PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID

Product NDC: 0093-3560
11-digit product format: 000933560
Labeler code: 0093
Product ID: 0093-3560_46e37694-3149-46b3-a949-fad3ccbb8052
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID
Dosage form: KIT
Labeler: Teva Pharmaceuticals USA, Inc.
Application: ANDA090145
Marketing category: ANDA
Marketing start: 2020-08-31
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A090145-001	PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID	ASCORBIC ACID; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM ASCORBATE; SODIUM CHLORIDE; SODIUM SULFATE	4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM	FOR SOLUTION / ORAL	AA		2012-01-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090145-001	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 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A090145-001	PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID	4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM	FOR SOLUTION / ORAL	AA	2012-01-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090145-001	PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID	4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM	FOR SOLUTION / ORAL	AA	2012-01-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090145-001	PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID	4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM	FOR SOLUTION / ORAL	AA	2012-01-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090145-001	PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID	4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM	FOR SOLUTION / ORAL	AA	2012-01-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090145-001	PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID	4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM	FOR SOLUTION / ORAL	AA	2012-01-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090145-001	PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID	4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM	FOR SOLUTION / ORAL	AA	2012-01-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090145-001	PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID	4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM	FOR SOLUTION / ORAL	AA	2012-01-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090145-001	PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID	4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM	FOR SOLUTION / ORAL	AA	2012-01-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090145-001	PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID	4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM	FOR SOLUTION / ORAL	AA	2012-01-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090145-001	PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID	4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM	FOR SOLUTION / ORAL	AA	2012-01-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090145-001	PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID	4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM	FOR SOLUTION / ORAL	AA	2012-01-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090145-001	PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID	4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM	FOR SOLUTION / ORAL	AA	2012-01-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090145-001	PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID	4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM	FOR SOLUTION / ORAL	AA	2012-01-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090145-001	PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID	4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM	FOR SOLUTION / ORAL	AA	2012-01-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090145-001	PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID	4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM	FOR SOLUTION / ORAL	AA	2012-01-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090145-001	PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID	4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM	FOR SOLUTION / ORAL	AA	2012-01-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090145-001	PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID	4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM	FOR SOLUTION / ORAL	AA	2012-01-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090145-001	PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID	4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM	FOR SOLUTION / ORAL	AA	2012-01-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090145-001	PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID	4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM	FOR SOLUTION / ORAL	AA	2012-01-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090145-001	PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID	4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM	FOR SOLUTION / ORAL		2012-01-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090145-001	PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID	4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM	FOR SOLUTION / ORAL	AA	2012-01-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090145-001	PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID	4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM	FOR SOLUTION / ORAL	AA	2012-01-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090145-001	PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID	4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM	FOR SOLUTION / ORAL	AA	2012-01-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090145-001	PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID	4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM	FOR SOLUTION / ORAL	AA	2012-01-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090145-001	PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID	4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM	FOR SOLUTION / ORAL	AA	2012-01-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090145-001	PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID	4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM	FOR SOLUTION / ORAL	AA	2012-01-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090145-001	PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID	4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM	FOR SOLUTION / ORAL	AA	2012-01-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090145-001	PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID	4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM	FOR SOLUTION / ORAL		2012-01-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090145-001	PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID	4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM	FOR SOLUTION / ORAL		2012-01-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090145-001	PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID	4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM	FOR SOLUTION / ORAL	AA	2012-01-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090145-001	PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID	4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM	FOR SOLUTION / ORAL	AA	2012-01-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090145-001	PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID	4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM	FOR SOLUTION / ORAL	AA	2012-01-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090145-001	PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID	4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM	FOR SOLUTION / ORAL	AA	2012-01-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090145-001	PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID	4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM	FOR SOLUTION / ORAL	AA	2012-01-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090145-001	PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID	4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM	FOR SOLUTION / ORAL	AA	2012-01-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090145-001	PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID	4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM	FOR SOLUTION / ORAL	AA	2012-01-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090145-001	PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID	4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM	FOR SOLUTION / ORAL	AA	2012-01-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090145-001	PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID	4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM	FOR SOLUTION / ORAL	AA	2012-01-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090145-001	PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID	4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM	FOR SOLUTION / ORAL	AA	2012-01-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090145-001	PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID	4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM	FOR SOLUTION / ORAL	AA	2012-01-25	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A090145-001	AA	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090145-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090145-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090145-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090145-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090145-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090145-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090145-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090145-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090145-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090145-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090145-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090145-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090145-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090145-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090145-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090145-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090145-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090145-001	AA	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A090145-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090145-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090145-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090145-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090145-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090145-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090145-001	AA	1	`3f01610625f2…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090145-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090145-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090145-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090145-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090145-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090145-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090145-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090145-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090145-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090145-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090145-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090145-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090145-001	AA	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A090145-001	AA	1	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2021-12-28 21:50 UTC	2021-12	A090145-001	PC	2021-02-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090145-001	PC	2021-02-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090145-001	PC	2021-02-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090145-001	PC	2021-02-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090145-001	PC	2021-02-27	`c0c555d07b60…`

