Polyethylene Glycol 3350

Product NDC: 63739-760
11-digit product format: 637390760
Labeler code: 63739
Product ID: 63739-760_3516c167-5589-2050-e063-6294a90a6942
Type: HUMAN OTC DRUG
Nonproprietary name: Polyethylene Glycol 3350
Dosage form: POWDER, FOR SOLUTION
Route: ORAL
Labeler: SKY Packaging
Application: ANDA202850
Marketing category: ANDA
Marketing start: 2024-08-01
Marketing end: 2026-09-30
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
Current FDA listing: Yes

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 package	package	63739-760	63739-760-02	D	Discontinued by firm		2026-08-10
excluded package	package	63739-760	63739-760-03	D	Discontinued by firm		2026-08-10

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 · 6 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…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A202850-001	POLYETHYLENE GLYCOL 3350	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL			2015-12-15
A202850-002	POLYETHYLENE GLYCOL 3350	POLYETHYLENE GLYCOL 3350	17GM/PACKET	FOR SOLUTION / ORAL			2021-11-30

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 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A202850-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2015-12-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202850-002	POLYETHYLENE GLYCOL 3350	17GM/PACKET	FOR SOLUTION / ORAL	2021-11-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202850-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2015-12-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202850-002	POLYETHYLENE GLYCOL 3350	17GM/PACKET	FOR SOLUTION / ORAL	2021-11-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202850-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2015-12-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202850-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2015-12-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202850-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2015-12-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202850-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2015-12-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202850-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2015-12-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202850-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2015-12-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202850-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2015-12-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202850-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2015-12-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202850-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2015-12-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202850-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2015-12-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202850-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2015-12-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202850-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2015-12-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202850-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2015-12-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202850-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2015-12-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202850-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2015-12-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202850-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2015-12-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202850-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2015-12-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202850-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2015-12-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202850-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2015-12-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202850-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2015-12-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202850-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2015-12-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202850-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2015-12-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202850-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2015-12-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202850-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2015-12-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202850-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2015-12-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202850-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2015-12-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202850-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2015-12-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202850-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2015-12-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202850-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2015-12-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202850-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2015-12-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202850-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2015-12-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202850-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2015-12-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202850-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2015-12-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202850-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2015-12-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202850-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2015-12-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202850-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2015-12-15	`f41ea6bd6efb…`

Additional Listing Data#

Finished product: Yes
Brand name base: Polyethylene Glycol 3350

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
POLYETHYLENE GLYCOL 3350	17 g/17g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
G2M7P15E5P	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
876193	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
173a62cb-9b20-4b50-e063-6294a90ac36b	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
63739-760-01	Polyethylene Glycol 3350	17 g in 1 PACKET	POWDER, FOR SOLUTION	17	5
63739-760-02	Polyethylene Glycol 3350	14 in 1 CARTON	POWDER, FOR SOLUTION	14	5
63739-760-03	Polyethylene Glycol 3350	30 in 1 CARTON	POWDER, FOR SOLUTION	30	5
63739-760-04	Polyethylene Glycol 3350	100 in 1 CARTON	POWDER, FOR SOLUTION	100	5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63739-760-01	EA - Each	63739-760	9b1db098-df7f-4abf-9799-84881eaa303c	1	2024-08-12
63739-760-02	EA - Each	63739-760	0dcbdd38-5795-4a94-a9fc-40c2225e128c	1	2024-08-12
63739-760-03	EA - Each	63739-760	a3dca200-7355-478d-b728-378f80fec564	1	2024-11-05
63739-760-04	EA - Each	63739-760	0ecc35c9-cc15-4806-b2be-f9adeb92db9d	1	2024-09-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63739-760	POLYETHYLENE GLYCOL 3350 POWDER, FOR SOLUTION [SKY PACKAGING]	5	Current NDC, 4 package rows	20250515_173a62cb-9b20-4b50-e063-6294a90ac36b.zip

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Polyethylene Glycol 3350	POLYETHYLENE GLYCOL 3350	ANI Pharmaceuticals, Inc.	1afff730-b2d3-4e01-8403-97f2ecef3a74	2025-12-10	Warnings	Exact identifier application applno (ANDA): 202850 application number: ANDA202850
Polyethylene Glycol 3350	POLYETHYLENE GLYCOL 3350	SKY Packaging	173a62cb-9b20-4b50-e063-6294a90ac36b	2025-05-14	Warnings	Exact identifier application applno (ANDA): 202850 application number: ANDA202850 ndc (product): 63739-760
Polyethylene Glycol 3350	POLYETHYLENE GLYCOL 3350	NorthStar Rx LLC	2e7e72eb-b759-5b59-e063-6394a90aa7ff	2025-02-19	Warnings	Exact identifier application applno (ANDA): 202850 application number: ANDA202850

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
G2M7P15E5P	POLYETHYLENE GLYCOL 3350	25322-68-3	POLYETHYLENE GLYCOL 3350

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
876193	polyethylene glycol 3350 17 GM Powder for Oral Solution	PSN	173a62cb-9b20-4b50-e063-6294a90ac36b	5
876193	polyethylene glycol 3350 17000 MG Powder for Oral Solution	SCD	173a62cb-9b20-4b50-e063-6294a90ac36b	5
876193	polyethylene glycol 3350 17 GM Powder for Oral Solution	SY	173a62cb-9b20-4b50-e063-6294a90ac36b	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63739-760-01	63739076001	17 g in 1 PACKET	17 g					Historical
63739-760-02	63739076002	14 PACKET in 1 CARTON (63739-760-02) / 17 g in 1 PACKET (63739-760-01)	14 packet	2024-08-01	2026-06-30	No	No	Historical
63739-760-03	63739076003	30 in 1 CARTON						Historical
63739-760-04	63739076004	100 PACKET in 1 CARTON (63739-760-04) / 17 g in 1 PACKET (63739-760-01)	100 packet	2024-08-01	2026-09-30	No	No	Historical