Home NDC 69784-180-10 POLYETHYLENE GLYCOL 3350 NF
Product NDC 69784-180
Requested package NDC 69784-180-10
11-digit product format 697840180
Labeler code 69784
Product ID 69784-180_41a32cdc-41d3-4f7c-9cff-d2847dc52b12
Type HUMAN OTC DRUG
Nonproprietary name polyethylene glycol 3350
Dosage form POWDER, FOR SOLUTION
Route ORAL
Labeler Woodward Pharma Services LLC
Application ANDA206105
Marketing category ANDA
Marketing start 2018-06-06
Marketing end 0000-00-00
Substance POLYETHYLENE GLYCOL 3350
Active strength 17 g/17g
Pharmacologic classes Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record 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 · 3 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 69784-180 69784-180-10 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 69784-180 69784-180-10 I Inactivated by FDA excluded / ndc_excluded.zip 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 69784-180 69784-180-10 I Inactivated by FDA excluded / ndc_excluded.zip bd6a592717d7…303034d00443…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A206105-001 POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2016-10-28
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 · 43 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A206105-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2016-10-28 84e616aacf4f…2026-08-18 06:07:40 2026-07 A206105-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2016-10-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A206105-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2016-10-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206105-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2016-10-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A206105-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2016-10-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206105-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2016-10-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206105-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2016-10-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206105-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2016-10-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206105-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2016-10-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206105-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2016-10-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206105-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2016-10-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A206105-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2016-10-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206105-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2016-10-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206105-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2016-10-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206105-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2016-10-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A206105-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2016-10-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A206105-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2016-10-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A206105-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2016-10-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A206105-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2016-10-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A206105-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2016-10-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A206105-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2016-10-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A206105-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2016-10-28 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A206105-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2016-10-28 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A206105-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2016-10-28 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A206105-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2016-10-28 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A206105-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2016-10-28 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A206105-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2016-10-28 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A206105-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2016-10-28 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A206105-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2016-10-28 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A206105-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2016-10-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A206105-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2016-10-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A206105-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2016-10-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A206105-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2016-10-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A206105-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2016-10-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A206105-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2016-10-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A206105-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2016-10-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A206105-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2016-10-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A206105-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2016-10-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A206105-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2016-10-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A206105-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2016-10-28 f41ea6bd6efb…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69784-180 POLYETHYLENE GLYCOL 3350 NF (POLYETHYLENE GLYCOL 3350) POWDER, FOR SOLUTION [WOODWARD PHARMA SERVICES LLC] 5 Legacy NDC 20220801_657a51f5-f12f-4b7a-b8fa-2d75d7289f2a.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 69784-180-10 69784018010 100 POUCH in 1 CARTON (69784-180-10) > 17 g in 1 POUCH (69784-180-01) 100 pouch 2018-06-06 0000-00-00 No No Current