FDA.reportPublic FDA data

GaviLyte - C

Product NDC
43386-060
11-digit product format
433860060
Labeler code
43386
Product ID
43386-060_5105b61a-4ca7-4096-9cd0-cf22f46ffaf8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
polyethylene glycol-3350 and electrolytes with Flavor Pack
Dosage form
POWDER, FOR SOLUTION
Route
ORAL
Labeler
Lupin Pharmaceuticals,Inc.
Application
ANDA090186
Marketing category
ANDA
Marketing start
2009-01-06
Substance
POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS
Active strength
240; 2.98; 6.72; 5.84; 22.72 g/278.26g; g/278.26g; g/278.26g; g/278.26g; g/278.26g
Pharmacologic classes
Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [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 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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090186-001PEG 3350 AND ELECTROLYTESPOLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOTFOR SOLUTION / ORALRS2009-06-01

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A090186-001PEG 3350 AND ELECTROLYTES240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOTFOR SOLUTION / ORAL2009-06-01011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090186-001PEG 3350 AND ELECTROLYTES240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOTFOR SOLUTION / ORAL2009-06-0131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090186-001PEG 3350 AND ELECTROLYTES240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOTFOR SOLUTION / ORAL2009-06-016a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090186-001PEG 3350 AND ELECTROLYTES240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOTFOR SOLUTION / ORAL2009-06-01fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090186-001PEG 3350 AND ELECTROLYTES240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOTFOR SOLUTION / ORAL2009-06-01b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090186-001PEG 3350 AND ELECTROLYTES240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOTFOR SOLUTION / ORAL2009-06-0103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090186-001PEG 3350 AND ELECTROLYTES240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOTFOR SOLUTION / ORAL2009-06-012680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090186-001PEG 3350 AND ELECTROLYTES240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOTFOR SOLUTION / ORAL2009-06-015bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090186-001PEG 3350 AND ELECTROLYTES240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOTFOR SOLUTION / ORAL2009-06-01d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090186-001PEG 3350 AND ELECTROLYTES240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOTFOR SOLUTION / ORAL2009-06-01d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090186-001PEG 3350 AND ELECTROLYTES240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOTFOR SOLUTION / ORAL2009-06-0179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090186-001PEG 3350 AND ELECTROLYTES240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOTFOR SOLUTION / ORAL2009-06-01301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090186-001PEG 3350 AND ELECTROLYTES240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOTFOR SOLUTION / ORAL2009-06-011e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090186-001PEG 3350 AND ELECTROLYTES240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOTFOR SOLUTION / ORAL2009-06-018072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090186-001PEG 3350 AND ELECTROLYTES240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOTFOR SOLUTION / ORALAA2009-06-015c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090186-001PEG 3350 AND ELECTROLYTES240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOTFOR SOLUTION / ORALAA2009-06-015d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090186-001PEG 3350 AND ELECTROLYTES240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOTFOR SOLUTION / ORALAA2009-06-014b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090186-001PEG 3350 AND ELECTROLYTES240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOTFOR SOLUTION / ORALAA2009-06-0174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090186-001PEG 3350 AND ELECTROLYTES240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOTFOR SOLUTION / ORALAA2009-06-01bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090186-001PEG 3350 AND ELECTROLYTES240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOTFOR SOLUTION / ORALAA2009-06-01782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090186-001PEG 3350 AND ELECTROLYTES240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOTFOR SOLUTION / ORALAA2009-06-0187673890dc5c…
2021-03-12 10:30 UTC2021-03A090186-001PEG 3350 AND ELECTROLYTES240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOTFOR SOLUTION / ORALAA2009-06-015aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090186-001PEG 3350 AND ELECTROLYTES240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOTFOR SOLUTION / ORALAA2009-06-018869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090186-001PEG 3350 AND ELECTROLYTES240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOTFOR SOLUTION / ORALAA2009-06-01c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090186-001PEG 3350 AND ELECTROLYTES240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOTFOR SOLUTION / ORALAA2009-06-013f01610625f2…
