FDA.reportPublic FDA data

GAVILYTE G

Product NDC
43386-090
11-digit product format
433860090
Labeler code
43386
Product ID
43386-090_896fc5ca-9a67-47c1-a317-f8dd4a3654c8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
polyethylene glycol-3350 and Electrolytes
Dosage form
POWDER, FOR SOLUTION
Route
ORAL
Labeler
Lupin Pharmaceuticals,Inc.
Application
ANDA090231
Marketing category
ANDA
Marketing start
2009-06-01
Substance
POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS
Active strength
236; 2.97; 6.74; 5.86; 22.74 g/274.31g; g/274.31g; g/274.31g; g/274.31g; g/274.31g
Pharmacologic classes
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]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
GAVILYTE G
Brand name suffix
TM
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POLYETHYLENE GLYCOL 3350236 g/274.31g
POTASSIUM CHLORIDE2.97 g/274.31g
SODIUM BICARBONATE6.74 g/274.31g
SODIUM CHLORIDE5.86 g/274.31g
SODIUM SULFATE ANHYDROUS22.74 g/274.31g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiG2M7P15E5P, 660YQ98I10, 8MDF5V39QO, 451W47IQ8X, 36KCS0R750
Rxcui966920, 967012

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43386-090-912020-01-31C16284748780-19d75b9d0-9d7b-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use GaviLyte™ G safely and effectively. See full prescribing information for GaviLyte™ G. GaviLyte™ G (PEG-3350 (236 g) and Electrolytes for Oral Solution, USP) Initial U.S. Approval:1984
43386-090-192019-10-28C16284748780-1956f9ecf-de00-621f-e053-dbdaa90a74adThese highlights do not include all the information needed to use GaviLyte™- G safely and effectively. See full prescribing information for GaviLyte™- G. GaviLyte™- G (PEG-3350 (236 g) and Electrolytes for Oral Solution, USP) Initial U.S. Approval:1984
43386-090-192019-10-21C16284748780-1956f9ecf-de00-621f-e053-dbdaa90a74adThese highlights do not include all the information needed to use GaviLyte™- G safely and effectively. See full prescribing information for GaviLyte™- G. GaviLyte™- G (PEG-3350 (236 g) and Electrolytes for Oral Solution, USP) Initial U.S. Approval:1984

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43386-090-19GAVILYTE GTM274.31 g in 1 BOTTLEPOWDER, FOR SOLUTION274.319
43386-090-91GaviLyte G TM274.31 g in 1 BOTTLEPOWDER, FOR SOLUTION274.311

