polyethylene glycol 3350

Generic: polyethylene glycol 3350

Labeler: aurobindo pharma limited
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name polyethylene glycol 3350
Generic Name polyethylene glycol 3350
Labeler aurobindo pharma limited
Dosage Form POWDER, FOR SOLUTION
Routes
ORAL
Active Ingredients

polyethylene glycol 3350 17 g/17g

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 84386-125
Product ID 84386-125_b51f2223-8266-4d6c-bf32-58e53e73b54d
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA209017
Listing Expiration 2027-12-31
Marketing Start 2026-01-07

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 84386125
Hyphenated Format 84386-125

Supplemental Identifiers

RxCUI
876193
UPC
0384386125084
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 ANDA209017 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 17 g/17g
source: ndc
Packaging
  • 119 g in 1 BOTTLE, PLASTIC (84386-125-08)
  • 14 PACKET in 1 CARTON (84386-125-14) / 17 g in 1 PACKET
  • 238 g in 1 BOTTLE, PLASTIC (84386-125-24)
  • 510 g in 1 BOTTLE, PLASTIC (84386-125-54)
source: ndc

Packages (4)

84386-125-08 119 g in 1 BOTTLE, PLASTIC (84386-125-08) 84386-125-14 14 PACKET in 1 CARTON (84386-125-14) / 17 g in 1 PACKET 84386-125-24 238 g in 1 BOTTLE, PLASTIC (84386-125-24) 84386-125-54 510 g in 1 BOTTLE, PLASTIC (84386-125-54)

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": "b51f2223-8266-4d6c-bf32-58e53e73b54d", "openfda": {"nui": ["N0000010288", "N0000175811", "N0000009871"], "upc": ["0384386125084"], "unii": ["G2M7P15E5P"], "rxcui": ["876193"], "spl_set_id": ["b51f2223-8266-4d6c-bf32-58e53e73b54d"], "pharm_class_pe": ["Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]"], "pharm_class_epc": ["Osmotic Laxative [EPC]"], "pharm_class_moa": ["Osmotic Activity [MoA]"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "119 g in 1 BOTTLE, PLASTIC (84386-125-08)", "package_ndc": "84386-125-08", "marketing_start_date": "20260107"}, {"sample": false, "description": "14 PACKET in 1 CARTON (84386-125-14)  / 17 g in 1 PACKET", "package_ndc": "84386-125-14", "marketing_start_date": "20260107"}, {"sample": false, "description": "238 g in 1 BOTTLE, PLASTIC (84386-125-24)", "package_ndc": "84386-125-24", "marketing_start_date": "20260107"}, {"sample": false, "description": "510 g in 1 BOTTLE, PLASTIC (84386-125-54)", "package_ndc": "84386-125-54", "marketing_start_date": "20260107"}], "brand_name": "Polyethylene Glycol 3350", "product_id": "84386-125_b51f2223-8266-4d6c-bf32-58e53e73b54d", "dosage_form": "POWDER, FOR SOLUTION", "pharm_class": ["Osmotic Activity [MoA]", "Osmotic Laxative [EPC]", "Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]"], "product_ndc": "84386-125", "generic_name": "Polyethylene Glycol 3350", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Polyethylene Glycol 3350", "active_ingredients": [{"name": "POLYETHYLENE GLYCOL 3350", "strength": "17 g/17g"}], "application_number": "ANDA209017", "marketing_category": "ANDA", "marketing_start_date": "20260107", "listing_expiration_date": "20271231"}