COLYTE

Product NDC: 0037-6820
11-digit product format: 000376820
Labeler code: 0037
Product ID: 0037-6820_7bb877c3-fc2b-4bf3-9e06-e940f0cfa381
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: peg-3350 and electrolytes
Dosage form: POWDER, FOR SOLUTION
Route: NASOGASTRIC
Labeler: Meda Pharmaceuticals
Application: NDA018983
Marketing category: NDA
Marketing start: 2014-08-05
Marketing end: 2021-09-30
Substance: POLYETHYLENE GLYCOL 3350; SODIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM SULFATE
Active strength: 240 g/4L; 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],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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	0037-6820		D	Discontinued by firm		2026-09-14
excluded package	package	0037-6820	0037-6820-04	D	Discontinued by firm		2026-09-14

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 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0037-6820-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0037-6820-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0037-6820-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0037-6820-04	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0037-6820-04	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0037-6820-04	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0037-6820-04	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0037-6820-04	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0037-6820-04	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0037-6820-04	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0037-6820-04	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0037-6820-04	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 8 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N018983-004	COLYTE	POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS	227.1GM/PACKET;2.82GM/PACKET;6.36GM/PACKET;5.53GM/PACKET;21.5GM/PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SOLUTION / ORAL	RLD	1984-10-26
N018983-005	COLYTE	POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS	120GM/PACKET;1.49GM/PACKET;3.36GM/PACKET;2.92GM/PACKET;11.36GM/PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SOLUTION / ORAL	RLD	1984-10-26
N018983-006	COLYTE	POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS	360GM/PACKET;4.47GM/PACKET;10.08GM/PACKET;8.76GM/PACKET;34.08GM/PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SOLUTION / ORAL	RLD	1984-10-26
N018983-007	COLYTE	POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS	240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOT Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SOLUTION / ORAL	RLD	1987-06-12
N018983-008	COLYTE-FLAVORED	POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS	227.1GM/BOT;2.82GM/BOT;6.36GM/BOT;5.53GM/BOT;21.5GM/BOT Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SOLUTION / ORAL	RLD	1991-11-14
N018983-009	COLYTE-FLAVORED	POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS	240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOT Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SOLUTION / ORAL	RLD	1991-11-14
N018983-010	COLYTE	POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS	227.1GM/BOT;2.82GM/BOT;6.36GM/BOT;5.53GM/BOT;21.5GM/BOT Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SOLUTION / ORAL	RLD	1989-01-31
N018983-012	COLYTE WITH FLAVOR PACKS	POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS	240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOT	FOR SOLUTION / ORAL	RLD	1998-10-08

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 9 · 344 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N018983-004	COLYTE	227.1GM/PACKET;2.82GM/PACKET;6.36GM/PACKET;5.53GM/PACKET;21.5GM/PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SOLUTION / ORAL	RLD	1984-10-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018983-005	COLYTE	120GM/PACKET;1.49GM/PACKET;3.36GM/PACKET;2.92GM/PACKET;11.36GM/PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SOLUTION / ORAL	RLD	1984-10-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018983-006	COLYTE	360GM/PACKET;4.47GM/PACKET;10.08GM/PACKET;8.76GM/PACKET;34.08GM/PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SOLUTION / ORAL	RLD	1984-10-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018983-007	COLYTE	240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOT Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SOLUTION / ORAL	RLD	1987-06-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018983-008	COLYTE-FLAVORED	227.1GM/BOT;2.82GM/BOT;6.36GM/BOT;5.53GM/BOT;21.5GM/BOT Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SOLUTION / ORAL	RLD	1991-11-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018983-009	COLYTE-FLAVORED	240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOT Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SOLUTION / ORAL	RLD	1991-11-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018983-010	COLYTE	227.1GM/BOT;2.82GM/BOT;6.36GM/BOT;5.53GM/BOT;21.5GM/BOT Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SOLUTION / ORAL	RLD	1989-01-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018983-012	COLYTE WITH FLAVOR PACKS	