Polyethylene Glycol 3350

Product NDC: 72603-302
Requested package NDC: 72603-302-03
11-digit product format: 726030302
Labeler code: 72603
Product ID: 72603-302_2e7e711f-65c3-a4b4-e063-6294a90a85ef
Type: HUMAN OTC DRUG
Nonproprietary name: Polyethylene Glycol 3350
Dosage form: POWDER, FOR SOLUTION
Route: ORAL
Labeler: NorthStar Rx LLC
Application: ANDA202850
Marketing category: ANDA
Marketing start: 2025-04-01
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
Listing certified through: 2026-12-31
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
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 · 48 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A202850-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2015-12-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202850-002	POLYETHYLENE GLYCOL 3350	17GM/PACKET	FOR SOLUTION / ORAL	2021-11-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202850-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2015-12-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202850-002	POLYETHYLENE GLYCOL 3350	17GM/PACKET	FOR SOLUTION / ORAL	2021-11-30	`caaa826d4ba7…`
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…`

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: Polyethylene Glycol 3350
Listing expiration: 2026-12-31

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
2e7e72eb-b759-5b59-e063-6394a90aa7ff	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
72603-302-01	Polyethylene Glycol 3350	17 g in 1 PACKET	POWDER, FOR SOLUTION	17	1
72603-302-02	Polyethylene Glycol 3350	14 in 1 CARTON	POWDER, FOR SOLUTION	14	1
72603-302-03	Polyethylene Glycol 3350	30 in 1 CARTON	POWDER, FOR SOLUTION	30	1
72603-302-04	Polyethylene Glycol 3350	100 in 1 CARTON	POWDER, FOR SOLUTION	100	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72603-302-01	EA - Each	72603-302	83c23bd8-5f1d-4bce-8e34-861b906a176a	1	2025-03-04
72603-302-02	EA - Each	72603-302	778c2e9d-b1ea-49f8-b0d4-594e301e89ad	1	2025-03-04
72603-302-03	EA - Each	72603-302	0fd32dfa-1d19-4c69-96ef-e6d4b7376e16	1	2025-03-04
72603-302-04	EA - Each	72603-302	31ccdac1-12f4-4385-81be-6e3f22649aea	1	2025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72603-302	POLYETHYLENE GLYCOL 3350 POWDER, FOR SOLUTION [NORTHSTAR RX LLC]	1	Current NDC, 4 package rows	20250402_2e7e72eb-b759-5b59-e063-6394a90aa7ff.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
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 ndc (package): 72603-302-03 ndc (product): 72603-302 ndc11 (package): 72603030203

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	2e7e72eb-b759-5b59-e063-6394a90aa7ff	1
876193	polyethylene glycol 3350 17000 MG Powder for Oral Solution	SCD	2e7e72eb-b759-5b59-e063-6394a90aa7ff	1
876193	polyethylene glycol 3350 17 GM Powder for Oral Solution	SY	2e7e72eb-b759-5b59-e063-6394a90aa7ff	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
72603-302-03	72603030203	30 PACKET in 1 CARTON (72603-302-03) / 17 g in 1 PACKET (72603-302-01)	30 packet	2025-04-01	No	No	Current