polyethylene glycol 3350 (68001-607)

Drug Facts

Product Profile

Brand Name polyethylene glycol 3350

Generic Name polyethylene glycol 3350

Labeler bluepoint laboratories

Dosage Form POWDER, FOR SOLUTION

Routes

ORAL

Active Ingredients

polyethylene glycol 3350 17 g/17g

Manufacturer

BluePoint Laboratories

Identifiers & Regulatory

Product NDC 68001-607

Product ID 68001-607_12fe5bcd-8ad0-e159-e063-6294a90a444e

Product Type HUMAN OTC DRUG

Marketing Category ANDA

Application Number ANDA214990

Listing Expiration 2026-12-31

Marketing Start 2023-10-01

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 68001607

Hyphenated Format 68001-607

Supplemental Identifiers

RxCUI

876193

UPC

0368001607551 0368001607698

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 (68001-607-55)
510 g in 1 BOTTLE (68001-607-69)

source: ndc

Packages (2)

68001-607-55 238 g in 1 BOTTLE (68001-607-55) 68001-607-69 510 g in 1 BOTTLE (68001-607-69)

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": "12fe5bcd-8ad0-e159-e063-6294a90a444e", "openfda": {"nui": ["N0000010288", "N0000175811", "N0000009871"], "upc": ["0368001607551", "0368001607698"], "unii": ["G2M7P15E5P"], "rxcui": ["876193"], "spl_set_id": ["02e36812-53c2-003b-e063-6394a90aed12"], "pharm_class_pe": ["Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]"], "pharm_class_epc": ["Osmotic Laxative [EPC]"], "pharm_class_moa": ["Osmotic Activity [MoA]"], "manufacturer_name": ["BluePoint Laboratories"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "238 g in 1 BOTTLE (68001-607-55)", "package_ndc": "68001-607-55", "marketing_start_date": "20231001"}, {"sample": false, "description": "510 g in 1 BOTTLE (68001-607-69)", "package_ndc": "68001-607-69", "marketing_start_date": "20231001"}], "brand_name": "Polyethylene Glycol 3350", "product_id": "68001-607_12fe5bcd-8ad0-e159-e063-6294a90a444e", "dosage_form": "POWDER, FOR SOLUTION", "pharm_class": ["Osmotic Activity [MoA]", "Osmotic Laxative [EPC]", "Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]"], "product_ndc": "68001-607", "generic_name": "Polyethylene Glycol 3350", "labeler_name": "BluePoint Laboratories", "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": "20231001", "listing_expiration_date": "20261231"}