GoLYTELY

Product NDC
52268-101
11-digit product format
522680101
Labeler code
52268
Product ID
52268-101_c3649858-77b7-2295-e053-2995a90a048f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Polyethylene Glycol 3350, Sodium Sulfate Anhydrous, Sodium Bicarbonate, Sodium Chloride, Potassium Chloride
Dosage form
POWDER, FOR SOLUTION
Route
ORAL
Labeler
Braintree Laboratories, Inc.
Application
NDA019011
Marketing category
NDA
Marketing start
1984-07-13
Marketing end
2022-10-31
Substance
POLYETHYLENE GLYCOL 3350; SODIUM SULFATE ANHYDROUS; SODIUM BICARBONATE; SODIUM CHLORIDE; POTASSIUM CHLORIDE
Active strength
236 g/4L; g/4L; g/4L; g/4L; g/4L
Pharmacologic classes
Osmotic Activity [MoA],Osmotic Laxative [EPC],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [CS],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9e37788c-b1bf-42ae-aac9-b60601606144Product name820260122
95250459-30e4-45c1-b08a-993044f49109Product name220250805
d9771140-739b-484b-ae64-b79528ff1211Product name320250801
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
1527ac37-808d-43be-a63e-74e1258dbe46Product name920250219
a21a21e5-f36d-4c1f-8918-def921b8f7e3Product name320250124
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
9fcb7a91-de07-4f00-aabf-e4d6fda403d5Product name820230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
0ec3537a-6c9b-432a-896c-b9ea8723049aProduct name920200701
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
7916de40-e296-41f0-b811-6d0df1a33e2cProduct name920180627
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52268-101-01GoLYTELY4 L in 1 BOTTLE, PLASTICPOWDER, FOR SOLUTION45

