polyethylene gycol 3350

Generic: polyethylene gycol 3350

Labeler: allegiant health
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name polyethylene gycol 3350
Generic Name polyethylene gycol 3350
Labeler allegiant health
Dosage Form POWDER, FOR SOLUTION
Routes
ORAL
Active Ingredients

polyethylene glycol 3350 17 g/g

Manufacturer
Allegiant Health

Identifiers & Regulatory

Product NDC 69168-473
Product ID 69168-473_3f5e8be5-96ac-462d-94b1-d8caaac1bf3a
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA214990
Listing Expiration 2026-12-31
Marketing Start 2025-03-17

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 69168473
Hyphenated Format 69168-473

Supplemental Identifiers

RxCUI
876193
UPC
0369168473560
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 gycol 3350 (source: ndc)
Generic Name polyethylene gycol 3350 (source: ndc)
Application Number ANDA214990 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 17 g/g
source: ndc
Packaging
  • 510 g in 1 BOTTLE (69168-473-55)
  • 238 g in 1 BOTTLE (69168-473-56)
  • 238 g in 1 BOTTLE (69168-473-61)
  • 510 g in 1 BOTTLE (69168-473-62)
source: ndc

Packages (4)

69168-473-55 510 g in 1 BOTTLE (69168-473-55) 69168-473-56 238 g in 1 BOTTLE (69168-473-56) 69168-473-61 238 g in 1 BOTTLE (69168-473-61) 69168-473-62 510 g in 1 BOTTLE (69168-473-62)

Ingredients (1)

polyethylene glycol 3350 (17 g/g)

Linked Drug Pages (1)

Polyethylene Gycol 3350 ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3f5e8be5-96ac-462d-94b1-d8caaac1bf3a", "openfda": {"nui": ["N0000010288", "N0000175811", "N0000009871"], "upc": ["0369168473560"], "unii": ["G2M7P15E5P"], "rxcui": ["876193"], "spl_set_id": ["13851c9a-a226-481b-9db5-bc7053997df7"], "pharm_class_pe": ["Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]"], "pharm_class_epc": ["Osmotic Laxative [EPC]"], "pharm_class_moa": ["Osmotic Activity [MoA]"], "manufacturer_name": ["Allegiant Health"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "510 g in 1 BOTTLE (69168-473-55)", "package_ndc": "69168-473-55", "marketing_start_date": "20250317"}, {"sample": false, "description": "238 g in 1 BOTTLE (69168-473-56)", "package_ndc": "69168-473-56", "marketing_start_date": "20250317"}, {"sample": false, "description": "238 g in 1 BOTTLE (69168-473-61)", "package_ndc": "69168-473-61", "marketing_start_date": "20250317"}, {"sample": false, "description": "510 g in 1 BOTTLE (69168-473-62)", "package_ndc": "69168-473-62", "marketing_start_date": "20250317"}], "brand_name": "Polyethylene Gycol 3350", "product_id": "69168-473_3f5e8be5-96ac-462d-94b1-d8caaac1bf3a", "dosage_form": "POWDER, FOR SOLUTION", "pharm_class": ["Osmotic Activity [MoA]", "Osmotic Laxative [EPC]", "Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]"], "product_ndc": "69168-473", "generic_name": "Polyethylene Gycol 3350", "labeler_name": "Allegiant Health", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Polyethylene Gycol 3350", "active_ingredients": [{"name": "POLYETHYLENE GLYCOL 3350", "strength": "17 g/g"}], "application_number": "ANDA214990", "marketing_category": "ANDA", "marketing_start_date": "20250317", "listing_expiration_date": "20261231"}