peg-3350, sodium chloride, sodium bicarbonate and potassium chloride

Generic: polyethylene glycol 3350, sodium chloride, sodium bicarbonate, potassium chloride

Labeler: affordable pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name peg-3350, sodium chloride, sodium bicarbonate and potassium chloride
Generic Name polyethylene glycol 3350, sodium chloride, sodium bicarbonate, potassium chloride
Labeler affordable pharmaceuticals, llc
Dosage Form POWDER, FOR SOLUTION
Routes
ORAL
Active Ingredients

polyethylene glycol 3350 420 g/4L, potassium chloride 1.48 g/4L, sodium bicarbonate 5.72 g/4L, sodium chloride 11.2 g/4L

Manufacturer
Affordable Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 10572-302
Product ID 10572-302_d21af010-592c-bd05-e053-2995a90a3d39
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA019797
Listing Expiration 2026-12-31
Marketing Start 2013-02-08

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 10572302
Hyphenated Format 10572-302

Supplemental Identifiers

RxCUI
801054
UNII
G2M7P15E5P 660YQ98I10 8MDF5V39QO 451W47IQ8X
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 peg-3350, sodium chloride, sodium bicarbonate and potassium chloride (source: ndc)
Generic Name polyethylene glycol 3350, sodium chloride, sodium bicarbonate, potassium chloride (source: ndc)
Application Number NDA019797 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 420 g/4L
  • 1.48 g/4L
  • 5.72 g/4L
  • 11.2 g/4L
source: ndc
Packaging
  • 4 L in 1 BOTTLE (10572-302-01)
source: ndc

Packages (1)

10572-302-01 4 L in 1 BOTTLE (10572-302-01)

Ingredients (4)

polyethylene glycol 3350 (420 g/4L) potassium chloride (1.48 g/4L) sodium bicarbonate (5.72 g/4L) sodium chloride (11.2 g/4L)

Linked Drug Pages (1)

PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "d21af010-592c-bd05-e053-2995a90a3d39", "openfda": {"nui": ["N0000010288", "N0000175811", "N0000009871"], "unii": ["G2M7P15E5P", "660YQ98I10", "8MDF5V39QO", "451W47IQ8X"], "rxcui": ["801054"], "spl_set_id": ["89ca6d56-527a-4be2-baea-531156f0a7be"], "pharm_class_pe": ["Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]"], "pharm_class_epc": ["Osmotic Laxative [EPC]"], "pharm_class_moa": ["Osmotic Activity [MoA]"], "manufacturer_name": ["Affordable Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "4 L in 1 BOTTLE (10572-302-01)", "package_ndc": "10572-302-01", "marketing_start_date": "20130301"}], "brand_name": "PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride", "product_id": "10572-302_d21af010-592c-bd05-e053-2995a90a3d39", "dosage_form": "POWDER, FOR SOLUTION", "pharm_class": ["Increased Large Intestinal Motility [PE]", "Increased Large Intestinal Motility [PE]", "Increased Large Intestinal Motility [PE]", "Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]", "Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]", "Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]", "Osmotic Activity [MoA]", "Osmotic Activity [MoA]", "Osmotic Activity [MoA]", "Osmotic Activity [MoA]", "Osmotic Laxative [EPC]", "Osmotic Laxative [EPC]", "Osmotic Laxative [EPC]", "Osmotic Laxative [EPC]", "Potassium Compounds [CS]", "Potassium Salt [EPC]", "Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]"], "product_ndc": "10572-302", "generic_name": "polyethylene glycol 3350, sodium chloride, sodium bicarbonate, potassium chloride", "labeler_name": "Affordable Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride", "active_ingredients": [{"name": "POLYETHYLENE GLYCOL 3350", "strength": "420 g/4L"}, {"name": "POTASSIUM CHLORIDE", "strength": "1.48 g/4L"}, {"name": "SODIUM BICARBONATE", "strength": "5.72 g/4L"}, {"name": "SODIUM CHLORIDE", "strength": "11.2 g/4L"}], "application_number": "NDA019797", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20130208", "listing_expiration_date": "20261231"}