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52268-101-01ML - Milliliter52268-101f56d6035-c2af-4c1c-ba8e-86671021f8f012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Polyethylene Glycol 3350ACTIVE INGREDIENTG2M7P15E5PGOLYTELY (POLYETHYLENE GLYCOL 3350, SODIUM SULFATE ANHYDROUS, SODIUM BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE) POWDER, FOR SOLUTION [BRAINTREE LABORATORIES, INC.]2
Potassium ChlorideACTIVE INGREDIENT660YQ98I10GOLYTELY (POLYETHYLENE GLYCOL 3350, SODIUM SULFATE ANHYDROUS, SODIUM BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE) POWDER, FOR SOLUTION [BRAINTREE LABORATORIES, INC.]2
Sodium BicarbonateACTIVE INGREDIENT8MDF5V39QOGOLYTELY (POLYETHYLENE GLYCOL 3350, SODIUM SULFATE ANHYDROUS, SODIUM BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE) POWDER, FOR SOLUTION [BRAINTREE LABORATORIES, INC.]2
Sodium ChlorideACTIVE INGREDIENT451W47IQ8XGOLYTELY (POLYETHYLENE GLYCOL 3350, SODIUM SULFATE ANHYDROUS, SODIUM BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE) POWDER, FOR SOLUTION [BRAINTREE LABORATORIES, INC.]2
Sodium Sulfate AnhydrousACTIVE INGREDIENT36KCS0R750GOLYTELY (POLYETHYLENE GLYCOL 3350, SODIUM SULFATE ANHYDROUS, SODIUM BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE) POWDER, FOR SOLUTION [BRAINTREE LABORATORIES, INC.]2
Bicarbonate IonACTIVE MOIETYHN1ZRA3Q20GOLYTELY (POLYETHYLENE GLYCOL 3350, SODIUM SULFATE ANHYDROUS, SODIUM BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE) POWDER, FOR SOLUTION [BRAINTREE LABORATORIES, INC.]2
Chloride IonACTIVE MOIETYQ32ZN48698GOLYTELY (POLYETHYLENE GLYCOL 3350, SODIUM SULFATE ANHYDROUS, SODIUM BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE) POWDER, FOR SOLUTION [BRAINTREE LABORATORIES, INC.]2
Polyethylene Glycol 3350ACTIVE MOIETYG2M7P15E5PGOLYTELY (POLYETHYLENE GLYCOL 3350, SODIUM SULFATE ANHYDROUS, SODIUM BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE) POWDER, FOR SOLUTION [BRAINTREE LABORATORIES, INC.]2
Sulfate IonACTIVE MOIETY7IS9N8KPMGGOLYTELY (POLYETHYLENE GLYCOL 3350, SODIUM SULFATE ANHYDROUS, SODIUM BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE) POWDER, FOR SOLUTION [BRAINTREE LABORATORIES, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52268-101GOLYTELY (POLYETHYLENE GLYCOL 3350, SODIUM SULFATE ANHYDROUS, SODIUM BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE) POWDER, FOR SOLUTION [BRAINTREE LABORATORIES, INC.]5Legacy NDC, 1 package rows20210529_57d22b0b-1ae0-4203-babc-f3bac17bd1c9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
966916GoLYTELY Packet Powder for Oral SolutionPSN57d22b0b-1ae0-4203-babc-f3bac17bd1c95
966922GoLYTELY Plastic Bottle Powder for Oral SolutionPSN57d22b0b-1ae0-4203-babc-f3bac17bd1c95
1870431polyethylene glycol 3350 227.1 GM / potassium chloride 2.82 GM / sodium bicarbonate 6.36 GM / sodium chloride 5.53 GM / sodium sulfate 21.5 GM Powder for Oral SolutionPSN57d22b0b-1ae0-4203-babc-f3bac17bd1c95
966920polyethylene glycol 3350 236 GM / potassium chloride 2.97 GM / sodium bicarbonate 6.74 GM / sodium chloride 5.86 GM / sodium sulfate 22.74 GM Powder for Oral SolutionPSN57d22b0b-1ae0-4203-babc-f3bac17bd1c95
966916polyethylene glycol 3350 227100 MG / potassium chloride 2820 MG / sodium bicarbonate 6360 MG / sodium chloride 5530 MG / sodium sulfate 21500 MG Powder for Oral Solution [Golytely]SBD57d22b0b-1ae0-4203-babc-f3bac17bd1c95
966922polyethylene glycol 3350 236000 MG / potassium chloride 2970 MG / sodium bicarbonate 6740 MG / sodium chloride 5860 MG / sodium sulfate 22740 MG Powder for Oral Solution [Golytely]SBD57d22b0b-1ae0-4203-babc-f3bac17bd1c95
1870431polyethylene glycol 3350 227100 MG / potassium chloride 2820 MG / sodium bicarbonate 6360 MG / sodium chloride 5530 MG / sodium sulfate 21500 MG Powder for Oral SolutionSCD57d22b0b-1ae0-4203-babc-f3bac17bd1c95
966920polyethylene glycol 3350 236000 MG / potassium chloride 2970 MG / sodium bicarbonate 6740 MG / sodium chloride 5860 MG / sodium sulfate 22740 MG Powder for Oral SolutionSCD57d22b0b-1ae0-4203-babc-f3bac17bd1c95
966916Golytely (polyethylene glycol 3350 227.1 GM / potassium chloride 2.82 GM / sodium bicarbonate 6.36 GM / sodium chloride 5.53 GM / sodium sulfate 21.5 GM) Powder for Oral SolutionSY57d22b0b-1ae0-4203-babc-f3bac17bd1c95
966922Golytely (polyethylene glycol 3350 236 GM / potassium chloride 2.97 GM / sodium bicarbonate 6.74 GM / sodium chloride 5.86 GM / sodium sulfate 22.74 GM) Powder for Oral SolutionSY57d22b0b-1ae0-4203-babc-f3bac17bd1c95
1870431polyethylene glycol 3350 227.1 GM / potassium chloride 2.82 GM / sodium bicarbonate 6.36 GM / sodium chloride 5.53 GM / sodium sulfate 21.5 GM Powder for Oral SolutionSY57d22b0b-1ae0-4203-babc-f3bac17bd1c95
1870431POLYETHYLENE GLYCOL 3350 227100 MG / K+ Chloride 2820 MG / NaHCO3 6360 MG / NaCl 5530 MG / sodium sulfate 21500 MG Powder for Oral SolutionSY57d22b0b-1ae0-4203-babc-f3bac17bd1c95
966916POLYETHYLENE GLYCOL 3350 227100 MG / K+ Chloride 2820 MG / NaHCO3 6360 MG / NaCl 5530 MG / sodium sulfate 21500 MG Powder for Oral Solution [Golytely]SY57d22b0b-1ae0-4203-babc-f3bac17bd1c95
1870431POLYETHYLENE GLYCOL 3350 227100 MG / Pot Chloride 2820 MG / NaHCO3 6360 MG / NaCl 5530 MG / sodium sulfate 21500 MG Powder for Oral SolutionSY57d22b0b-1ae0-4203-babc-f3bac17bd1c95
966916POLYETHYLENE GLYCOL 3350 227100 MG / Pot Chloride 2820 MG / NaHCO3 6360 MG / NaCl 5530 MG / sodium sulfate 21500 MG Powder for Oral Solution [Golytely]SY57d22b0b-1ae0-4203-babc-f3bac17bd1c95
966920polyethylene glycol 3350 236 GM / potassium chloride 2.97 GM / sodium bicarbonate 6.74 GM / sodium chloride 5.86 GM / sodium sulfate 22.74 GM Powder for Oral SolutionSY57d22b0b-1ae0-4203-babc-f3bac17bd1c95
966920POLYETHYLENE GLYCOL 3350 236000 MG / K+ Chloride 2970 MG / NaHCO3 6740 MG / NaCl 5860 MG / sodium sulfate 22740 MG Powder for Oral SolutionSY57d22b0b-1ae0-4203-babc-f3bac17bd1c95
966922POLYETHYLENE GLYCOL 3350 236000 MG / K+ Chloride 2970 MG / NaHCO3 6740 MG / NaCl 5860 MG / sodium sulfate 22740 MG Powder for Oral Solution [Golytely]SY57d22b0b-1ae0-4203-babc-f3bac17bd1c95
966920POLYETHYLENE GLYCOL 3350 236000 MG / Pot Chloride 2970 MG / NaHCO3 6740 MG / NaCl 5860 MG / sodium sulfate 22740 MG Powder for Oral SolutionSY57d22b0b-1ae0-4203-babc-f3bac17bd1c95
966922POLYETHYLENE GLYCOL 3350 236000 MG / Pot Chloride 2970 MG / NaHCO3 6740 MG / NaCl 5860 MG / sodium sulfate 22740 MG Powder for Oral Solution [Golytely]SY57d22b0b-1ae0-4203-babc-f3bac17bd1c95

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52268-101-01522680101014 L in 1 BOTTLE, PLASTIC (52268-101-01) 4 l1984-07-132022-10-31NoNoCurrent