polyethylene glycol 3350 (83324-002)

Drug Facts

Product Profile

Brand Name polyethylene glycol 3350

Generic Name polyethylene glycol 3350

Labeler chain drug marketing association, inc.

Dosage Form POWDER, FOR SOLUTION

Routes

ORAL

Active Ingredients

polyethylene glycol 3350 17 g/17g

Manufacturer

CHAIN DRUG MARKETING ASSOCIATION, INC.

Identifiers & Regulatory

Product NDC 83324-002

Product ID 83324-002_148df422-86ec-3bae-e063-6394a90a364e

Product Type HUMAN OTC DRUG

Marketing Category ANDA

Application Number ANDA214990

Listing Expiration 2026-12-31

Marketing Start 2024-03-01

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 83324002

Hyphenated Format 83324-002

Supplemental Identifiers

RxCUI

876193

UPC

0635515959811

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 ANDA214990 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

17 g/17g

source: ndc

Packaging

238 g in 1 BOTTLE (83324-002-08)
510 g in 1 BOTTLE (83324-002-16)

source: ndc

Packages (2)

83324-002-08 238 g in 1 BOTTLE (83324-002-08) 83324-002-16 510 g in 1 BOTTLE (83324-002-16)

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": "148df422-86ec-3bae-e063-6394a90a364e", "openfda": {"nui": ["N0000010288", "N0000175811", "N0000009871"], "upc": ["0635515959811"], "unii": ["G2M7P15E5P"], "rxcui": ["876193"], "spl_set_id": ["901a1918-87bb-47c2-a465-8c468c3a1ee5"], "pharm_class_pe": ["Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]"], "pharm_class_epc": ["Osmotic Laxative [EPC]"], "pharm_class_moa": ["Osmotic Activity [MoA]"], "manufacturer_name": ["CHAIN DRUG MARKETING ASSOCIATION, INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "238 g in 1 BOTTLE (83324-002-08)", "package_ndc": "83324-002-08", "marketing_start_date": "20240301"}, {"sample": false, "description": "510 g in 1 BOTTLE (83324-002-16)", "package_ndc": "83324-002-16", "marketing_start_date": "20240301"}], "brand_name": "Polyethylene Glycol 3350", "product_id": "83324-002_148df422-86ec-3bae-e063-6394a90a364e", "dosage_form": "POWDER, FOR SOLUTION", "pharm_class": ["Osmotic Activity [MoA]", "Osmotic Laxative [EPC]", "Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]"], "product_ndc": "83324-002", "generic_name": "Polyethylene Glycol 3350", "labeler_name": "CHAIN DRUG MARKETING ASSOCIATION, INC.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Polyethylene Glycol 3350", "active_ingredients": [{"name": "POLYETHYLENE GLYCOL 3350", "strength": "17 g/17g"}], "application_number": "ANDA214990", "marketing_category": "ANDA", "marketing_start_date": "20240301", "listing_expiration_date": "20261231"}