/274.31g, sodium chloride 5.86 g/274.31g, sodium sulfate anhydrous 22.74 g/274.31g
Manufacturer
Identifiers & Regulatory
Product NDC
43386-090
Product ID
43386-090_896fc5ca-9a67-47c1-a317-f8dd4a3654c8
Product Type
HUMAN PRESCRIPTION DRUG
Marketing Category
ANDA
Application Number
ANDA090231
Listing Expiration
2026-12-31
Marketing Start
2009-06-01
Pharmacologic Class
Established (EPC)
Mechanism of Action
Physiologic Effect
Normalized Code Variants
Searchable formats for this product NDC code
Digits Only
43386090
Hyphenated Format
43386-090
Supplemental Identifiers
RxCUI
UNII
NUI
Packaging Origin
Original Packager
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
gavilyte g tm (source: ndc)
Generic Name
polyethylene glycol-3350 and electrolytes (source: ndc)
Application Number
ANDA090231 (source: ndc)
Routes
source: ndc
Resolved Composition
Strengths
- 236 g/274.31g
- 2.97 g/274.31g
- 6.74 g/274.31g
- 5.86 g/274.31g
- 22.74 g/274.31g
Packaging
- 274.31 g in 1 BOTTLE (43386-090-19)
Packages (1)
Ingredients (5)
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "896fc5ca-9a67-47c1-a317-f8dd4a3654c8", "openfda": {"nui": ["N0000010288", "N0000175811", "N0000009871"], "unii": ["G2M7P15E5P", "660YQ98I10", "8MDF5V39QO", "451W47IQ8X", "36KCS0R750"], "rxcui": ["966920", "967012"], "spl_set_id": ["3978822b-6473-4072-9f80-20ceb9bea355"], "pharm_class_pe": ["Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]"], "pharm_class_epc": ["Osmotic Laxative [EPC]"], "pharm_class_moa": ["Osmotic Activity [MoA]"], "manufacturer_name": ["Lupin Pharmaceuticals,Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "274.31 g in 1 BOTTLE (43386-090-19)", "package_ndc": "43386-090-19", "marketing_start_date": "20090601"}], "brand_name": "GAVILYTE G TM", "product_id": "43386-090_896fc5ca-9a67-47c1-a317-f8dd4a3654c8", "dosage_form": "POWDER, FOR SOLUTION", "pharm_class": ["Increased Large Intestinal Motility [PE]", "Increased Large Intestinal Motility [PE]", "Increased Large Intestinal Motility [PE]", "Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]", "Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]", "Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]", "Osmotic Activity [MoA]", "Osmotic Activity [MoA]", "Osmotic Activity [MoA]", "Osmotic Activity [MoA]", "Osmotic Laxative [EPC]", "Osmotic Laxative [EPC]", "Osmotic Laxative [EPC]", "Osmotic Laxative [EPC]", "Potassium Compounds [CS]", "Potassium Salt [EPC]", "Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]"], "product_ndc": "43386-090", "generic_name": "polyethylene glycol-3350 and Electrolytes", "labeler_name": "Lupin Pharmaceuticals,Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "GAVILYTE G", "brand_name_suffix": "TM", "active_ingredients": [{"name": "POLYETHYLENE GLYCOL 3350", "strength": "236 g/274.31g"}, {"name": "POTASSIUM CHLORIDE", "strength": "2.97 g/274.31g"}, {"name": "SODIUM BICARBONATE", "strength": "6.74 g/274.31g"}, {"name": "SODIUM CHLORIDE", "strength": "5.86 g/274.31g"}, {"name": "SODIUM SULFATE ANHYDROUS", "strength": "22.74 g/274.31g"}], "application_number": "ANDA090231", "marketing_category": "ANDA", "marketing_start_date": "20090601", "listing_expiration_date": "20261231"}