POLYETHYLENE GLYCOL 3350

Product NDC
62175-442
11-digit product format
621750442
Labeler code
62175
Product ID
62175-442_84da693b-656f-48bc-b4e0-624abe6efa88
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
POLYETHYLENE GLYCOL 3350
Dosage form
POWDER
Route
ORAL
Labeler
Lannett Company, Inc..
Application
ANDA076652
Marketing category
ANDA
Marketing start
2011-10-01
Marketing end
0000-00-00
Substance
POLYETHYLENE GLYCOL 3350
Active strength
1 g/g
Pharmacologic classes
Osmotic Activity [MoA],Osmotic Laxative [EPC],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
NDC exclude flag
No
Listing certified through
2019-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct62175-442DDiscontinued by firm2026-08-11
excluded packagepackage62175-44262175-442-15DDiscontinued by firm2026-08-11
excluded packagepackage62175-44262175-442-31DDiscontinued by firm2026-08-11

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 · 42 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 productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage62175-442-15DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage62175-442-31DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage62175-442-15DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage62175-442-31DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage62175-442-15DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage62175-442-31DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage62175-442-15DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage62175-442-31DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductDDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage62175-442-15DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage62175-442-31DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductDDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage62175-442-15DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage62175-442-31DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductDDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage62175-442-15DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage62175-442-31DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductDDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage62175-442-15DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage62175-442-31DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductDDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage62175-442-15DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage62175-442-31DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductDDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage62175-442-15DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage62175-442-31DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductDDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage62175-442-15DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage62175-442-31DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductDDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage62175-442-15DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage62175-442-31DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage62175-442-31IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage62175-442-15IInactivated 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 packagepackage62175-442-31IInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage62175-442-15IInactivated by FDA9bebd1f3094a…5416666fcb17…

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
A076652-001GLYCOLAXPOLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2004-07-02