240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOT	FOR SOLUTION / ORAL	RLD	1998-10-08	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N018983-004	COLYTE	227.1GM/PACKET;2.82GM/PACKET;6.36GM/PACKET;5.53GM/PACKET;21.5GM/PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SOLUTION / ORAL	RLD	1984-10-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018983-005	COLYTE	120GM/PACKET;1.49GM/PACKET;3.36GM/PACKET;2.92GM/PACKET;11.36GM/PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SOLUTION / ORAL	RLD	1984-10-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018983-006	COLYTE	360GM/PACKET;4.47GM/PACKET;10.08GM/PACKET;8.76GM/PACKET;34.08GM/PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SOLUTION / ORAL	RLD	1984-10-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018983-007	COLYTE	240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOT Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SOLUTION / ORAL	RLD	1987-06-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018983-008	COLYTE-FLAVORED	227.1GM/BOT;2.82GM/BOT;6.36GM/BOT;5.53GM/BOT;21.5GM/BOT Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SOLUTION / ORAL	RLD	1991-11-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018983-009	COLYTE-FLAVORED	240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOT Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SOLUTION / ORAL	RLD	1991-11-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018983-010	COLYTE	227.1GM/BOT;2.82GM/BOT;6.36GM/BOT;5.53GM/BOT;21.5GM/BOT Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SOLUTION / ORAL	RLD	1989-01-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018983-012	COLYTE WITH FLAVOR PACKS	240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOT	FOR SOLUTION / ORAL	RLD	1998-10-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018983-004	COLYTE	227.1GM/PACKET;2.82GM/PACKET;6.36GM/PACKET;5.53GM/PACKET;21.5GM/PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SOLUTION / ORAL		1984-10-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018983-005	COLYTE	120GM/PACKET;1.49GM/PACKET;3.36GM/PACKET;2.92GM/PACKET;11.36GM/PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SOLUTION / ORAL		1984-10-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018983-006	COLYTE	360GM/PACKET;4.47GM/PACKET;10.08GM/PACKET;8.76GM/PACKET;34.08GM/PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SOLUTION / ORAL		1984-10-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018983-007	COLYTE	240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOT Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SOLUTION / ORAL		1987-06-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018983-008	COLYTE-FLAVORED	227.1GM/BOT;2.82GM/BOT;6.36GM/BOT;5.53GM/BOT;21.5GM/BOT Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SOLUTION / ORAL		1991-11-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018983-009	COLYTE-FLAVORED	240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOT Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SOLUTION / ORAL		1991-11-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018983-010	COLYTE	227.1GM/BOT;2.82GM/BOT;6.36GM/BOT;5.53GM/BOT;21.5GM/BOT Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SOLUTION / ORAL		1989-01-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018983-012	COLYTE WITH FLAVOR PACKS	240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOT	FOR SOLUTION / ORAL		1998-10-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018983-004	COLYTE	227.1GM/PACKET;2.82GM/PACKET;6.36GM/PACKET;5.53GM/PACKET;21.5GM/PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SOLUTION / ORAL		1984-10-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018983-005	COLYTE	120GM/PACKET;1.49GM/PACKET;3.36GM/PACKET;2.92GM/PACKET;11.36GM/PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SOLUTION / ORAL		1984-10-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018983-006	COLYTE	360GM/PACKET;4.47GM/PACKET;10.08GM/PACKET;8.76GM/PACKET;34.08GM/PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SOLUTION / ORAL		1984-10-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018983-007	COLYTE	240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOT Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SOLUTION / ORAL		1987-06-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018983-008	COLYTE-FLAVORED	227.1GM/BOT;2.82GM/BOT;6.36GM/BOT;5.53GM/BOT;21.5GM/BOT Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SOLUTION / ORAL		1991-11-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018983-009	COLYTE-FLAVORED	240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOT Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SOLUTION / ORAL		1991-11-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018983-010	COLYTE	227.1GM/BOT;2.82GM/BOT;6.36GM/BOT;5.53GM/BOT;21.5GM/BOT Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SOLUTION / ORAL		1989-01-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018983-012	COLYTE WITH FLAVOR PACKS	240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOT	FOR SOLUTION / ORAL		1998-10-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018983-004	COLYTE	