Kionex

Product NDC: 0574-2002
11-digit product format: 005742002
Labeler code: 0574
Product ID: 0574-2002_88500449-5498-44f7-a97a-58e573bd833c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Sodium Polystyrene Sulfonate
Dosage form: SUSPENSION
Route: ORAL; RECTAL
Labeler: Paddock Laboratories, LLC
Application: ANDA040028
Marketing category: ANDA
Marketing start: 2008-12-30
Marketing end: 0000-00-00
Substance: SODIUM POLYSTYRENE SULFONATE
Active strength: 15 g/60mL
NDC exclude flag: No
Listing certified through: 2020-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0574-2002		D	Discontinued by firm	2026-08-17
excluded package	package	0574-2002	0574-2002-02	D	Discontinued by firm	2026-08-17
excluded package	package	0574-2002	0574-2002-16	D	Discontinued by firm	2026-08-17

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 · 36 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	0574-2002-16	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0574-2002-02	`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	0574-2002-16	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0574-2002-02	`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	0574-2002-16	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0574-2002-02	`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	0574-2002-16	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0574-2002-02	`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	0574-2002-16	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0574-2002-02	`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	0574-2002-16	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0574-2002-02	`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	0574-2002-16	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0574-2002-02	`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	0574-2002-16	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0574-2002-02	`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	0574-2002-16	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0574-2002-02	`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	0574-2002-16	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0574-2002-02	`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	0574-2002-16	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0574-2002-02	`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	0574-2002-16	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0574-2002-02	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A040028-001	KIONEX	SODIUM POLYSTYRENE SULFONATE	15GM/60ML	SUSPENSION / ORAL, RECTAL	AA		2007-09-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040028-001	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 · 42 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
2026-08-18 06:07:40	2026-07	A040028-001	KIONEX	15GM/60ML	SUSPENSION / ORAL, RECTAL	AA	2007-09-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040028-001	KIONEX	15GM/60ML	SUSPENSION / ORAL, RECTAL	AA	2007-09-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040028-001	KIONEX	15GM/60ML	SUSPENSION / ORAL, RECTAL	AA	2007-09-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040028-001	KIONEX	15GM/60ML	SUSPENSION / ORAL, RECTAL	AA	2007-09-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040028-001	KIONEX	15GM/60ML	SUSPENSION / ORAL, RECTAL	AA	2007-09-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040028-001	KIONEX	15GM/60ML	SUSPENSION / ORAL, RECTAL	AA	2007-09-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040028-001	KIONEX	15GM/60ML	SUSPENSION / ORAL, RECTAL	AA	2007-09-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040028-001	KIONEX	15GM/60ML	SUSPENSION / ORAL, RECTAL	AA	2007-09-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040028-001	KIONEX	15GM/60ML	SUSPENSION / ORAL, RECTAL	AA	2007-09-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040028-001	KIONEX	15GM/60ML	SUSPENSION / ORAL, RECTAL	AA	2007-09-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040028-001	KIONEX	15GM/60ML	SUSPENSION / ORAL, RECTAL	AA	2007-09-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040028-001	KIONEX	15GM/60ML	SUSPENSION / ORAL, RECTAL	AA	2007-09-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040028-001	KIONEX	15GM/60ML	SUSPENSION / ORAL, RECTAL	AA	2007-09-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040028-001	KIONEX	15GM/60ML	SUSPENSION / ORAL, RECTAL	AA	2007-09-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040028-001	KIONEX	15GM/60ML	SUSPENSION / ORAL, RECTAL	AA	2007-09-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040028-001	KIONEX	15GM/60ML	SUSPENSION / ORAL, RECTAL	AA	2007-09-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040028-001	KIONEX	15GM/60ML	SUSPENSION / ORAL, RECTAL	AA	2007-09-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040028-001	KIONEX	15GM/60ML	SUSPENSION / ORAL, RECTAL		2007-09-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040028-001	KIONEX	15GM/60ML	SUSPENSION / ORAL, RECTAL	AA	2007-09-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040028-001	KIONEX	15GM/60ML	SUSPENSION / ORAL, RECTAL		2007-09-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040028-001	KIONEX	15GM/60ML	SUSPENSION / ORAL, RECTAL		2007-09-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040028-001	KIONEX	15GM/60ML	SUSPENSION / ORAL, RECTAL		2007-09-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040028-001	KIONEX	15GM/60ML	SUSPENSION / ORAL, RECTAL		2007-09-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040028-001	KIONEX	15GM/60ML	SUSPENSION / ORAL, RECTAL	AA	2007-09-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040028-001	KIONEX	15GM/60ML	SUSPENSION / ORAL, RECTAL	AA	2007-09-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040028-001	KIONEX	15GM/60ML	SUSPENSION / ORAL, RECTAL	AA	2007-09-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040028-001	KIONEX	15GM/60ML	SUSPENSION / ORAL, RECTAL	AA	2007-09-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040028-001	KIONEX	15GM/60ML	SUSPENSION / ORAL, RECTAL	AA	