polyethylene glycol 3350

Generic: polyethylene glycol 3350

Labeler: geri-care pharmaceutical corp
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name polyethylene glycol 3350
Generic Name polyethylene glycol 3350
Labeler geri-care pharmaceutical corp
Dosage Form POWDER, FOR SOLUTION
Routes
ORAL
Active Ingredients

polyethylene glycol 3350 17 g/17g

Manufacturer
Geri-Care Pharmaceutical Corp

Identifiers & Regulatory

Product NDC 57896-489
Product ID 57896-489_ee3ad47b-8219-3bc4-e053-2a95a90af736
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA090812
Listing Expiration 2026-12-31
Marketing Start 2014-05-01

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 57896489
Hyphenated Format 57896-489

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 (source: ndc)
Generic Name polyethylene glycol 3350 (source: ndc)
Application Number ANDA090812 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 17 g/17g
source: ndc
Packaging
  • 238 g in 1 BOTTLE (57896-489-14)
  • 510 g in 1 BOTTLE (57896-489-30)
source: ndc

Packages (2)

57896-489-14 238 g in 1 BOTTLE (57896-489-14) 57896-489-30 510 g in 1 BOTTLE (57896-489-30)

Ingredients (1)

polyethylene glycol 3350 (17 g/17g)

Linked Drug Pages (1)

POLYETHYLENE GLYCOL 3350 ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "ee3ad47b-8219-3bc4-e053-2a95a90af736", "openfda": {"nui": ["N0000010288", "N0000175811", "N0000009871"], "unii": ["G2M7P15E5P"], "rxcui": ["876193"], "spl_set_id": ["f4c7eb80-d8d5-406d-90d0-9d17914d71f2"], "pharm_class_pe": ["Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]"], "pharm_class_epc": ["Osmotic Laxative [EPC]"], "pharm_class_moa": ["Osmotic Activity [MoA]"], "manufacturer_name": ["Geri-Care Pharmaceutical Corp"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "238 g in 1 BOTTLE (57896-489-14)", "package_ndc": "57896-489-14", "marketing_start_date": "20160701"}, {"sample": false, "description": "510 g in 1 BOTTLE (57896-489-30)", "package_ndc": "57896-489-30", "marketing_start_date": "20160701"}], "brand_name": "POLYETHYLENE GLYCOL 3350", "product_id": "57896-489_ee3ad47b-8219-3bc4-e053-2a95a90af736", "dosage_form": "POWDER, FOR SOLUTION", "pharm_class": ["Osmotic Activity [MoA]", "Osmotic Laxative [EPC]", "Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]"], "product_ndc": "57896-489", "generic_name": "polyethylene glycol 3350", "labeler_name": "Geri-Care Pharmaceutical Corp", "product_type": "HUMAN OTC DRUG", "brand_name_base": "POLYETHYLENE GLYCOL 3350", "active_ingredients": [{"name": "POLYETHYLENE GLYCOL 3350", "strength": "17 g/17g"}], "application_number": "ANDA090812", "marketing_category": "ANDA", "marketing_start_date": "20140501", "listing_expiration_date": "20261231"}