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43386-090-19ML - Milliliter43386-0905e525291-10ca-410e-bed1-3abd130a8a8d12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
POLYETHYLENE GLYCOL 3350ACTIVE INGREDIENTG2M7P15E5PGAVILYTE G TM (POLYETHYLENE GLYCOL-3350 AND ELECTROLYTES) POWDER, FOR SOLUTION [GAVIS PHARMACEUTICALS, LLC]1
POTASSIUM CHLORIDEACTIVE INGREDIENT660YQ98I10GAVILYTE G TM (POLYETHYLENE GLYCOL-3350 AND ELECTROLYTES) POWDER, FOR SOLUTION [GAVIS PHARMACEUTICALS, LLC]1
SODIUM BICARBONATEACTIVE INGREDIENT8MDF5V39QOGAVILYTE G TM (POLYETHYLENE GLYCOL-3350 AND ELECTROLYTES) POWDER, FOR SOLUTION [GAVIS PHARMACEUTICALS, LLC]1
SODIUM CHLORIDEACTIVE INGREDIENT451W47IQ8XGAVILYTE G TM (POLYETHYLENE GLYCOL-3350 AND ELECTROLYTES) POWDER, FOR SOLUTION [GAVIS PHARMACEUTICALS, LLC]1
SODIUM SULFATE ANHYDROUSACTIVE INGREDIENT36KCS0R750GAVILYTE G TM (POLYETHYLENE GLYCOL-3350 AND ELECTROLYTES) POWDER, FOR SOLUTION [GAVIS PHARMACEUTICALS, LLC]1
CHLORIDE IONACTIVE MOIETYQ32ZN48698GAVILYTE G TM (POLYETHYLENE GLYCOL-3350 AND ELECTROLYTES) POWDER, FOR SOLUTION [GAVIS PHARMACEUTICALS, LLC]1
POLYETHYLENE GLYCOL 3350ACTIVE MOIETYG2M7P15E5PGAVILYTE G TM (POLYETHYLENE GLYCOL-3350 AND ELECTROLYTES) POWDER, FOR SOLUTION [GAVIS PHARMACEUTICALS, LLC]1
POTASSIUM CATIONACTIVE MOIETY295O53K152GAVILYTE G TM (POLYETHYLENE GLYCOL-3350 AND ELECTROLYTES) POWDER, FOR SOLUTION [GAVIS PHARMACEUTICALS, LLC]1
SODIUM CATIONACTIVE MOIETYLYR4M0NH37GAVILYTE G TM (POLYETHYLENE GLYCOL-3350 AND ELECTROLYTES) POWDER, FOR SOLUTION [GAVIS PHARMACEUTICALS, LLC]1
SULFATE IONACTIVE MOIETY7IS9N8KPMGGAVILYTE G TM (POLYETHYLENE GLYCOL-3350 AND ELECTROLYTES) POWDER, FOR SOLUTION [GAVIS PHARMACEUTICALS, LLC]1
ACACIAINACTIVE INGREDIENT5C5403N26OGAVILYTE G TM (POLYETHYLENE GLYCOL-3350 AND ELECTROLYTES) POWDER, FOR SOLUTION [GAVIS PHARMACEUTICALS, LLC]1
ALPHA-TOCOPHEROL, DL-INACTIVE INGREDIENT7QWA1RIO01GAVILYTE G TM (POLYETHYLENE GLYCOL-3350 AND ELECTROLYTES) POWDER, FOR SOLUTION [GAVIS PHARMACEUTICALS, LLC]1
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DGAVILYTE G TM (POLYETHYLENE GLYCOL-3350 AND ELECTROLYTES) POWDER, FOR SOLUTION [GAVIS PHARMACEUTICALS, LLC]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYGAVILYTE G TM (POLYETHYLENE GLYCOL-3350 AND ELECTROLYTES) POWDER, FOR SOLUTION [GAVIS PHARMACEUTICALS, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43386-090GAVILYTE G TM (POLYETHYLENE GLYCOL-3350 AND ELECTROLYTES) POWDER, FOR SOLUTION [LUPIN PHARMACEUTICALS,INC.]8Current NDC, Legacy NDC, 1 package rows20250117_3978822b-6473-4072-9f80-20ceb9bea355.zip
43386-090GAVILYTE G TM (POLYETHYLENE GLYCOL-3350 AND ELECTROLYTES) POWDER, FOR SOLUTION [LUPIN PHARMACEUTICALS,INC.]1Current NDC, Legacy NDC, 1 package rows20161224_4b5254c5-4a61-4711-92b4-acc8e3137904.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
967012Gavilyte-G Powder for Oral SolutionPSN3978822b-6473-4072-9f80-20ceb9bea3559
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 SolutionPSN3978822b-6473-4072-9f80-20ceb9bea3559
967012polyethylene glycol 3350 236000 MG / potassium chloride 2970 MG / sodium bicarbonate 6740 MG / sodium chloride 5860 MG / sodium sulfate 22740 MG Powder for Oral Solution [Gavilyte-G]SBD3978822b-6473-4072-9f80-20ceb9bea3559
