PEG

Product NDC: 50090-8020
11-digit product format: 500908020
Labeler code: 50090
Product ID: 50090-8020_f99a11eb-0104-4a81-af57-34900c8d701b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Polyethylene Glycol 3350, Sodium Sulfate Anhydrous, Sodium Bicarbonate, Sodium Chloride, Potassium Chloride
Dosage form: POWDER, FOR SOLUTION
Route: ORAL
Labeler: A-S Medication Solutions
Application: NDA019011
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2009-07-01
Substance: POLYETHYLENE GLYCOL 3350; SODIUM SULFATE ANHYDROUS; SODIUM BICARBONATE; SODIUM CHLORIDE; POTASSIUM CHLORIDE
Active strength: 236; 22.74; 6.74; 5.86; 2.97 g/4L; 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], 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], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], 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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N019011-001	GOLYTELY	POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS	236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT	FOR SOLUTION / ORAL	AA	RLD, RS	1984-07-13
N019011-002	GOLYTELY	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	FOR SOLUTION / ORAL		RLD	1992-06-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N019011-001	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 3 · 86 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	N019011-001	GOLYTELY	236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT	FOR SOLUTION / ORAL	AA	RLD, RS	1984-07-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019011-002	GOLYTELY	227.1GM/PACKET;2.82GM/PACKET;6.36GM/PACKET;5.53GM/PACKET;21.5GM/PACKET	FOR SOLUTION / ORAL		RLD	1992-06-02	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N019011-001	GOLYTELY	236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT	FOR SOLUTION / ORAL	AA	RLD, RS	1984-07-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019011-002	GOLYTELY	227.1GM/PACKET;2.82GM/PACKET;6.36GM/PACKET;5.53GM/PACKET;21.5GM/PACKET	FOR SOLUTION / ORAL		RLD	1992-06-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019011-001	GOLYTELY	236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT	FOR SOLUTION / ORAL	AA	RLD, RS	1984-07-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019011-002	GOLYTELY	227.1GM/PACKET;2.82GM/PACKET;6.36GM/PACKET;5.53GM/PACKET;21.5GM/PACKET	FOR SOLUTION / ORAL		RLD	1992-06-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019011-001	GOLYTELY	236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT	FOR SOLUTION / ORAL	AA	RLD, RS	1984-07-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019011-002	GOLYTELY	227.1GM/PACKET;2.82GM/PACKET;6.36GM/PACKET;5.53GM/PACKET;21.5GM/PACKET	FOR SOLUTION / ORAL		RLD	1992-06-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019011-001	GOLYTELY	236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT	FOR SOLUTION / ORAL	AA	RLD, RS	1984-07-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019011-002	GOLYTELY	227.1GM/PACKET;2.82GM/PACKET;6.36GM/PACKET;5.53GM/PACKET;21.5GM/PACKET	FOR SOLUTION / ORAL		RLD	1992-06-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019011-001	GOLYTELY	236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT	FOR SOLUTION / ORAL	AA	RLD, RS	1984-07-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019011-002	GOLYTELY	227.1GM/PACKET;2.82GM/PACKET;6.36GM/PACKET;5.53GM/PACKET;21.5GM/PACKET	FOR SOLUTION / ORAL		RLD	1992-06-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019011-001	GOLYTELY	236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT	FOR SOLUTION / ORAL	AA	RLD, RS	1984-07-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019011-002	GOLYTELY	227.1GM/PACKET;2.82GM/PACKET;6.36GM/PACKET;5.53GM/PACKET;21.5GM/PACKET	FOR SOLUTION / ORAL		RLD	1992-06-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019011-001	GOLYTELY	236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT	FOR SOLUTION / ORAL	AA	RLD, RS	1984-07-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019011-002	GOLYTELY	227.1GM/PACKET;2.82GM/PACKET;6.36GM/PACKET;5.53GM/PACKET;21.5GM/PACKET	FOR SOLUTION / ORAL		RLD	1992-06-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019011-001	GOLYTELY	236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT	FOR SOLUTION / ORAL	AA	RLD, RS	1984-07-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019011-002	GOLYTELY	227.1GM/PACKET;2.82GM/PACKET;6.36GM/PACKET;5.53GM/PACKET;21.5GM/PACKET	FOR SOLUTION / ORAL		RLD	1992-06-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019011-001	GOLYTELY	236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT	FOR SOLUTION / ORAL	AA	RLD, RS	1984-07-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019011-002	GOLYTELY	227.1GM/PACKET;2.82GM/PACKET;6.36GM/PACKET;5.53GM/PACKET;21.5GM/PACKET	FOR SOLUTION / ORAL		RLD	1992-06-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019011-001	GOLYTELY	236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT	FOR SOLUTION / ORAL	AA	RLD, RS	1984-07-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019011-002	GOLYTELY	227.1GM/PACKET;2.82GM/PACKET;6.36GM/PACKET;5.53GM/PACKET;21.5GM/PACKET	FOR SOLUTION / ORAL		RLD	1992-06-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019011-001	GOLYTELY	236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT	FOR SOLUTION / ORAL	AA	RLD, RS	1984-07-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019011-002	