FDA.reportPublic FDA data

Polyethylene Glycol-3350 and Electrolytes with Flavor Pack

Product NDC
40032-060
11-digit product format
400320060
Labeler code
40032
Product ID
40032-060_b76cfbc2-2ecf-478c-adae-a141ec93553d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Polyethylene Glycol-3350 and Electrolytes with Flavor Pack
Dosage form
POWDER, FOR SOLUTION
Route
ORAL
Labeler
Novel Laboratories, Inc.
Application
ANDA090186
Marketing category
ANDA
Marketing start
2009-06-01
Marketing end
0000-00-00
Substance
POLYETHYLENE GLYCOL 3350; SODIUM CHLORIDE; SODIUM BICARBONATE; POTASSIUM CHLORIDE; SODIUM SULFATE ANHYDROUS
Active strength
240 g/278.26g; g/278.26g; g/278.26g; g/278.26g; g/278.26g
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],Potassium Compounds [CS],Potassium Salt [EPC],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]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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 productproduct40032-060IInactivated by FDA2026-08-11
excluded packagepackage40032-06040032-060-19IInactivated 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 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage40032-060-19d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage40032-060-19f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage40032-060-192ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage40032-060-19a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage40032-060-19cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage40032-060-19cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage40032-060-19302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage40032-060-19ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage40032-060-190efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage40032-060-19ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage40032-060-19367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage40032-060-19557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage40032-060-198af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage40032-060-19834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage40032-060-191332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage40032-060-19fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage40032-060-1986f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage40032-060-19bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage40032-060-198dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage40032-060-19e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage40032-060-199bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage40032-060-19110d247fa046…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
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…

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
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FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
40032-060-192019-10-21C16284748780-1956f9ecf-de4e-621f-e053-dbdaa90a74adPEG-3350 (240 g) and Electrolytes for Oral Solution, USP with flavor pack

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
40032-060-19Polyethylene Glycol-3350 and Electrolytes with Flavor Pack278.26 g in 1 BOTTLEPOWDER, FOR SOLUTION278.262

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
POLYETHYLENE GLYCOL 3350ACTIVE INGREDIENTG2M7P15E5PPOLYETHYLENE GLYCOL-3350 AND ELECTROLYTES WITH FLAVOR PACK POWDER, FOR SOLUTION [NOVEL LABORATORIES, INC.]2
POTASSIUM CHLORIDEACTIVE INGREDIENT660YQ98I10POLYETHYLENE GLYCOL-3350 AND ELECTROLYTES WITH FLAVOR PACK POWDER, FOR SOLUTION [NOVEL LABORATORIES, INC.]2
SODIUM BICARBONATEACTIVE INGREDIENT8MDF5V39QOPOLYETHYLENE GLYCOL-3350 AND ELECTROLYTES WITH FLAVOR PACK POWDER, FOR SOLUTION [NOVEL LABORATORIES, INC.]2
SODIUM CHLORIDEACTIVE INGREDIENT451W47IQ8XPOLYETHYLENE GLYCOL-3350 AND ELECTROLYTES WITH FLAVOR PACK POWDER, FOR SOLUTION [NOVEL LABORATORIES, INC.]2
SODIUM SULFATE ANHYDROUSACTIVE INGREDIENT36KCS0R750POLYETHYLENE GLYCOL-3350 AND ELECTROLYTES WITH FLAVOR PACK POWDER, FOR SOLUTION [NOVEL LABORATORIES, INC.]2
CHLORIDE IONACTIVE MOIETYQ32ZN48698POLYETHYLENE GLYCOL-3350 AND ELECTROLYTES WITH FLAVOR PACK POWDER, FOR SOLUTION [NOVEL LABORATORIES, INC.]2
POLYETHYLENE GLYCOL 3350ACTIVE MOIETYG2M7P15E5PPOLYETHYLENE GLYCOL-3350 AND ELECTROLYTES WITH FLAVOR PACK POWDER, FOR SOLUTION [NOVEL LABORATORIES, INC.]2
POTASSIUM CATIONACTIVE MOIETY295O53K152POLYETHYLENE GLYCOL-3350 AND ELECTROLYTES WITH FLAVOR PACK POWDER, FOR SOLUTION [NOVEL LABORATORIES, INC.]2
SODIUM CATIONACTIVE MOIETYLYR4M0NH37POLYETHYLENE GLYCOL-3350 AND ELECTROLYTES WITH FLAVOR PACK POWDER, FOR SOLUTION [NOVEL LABORATORIES, INC.]2
SULFATE IONACTIVE MOIETY7IS9N8KPMGPOLYETHYLENE GLYCOL-3350 AND ELECTROLYTES WITH FLAVOR PACK POWDER, FOR SOLUTION [NOVEL LABORATORIES, INC.]2
ACACIAINACTIVE INGREDIENT5C5403N26OPOLYETHYLENE GLYCOL-3350 AND ELECTROLYTES WITH FLAVOR PACK POWDER, FOR SOLUTION [NOVEL LABORATORIES, INC.]2
ALPHA-TOCOPHEROL, DL-INACTIVE INGREDIENT7QWA1RIO01POLYETHYLENE GLYCOL-3350 AND ELECTROLYTES WITH FLAVOR PACK POWDER, FOR SOLUTION [NOVEL LABORATORIES, INC.]2
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DPOLYETHYLENE GLYCOL-3350 AND ELECTROLYTES WITH FLAVOR PACK POWDER, FOR SOLUTION [NOVEL LABORATORIES, INC.]2
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYPOLYETHYLENE GLYCOL-3350 AND ELECTROLYTES WITH FLAVOR PACK POWDER, FOR SOLUTION [NOVEL LABORATORIES, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
40032-060POLYETHYLENE GLYCOL-3350 AND ELECTROLYTES WITH FLAVOR PACK POWDER, FOR SOLUTION [NOVEL LABORATORIES, INC.]2Legacy NDC, 1 package rows20091119_bf8925e7-6ea6-448c-810d-6f0d99127896.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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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 SolutionPSNbf8925e7-6ea6-448c-810d-6f0d991278962
966914polyethylene glycol 3350 240000 MG / potassium chloride 2980 MG / sodium bicarbonate 6720 MG / sodium chloride 5840 MG / sodium sulfate 22720 MG Powder for Oral SolutionSCDbf8925e7-6ea6-448c-810d-6f0d991278962
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 SolutionSYbf8925e7-6ea6-448c-810d-6f0d991278962
966914POLYETHYLENE GLYCOL 3350 240000 MG / K+ Chloride 2980 MG / NaHCO3 6720 MG / NaCl 5840 MG / sodium sulfate 22720 MG Powder for Oral SolutionSYbf8925e7-6ea6-448c-810d-6f0d991278962
966914POLYETHYLENE GLYCOL 3350 240000 MG / Pot Chloride 2980 MG / NaHCO3 6720 MG / NaCl 5840 MG / sodium sulfate 22720 MG Powder for Oral SolutionSYbf8925e7-6ea6-448c-810d-6f0d991278962

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
40032-060-1940032006019278.26 g in 1 BOTTLE278.26 gHistorical