2019-09-15 20:21 UTC2019-09A090186-001PEG 3350 AND ELECTROLYTES240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOTFOR SOLUTION / ORALAA2009-06-01b00525d2431f…
2019-07-19 19:46 UTC2019-07A090186-001PEG 3350 AND ELECTROLYTES240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOTFOR SOLUTION / ORALAA2009-06-01ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090186-001PEG 3350 AND ELECTROLYTES240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOTFOR SOLUTION / ORALAA2009-06-016a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A090186-001PEG 3350 AND ELECTROLYTES240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOTFOR SOLUTION / ORALAA2009-06-011c564ffb4f44…
2023-12-20 04:57 UTC2023-12A090186-001PEG 3350 AND ELECTROLYTES240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOTFOR SOLUTION / ORALAA2009-06-01ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A090186-001PEG 3350 AND ELECTROLYTES240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOTFOR SOLUTION / ORALAA2009-06-01a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A090186-001PEG 3350 AND ELECTROLYTES240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOTFOR SOLUTION / ORALAA2009-06-019b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A090186-001PEG 3350 AND ELECTROLYTES240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOTFOR SOLUTION / ORALAA2009-06-01a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A090186-001PEG 3350 AND ELECTROLYTES240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOTFOR SOLUTION / ORALAA2009-06-013f0d92c62455…
2023-05-13 08:27 UTC2023-05A090186-001PEG 3350 AND ELECTROLYTES240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOTFOR SOLUTION / ORALAA2009-06-01053a50430f4f…
2023-01-26 05:58 UTC2023-01A090186-001PEG 3350 AND ELECTROLYTES240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOTFOR SOLUTION / ORALAA2009-06-013bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090186-001PEG 3350 AND ELECTROLYTES240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOTFOR SOLUTION / ORALAA2009-06-013a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A090186-001PEG 3350 AND ELECTROLYTES240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOTFOR SOLUTION / ORALAA2009-06-01f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A090186-001PEG 3350 AND ELECTROLYTES240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOTFOR SOLUTION / ORALAA2009-06-01e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A090186-001PEG 3350 AND ELECTROLYTES240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOTFOR SOLUTION / ORALAA2009-06-01cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090186-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090186-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090186-001AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090186-001AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090186-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090186-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090186-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A090186-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090186-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090186-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090186-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A090186-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A090186-001AA1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090186-001AA16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A090186-001AA11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A090186-001AA1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A090186-001AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A090186-001AA19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A090186-001AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A090186-001AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05A090186-001AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01A090186-001AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090186-001AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A090186-001AA1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A090186-001AA1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A090186-001AA1cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
GaviLyte - C
Brand name suffix
TM
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POLYETHYLENE GLYCOL 3350240 g/278.26g
SODIUM CHLORIDE2.98 g/278.26g
POTASSIUM CHLORIDE6.72 g/278.26g
SODIUM BICARBONATE5.84 g/278.26g
SODIUM SULFATE ANHYDROUS22.72 g/278.26g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 5 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
G2M7P15E5PInternal UNII lookup
451W47IQ8XInternal UNII lookup
660YQ98I10Internal UNII lookup
8MDF5V39QOInternal UNII lookup
36KCS0R750Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
966914Internal RxNorm lookup
967023Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
a8b15625-ca7c-4d57-9f36-3ac2a6d13665Available on FDA.report

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
43386-060-19GaviLyte - CTM278.26 g in 1 BOTTLEPOWDER, FOR SOLUTION278.264

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43386-060-19ML - Milliliter43386-0601d11e571-8e9f-4b71-a830-2e1e39fe2f0d12012-07-24

