polyethylene glycol 3350 (72603-302)

Drug Facts

Product Profile

Brand Name polyethylene glycol 3350

Generic Name polyethylene glycol 3350

Labeler northstar rx llc

Dosage Form POWDER, FOR SOLUTION

Routes

ORAL

Active Ingredients

polyethylene glycol 3350 17 g/17g

Manufacturer

NorthStar Rx LLC

Identifiers & Regulatory

Product NDC 72603-302

Product ID 72603-302_2e7e711f-65c3-a4b4-e063-6294a90a85ef

Product Type HUMAN OTC DRUG

Marketing Category ANDA

Application Number ANDA202850

Listing Expiration 2026-12-31

Marketing Start 2025-04-01

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 72603302

Hyphenated Format 72603-302

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 ANDA202850 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

17 g/17g

source: ndc

Packaging

14 PACKET in 1 CARTON (72603-302-02) / 17 g in 1 PACKET (72603-302-01)
30 PACKET in 1 CARTON (72603-302-03) / 17 g in 1 PACKET (72603-302-01)
100 PACKET in 1 CARTON (72603-302-04) / 17 g in 1 PACKET (72603-302-01)

source: ndc

Packages (3)

72603-302-02 14 PACKET in 1 CARTON (72603-302-02) / 17 g in 1 PACKET (72603-302-01) 72603-302-03 30 PACKET in 1 CARTON (72603-302-03) / 17 g in 1 PACKET (72603-302-01) 72603-302-04 100 PACKET in 1 CARTON (72603-302-04) / 17 g in 1 PACKET (72603-302-01)

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": "2e7e711f-65c3-a4b4-e063-6294a90a85ef", "openfda": {"nui": ["N0000010288", "N0000175811", "N0000009871"], "unii": ["G2M7P15E5P"], "rxcui": ["876193"], "spl_set_id": ["2e7e72eb-b759-5b59-e063-6394a90aa7ff"], "pharm_class_pe": ["Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]"], "pharm_class_epc": ["Osmotic Laxative [EPC]"], "pharm_class_moa": ["Osmotic Activity [MoA]"], "manufacturer_name": ["NorthStar Rx LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "14 PACKET in 1 CARTON (72603-302-02)  / 17 g in 1 PACKET (72603-302-01)", "package_ndc": "72603-302-02", "marketing_start_date": "20250401"}, {"sample": false, "description": "30 PACKET in 1 CARTON (72603-302-03)  / 17 g in 1 PACKET (72603-302-01)", "package_ndc": "72603-302-03", "marketing_start_date": "20250401"}, {"sample": false, "description": "100 PACKET in 1 CARTON (72603-302-04)  / 17 g in 1 PACKET (72603-302-01)", "package_ndc": "72603-302-04", "marketing_start_date": "20250401"}], "brand_name": "Polyethylene Glycol 3350", "product_id": "72603-302_2e7e711f-65c3-a4b4-e063-6294a90a85ef", "dosage_form": "POWDER, FOR SOLUTION", "pharm_class": ["Osmotic Activity [MoA]", "Osmotic Laxative [EPC]", "Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]"], "product_ndc": "72603-302", "generic_name": "Polyethylene Glycol 3350", "labeler_name": "NorthStar Rx LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Polyethylene Glycol 3350", "active_ingredients": [{"name": "POLYETHYLENE GLYCOL 3350", "strength": "17 g/17g"}], "application_number": "ANDA202850", "marketing_category": "ANDA", "marketing_start_date": "20250401", "listing_expiration_date": "20261231"}