polyethylene glycol 3350, nf powder for solution, laxative

Generic: polyethylene glycol 3350, nf powder for solution, laxative

Labeler: pharmaceutica north america, inc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name polyethylene glycol 3350, nf powder for solution, laxative
Generic Name polyethylene glycol 3350, nf powder for solution, laxative
Labeler pharmaceutica north america, inc.
Dosage Form POWDER, FOR SOLUTION
Routes
ORAL
Active Ingredients

polyethylene glycol 3350 17 g/d

Manufacturer
Pharmaceutica North America, Inc.

Identifiers & Regulatory

Product NDC 45861-083
Product ID 45861-083_2f83c954-31c2-fa95-e063-6394a90a5861
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA090812
Listing Expiration 2026-12-31
Marketing Start 2025-02-10

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 45861083
Hyphenated Format 45861-083

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, nf powder for solution, laxative (source: ndc)
Generic Name polyethylene glycol 3350, nf powder for solution, laxative (source: ndc)
Application Number ANDA090812 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 17 g/d
source: ndc
Packaging
  • 238 d in 1 BOTTLE (45861-083-05)
  • 2 BOTTLE in 1 BOX (45861-083-06) / 476 d in 1 BOTTLE
source: ndc

Packages (2)

45861-083-05 238 d in 1 BOTTLE (45861-083-05) 45861-083-06 2 BOTTLE in 1 BOX (45861-083-06) / 476 d in 1 BOTTLE

Ingredients (1)

polyethylene glycol 3350 (17 g/d)

Linked Drug Pages (1)

Polyethylene Glycol 3350, NF Powder for Solution, Laxative ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2f83c954-31c2-fa95-e063-6394a90a5861", "openfda": {"nui": ["N0000010288", "N0000175811", "N0000009871"], "unii": ["G2M7P15E5P"], "rxcui": ["876193"], "spl_set_id": ["d048111f-8144-4d51-a0c2-a967b2bce455"], "pharm_class_pe": ["Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]"], "pharm_class_epc": ["Osmotic Laxative [EPC]"], "pharm_class_moa": ["Osmotic Activity [MoA]"], "manufacturer_name": ["Pharmaceutica North America, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "238 d in 1 BOTTLE (45861-083-05)", "package_ndc": "45861-083-05", "marketing_start_date": "20250210"}, {"sample": false, "description": "2 BOTTLE in 1 BOX (45861-083-06)  / 476 d in 1 BOTTLE", "package_ndc": "45861-083-06", "marketing_start_date": "20250210"}], "brand_name": "Polyethylene Glycol 3350, NF Powder for Solution, Laxative", "product_id": "45861-083_2f83c954-31c2-fa95-e063-6394a90a5861", "dosage_form": "POWDER, FOR SOLUTION", "pharm_class": ["Osmotic Activity [MoA]", "Osmotic Laxative [EPC]", "Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]"], "product_ndc": "45861-083", "generic_name": "Polyethylene Glycol 3350, NF Powder for Solution, Laxative", "labeler_name": "Pharmaceutica North America, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Polyethylene Glycol 3350, NF Powder for Solution, Laxative", "active_ingredients": [{"name": "POLYETHYLENE GLYCOL 3350", "strength": "17 g/d"}], "application_number": "ANDA090812", "marketing_category": "ANDA", "marketing_start_date": "20250210", "listing_expiration_date": "20261231"}