golytely

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

Labeler: braintree laboratories, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name golytely
Generic Name polyethylene glycol 3350, sodium sulfate anhydrous, sodium bicarbonate, sodium chloride, potassium chloride
Labeler braintree laboratories, inc.
Dosage Form POWDER, FOR SOLUTION
Routes
ORAL
Active Ingredients

polyethylene glycol 3350 236 g/4L, potassium chloride 2.97 g/4L, sodium bicarbonate 6.74 g/4L, sodium chloride 5.86 g/4L, sodium sulfate anhydrous 22.74 g/4L

Manufacturer
Braintree Laboratories, Inc.

Identifiers & Regulatory

Product NDC 52268-100
Product ID 52268-100_c3649858-77b7-2295-e053-2995a90a048f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA019011
Listing Expiration 2026-12-31
Marketing Start 1984-07-13

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 52268100
Hyphenated Format 52268-100

Supplemental Identifiers

RxCUI
966916 966920 966922 1870431
UNII
G2M7P15E5P 660YQ98I10 8MDF5V39QO 451W47IQ8X 36KCS0R750
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 golytely (source: ndc)
Generic Name polyethylene glycol 3350, sodium sulfate anhydrous, sodium bicarbonate, sodium chloride, potassium chloride (source: ndc)
Application Number NDA019011 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 236 g/4L
  • 2.97 g/4L
  • 6.74 g/4L
  • 5.86 g/4L
  • 22.74 g/4L
source: ndc
Packaging
  • 4 L in 1 BOTTLE, PLASTIC (52268-100-01)
source: ndc

Packages (1)

52268-100-01 4 L in 1 BOTTLE, PLASTIC (52268-100-01)

Ingredients (5)

polyethylene glycol 3350 (236 g/4L) potassium chloride (2.97 g/4L) sodium bicarbonate (6.74 g/4L) sodium chloride (5.86 g/4L) sodium sulfate anhydrous (22.74 g/4L)

Linked Drug Pages (1)

GoLYTELY ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "c3649858-77b7-2295-e053-2995a90a048f", "openfda": {"nui": ["N0000010288", "N0000175811", "N0000009871"], "unii": ["G2M7P15E5P", "660YQ98I10", "8MDF5V39QO", "451W47IQ8X", "36KCS0R750"], "rxcui": ["966916", "966920", "966922", "1870431"], "spl_set_id": ["57d22b0b-1ae0-4203-babc-f3bac17bd1c9"], "pharm_class_pe": ["Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]"], "pharm_class_epc": ["Osmotic Laxative [EPC]"], "pharm_class_moa": ["Osmotic Activity [MoA]"], "manufacturer_name": ["Braintree Laboratories, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "4 L in 1 BOTTLE, PLASTIC (52268-100-01)", "package_ndc": "52268-100-01", "marketing_start_date": "19840713"}], "brand_name": "GoLYTELY", "product_id": "52268-100_c3649858-77b7-2295-e053-2995a90a048f", "dosage_form": "POWDER, FOR SOLUTION", "pharm_class": ["Increased Large Intestinal Motility [PE]", "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]", "Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]", "Osmotic Activity [MoA]", "Osmotic Activity [MoA]", "Osmotic Activity [MoA]", "Osmotic Activity [MoA]", "Osmotic Activity [MoA]", "Osmotic Laxative [EPC]", "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": "52268-100", "generic_name": "Polyethylene Glycol 3350, Sodium Sulfate Anhydrous, Sodium Bicarbonate, Sodium Chloride, Potassium Chloride", "labeler_name": "Braintree Laboratories, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "GoLYTELY", "active_ingredients": [{"name": "POLYETHYLENE GLYCOL 3350", "strength": "236 g/4L"}, {"name": "POTASSIUM CHLORIDE", "strength": "2.97 g/4L"}, {"name": "SODIUM BICARBONATE", "strength": "6.74 g/4L"}, {"name": "SODIUM CHLORIDE", "strength": "5.86 g/4L"}, {"name": "SODIUM SULFATE ANHYDROUS", "strength": "22.74 g/4L"}], "application_number": "NDA019011", "marketing_category": "NDA", "marketing_start_date": "19840713", "listing_expiration_date": "20261231"}