FDA.reportPublic FDA data

TRILYTE

Product NDC
84386-013
11-digit product format
843860013
Labeler code
84386
Product ID
84386-013_79f5e596-8d51-4227-afcc-f5e341150957
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
polyethylene glyocol 3350, sodium chloride, sodium bicarbonate and potassium chloride
Dosage form
POWDER, FOR SOLUTION
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA076491
Marketing category
ANDA
Marketing start
2026-04-14
Substance
POLYETHYLENE GLYCOL 3350; SODIUM BICARBONATE; SODIUM CHLORIDE; POTASSIUM CHLORIDE
Active strength
420; 5.72; 11.2; 1.48 g/4L; g/4L; g/4L; g/4L
Pharmacologic classes
Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A076491-001TRILYTEPOLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOTFOR SOLUTION / ORALAA2004-02-05

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A076491-001AA

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A076491-001TRILYTE420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOTFOR SOLUTION / ORALAA2004-02-0584e616aacf4f…
2026-08-18 06:07:402026-07A076491-001TRILYTE420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOTFOR SOLUTION / ORALAA2004-02-05caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076491-001TRILYTE420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOTFOR SOLUTION / ORAL2004-02-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076491-001TRILYTE420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOTFOR SOLUTION / ORAL2004-02-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A076491-001TRILYTE420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOTFOR SOLUTION / ORAL2004-02-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076491-001TRILYTE420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOTFOR SOLUTION / ORAL2004-02-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076491-001TRILYTE420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOTFOR SOLUTION / ORAL2004-02-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076491-001TRILYTE420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOTFOR SOLUTION / ORAL2004-02-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076491-001TRILYTE420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOTFOR SOLUTION / ORAL2004-02-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076491-001TRILYTE420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOTFOR SOLUTION / ORAL2004-02-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076491-001TRILYTE420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOTFOR SOLUTION / ORAL2004-02-05d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076491-001TRILYTE420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOTFOR SOLUTION / ORAL2004-02-05d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076491-001TRILYTE420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOTFOR SOLUTION / ORAL2004-02-0579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076491-001TRILYTE420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOTFOR SOLUTION / ORAL2004-02-05301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076491-001TRILYTE420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOTFOR SOLUTION / ORAL2004-02-051e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076491-001TRILYTE420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOTFOR SOLUTION / ORAL2004-02-058072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076491-001TRILYTE420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOTFOR SOLUTION / ORAL2004-02-055c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076491-001TRILYTE420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOTFOR SOLUTION / ORAL2004-02-055d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076491-001TRILYTE420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOTFOR SOLUTION / ORAL2004-02-054b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076491-001TRILYTE420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOTFOR SOLUTION / ORALAA2004-02-0574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076491-001TRILYTE420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOTFOR SOLUTION / ORAL2004-02-05bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076491-001TRILYTE420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOTFOR SOLUTION / ORAL2004-02-05782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076491-001TRILYTE420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOTFOR SOLUTION / ORALAA2004-02-0587673890dc5c…
2021-03-12 10:30 UTC2021-03A076491-001TRILYTE420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOTFOR SOLUTION / ORALAA2004-02-055aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076491-001TRILYTE420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOTFOR SOLUTION / ORALAA2004-02-058869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076491-001TRILYTE420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOTFOR SOLUTION / ORALAA2004-02-05c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076491-001TRILYTE420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOTFOR SOLUTION / ORALAA2004-02-053f01610625f2…
2019-09-15 20:21 UTC2019-09A076491-001TRILYTE420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOTFOR SOLUTION / ORALAA2004-02-05b00525d2431f…
2019-07-19 19:46 UTC2019-07A076491-001TRILYTE420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOTFOR SOLUTION / ORALAA2004-02-05ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A076491-001TRILYTE420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOTFOR SOLUTION / ORAL2004-02-056a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A076491-001TRILYTE420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOTFOR SOLUTION / ORAL2004-02-051c564ffb4f44…
2023-12-20 04:57 UTC2023-12A076491-001TRILYTE420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOTFOR SOLUTION / ORAL2004-02-05ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A076491-001TRILYTE420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOTFOR SOLUTION / ORAL2004-02-05a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A076491-001TRILYTE420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOTFOR SOLUTION / ORAL2004-02-059b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A076491-001TRILYTE420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOTFOR SOLUTION / ORAL2004-02-05a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A076491-001TRILYTE420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOTFOR SOLUTION / ORAL2004-02-053f0d92c62455…
2023-05-13 08:27 UTC2023-05A076491-001TRILYTE420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOTFOR SOLUTION / ORAL2004-02-05053a50430f4f…
2023-01-26 05:58 UTC2023-01A076491-001TRILYTE420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOTFOR SOLUTION / ORAL2004-02-053bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076491-001TRILYTE420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOTFOR SOLUTION / ORAL2004-02-053a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A076491-001TRILYTE420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOTFOR SOLUTION / ORAL2004-02-05f41ea6bd6efb…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A076491-001AA184e616aacf4f…
2026-08-18 06:07:402026-07A076491-001AA1caaa826d4ba7…
2019-12-13 00:20 UTC2019-12A076491-001AA174a2ff9319b5…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076491-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A076491-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076491-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076491-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076491-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A076491-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A076491-001AA1ea99ee380514…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A076491-001AA1a50c72e98297…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
TRILYTE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POLYETHYLENE GLYCOL 3350420 g/4L
SODIUM BICARBONATE5.72 g/4L
SODIUM CHLORIDE11.2 g/4L
POTASSIUM CHLORIDE1.48 g/4L

