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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct43386-090IInactivated by FDA2026-08-11
excluded packagepackage43386-09043386-090-91IInactivated by FDA2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 46 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage43386-090-91IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage43386-090-91IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage43386-090-91IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage43386-090-91IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage43386-090-91IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage43386-090-91IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage43386-090-91IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage43386-090-91IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductUExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage43386-090-91IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage43386-090-19UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage43386-090-91IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage43386-090-91IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage43386-090-91IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage43386-090-91IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage43386-090-91IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage43386-090-91IInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage43386-090-91IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage43386-090-91IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage43386-090-91IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage43386-090-91IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage43386-090-91IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage43386-090-91IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage43386-090-91EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

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
A090231-001PEG 3350 AND ELECTROLYTESPOLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOTFOR SOLUTION / ORALAA2009-06-01

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A090231-001AA

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 UTC2026-02A090231-001PEG 3350 AND ELECTROLYTES236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOTFOR SOLUTION / ORALAA2009-06-01011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090231-001PEG 3350 AND ELECTROLYTES236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOTFOR SOLUTION / ORALAA2009-06-0131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090231-001PEG 3350 AND ELECTROLYTES236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOTFOR SOLUTION / ORALAA2009-06-016a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090231-001PEG 3350 AND ELECTROLYTES236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOTFOR SOLUTION / ORALAA2009-06-01fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090231-001PEG 3350 AND ELECTROLYTES236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOTFOR SOLUTION / ORALAA2009-06-01b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090231-001PEG 3350 AND ELECTROLYTES236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOTFOR SOLUTION / ORALAA2009-06-0103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090231-001PEG 3350 AND ELECTROLYTES236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOTFOR SOLUTION / ORALAA2009-06-012680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090231-001PEG 3350 AND ELECTROLYTES236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOTFOR SOLUTION / ORALAA2009-06-015bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090231-001PEG 3350 AND ELECTROLYTES236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOTFOR SOLUTION / ORALAA2009-06-01d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090231-001PEG 3350 AND ELECTROLYTES236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOTFOR SOLUTION / ORALAA2009-06-01d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090231-001PEG 3350 AND ELECTROLYTES236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOTFOR SOLUTION / ORALAA2009-06-0179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090231-001PEG 3350 AND ELECTROLYTES236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOTFOR SOLUTION / ORALAA2009-06-01301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090231-001PEG 3350 AND ELECTROLYTES236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOTFOR SOLUTION / ORALAA2009-06-011e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090231-001PEG 3350 AND ELECTROLYTES236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOTFOR SOLUTION / ORALAA2009-06-018072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090231-001PEG 3350 AND ELECTROLYTES236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOTFOR SOLUTION / ORALAA2009-06-015c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090231-001PEG 3350 AND ELECTROLYTES236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOTFOR SOLUTION / ORALAA2009-06-015d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090231-001PEG 3350 AND ELECTROLYTES236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOTFOR SOLUTION / ORALAA2009-06-014b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090231-001PEG 3350 AND ELECTROLYTES236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOTFOR SOLUTION / ORALAA2009-06-0174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090231-001PEG 3350 AND ELECTROLYTES236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOTFOR SOLUTION / ORALAA2009-06-01bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090231-001PEG 3350 AND ELECTROLYTES236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOTFOR SOLUTION / ORALAA2009-06-01782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090231-001PEG 3350 AND ELECTROLYTES236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOTFOR SOLUTION / ORALAA2009-06-0187673890dc5c…
2021-03-12 10:30 UTC2021-03A090231-001PEG 3350 AND ELECTROLYTES236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOTFOR SOLUTION / ORALAA2009-06-015aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090231-001PEG 3350 AND ELECTROLYTES236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOTFOR SOLUTION / ORALAA2009-06-018869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090231-001PEG 3350 AND ELECTROLYTES236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOTFOR SOLUTION / ORALAA2009-06-01c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090231-001PEG 3350 AND ELECTROLYTES236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOTFOR SOLUTION / ORALAA2009-06-013f01610625f2…