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 UTC2026-02A076652-001GLYCOLAX17GM/SCOOPFULFOR SOLUTION / ORAL2004-07-02011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076652-001GLYCOLAX17GM/SCOOPFULFOR SOLUTION / ORAL2004-07-0231067a03dcf5…
2025-08-23 18:47 UTC2025-08A076652-001GLYCOLAX17GM/SCOOPFULFOR SOLUTION / ORAL2004-07-026a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076652-001GLYCOLAX17GM/SCOOPFULFOR SOLUTION / ORAL2004-07-02fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076652-001GLYCOLAX17GM/SCOOPFULFOR SOLUTION / ORAL2004-07-02b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076652-001GLYCOLAX17GM/SCOOPFULFOR SOLUTION / ORAL2004-07-0203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076652-001GLYCOLAX17GM/SCOOPFULFOR SOLUTION / ORAL2004-07-022680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076652-001GLYCOLAX17GM/SCOOPFULFOR SOLUTION / ORAL2004-07-025bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076652-001GLYCOLAX17GM/SCOOPFULFOR SOLUTION / ORAL2004-07-02d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076652-001GLYCOLAX17GM/SCOOPFULFOR SOLUTION / ORAL2004-07-02d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076652-001GLYCOLAX17GM/SCOOPFULFOR SOLUTION / ORAL2004-07-0279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076652-001GLYCOLAX17GM/SCOOPFULFOR SOLUTION / ORAL2004-07-02301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076652-001GLYCOLAX17GM/SCOOPFULFOR SOLUTION / ORAL2004-07-021e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076652-001GLYCOLAX17GM/SCOOPFULFOR SOLUTION / ORAL2004-07-028072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076652-001GLYCOLAX17GM/SCOOPFULFOR SOLUTION / ORAL2004-07-025c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076652-001GLYCOLAX17GM/SCOOPFULFOR SOLUTION / ORAL2004-07-025d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076652-001GLYCOLAX17GM/SCOOPFULFOR SOLUTION / ORAL2004-07-024b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076652-001GLYCOLAX17GM/SCOOPFULFOR SOLUTION / ORAL2004-07-0274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076652-001GLYCOLAX17GM/SCOOPFULFOR SOLUTION / ORAL2004-07-02bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076652-001GLYCOLAX17GM/SCOOPFULFOR SOLUTION / ORAL2004-07-02782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076652-001GLYCOLAX17GM/SCOOPFULFOR SOLUTION / ORAL2004-07-0287673890dc5c…
2021-03-12 10:30 UTC2021-03A076652-001GLYCOLAX17GM/SCOOPFULFOR SOLUTION / ORAL2004-07-025aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076652-001GLYCOLAX17GM/SCOOPFULFOR SOLUTION / ORAL2004-07-028869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076652-001GLYCOLAX17GM/SCOOPFULFOR SOLUTION / ORAL2004-07-02c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076652-001GLYCOLAX17GM/SCOOPFULFOR SOLUTION / ORAL2004-07-023f01610625f2…
2019-09-15 20:21 UTC2019-09A076652-001GLYCOLAX17GM/SCOOPFULFOR SOLUTION / ORAL2004-07-02b00525d2431f…
2019-07-19 19:46 UTC2019-07A076652-001GLYCOLAX17GM/SCOOPFULFOR SOLUTION / ORAL2004-07-02ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A076652-001GLYCOLAX17GM/SCOOPFULFOR SOLUTION / ORAL2004-07-026a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A076652-001GLYCOLAX17GM/SCOOPFULFOR SOLUTION / ORAL2004-07-021c564ffb4f44…
2023-12-20 04:57 UTC2023-12A076652-001GLYCOLAX17GM/SCOOPFULFOR SOLUTION / ORAL2004-07-02ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A076652-001GLYCOLAX17GM/SCOOPFULFOR SOLUTION / ORAL2004-07-02a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A076652-001GLYCOLAX17GM/SCOOPFULFOR SOLUTION / ORAL2004-07-029b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A076652-001GLYCOLAX17GM/SCOOPFULFOR SOLUTION / ORAL2004-07-02a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A076652-001GLYCOLAX17GM/SCOOPFULFOR SOLUTION / ORAL2004-07-023f0d92c62455…
2023-05-13 08:27 UTC2023-05A076652-001GLYCOLAX17GM/SCOOPFULFOR SOLUTION / ORAL2004-07-02053a50430f4f…
2023-01-26 05:58 UTC2023-01A076652-001GLYCOLAX17GM/SCOOPFULFOR SOLUTION / ORAL2004-07-023bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076652-001GLYCOLAX17GM/SCOOPFULFOR SOLUTION / ORAL2004-07-023a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A076652-001GLYCOLAX17GM/SCOOPFULFOR SOLUTION / ORAL2004-07-02f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A076652-001GLYCOLAX17GM/SCOOPFULFOR SOLUTION / ORAL2004-07-02e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A076652-001GLYCOLAX17GM/SCOOPFULFOR SOLUTION / ORAL2004-07-02cb3db0bc1861…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62175-442-15GM - Gram62175-442517e0497-c26e-434e-9708-acad8a2c6d7012012-07-24
62175-442-31GM - Gram62175-442c738ab39-cf4e-4e4c-870e-fa73a199796512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
POLYETHYLENE GLYCOL 3350ACTIVE INGREDIENTG2M7P15E5PPOLYETHYLENE GLYCOL 3350 POWDER [KREMERS URBAN PHARMACEUTICALS INC.]1
POLYETHYLENE GLYCOL 3350ACTIVE INGREDIENTG2M7P15E5PPOLYETHYLENE GLYCOL 3350 POWDER [PHYSICIANS TOTAL CARE, INC.]1
POLYETHYLENE GLYCOL 3350ACTIVE MOIETYG2M7P15E5PPOLYETHYLENE GLYCOL 3350 POWDER [KREMERS URBAN PHARMACEUTICALS INC.]1
POLYETHYLENE GLYCOL 3350ACTIVE MOIETYG2M7P15E5PPOLYETHYLENE GLYCOL 3350 POWDER [PHYSICIANS TOTAL CARE, INC.]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionPSNaa3bc313-3c42-4d4d-bfac-5215def68dab1
876193polyethylene glycol 3350 17000 MG Powder for Oral SolutionSCDaa3bc313-3c42-4d4d-bfac-5215def68dab1
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionSYaa3bc313-3c42-4d4d-bfac-5215def68dab1