Kionex

Product NDC: 62559-356
11-digit product format: 625590356
Labeler code: 62559
Product ID: 62559-356_4d8f40b7-bd03-44af-8c72-641a31b76d26
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Sodium Polystyrene Sulfonate
Dosage form: SUSPENSION
Route: ORAL
Labeler: ANI Pharmaceuticals, Inc.
Application: ANDA040028
Marketing category: ANDA
Marketing start: 2024-05-03
Substance: SODIUM POLYSTYRENE SULFONATE
Active strength: 15 g/60mL
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 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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Kionex
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SODIUM POLYSTYRENE SULFONATE	15 g/60mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1699G8679Z	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
313072	Internal RxNorm lookup
793741	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
676c3d81-d575-43f6-8748-e04b7c0cafeb	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
a90f088a-9578-47a2-8f6e-0a9d32aafec6	Product name	1	20181030
f6c90bdc-1674-455a-aadd-1b1b59e5edeb	Product name	2	20181030
f1ec5c2f-d01e-a277-5826-c7eba86ed99b	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
62559-356-01	Kionex	10 in 1 CASE	SUSPENSION	10		2
62559-356-60	Kionex	60 mL in 1 BOTTLE	SUSPENSION	60		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
62559-356-01	ML - Milliliter	62559-356	feb68bd7-8a84-4804-b9f8-4054320bf054	1	2024-06-10
62559-356-60	ML - Milliliter	62559-356	4cf72a42-fc1b-4b80-9f64-fbb25427b292	1	2024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
62559-356	KIONEX (SODIUM POLYSTYRENE SULFONATE) SUSPENSION [ANI PHARMACEUTICALS, INC.]	1	Current NDC, 2 package rows	20240508_676c3d81-d575-43f6-8748-e04b7c0cafeb.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
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 ndc (product): 62559-356

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
793741	Kionex 15 GM in 60 mL Oral or Rectal Suspension	PSN	676c3d81-d575-43f6-8748-e04b7c0cafeb	2
313072	sodium polystyrene sulfonate 15 GM in 60 mL Oral or Rectal Suspension	PSN	676c3d81-d575-43f6-8748-e04b7c0cafeb	2
793741	sodium polystyrene sulfonate 250 MG/ML Oral Suspension [Kionex]	SBD	676c3d81-d575-43f6-8748-e04b7c0cafeb	2
313072	sodium polystyrene sulfonate 250 MG/ML Oral Suspension	SCD	676c3d81-d575-43f6-8748-e04b7c0cafeb	2
793741	Kionex 15 GM per 60 ML Oral or Rectal Suspension	SY	676c3d81-d575-43f6-8748-e04b7c0cafeb	2
313072	sodium polystyrene sulfonate 15 GM per 60 ML Oral Suspension	SY	676c3d81-d575-43f6-8748-e04b7c0cafeb	2
313072	sodium polystyrene sulfonate 30 GM per 120 ML Oral Suspension	SY	676c3d81-d575-43f6-8748-e04b7c0cafeb	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
62559-356-01	62559035601	10 BOTTLE in 1 CASE (62559-356-01) / 60 mL in 1 BOTTLE (62559-356-60)	10 bottle	2024-05-03	No	No	Current
62559-356-60	62559035660	60 mL in 1 BOTTLE	60 ml				Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Kionex ® (Sodium Polystyrene Sulfonate Suspension USP)	ANI Pharmaceuticals, Inc.	2025-09-19	HUMAN PRESCRIPTION DRUG LABEL	2