2019-09-15 20:21 UTC2019-09A090231-001PEG 3350 AND ELECTROLYTES236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOTFOR SOLUTION / ORALAA2009-06-01b00525d2431f…
2019-07-19 19:46 UTC2019-07A090231-001PEG 3350 AND ELECTROLYTES236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOTFOR SOLUTION / ORALAA2009-06-01ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090231-001PEG 3350 AND ELECTROLYTES236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOTFOR SOLUTION / ORALAA2009-06-016a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A090231-001PEG 3350 AND ELECTROLYTES236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOTFOR SOLUTION / ORALAA2009-06-011c564ffb4f44…
2023-12-20 04:57 UTC2023-12A090231-001PEG 3350 AND ELECTROLYTES236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOTFOR SOLUTION / ORALAA2009-06-01ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A090231-001PEG 3350 AND ELECTROLYTES236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOTFOR SOLUTION / ORALAA2009-06-01a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A090231-001PEG 3350 AND ELECTROLYTES236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOTFOR SOLUTION / ORALAA2009-06-019b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A090231-001PEG 3350 AND ELECTROLYTES236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOTFOR SOLUTION / ORALAA2009-06-01a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A090231-001PEG 3350 AND ELECTROLYTES236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOTFOR SOLUTION / ORALAA2009-06-013f0d92c62455…
2023-05-13 08:27 UTC2023-05A090231-001PEG 3350 AND ELECTROLYTES236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOTFOR SOLUTION / ORALAA2009-06-01053a50430f4f…
2023-01-26 05:58 UTC2023-01A090231-001PEG 3350 AND ELECTROLYTES236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOTFOR SOLUTION / ORALAA2009-06-013bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090231-001PEG 3350 AND ELECTROLYTES236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOTFOR SOLUTION / ORALAA2009-06-013a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A090231-001PEG 3350 AND ELECTROLYTES236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOTFOR SOLUTION / ORALAA2009-06-01f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A090231-001PEG 3350 AND ELECTROLYTES236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOTFOR SOLUTION / ORALAA2009-06-01e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A090231-001PEG 3350 AND ELECTROLYTES236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOTFOR SOLUTION / ORALAA2009-06-01cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A090231-001AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090231-001AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090231-001AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090231-001AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090231-001AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090231-001AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090231-001AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090231-001AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090231-001AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090231-001AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090231-001AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090231-001AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090231-001AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090231-001AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090231-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090231-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090231-001AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090231-001AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090231-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090231-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090231-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A090231-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090231-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090231-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090231-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A090231-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A090231-001AA1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090231-001AA16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A090231-001AA11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A090231-001AA1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A090231-001AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A090231-001AA19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A090231-001AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A090231-001AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05A090231-001AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01A090231-001AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090231-001AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A090231-001AA1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A090231-001AA1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A090231-001AA1cb3db0bc1861…

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
SODIUM SULFATE ANHYDROUS2.97 g/274.31g
SODIUM BICARBONATE6.74 g/274.31g
SODIUM CHLORIDE5.86 g/274.31g
POTASSIUM CHLORIDE22.74 g/274.31g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 5 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
966920Internal RxNorm lookup
967012Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3978822b-6473-4072-9f80-20ceb9bea355Available 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

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

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GAVILYTE G TMPOLYETHYLENE GLYCOL-3350 AND ELECTROLYTESLupin Pharmaceuticals,Inc.3978822b-6473-4072-9f80-20ceb9bea3552025-09-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090231
application number: ANDA090231
ndc (product): 43386-090
POLYETHYLENE GLYCOL-3350 AND ELECTROLYTESPOLYETHYLENE GLYCOL-3350 AND ELECTROLYTESNovel Laboratories, Inc.29d821ff-389c-41fb-8a27-89bd3f022b822023-02-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090231
application number: ANDA090231

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