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-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID
Listing expiration: 2026-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
800915	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
475a06c6-f295-406c-a110-f1497cf51566	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
9e37788c-b1bf-42ae-aac9-b60601606144	Product name	8	20260122
95250459-30e4-45c1-b08a-993044f49109	Product name	2	20250805
d9771140-739b-484b-ae64-b79528ff1211	Product name	3	20250801
efd58dcf-540a-4531-8766-e713129ca6f2	Product name	1	20250307
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2	Product name	5	20250304
1527ac37-808d-43be-a63e-74e1258dbe46	Product name	9	20250219
bed0530e-f939-4541-956b-6928a2f6404f	Product name	1	20241008
cefa60e2-a5b5-493e-9c54-24735b7dc509	Product name	6	20240814
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
9fcb7a91-de07-4f00-aabf-e4d6fda403d5	Product name	8	20230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7	Product name	2	20211025
9badc7be-250a-44ab-aa36-926af3f02679	Product name	1	20210527
e4870509-7e28-6f92-f0be-dd3dd889a9cf	Product name	5	20200810
0ec3537a-6c9b-432a-896c-b9ea8723049a	Product name	9	20200701
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cd	Product name	2	20190619
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
7916de40-e296-41f0-b811-6d0df1a33e2c	Product name	9	20180627
cefa60e2-a5b5-493e-9c54-24735b7dc509	Product name	2	20171212
c5cd4727-ac49-4409-82b1-5bd8006c3ec7	Product name	1	20171122
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
26acd337-b838-40ac-bcbc-05c3b81c8712	Product name	1	20170323
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
684ea482-2e8b-14af-5664-b98f1e402036	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
b060cc1a-fe47-856b-0b77-4448b5963de8	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0093-3560-19	PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID	1 in 1 CARTON	KIT	1		3
0093-3560-26	PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID	2 in 1 CARTON	KIT	2		3
0093-9043-19	PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID	1 L in 1 POUCH	POWDER, FOR SOLUTION	1 L	4.7 g in 1L	3
0093-9044-19	PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID	1 L in 1 POUCH	POWDER, FOR SOLUTION	1 L	7.5 g in 1L	3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0093-3560-19	EA - Each	0093-3560	e2e77a78-72a3-4142-b57f-91dd643ceed1	1	2022-06-06
0093-3560-26	EA - Each	0093-3560	73f344a3-cdbc-4faf-8ee7-fa72aa04b994	1	2020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0093-3560	PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID (PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID) KIT [TEVA PHARMACEUTICALS USA, INC.]	3	Current NDC, Legacy NDC, 4 package rows	20230223_475a06c6-f295-406c-a110-f1497cf51566.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID	PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID	Teva Pharmaceuticals USA, Inc.	475a06c6-f295-406c-a110-f1497cf51566	2022-04-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090145 application number: ANDA090145 ndc (product): 0093-3560

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
800915	ascorbic acid 4.7 GM / polyethylene glycol 3350 100 GM / potassium chloride 1.015 GM / sodium ascorbate 5.9 GM / sodium chloride 2.69 GM / sodium sulfate 7.5 GM Powder for Oral Solution	PSN	475a06c6-f295-406c-a110-f1497cf51566	3
800915	ascorbic acid 4700 MG / polyethylene glycol 3350 100000 MG / potassium chloride 1015 MG / sodium ascorbate 5900 MG / sodium chloride 2690 MG / sodium sulfate 7500 MG Powder for Oral Solution	SCD	475a06c6-f295-406c-a110-f1497cf51566	3
800915	ascorbic acid 4.7 GM / polyethylene glycol 3350 100 GM / potassium chloride 1.015 GM / sodium ascorbate 5.9 GM / sodium chloride 2.69 GM / sodium sulfate 7.5 GM Powder for Oral Solution	SY	475a06c6-f295-406c-a110-f1497cf51566	3
800915	vit-C 4700 MG / POLYETHYLENE GLYCOL 3350 100000 MG / K+ Chloride 1015 MG / Sodium Ascorbate 5900 MG / NaCl 2690 MG / sodium sulfate 7500 MG Powder for Oral Solution	SY	475a06c6-f295-406c-a110-f1497cf51566	3
800915	vit-C 4700 MG / POLYETHYLENE GLYCOL 3350 100000 MG / Pot Chloride 1015 MG / Sodium Ascorbate 5900 MG / NaCl 2690 MG / sodium sulfate 7500 MG Powder for Oral Solution	SY	475a06c6-f295-406c-a110-f1497cf51566	3
800915	vitamin C 4700 MG / POLYETHYLENE GLYCOL 3350 100000 MG / K+ Chloride 1015 MG / Sodium Ascorbate 5900 MG / NaCl 2690 MG / sodium sulfate 7500 MG Powder for Oral Solution	SY	475a06c6-f295-406c-a110-f1497cf51566	3
800915	vitamin C 4700 MG / POLYETHYLENE GLYCOL 3350 100000 MG / Pot Chloride 1015 MG / Sodium Ascorbate 5900 MG / NaCl 2690 MG / sodium sulfate 7500 MG Powder for Oral Solution	SY	475a06c6-f295-406c-a110-f1497cf51566	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0093-3560-19	00093356019	1 in 1 CARTON						Historical
0093-3560-26	00093356026	2 CARTON in 1 CARTON (0093-3560-26) / 1 KIT in 1 CARTON (0093-3560-19) * 1 L in 1 POUCH (0093-9043-19) * 1 L in 1 POUCH * 1 L in 1 POUCH (0093-9044-19)	2 carton	2020-08-31	0000-00-00	No	No	Current
0093-9043-19	00093904319	1 L in 1 POUCH	1 l					Historical
0093-9044-19	00093904419	1 L in 1 POUCH	1 l					Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
POUCH A	Teva Pharmaceuticals USA, Inc. \| Novel Laboratories, Inc.	2022-04-14	HUMAN PRESCRIPTION DRUG LABEL	3