polyethylene glycol 3350

Generic: instalax polyethylene glycol 3350

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name polyethylene glycol 3350
Generic Name instalax polyethylene glycol 3350
Labeler sun pharmaceutical industries, inc.
Dosage Form POWDER, FOR SOLUTION
Routes
ORAL
Active Ingredients

polyethylene glycol 3350 17 g/17g

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 51672-2104
Product ID 51672-2104_43e02980-58b9-7991-e063-6294a90a7a29
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA203928
Listing Expiration 2026-12-31
Marketing Start 2025-10-09

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 516722104
Hyphenated Format 51672-2104

Supplemental Identifiers

RxCUI
876193
UPC
0351672210434
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 instalax polyethylene glycol 3350 (source: ndc)
Application Number ANDA203928 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 17 g/17g
source: ndc
Packaging
  • 765 g in 1 CAN (51672-2104-3)
source: ndc

Packages (1)

51672-2104-3 765 g in 1 CAN (51672-2104-3)

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": "43e02980-58b9-7991-e063-6294a90a7a29", "openfda": {"nui": ["N0000010288", "N0000175811", "N0000009871"], "upc": ["0351672210434"], "unii": ["G2M7P15E5P"], "rxcui": ["876193"], "spl_set_id": ["40bd1be7-de67-8dff-e063-6294a90aca95"], "pharm_class_pe": ["Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]"], "pharm_class_epc": ["Osmotic Laxative [EPC]"], "pharm_class_moa": ["Osmotic Activity [MoA]"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "765 g in 1 CAN (51672-2104-3)", "package_ndc": "51672-2104-3", "marketing_start_date": "20251009"}], "brand_name": "Polyethylene Glycol 3350", "product_id": "51672-2104_43e02980-58b9-7991-e063-6294a90a7a29", "dosage_form": "POWDER, FOR SOLUTION", "pharm_class": ["Osmotic Activity [MoA]", "Osmotic Laxative [EPC]", "Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]"], "product_ndc": "51672-2104", "generic_name": "InstaLax Polyethylene Glycol 3350", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "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": "20251009", "listing_expiration_date": "20261231"}