Home NDC 42576-180 POLYETHYLENE GLYCOL 3350 NF
Product NDC 42576-180
11-digit product format 425760180
Labeler code 42576
Product ID 42576-180_9a6f7c98-8459-40a6-99c2-03a990ae69d2
Type HUMAN OTC DRUG
Nonproprietary name polyethylene glycol 3350
Dosage form POWDER, FOR SOLUTION
Route ORAL
Labeler NUVO PHARMACEUTICAL INC.
Application ANDA206105
Marketing category ANDA
Marketing start 2017-07-03
Marketing end 0000-00-00
Substance POLYETHYLENE GLYCOL 3350
Active strength 17 g/17g
NDC exclude flag E
Listing certified through 2018-12-31
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 2 · 88 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 · 42 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 2026-08-18 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…2022-09-29 23:25 UTC 2022-09 A206105-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2016-10-28 e64feba35796…
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 42576-180-19 POLYETHYLENE GLYCOL 3350 NF 119 g in 1 BOTTLE POWDER, FOR SOLUTION 119 3 42576-180-28 POLYETHYLENE GLYCOL 3350 NF 238 g in 1 BOTTLE POWDER, FOR SOLUTION 238 3 42576-180-50 POLYETHYLENE GLYCOL 3350 NF 510 g in 1 BOTTLE POWDER, FOR SOLUTION 510 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42576-180 POLYETHYLENE GLYCOL 3350 NF (POLYETHYLENE GLYCOL 3350) POWDER, FOR SOLUTION [NUVO PHARMACEUTICAL INC.] 3 Legacy NDC, 3 package rows 20170703_49c3aa94-3b32-4929-b9c6-52e3f58e4a57.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Status 42576-180-19 42576018019 119 g in 1 BOTTLE 119 g Historical 42576-180-28 42576018028 238 g in 1 BOTTLE 238 g Historical 42576-180-50 42576018050 510 g in 1 BOTTLE 510 g Historical