227.1GM/PACKET;2.82GM/PACKET;6.36GM/PACKET;5.53GM/PACKET;21.5GM/PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SOLUTION / ORAL		1984-10-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018983-005	COLYTE	120GM/PACKET;1.49GM/PACKET;3.36GM/PACKET;2.92GM/PACKET;11.36GM/PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SOLUTION / ORAL		1984-10-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018983-006	COLYTE	360GM/PACKET;4.47GM/PACKET;10.08GM/PACKET;8.76GM/PACKET;34.08GM/PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SOLUTION / ORAL		1984-10-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018983-007	COLYTE	240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOT Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SOLUTION / ORAL		1987-06-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018983-008	COLYTE-FLAVORED	227.1GM/BOT;2.82GM/BOT;6.36GM/BOT;5.53GM/BOT;21.5GM/BOT Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SOLUTION / ORAL		1991-11-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018983-009	COLYTE-FLAVORED	240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOT Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SOLUTION / ORAL		1991-11-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018983-010	COLYTE	227.1GM/BOT;2.82GM/BOT;6.36GM/BOT;5.53GM/BOT;21.5GM/BOT Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SOLUTION / ORAL		1989-01-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018983-012	COLYTE WITH FLAVOR PACKS	240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOT	FOR SOLUTION / ORAL		1998-10-08	`6a471c1ec25d…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018983-012	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018983-012	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018983-012	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018983-012	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018983-012	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018983-012	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018983-012	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018983-012	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018983-012	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018983-012	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018983-012	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018983-012	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018983-012	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018983-012	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N018983-012	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N018983-012	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018983-012	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018983-012	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018983-012	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018983-012	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N018983-012	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N018983-012	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018983-012	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N018983-012	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N018983-012	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N018983-012	AA	1	`cb3db0bc1861…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0037-6820-04	ML - Milliliter	0037-6820	c0cb080d-39d6-4298-a040-78ffdce0a8fe	1	2014-09-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
POLYETHYLENE GLYCOL 3350	ACTIVE INGREDIENT	G2M7P15E5P	COLYTE (PEG-3350 AND ELECTROLYTES) POWDER, FOR SOLUTION [MEDA PHARMACEUTICALS]	1
POTASSIUM CHLORIDE	ACTIVE INGREDIENT	660YQ98I10	COLYTE (PEG-3350 AND ELECTROLYTES) POWDER, FOR SOLUTION [MEDA PHARMACEUTICALS]	1
SODIUM BICARBONATE	ACTIVE INGREDIENT	8MDF5V39QO	COLYTE (PEG-3350 AND ELECTROLYTES) POWDER, FOR SOLUTION [MEDA PHARMACEUTICALS]	1
SODIUM CHLORIDE	ACTIVE INGREDIENT	451W47IQ8X	COLYTE (PEG-3350 AND ELECTROLYTES) POWDER, FOR SOLUTION [MEDA PHARMACEUTICALS]	1
SODIUM SULFATE	ACTIVE INGREDIENT	0YPR65R21J	COLYTE (PEG-3350 AND ELECTROLYTES) POWDER, FOR SOLUTION [MEDA PHARMACEUTICALS]	1
BICARBONATE ION	ACTIVE MOIETY	HN1ZRA3Q20	COLYTE (PEG-3350 AND ELECTROLYTES) POWDER, FOR SOLUTION [MEDA PHARMACEUTICALS]	1
POLYETHYLENE GLYCOL 3350	ACTIVE MOIETY	G2M7P15E5P	COLYTE (PEG-3350 AND ELECTROLYTES) POWDER, FOR SOLUTION [MEDA PHARMACEUTICALS]	1
POTASSIUM CATION	ACTIVE MOIETY	295O53K152	COLYTE (PEG-3350 AND ELECTROLYTES) POWDER, FOR SOLUTION [MEDA PHARMACEUTICALS]	1
SODIUM CATION	ACTIVE MOIETY	LYR4M0NH37	COLYTE (PEG-3350 AND ELECTROLYTES) POWDER, FOR SOLUTION [MEDA PHARMACEUTICALS]	1
SODIUM SULFATE ANHYDROUS	ACTIVE MOIETY	36KCS0R750	COLYTE (PEG-3350 AND ELECTROLYTES) POWDER, FOR SOLUTION [MEDA PHARMACEUTICALS]	1

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
G2M7P15E5P	POLYETHYLENE GLYCOL 3350	25322-68-3	POLYETHYLENE GLYCOL 3350
451W47IQ8X	SODIUM CHLORIDE	7647-14-5	SODIUM CHLORIDE
660YQ98I10	POTASSIUM CHLORIDE	7447-40-7	POTASSIUM CHLORIDE
8MDF5V39QO	SODIUM BICARBONATE	144-55-8	SODIUM BICARBONATE
0YPR65R21J	SODIUM SULFATE	7727-73-3	SODIUM SULFATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0037-6820-04	00037682004	4 L in 1 BOTTLE (0037-6820-04)	4 l	2014-08-05	2021-09-30	No	No	Current