Home NDC 11534-180 POLYETHYLENE GLYCOL 3350 NF
Product NDC 11534-180
11-digit product format 115340180
Labeler code 11534
Product ID 11534-180_020b7f87-0f3a-4223-a402-dea12a6c53d2
Type HUMAN OTC DRUG
Nonproprietary name polyethylene glycol 3350
Dosage form POWDER, FOR SOLUTION
Route ORAL
Labeler SUNRISE PHARMACEUTICAL, INC
Application ANDA206105
Marketing category ANDA
Marketing start 2017-06-13
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 2026-12-31
Current FDA listing Yes 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-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 · 41 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 2026-02-19 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…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A206105-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2016-10-28 cb3db0bc1861…
Additional Listing Data#
Finished product Yes
Brand name base POLYETHYLENE GLYCOL 3350 NF
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength POLYETHYLENE GLYCOL 3350 17 g/17g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination G2M7P15E5P Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 876193 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 11534-180-19 POLYETHYLENE GLYCOL 3350 NF 119 g in 1 BOTTLE POWDER, FOR SOLUTION 119 2 11534-180-28 POLYETHYLENE GLYCOL 3350 NF 238 g in 1 BOTTLE POWDER, FOR SOLUTION 238 2 11534-180-50 POLYETHYLENE GLYCOL 3350 NF 510 g in 1 BOTTLE POWDER, FOR SOLUTION 510 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 11534-180 POLYETHYLENE GLYCOL 3350 NF (POLYETHYLENE GLYCOL 3350) POWDER, FOR SOLUTION [SUNRISE PHARMACEUTICAL, INC] 2 Current NDC, Legacy NDC, 3 package rows 20200123_ce5197a1-2677-4ffb-aef2-9221b28ebd23.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 Marketing start Marketing end Sample Exclude flag Status 11534-180-19 11534018019 119 g in 1 BOTTLE (11534-180-19) 119 g 2017-06-13 0000-00-00 No No Current 11534-180-28 11534018028 238 g in 1 BOTTLE (11534-180-28) 238 g 2017-06-13 0000-00-00 No No Current 11534-180-50 11534018050 510 g in 1 BOTTLE (11534-180-50) 510 g 2017-06-13 0000-00-00 No No Current