gavilyte - c tm
Generic: polyethylene glycol-3350 and electrolytes with flavor pack
Labeler: lupin pharmaceuticals,inc.Drug Facts
Product Profile
Brand Name
gavilyte - c tm
Generic Name
polyethylene glycol-3350 and electrolytes with flavor pack
Labeler
lupin pharmaceuticals,inc.
Dosage Form
POWDER, FOR SOLUTION
Routes
Active Ingredients
polyethylene glycol 3350 240 g/278.26g, potassium chloride 2.98 g/278.26g, sodium bicarbonate 6.72 g/278.26g, sodium chloride 5.84 g/278.26g, sodium sulfate anhydrous 22.72 g/278.26g
Manufacturer
Identifiers & Regulatory
Product NDC
43386-060
Product ID
43386-060_5105b61a-4ca7-4096-9cd0-cf22f46ffaf8
Product Type
HUMAN PRESCRIPTION DRUG
Marketing Category
ANDA
Application Number
ANDA090186
Listing Expiration
2026-12-31
Marketing Start
2009-01-06
Pharmacologic Class
Established (EPC)
Mechanism of Action
Physiologic Effect
Normalized Code Variants
Searchable formats for this product NDC code
Digits Only
43386060
Hyphenated Format
43386-060
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 - c tm (source: ndc)
Generic Name
polyethylene glycol-3350 and electrolytes with flavor pack (source: ndc)
Application Number
ANDA090186 (source: ndc)
Routes
source: ndc
Resolved Composition
Strengths
- 240 g/278.26g
- 2.98 g/278.26g
- 6.72 g/278.26g
- 5.84 g/278.26g
- 22.72 g/278.26g
Packaging
- 278.26 g in 1 BOTTLE (43386-060-19)
Packages (1)
Ingredients (5)
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "5105b61a-4ca7-4096-9cd0-cf22f46ffaf8", "openfda": {"nui": ["N0000010288", "N0000175811", "N0000009871"], "unii": ["G2M7P15E5P", "660YQ98I10", "8MDF5V39QO", "451W47IQ8X", "36KCS0R750"], "rxcui": ["966914", "967023"], "spl_set_id": ["a8b15625-ca7c-4d57-9f36-3ac2a6d13665"], "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": "278.26 g in 1 BOTTLE (43386-060-19)", "package_ndc": "43386-060-19", "marketing_start_date": "20090601"}], "brand_name": "GaviLyte - C TM", "product_id": "43386-060_5105b61a-4ca7-4096-9cd0-cf22f46ffaf8", "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": "43386-060", "generic_name": "polyethylene glycol-3350 and electrolytes with Flavor Pack", "labeler_name": "Lupin Pharmaceuticals,Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "GaviLyte - C", "brand_name_suffix": "TM", "active_ingredients": [{"name": "POLYETHYLENE GLYCOL 3350", "strength": "240 g/278.26g"}, {"name": "POTASSIUM CHLORIDE", "strength": "2.98 g/278.26g"}, {"name": "SODIUM BICARBONATE", "strength": "6.72 g/278.26g"}, {"name": "SODIUM CHLORIDE", "strength": "5.84 g/278.26g"}, {"name": "SODIUM SULFATE ANHYDROUS", "strength": "22.72 g/278.26g"}], "application_number": "ANDA090186", "marketing_category": "ANDA", "marketing_start_date": "20090106", "listing_expiration_date": "20261231"}