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43386-060GAVILYTE - C TM (POLYETHYLENE GLYCOL-3350 AND ELECTROLYTES WITH FLAVOR PACK) POWDER, FOR SOLUTION [LUPIN PHARMACEUTICALS,INC.]3Current NDC, Legacy NDC, 1 package rows20171228_a8b15625-ca7c-4d57-9f36-3ac2a6d13665.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GaviLyte - C TMPOLYETHYLENE GLYCOL-3350 AND ELECTROLYTES WITH FLAVOR PACKLupin Pharmaceuticals,Inc.a8b15625-ca7c-4d57-9f36-3ac2a6d136652025-09-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090186
application number: ANDA090186
ndc (product): 43386-060

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
967023Gavilyte-C Powder for Oral SolutionPSNa8b15625-ca7c-4d57-9f36-3ac2a6d136654
966914polyethylene glycol 3350 240 GM / potassium chloride 2.98 GM / sodium bicarbonate 6.74 GM / sodium chloride 5.86 GM / sodium sulfate 227.41 GM Powder for Oral SolutionPSNa8b15625-ca7c-4d57-9f36-3ac2a6d136654
967023polyethylene glycol 3350 240000 MG / potassium chloride 2980 MG / sodium bicarbonate 6720 MG / sodium chloride 5840 MG / sodium sulfate 22720 MG Powder for Oral Solution [GaviLyte-C]SBDa8b15625-ca7c-4d57-9f36-3ac2a6d136654
966914polyethylene glycol 3350 240000 MG / potassium chloride 2980 MG / sodium bicarbonate 6720 MG / sodium chloride 5840 MG / sodium sulfate 22720 MG Powder for Oral SolutionSCDa8b15625-ca7c-4d57-9f36-3ac2a6d136654
967023Gavilyte-C (PEG-3350 240 GM / KCl 2.98 GM / NaCl 5.84 GM / NaHCO3 6.72 GM / Na2SO4 22.72 GM) Powder for 4 L Oral SolutionSYa8b15625-ca7c-4d57-9f36-3ac2a6d136654
967023Gavilyte-C (polyethylene glycol 3350 240 GM / potassium chloride 2.98 GM / sodium bicarbonate 6.72 GM / sodium chloride 5.84 GM / sodium sulfate 22.72 GM) Powder for Oral SolutionSYa8b15625-ca7c-4d57-9f36-3ac2a6d136654
966914polyethylene glycol 3350 240 GM / potassium chloride 2.98 GM / sodium bicarbonate 6.74 GM / sodium chloride 5.86 GM / sodium sulfate 227.41 GM Powder for Oral SolutionSYa8b15625-ca7c-4d57-9f36-3ac2a6d136654
966914POLYETHYLENE GLYCOL 3350 240000 MG / K+ Chloride 2980 MG / NaHCO3 6720 MG / NaCl 5840 MG / sodium sulfate 22720 MG Powder for Oral SolutionSYa8b15625-ca7c-4d57-9f36-3ac2a6d136654
967023POLYETHYLENE GLYCOL 3350 240000 MG / K+ Chloride 2980 MG / NaHCO3 6720 MG / NaCl 5840 MG / sodium sulfate 22720 MG Powder for Oral Solution [GaviLyte-C]SYa8b15625-ca7c-4d57-9f36-3ac2a6d136654
966914POLYETHYLENE GLYCOL 3350 240000 MG / Pot Chloride 2980 MG / NaHCO3 6720 MG / NaCl 5840 MG / sodium sulfate 22720 MG Powder for Oral SolutionSYa8b15625-ca7c-4d57-9f36-3ac2a6d136654
967023POLYETHYLENE GLYCOL 3350 240000 MG / Pot Chloride 2980 MG / NaHCO3 6720 MG / NaCl 5840 MG / sodium sulfate 22720 MG Powder for Oral Solution [GaviLyte-C]SYa8b15625-ca7c-4d57-9f36-3ac2a6d136654

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43386-060-1943386006019278.26 g in 1 BOTTLE (43386-060-19) 278.26 g2009-06-010000-00-00YesNoCurrent