2007-09-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040028-001	KIONEX	15GM/60ML	SUSPENSION / ORAL, RECTAL	AA	2007-09-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040028-001	KIONEX	15GM/60ML	SUSPENSION / ORAL, RECTAL	AA	2007-09-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040028-001	KIONEX	15GM/60ML	SUSPENSION / ORAL, RECTAL	AA	2007-09-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040028-001	KIONEX	15GM/60ML	SUSPENSION / ORAL, RECTAL	AA	2007-09-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040028-001	KIONEX	15GM/60ML	SUSPENSION / ORAL, RECTAL	AA	2007-09-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040028-001	KIONEX	15GM/60ML	SUSPENSION / ORAL, RECTAL	AA	2007-09-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040028-001	KIONEX	15GM/60ML	SUSPENSION / ORAL, RECTAL	AA	2007-09-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040028-001	KIONEX	15GM/60ML	SUSPENSION / ORAL, RECTAL	AA	2007-09-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040028-001	KIONEX	15GM/60ML	SUSPENSION / ORAL, RECTAL	AA	2007-09-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040028-001	KIONEX	15GM/60ML	SUSPENSION / ORAL, RECTAL	AA	2007-09-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040028-001	KIONEX	15GM/60ML	SUSPENSION / ORAL, RECTAL	AA	2007-09-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040028-001	KIONEX	15GM/60ML	SUSPENSION / ORAL, RECTAL	AA	2007-09-17	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A040028-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040028-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040028-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040028-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040028-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040028-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040028-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040028-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040028-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040028-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040028-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040028-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040028-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040028-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040028-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040028-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040028-001	AA	1	`5d02ea3f76ae…`
2019-12-13 00:20 UTC	2019-12	A040028-001	AA	1	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	A040028-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040028-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040028-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040028-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040028-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040028-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040028-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040028-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040028-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040028-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040028-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040028-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040028-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040028-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040028-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040028-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040028-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040028-001	AA	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A040028-001	AA	1	`a50c72e98297…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0574-2002-02	ML - Milliliter	0574-2002	65dd9193-3e09-4c03-8aec-0b1f4eb4d76e	1	2012-07-24
0574-2002-16	ML - Milliliter	0574-2002	d842da83-60ff-452a-ac30-f5533e2967bf	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Sodium Polystyrene Sulfonate	ACTIVE INGREDIENT	1699G8679Z	KIONEX (SODIUM POLYSTYRENE SULFONATE) SUSPENSION [PADDOCK LABORATORIES, LLC]	7
Polystyrene Sulfonic Acid	ACTIVE MOIETY	70KO0R01RY	KIONEX (SODIUM POLYSTYRENE SULFONATE) SUSPENSION [PADDOCK LABORATORIES, LLC]	7
alcohol	INACTIVE INGREDIENT	3K9958V90M	KIONEX (SODIUM POLYSTYRENE SULFONATE) SUSPENSION [PADDOCK LABORATORIES, LLC]	7
magnesium aluminum silicate	INACTIVE INGREDIENT	6M3P64V0NC	KIONEX (SODIUM POLYSTYRENE SULFONATE) SUSPENSION [PADDOCK LABORATORIES, LLC]	7
methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	KIONEX (SODIUM POLYSTYRENE SULFONATE) SUSPENSION [PADDOCK LABORATORIES, LLC]	7
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	KIONEX (SODIUM POLYSTYRENE SULFONATE) SUSPENSION [PADDOCK LABORATORIES, LLC]	7
propylparaben	INACTIVE INGREDIENT	Z8IX2SC1OH	KIONEX (SODIUM POLYSTYRENE SULFONATE) SUSPENSION [PADDOCK LABORATORIES, LLC]	7
saccharin sodium	INACTIVE INGREDIENT	SB8ZUX40TY	KIONEX (SODIUM POLYSTYRENE SULFONATE) SUSPENSION [PADDOCK LABORATORIES, LLC]	7
sorbic Acid	INACTIVE INGREDIENT	X045WJ989B	KIONEX (SODIUM POLYSTYRENE SULFONATE) SUSPENSION [PADDOCK LABORATORIES, LLC]	7
Sorbitol	INACTIVE INGREDIENT	506T60A25R	KIONEX (SODIUM POLYSTYRENE SULFONATE) SUSPENSION [PADDOCK LABORATORIES, LLC]	7
water	INACTIVE INGREDIENT	059QF0KO0R	KIONEX (SODIUM POLYSTYRENE SULFONATE) SUSPENSION [PADDOCK LABORATORIES, LLC]	7
xanthan gum	INACTIVE INGREDIENT	TTV12P4NEE	KIONEX (SODIUM POLYSTYRENE SULFONATE) SUSPENSION [PADDOCK LABORATORIES, LLC]	7

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
Kionex	SODIUM POLYSTYRENE SULFONATE	ANI Pharmaceuticals, Inc.	676c3d81-d575-43f6-8748-e04b7c0cafeb	2025-09-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040028 application number: ANDA040028

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
1699G8679Z	SODIUM POLYSTYRENE SULFONATE	9080-79-9	SODIUM POLYSTYRENE SULFONATE

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Kionex ® Sodium Polystyrene Sulfonate Suspension USP	Paddock Laboratories, LLC	2018-11-12	HUMAN PRESCRIPTION DRUG LABEL	9