gavilax

Generic: polyethylene glycol 3350

Labeler: lupin pharmaceuticals,inc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name gavilax
Generic Name polyethylene glycol 3350
Labeler lupin pharmaceuticals,inc.
Dosage Form POWDER, FOR SOLUTION
Routes
ORAL
Active Ingredients

polyethylene glycol 3350 17 g/17g

Manufacturer
Lupin Pharmaceuticals,Inc.

Identifiers & Regulatory

Product NDC 43386-312
Product ID 43386-312_ced29c35-5d51-4eb1-8119-1c988d29a592
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA091077
Listing Expiration 2026-12-31
Marketing Start 2009-10-09

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 43386312
Hyphenated Format 43386-312

Supplemental Identifiers

RxCUI
876193 876214
UPC
0343386312085
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 gavilax (source: ndc)
Generic Name polyethylene glycol 3350 (source: ndc)
Application Number ANDA091077 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 17 g/17g
source: ndc
Packaging
  • 238 g in 1 BOTTLE (43386-312-08)
  • 510 g in 1 BOTTLE (43386-312-14)
source: ndc

Packages (2)

43386-312-08 238 g in 1 BOTTLE (43386-312-08) 43386-312-14 510 g in 1 BOTTLE (43386-312-14)

Ingredients (1)

polyethylene glycol 3350 (17 g/17g)

Linked Drug Pages (1)

GAVILAX ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "ced29c35-5d51-4eb1-8119-1c988d29a592", "openfda": {"nui": ["N0000010288", "N0000175811", "N0000009871"], "upc": ["0343386312085"], "unii": ["G2M7P15E5P"], "rxcui": ["876193", "876214"], "spl_set_id": ["19672e23-1606-497e-a112-939af33af195"], "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": "238 g in 1 BOTTLE (43386-312-08)", "package_ndc": "43386-312-08", "marketing_start_date": "20091009"}, {"sample": true, "description": "510 g in 1 BOTTLE (43386-312-14)", "package_ndc": "43386-312-14", "marketing_start_date": "20091009"}], "brand_name": "GAVILAX", "product_id": "43386-312_ced29c35-5d51-4eb1-8119-1c988d29a592", "dosage_form": "POWDER, FOR SOLUTION", "pharm_class": ["Osmotic Activity [MoA]", "Osmotic Laxative [EPC]", "Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]"], "product_ndc": "43386-312", "generic_name": "Polyethylene Glycol 3350", "labeler_name": "Lupin Pharmaceuticals,Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "GAVILAX", "active_ingredients": [{"name": "POLYETHYLENE GLYCOL 3350", "strength": "17 g/17g"}], "application_number": "ANDA091077", "marketing_category": "ANDA", "marketing_start_date": "20091009", "listing_expiration_date": "20261231"}