Home NDC 51525-6831-4 TriLyte
Product NDC 51525-6831
Requested package NDC 51525-6831-4
11-digit product format 515256831
Labeler code 51525
Product ID 51525-6831_71ee65e3-2a55-4fe4-bdad-cfbd4a8835a4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Polyethylene glyocol 3350, sodium chloride, sodium bicarbonate and potassium chloride
Dosage form POWDER, FOR SOLUTION
Route NASOGASTRIC; ORAL
Labeler Wallace Pharmaceuticals Inc.
Application ANDA076491
Marketing category ANDA
Marketing start 2016-10-01
Marketing end 2021-09-30
Substance POLYETHYLENE GLYCOL 3350; SODIUM CHLORIDE; SODIUM BICARBONATE; POTASSIUM CHLORIDE
Active strength 420 g/4L; g/4L; g/4L; g/4L
Pharmacologic classes Osmotic Activity [MoA],Osmotic Laxative [EPC],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [CS],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]
NDC exclude flag No
Listing certified through 0000-00-00
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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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 A076491-001 TRILYTE POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION / ORAL AA 2004-02-05
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A076491-001 AA
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 A076491-001 TRILYTE 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION / ORAL AA 2004-02-05 84e616aacf4f…2026-08-18 06:07:40 2026-07 A076491-001 TRILYTE 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION / ORAL AA 2004-02-05 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076491-001 TRILYTE 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION / ORAL 2004-02-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076491-001 TRILYTE 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION / ORAL 2004-02-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076491-001 TRILYTE 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION / ORAL 2004-02-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076491-001 TRILYTE 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION / ORAL 2004-02-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076491-001 TRILYTE 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION / ORAL 2004-02-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076491-001 TRILYTE 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION / ORAL 2004-02-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076491-001 TRILYTE 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION / ORAL 2004-02-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076491-001 TRILYTE 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION / ORAL 2004-02-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076491-001 TRILYTE 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION / ORAL 2004-02-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076491-001 TRILYTE 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION / ORAL 2004-02-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076491-001 TRILYTE 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION / ORAL 2004-02-05 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076491-001 TRILYTE 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION / ORAL 2004-02-05 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076491-001 TRILYTE 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION / ORAL 2004-02-05 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076491-001 TRILYTE 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION / ORAL 2004-02-05 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076491-001 TRILYTE 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION / ORAL 2004-02-05 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076491-001 TRILYTE 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION / ORAL 2004-02-05 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076491-001 TRILYTE 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION / ORAL 2004-02-05 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076491-001 TRILYTE 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION / ORAL AA 2004-02-05 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A076491-001 TRILYTE 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION / ORAL 2004-02-05 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A076491-001 TRILYTE 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION / ORAL 2004-02-05 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A076491-001 TRILYTE 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION / ORAL AA 2004-02-05 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A076491-001 TRILYTE 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION / ORAL AA 2004-02-05 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A076491-001 TRILYTE 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION / ORAL AA 2004-02-05 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A076491-001 TRILYTE 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION / ORAL AA 2004-02-05 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A076491-001 TRILYTE 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION / ORAL AA 2004-02-05 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A076491-001 TRILYTE 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION / ORAL AA 2004-02-05 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A076491-001 TRILYTE 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION / ORAL AA 2004-02-05 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A076491-001 TRILYTE 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION / ORAL 2004-02-05 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A076491-001 TRILYTE 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION / ORAL 2004-02-05 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A076491-001 TRILYTE 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION / ORAL 2004-02-05 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A076491-001 TRILYTE 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION / ORAL 2004-02-05 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A076491-001 TRILYTE 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION / ORAL 2004-02-05 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A076491-001 TRILYTE 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION / ORAL 2004-02-05 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A076491-001 TRILYTE 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION / ORAL 2004-02-05 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A076491-001 TRILYTE 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION / ORAL 2004-02-05 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A076491-001 TRILYTE 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION / ORAL 2004-02-05 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A076491-001 TRILYTE 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION / ORAL 2004-02-05 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A076491-001 TRILYTE 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION / ORAL 2004-02-05 f41ea6bd6efb…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded POLYETHYLENE GLYCOL 3350 ACTIVE INGREDIENT G2M7P15E5P TRILYTE WITH FLAVOR PACKS (POLYETHYLENE GLYOCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE AND POTASSIUM CHLORIDE) POWDER, FOR SOLUTION [WALLACE PHARMACEUTICALS INC.] 1 POTASSIUM CHLORIDE ACTIVE INGREDIENT 660YQ98I10 TRILYTE WITH FLAVOR PACKS (POLYETHYLENE GLYOCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE AND POTASSIUM CHLORIDE) POWDER, FOR SOLUTION [WALLACE PHARMACEUTICALS INC.] 1 SODIUM BICARBONATE ACTIVE INGREDIENT 8MDF5V39QO TRILYTE WITH FLAVOR PACKS (POLYETHYLENE GLYOCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE AND POTASSIUM CHLORIDE) POWDER, FOR SOLUTION [WALLACE PHARMACEUTICALS INC.] 1 SODIUM CHLORIDE ACTIVE INGREDIENT 451W47IQ8X TRILYTE WITH FLAVOR PACKS (POLYETHYLENE GLYOCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE AND POTASSIUM CHLORIDE) POWDER, FOR SOLUTION [WALLACE PHARMACEUTICALS INC.] 1 POLYETHYLENE GLYCOL 3350 ACTIVE MOIETY G2M7P15E5P TRILYTE WITH FLAVOR PACKS (POLYETHYLENE GLYOCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE AND POTASSIUM CHLORIDE) POWDER, FOR SOLUTION [WALLACE PHARMACEUTICALS INC.] 1 POTASSIUM CATION ACTIVE MOIETY 295O53K152 TRILYTE WITH FLAVOR PACKS (POLYETHYLENE GLYOCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE AND POTASSIUM CHLORIDE) POWDER, FOR SOLUTION [WALLACE PHARMACEUTICALS INC.] 1 SODIUM CATION ACTIVE MOIETY LYR4M0NH37 TRILYTE WITH FLAVOR PACKS (POLYETHYLENE GLYOCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE AND POTASSIUM CHLORIDE) POWDER, FOR SOLUTION [WALLACE PHARMACEUTICALS INC.] 1
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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join TRILYTE POLYETHYLENE GLYOCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE AND POTASSIUM CHLORIDE Aurobindo Pharma Limited 79f5e596-8d51-4227-afcc-f5e341150957 2026-04-15 Warnings, Adverse reactions Exact identifier application applno (ANDA): 076491 application number: ANDA076491
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 51525-6831-4 51525683104 4 L in 1 BOTTLE (51525-6831-4) 4 l 2016-10-01 2021-09-30 No No Current