966920polyethylene glycol 3350 236000 MG / potassium chloride 2970 MG / sodium bicarbonate 6740 MG / sodium chloride 5860 MG / sodium sulfate 22740 MG Powder for Oral SolutionSCD3978822b-6473-4072-9f80-20ceb9bea3559
967012Gavilyte-G (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 SolutionSY3978822b-6473-4072-9f80-20ceb9bea3559
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 SolutionSY3978822b-6473-4072-9f80-20ceb9bea3559
966920POLYETHYLENE GLYCOL 3350 236000 MG / K+ Chloride 2970 MG / NaHCO3 6740 MG / NaCl 5860 MG / sodium sulfate 22740 MG Powder for Oral SolutionSY3978822b-6473-4072-9f80-20ceb9bea3559
967012POLYETHYLENE GLYCOL 3350 236000 MG / K+ Chloride 2970 MG / NaHCO3 6740 MG / NaCl 5860 MG / sodium sulfate 22740 MG Powder for Oral Solution [Gavilyte-G]SY3978822b-6473-4072-9f80-20ceb9bea3559
966920POLYETHYLENE GLYCOL 3350 236000 MG / Pot Chloride 2970 MG / NaHCO3 6740 MG / NaCl 5860 MG / sodium sulfate 22740 MG Powder for Oral SolutionSY3978822b-6473-4072-9f80-20ceb9bea3559
967012POLYETHYLENE GLYCOL 3350 236000 MG / Pot Chloride 2970 MG / NaHCO3 6740 MG / NaCl 5860 MG / sodium sulfate 22740 MG Powder for Oral Solution [Gavilyte-G]SY3978822b-6473-4072-9f80-20ceb9bea3559
967012Gavilyte-G Powder for Oral SolutionPSN4b5254c5-4a61-4711-92b4-acc8e31379041
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 SolutionPSN4b5254c5-4a61-4711-92b4-acc8e31379041
967012polyethylene glycol 3350 236000 MG / potassium chloride 2970 MG / sodium bicarbonate 6740 MG / sodium chloride 5860 MG / sodium sulfate 22740 MG Powder for Oral Solution [Gavilyte-G]SBD4b5254c5-4a61-4711-92b4-acc8e31379041
966920polyethylene glycol 3350 236000 MG / potassium chloride 2970 MG / sodium bicarbonate 6740 MG / sodium chloride 5860 MG / sodium sulfate 22740 MG Powder for Oral SolutionSCD4b5254c5-4a61-4711-92b4-acc8e31379041
967012Gavilyte-G (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 SolutionSY4b5254c5-4a61-4711-92b4-acc8e31379041
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 SolutionSY4b5254c5-4a61-4711-92b4-acc8e31379041
966920POLYETHYLENE GLYCOL 3350 236000 MG / K+ Chloride 2970 MG / NaHCO3 6740 MG / NaCl 5860 MG / sodium sulfate 22740 MG Powder for Oral SolutionSY4b5254c5-4a61-4711-92b4-acc8e31379041
967012POLYETHYLENE GLYCOL 3350 236000 MG / K+ Chloride 2970 MG / NaHCO3 6740 MG / NaCl 5860 MG / sodium sulfate 22740 MG Powder for Oral Solution [Gavilyte-G]SY4b5254c5-4a61-4711-92b4-acc8e31379041
966920POLYETHYLENE GLYCOL 3350 236000 MG / Pot Chloride 2970 MG / NaHCO3 6740 MG / NaCl 5860 MG / sodium sulfate 22740 MG Powder for Oral SolutionSY4b5254c5-4a61-4711-92b4-acc8e31379041
967012POLYETHYLENE GLYCOL 3350 236000 MG / Pot Chloride 2970 MG / NaHCO3 6740 MG / NaCl 5860 MG / sodium sulfate 22740 MG Powder for Oral Solution [Gavilyte-G]SY4b5254c5-4a61-4711-92b4-acc8e31379041

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43386-090-1943386009019274.31 g in 1 BOTTLE (43386-090-19) 274.31 g2009-06-010000-00-00NoNoCurrent
43386-090-9143386009091274.31 g in 1 BOTTLE274.31 gHistorical