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
G2M7P15E5PInternal UNII lookup
8MDF5V39QOInternal UNII lookup
451W47IQ8XInternal UNII lookup
660YQ98I10Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
801054Internal RxNorm lookup
904158Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
79f5e596-8d51-4227-afcc-f5e341150957Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9e37788c-b1bf-42ae-aac9-b60601606144Product name820260122
95250459-30e4-45c1-b08a-993044f49109Product name220250805
d9771140-739b-484b-ae64-b79528ff1211Product name320250801
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
1527ac37-808d-43be-a63e-74e1258dbe46Product name920250219
a21a21e5-f36d-4c1f-8918-def921b8f7e3Product name320250124
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
9fcb7a91-de07-4f00-aabf-e4d6fda403d5Product name820230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
0ec3537a-6c9b-432a-896c-b9ea8723049aProduct name920200701
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
7916de40-e296-41f0-b811-6d0df1a33e2cProduct name920180627
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84386-013-04TRILYTE4 L in 1 BOTTLEPOWDER, FOR SOLUTION41

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TRILYTEPOLYETHYLENE GLYOCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE AND POTASSIUM CHLORIDEAurobindo Pharma Limited79f5e596-8d51-4227-afcc-f5e3411509572026-04-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076491
application number: ANDA076491
ndc (product): 84386-013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
801054PEG-3350 420 GM / sodium chloride 11.2 GM / sodium bicarbonate 5.72 GM / potassium chloride 1.48 GM Powder for Oral SolutionPSN79f5e596-8d51-4227-afcc-f5e3411509571
904158TriLyte Powder for Oral SolutionPSN79f5e596-8d51-4227-afcc-f5e3411509571
904158polyethylene glycol 3350 420000 MG / potassium chloride 1480 MG / sodium bicarbonate 5720 MG / sodium chloride 11200 MG Powder for Oral Solution [TriLyte]SBD79f5e596-8d51-4227-afcc-f5e3411509571
801054polyethylene glycol 3350 420000 MG / potassium chloride 1480 MG / sodium bicarbonate 5720 MG / sodium chloride 11200 MG Powder for Oral SolutionSCD79f5e596-8d51-4227-afcc-f5e3411509571
801054PEG 3350 420 GM / potassium chloride 1.48 GM / sodium bicarbonate 5.72 GM / sodium chloride 11.2 GM per 4 L Powder for Oral SolutionSY79f5e596-8d51-4227-afcc-f5e3411509571
801054PEG-3350 420 GM / KCl 1.48 GM / NaCl 11.2 GM / NaHCO3 5.72 GM Powder for 4 L Oral SolutionSY79f5e596-8d51-4227-afcc-f5e3411509571
801054POLYETHYLENE GLYCOL 3350 420000 MG / K+ Chloride 1480 MG / NaHCO3 5720 MG / NaCl 11200 MG Powder for Oral SolutionSY79f5e596-8d51-4227-afcc-f5e3411509571
904158POLYETHYLENE GLYCOL 3350 420000 MG / K+ Chloride 1480 MG / NaHCO3 5720 MG / NaCl 11200 MG Powder for Oral Solution [TriLyte]SY79f5e596-8d51-4227-afcc-f5e3411509571
801054POLYETHYLENE GLYCOL 3350 420000 MG / Pot Chloride 1480 MG / NaHCO3 5720 MG / NaCl 11200 MG Powder for Oral SolutionSY79f5e596-8d51-4227-afcc-f5e3411509571
904158POLYETHYLENE GLYCOL 3350 420000 MG / Pot Chloride 1480 MG / NaHCO3 5720 MG / NaCl 11200 MG Powder for Oral Solution [TriLyte]SY79f5e596-8d51-4227-afcc-f5e3411509571
904158TriLyte (PEG-3350 420 GM / KCL 1.48 GM / NaHCO3 5.72 GM / NaCL 11.2 GM) Powder for 4 L Oral SolutionSY79f5e596-8d51-4227-afcc-f5e3411509571
904158TriLyte (PEG-3350 420 GM / potassium chloride 1.48 GM / sodium bicarbonate 5.72 GM / sodium chloride 11.2 GM) Powder for 4 L Oral SolutionSY79f5e596-8d51-4227-afcc-f5e3411509571

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84386-013-04843860013044 L in 1 BOTTLE (84386-013-04) 4 l2026-04-14NoNoCurrent