polyethylene glycol 3350 (0904-6931)

Drug Facts

Product Profile

Brand Name polyethylene glycol 3350

Generic Name polyethylene glycol 3350

Labeler major pharmaceuticals

Dosage Form POWDER, FOR SOLUTION

Routes

ORAL

Active Ingredients

polyethylene glycol 3350 17 g/17g

Manufacturer

Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-6931

Product ID 0904-6931_6b0f37d7-5c0e-40e8-9466-4be0b6c96302

Product Type HUMAN OTC DRUG

Marketing Category ANDA

Application Number ANDA203928

Listing Expiration 2026-12-31

Marketing Start 2019-06-30

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 09046931

Hyphenated Format 0904-6931

Supplemental Identifiers

RxCUI

876193

UPC

0309046931263

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 ANDA203928 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

17 g/17g

source: ndc

Packaging

14 PACKET in 1 CARTON (0904-6931-26) / 17 g in 1 PACKET
30 PACKET in 1 CARTON (0904-6931-76) / 17 g in 1 PACKET
100 PACKET in 1 CARTON (0904-6931-81) / 17 g in 1 PACKET
17 g in 1 PACKET (0904-6931-86)

source: ndc

Packages (4)

0904-6931-26 14 PACKET in 1 CARTON (0904-6931-26) / 17 g in 1 PACKET 0904-6931-76 30 PACKET in 1 CARTON (0904-6931-76) / 17 g in 1 PACKET 0904-6931-81 100 PACKET in 1 CARTON (0904-6931-81) / 17 g in 1 PACKET 0904-6931-86 17 g in 1 PACKET (0904-6931-86)

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": "6b0f37d7-5c0e-40e8-9466-4be0b6c96302", "openfda": {"nui": ["N0000010288", "N0000175811", "N0000009871"], "upc": ["0309046931263"], "unii": ["G2M7P15E5P"], "rxcui": ["876193"], "spl_set_id": ["ddc9d2b1-87d8-44fa-bac6-0a7261f33564"], "pharm_class_pe": ["Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]"], "pharm_class_epc": ["Osmotic Laxative [EPC]"], "pharm_class_moa": ["Osmotic Activity [MoA]"], "manufacturer_name": ["Major Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "14 PACKET in 1 CARTON (0904-6931-26)  / 17 g in 1 PACKET", "package_ndc": "0904-6931-26", "marketing_start_date": "20190630"}, {"sample": false, "description": "30 PACKET in 1 CARTON (0904-6931-76)  / 17 g in 1 PACKET", "package_ndc": "0904-6931-76", "marketing_start_date": "20190630"}, {"sample": false, "description": "100 PACKET in 1 CARTON (0904-6931-81)  / 17 g in 1 PACKET", "package_ndc": "0904-6931-81", "marketing_start_date": "20190630"}, {"sample": false, "description": "17 g in 1 PACKET (0904-6931-86)", "package_ndc": "0904-6931-86", "marketing_start_date": "20190630"}], "brand_name": "Polyethylene glycol 3350", "product_id": "0904-6931_6b0f37d7-5c0e-40e8-9466-4be0b6c96302", "dosage_form": "POWDER, FOR SOLUTION", "pharm_class": ["Osmotic Activity [MoA]", "Osmotic Laxative [EPC]", "Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]"], "product_ndc": "0904-6931", "generic_name": "Polyethylene glycol 3350", "labeler_name": "Major Pharmaceuticals", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Polyethylene glycol 3350", "active_ingredients": [{"name": "POLYETHYLENE GLYCOL 3350", "strength": "17 g/17g"}], "application_number": "ANDA203928", "marketing_category": "ANDA", "marketing_start_date": "20190630", "listing_expiration_date": "20261231"}