GOLYTELY	227.1GM/PACKET;2.82GM/PACKET;6.36GM/PACKET;5.53GM/PACKET;21.5GM/PACKET	FOR SOLUTION / ORAL		RLD	1992-06-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019011-001	GOLYTELY	236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT	FOR SOLUTION / ORAL	AA	RLD, RS	1984-07-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019011-002	GOLYTELY	227.1GM/PACKET;2.82GM/PACKET;6.36GM/PACKET;5.53GM/PACKET;21.5GM/PACKET	FOR SOLUTION / ORAL		RLD	1992-06-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019011-001	GOLYTELY	236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT	FOR SOLUTION / ORAL	AA	RLD, RS	1984-07-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019011-002	GOLYTELY	227.1GM/PACKET;2.82GM/PACKET;6.36GM/PACKET;5.53GM/PACKET;21.5GM/PACKET	FOR SOLUTION / ORAL		RLD	1992-06-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019011-001	GOLYTELY	236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT	FOR SOLUTION / ORAL	AA	RLD, RS	1984-07-13	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019011-002	GOLYTELY	227.1GM/PACKET;2.82GM/PACKET;6.36GM/PACKET;5.53GM/PACKET;21.5GM/PACKET	FOR SOLUTION / ORAL		RLD	1992-06-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019011-001	GOLYTELY	236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT	FOR SOLUTION / ORAL	AA	RLD, RS	1984-07-13	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N019011-002	GOLYTELY	227.1GM/PACKET;2.82GM/PACKET;6.36GM/PACKET;5.53GM/PACKET;21.5GM/PACKET	FOR SOLUTION / ORAL		RLD	1992-06-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019011-001	GOLYTELY	236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT	FOR SOLUTION / ORAL	AA	RLD, RS	1984-07-13	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019011-002	GOLYTELY	227.1GM/PACKET;2.82GM/PACKET;6.36GM/PACKET;5.53GM/PACKET;21.5GM/PACKET	FOR SOLUTION / ORAL		RLD	1992-06-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019011-001	GOLYTELY	236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT	FOR SOLUTION / ORAL	AA	RLD, RS	1984-07-13	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N019011-002	GOLYTELY	227.1GM/PACKET;2.82GM/PACKET;6.36GM/PACKET;5.53GM/PACKET;21.5GM/PACKET	FOR SOLUTION / ORAL		RLD	1992-06-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019011-001	GOLYTELY	236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT	FOR SOLUTION / ORAL	AA	RLD, RS	1984-07-13	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N019011-002	GOLYTELY	227.1GM/PACKET;2.82GM/PACKET;6.36GM/PACKET;5.53GM/PACKET;21.5GM/PACKET	FOR SOLUTION / ORAL		RLD	1992-06-02	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019011-001	GOLYTELY	236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT	FOR SOLUTION / ORAL	AA	RLD, RS	1984-07-13	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019011-002	GOLYTELY	227.1GM/PACKET;2.82GM/PACKET;6.36GM/PACKET;5.53GM/PACKET;21.5GM/PACKET	FOR SOLUTION / ORAL		RLD, RS	1992-06-02	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N019011-001	AA	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N019011-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019011-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019011-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019011-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019011-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019011-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019011-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019011-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019011-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019011-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019011-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019011-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019011-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019011-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019011-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019011-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019011-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019011-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019011-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019011-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019011-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019011-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019011-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019011-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019011-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019011-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019011-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N019011-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N019011-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N019011-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N019011-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N019011-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N019011-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N019011-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N019011-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N019011-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N019011-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N019011-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N019011-001	AA	1	`f41ea6bd6efb…`

