Home NDC 68016-726 Laxative
Product NDC 68016-726
11-digit product format 680160726
Labeler code 68016
Product ID 68016-726_ee3a5c35-858a-c36b-e053-2a95a90a0516
Type HUMAN OTC DRUG
Nonproprietary name polyethylene glycol 3350
Dosage form POWDER, FOR SOLUTION
Route ORAL
Labeler Chain Drug Consortium, LLC
Application ANDA090812
Marketing category ANDA
Marketing start 2015-06-01
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 NDC auxiliary status# Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.
Dataset, Scope, Product NDC table Dataset Scope Product NDC Package NDC Code Status Reporting period Source date excluded product product 68016-726 D Discontinued by firm 2026-07-31 excluded package package 68016-726 68016-726-08 D Discontinued by firm 2026-07-31 excluded package package 68016-726 68016-726-17 D Discontinued by firm 2026-07-31
Orange Book products# Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A090812-001 POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2009-10-07
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join EasyLAX POLYETHYLENE GLYCOL 3350 VALU MERCHANDISERS COMPANY 6597811b-6471-5afd-e053-2991aa0a07c2 2025-12-16 Warnings Exact identifier CLEARLAX POLYETHYLENE GLYCOL 3350 STRATEGIC SOURCING SERVICES LLC 041157b8-476c-e7d2-e063-6394a90ac3a0 2025-06-11 Warnings Exact identifier Polyethylene Glycol 3350, NF Powder for Solution, Laxative POLYETHYLENE GLYCOL 3350, NF POWDER FOR SOLUTION, LAXATIVE Pharmaceutica North America, Inc. d048111f-8144-4d51-a0c2-a967b2bce455 2025-03-04 Warnings Exact identifier POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 3350 Bryant Ranch Prepack 66276671-0ccd-4c32-a697-31e679fce0e3 2024-02-06 Warnings Exact identifier Polyethylene Glycol 3350, NF Powder for Solution, Laxative POLYETHYLENE GLYCOL 3350, NF POWDER FOR SOLUTION, LAXATIVE LGM PHARMA SOLUTIONS, LLC d78bead5-ff19-4d45-9003-ec131f1f5a13 2024-01-17 Warnings Exact identifier POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 3350 Geri-Care Pharmaceutical Corp f4c7eb80-d8d5-406d-90d0-9d17914d71f2 2022-11-24 Warnings Exact identifier
Warnings cross-check# openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
warnings Warnings Allergy alert: Do not use if you are allergic to polyethylene glycol Do not use if you have kidney disease, except under the advice and supervision of a doctor Ask a doctor before use if you have nausea, vomiting or abdominal pain a sudden change in bowel habits that lasts over 2 weeks irritable bowel syndrome Ask a doctor or pharmacist before use if you are taking a prescription drug When using this product you may have loose, watery, more frequent stools Stop use and ask a doctor if you have rectal bleeding or your nausea, bloating, cramping or abdominal pain gets worse. These may be signs of a serious condition. you get diarrhea you need to use a laxative for longer than 1 week If pregnant or breast feeding, ask a health professional before use. Keep out of reach of children. In case of overdose , get medical help or contact a Poison Control Center right away.
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68016-726 LAXATIVE (POLYETHYLENE GLYCOL 3350) POWDER, FOR SOLUTION [CHAIN DRUG CONSORTIUM, LLC] 5 Legacy NDC 20241206_60cc2d39-745c-87a4-e053-2a91aa0a8a42.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68016-726-08 68016072608 238 g in 1 BOTTLE (68016-726-08) 238 g 2016-07-01 0000-00-00 No No Current 68016-726-17 68016072617 510 g in 1 BOTTLE (68016-726-17) 510 g 2016-07-01 0000-00-00 No No Current