polyethylene glycol 3350

Generic: polyethylene glycol 3350

Labeler: glenmark therapeutics inc., usa
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name polyethylene glycol 3350
Generic Name polyethylene glycol 3350
Labeler glenmark therapeutics inc., usa
Dosage Form POWDER, FOR SOLUTION
Routes
ORAL
Active Ingredients

polyethylene glycol 3350 17 g/17g

Manufacturer
GLENMARK THERAPEUTICS INC., USA

Identifiers & Regulatory

Product NDC 72657-196
Product ID 72657-196_7c2e19af-e03f-4d48-bac6-2efd716b70b3
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA203928
Listing Expiration 2027-12-31
Marketing Start 2024-09-19

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 72657196
Hyphenated Format 72657-196

Supplemental Identifiers

RxCUI
876193
UPC
0359556762079
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
  • 765 g in 1 CAN (72657-196-16)
source: ndc

Packages (1)

72657-196-16 765 g in 1 CAN (72657-196-16)

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": "7c2e19af-e03f-4d48-bac6-2efd716b70b3", "openfda": {"nui": ["N0000010288", "N0000175811", "N0000009871"], "upc": ["0359556762079"], "unii": ["G2M7P15E5P"], "rxcui": ["876193"], "spl_set_id": ["5aba6bb1-d25d-4901-8e9c-4cd4a3a06471"], "pharm_class_pe": ["Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]"], "pharm_class_epc": ["Osmotic Laxative [EPC]"], "pharm_class_moa": ["Osmotic Activity [MoA]"], "manufacturer_name": ["GLENMARK THERAPEUTICS INC., USA"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "765 g in 1 CAN (72657-196-16)", "package_ndc": "72657-196-16", "marketing_start_date": "20240919"}], "brand_name": "Polyethylene Glycol 3350", "product_id": "72657-196_7c2e19af-e03f-4d48-bac6-2efd716b70b3", "dosage_form": "POWDER, FOR SOLUTION", "pharm_class": ["Osmotic Activity [MoA]", "Osmotic Laxative [EPC]", "Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]"], "product_ndc": "72657-196", "generic_name": "Polyethylene Glycol 3350", "labeler_name": "GLENMARK THERAPEUTICS INC., USA", "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": "20240919", "listing_expiration_date": "20271231"}