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: PEG
Brand name suffix: 3350 and Electrolytes
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
POLYETHYLENE GLYCOL 3350	236 g/4L
SODIUM SULFATE ANHYDROUS	22.74 g/4L
SODIUM BICARBONATE	6.74 g/4L
SODIUM CHLORIDE	5.86 g/4L
POTASSIUM CHLORIDE	2.97 g/4L

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 5 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
G2M7P15E5P	Internal UNII lookup
36KCS0R750	Internal UNII lookup
8MDF5V39QO	Internal UNII lookup
451W47IQ8X	Internal UNII lookup
660YQ98I10	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
966920	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
19daf830-7270-4661-81b1-ded38f867f28	Available on FDA.report

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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PEG 3350 and Electrolytes	POLYETHYLENE GLYCOL 3350, SODIUM SULFATE ANHYDROUS, SODIUM BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE	A-S Medication Solutions	19daf830-7270-4661-81b1-ded38f867f28	2026-07-24	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019011 application number: NDA019011 ndc (product): 50090-8020
PEG 3350 and Electrolytes	POLYETHYLENE GLYCOL 3350, SODIUM SULFATE ANHYDROUS, SODIUM BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE	Wilshire Pharmaceuticals, Inc.	b251752d-7750-482a-9364-0acf4ad47cc8	2026-04-16	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019011 application number: NDA019011
GoLYTELY	POLYETHYLENE GLYCOL 3350, SODIUM SULFATE ANHYDROUS, SODIUM BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE	Azurity Pharmaceuticals, Inc.	7609ecf7-0ce0-4fbb-9c27-30987f689575	2026-04-15	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019011 application number: NDA019011
PEG-3350 and Electrolytes	POLYETHYLENE GLYCOL 3350, SODIUM SULFATE ANHYDROUS, SODIUM BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE	A-S Medication Solutions	7a2d8dab-750f-43c1-933c-4169a840c60c	2023-06-20	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019011 application number: NDA019011
PEG-3350 and Electrolytes	POLYETHYLENE GLYCOL 3350, SODIUM SULFATE ANHYDROUS, SODIUM BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE	Affordable Pharmaceuticals, LLC	448db7a5-1fea-4bf3-b1f5-e9d027a36603	2022-09-28	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019011 application number: NDA019011
GoLYTELY	POLYETHYLENE GLYCOL 3350, SODIUM SULFATE ANHYDROUS, SODIUM BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE	Braintree Laboratories, Inc.	57d22b0b-1ae0-4203-babc-f3bac17bd1c9	2021-05-28	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019011 application number: NDA019011

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
G2M7P15E5P	POLYETHYLENE GLYCOL 3350	25322-68-3	POLYETHYLENE GLYCOL 3350
36KCS0R750	SODIUM SULFATE ANHYDROUS	7757-82-6	SODIUM SULFATE ANHYDROUS
8MDF5V39QO	SODIUM BICARBONATE	144-55-8	SODIUM BICARBONATE
451W47IQ8X	SODIUM CHLORIDE	7647-14-5	SODIUM CHLORIDE
660YQ98I10	POTASSIUM CHLORIDE	7447-40-7	POTASSIUM CHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
50090-8020-0	50090802000	4 L in 1 JUG (50090-8020-0)	4 l	2026-07-22	No	No	Current

PEG