gavilyte-n
Generic: polyethylene glycol-3350, sodium chloride, potassium chloride and sodium bicarbonate
Labeler: lupin pharmaceuticals,inc.Drug Facts
Product Profile
Brand Name
gavilyte-n
Generic Name
polyethylene glycol-3350, sodium chloride, potassium chloride and sodium bicarbonate
Labeler
lupin pharmaceuticals,inc.
Dosage Form
POWDER, FOR SOLUTION
Routes
Active Ingredients
polyethylene glycol 3350 420 g/438.4g, potassium chloride 1.48 g/438.4g, sodium bicarbonate 5.72 g/438.4g, sodium chloride 11.2 g/438.4g
Manufacturer
Identifiers & Regulatory
Product NDC
43386-050
Product ID
43386-050_3839c7fd-e7c4-45c6-ae02-0302b40046b0
Product Type
HUMAN PRESCRIPTION DRUG
Marketing Category
ANDA
Application Number
ANDA090019
Listing Expiration
2026-12-31
Marketing Start
2009-05-28
Pharmacologic Class
Established (EPC)
Mechanism of Action
Physiologic Effect
Normalized Code Variants
Searchable formats for this product NDC code
Digits Only
43386050
Hyphenated Format
43386-050
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-n (source: ndc)
Generic Name
polyethylene glycol-3350, sodium chloride, potassium chloride and sodium bicarbonate (source: ndc)
Application Number
ANDA090019 (source: ndc)
Routes
source: ndc
Resolved Composition
Strengths
- 420 g/438.4g
- 1.48 g/438.4g
- 5.72 g/438.4g
- 11.2 g/438.4g
Packaging
- 438.4 g in 1 BOTTLE (43386-050-19)
Packages (1)
Ingredients (4)
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "3839c7fd-e7c4-45c6-ae02-0302b40046b0", "openfda": {"nui": ["N0000010288", "N0000175811", "N0000009871"], "unii": ["G2M7P15E5P", "660YQ98I10", "8MDF5V39QO", "451W47IQ8X"], "rxcui": ["801054", "979099"], "spl_set_id": ["27195187-75a3-431f-90d9-84da1b94e849"], "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": true, "description": "438.4 g in 1 BOTTLE (43386-050-19)", "package_ndc": "43386-050-19", "marketing_start_date": "20090528"}], "brand_name": "GAVILYTE-N", "product_id": "43386-050_3839c7fd-e7c4-45c6-ae02-0302b40046b0", "dosage_form": "POWDER, FOR SOLUTION", "pharm_class": ["Increased Large Intestinal Motility [PE]", "Increased Large Intestinal Motility [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 Laxative [EPC]", "Osmotic Laxative [EPC]", "Osmotic Laxative [EPC]", "Potassium Compounds [CS]", "Potassium Salt [EPC]", "Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]"], "product_ndc": "43386-050", "generic_name": "polyethylene glycol-3350, sodium chloride, potassium chloride and sodium bicarbonate", "labeler_name": "Lupin Pharmaceuticals,Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "GAVILYTE-N", "active_ingredients": [{"name": "POLYETHYLENE GLYCOL 3350", "strength": "420 g/438.4g"}, {"name": "POTASSIUM CHLORIDE", "strength": "1.48 g/438.4g"}, {"name": "SODIUM BICARBONATE", "strength": "5.72 g/438.4g"}, {"name": "SODIUM CHLORIDE", "strength": "11.2 g/438.4g"}], "application_number": "ANDA090019", "marketing_category": "ANDA", "marketing_start_date": "20090528", "listing_expiration_date": "20261231"}