Sodium Polystyrene Sulfonate

Product NDC: 10702-036
11-digit product format: 107020036
Labeler code: 10702
Product ID: 10702-036_1213e349-d5ef-2221-e063-6294a90a8e83
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Sodium Polystyrene Sulfonate
Dosage form: POWDER
Route: ORAL; RECTAL
Labeler: KVK-Tech, Inc.
Application: ANDA040905
Marketing category: ANDA
Marketing start: 2012-07-25
Substance: SODIUM POLYSTYRENE SULFONATE
Active strength: 1 g/g
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A040905-001	KALEXATE	SODIUM POLYSTYRENE SULFONATE	454GM/BOT	POWDER / ORAL, RECTAL	AA	RS	2009-03-30
A040905-002	KALEXATE	SODIUM POLYSTYRENE SULFONATE	15GM/BOT	POWDER / ORAL, RECTAL			2015-04-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040905-001	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 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A040905-001	KALEXATE	454GM/BOT	POWDER / ORAL, RECTAL	AA	RS	2009-03-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040905-002	KALEXATE	15GM/BOT	POWDER / ORAL, RECTAL			2015-04-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040905-001	KALEXATE	454GM/BOT	POWDER / ORAL, RECTAL	AA	RS	2009-03-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040905-002	KALEXATE	15GM/BOT	POWDER / ORAL, RECTAL			2015-04-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040905-001	KALEXATE	454GM/BOT	POWDER / ORAL, RECTAL	AA	RS	2009-03-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040905-002	KALEXATE	15GM/BOT	POWDER / ORAL, RECTAL			2015-04-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040905-001	KALEXATE	454GM/BOT	POWDER / ORAL, RECTAL	AA	RS	2009-03-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040905-002	KALEXATE	15GM/BOT	POWDER / ORAL, RECTAL			2015-04-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040905-001	KALEXATE	454GM/BOT	POWDER / ORAL, RECTAL	AA	RS	2009-03-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040905-002	KALEXATE	15GM/BOT	POWDER / ORAL, RECTAL			2015-04-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040905-001	KALEXATE	454GM/BOT	POWDER / ORAL, RECTAL	AA	RS	2009-03-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040905-002	KALEXATE	15GM/BOT	POWDER / ORAL, RECTAL			2015-04-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040905-001	KALEXATE	454GM/BOT	POWDER / ORAL, RECTAL	AA	RS	2009-03-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040905-002	KALEXATE	15GM/BOT	POWDER / ORAL, RECTAL			2015-04-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040905-001	KALEXATE	454GM/BOT	POWDER / ORAL, RECTAL	AA	RS	2009-03-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040905-002	KALEXATE	15GM/BOT	POWDER / ORAL, RECTAL			2015-04-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040905-001	KALEXATE	454GM/BOT	POWDER / ORAL, RECTAL	AA	RS	2009-03-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040905-002	KALEXATE	15GM/BOT	POWDER / ORAL, RECTAL			2015-04-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040905-001	KALEXATE	454GM/BOT	POWDER / ORAL, RECTAL	AA	RS	2009-03-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040905-002	KALEXATE	15GM/BOT	POWDER / ORAL, RECTAL			2015-04-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040905-001	KALEXATE	454GM/BOT	POWDER / ORAL, RECTAL	AA	RS	2009-03-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040905-002	KALEXATE	15GM/BOT	POWDER / ORAL, RECTAL			2015-04-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040905-001	KALEXATE	454GM/BOT	POWDER / ORAL, RECTAL	AA	RS	2009-03-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040905-002	KALEXATE	15GM/BOT	POWDER / ORAL, RECTAL			2015-04-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040905-001	KALEXATE	454GM/BOT	POWDER / ORAL, RECTAL	AA	RS	2009-03-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040905-002	KALEXATE	15GM/BOT	POWDER / ORAL, RECTAL			2015-04-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040905-001	KALEXATE	454GM/BOT	POWDER / ORAL, RECTAL	AA	RS	2009-03-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040905-002	KALEXATE	15GM/BOT	POWDER / ORAL, RECTAL			2015-04-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040905-001	KALEXATE	454GM/BOT	POWDER / ORAL, RECTAL	AA	RS	2009-03-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040905-002	KALEXATE	15GM/BOT	POWDER / ORAL, RECTAL			2015-04-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040905-001	KALEXATE	454GM/BOT	POWDER / ORAL, RECTAL	AA	RS	2009-03-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040905-002	KALEXATE	15GM/BOT	POWDER / ORAL, RECTAL			2015-04-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040905-001	KALEXATE	454GM/BOT	POWDER / ORAL, RECTAL	AA	RS	2009-03-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040905-002	KALEXATE	15GM/BOT	POWDER / ORAL, RECTAL			2015-04-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040905-001	KALEXATE	454GM/BOT	POWDER / ORAL, RECTAL	AA	RS	2009-03-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040905-002	KALEXATE	15GM/BOT	POWDER / ORAL, RECTAL			2015-04-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040905-001	KALEXATE	454GM/BOT	POWDER / ORAL, RECTAL	AA	RS	2009-03-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040905-002	KALEXATE	15GM/BOT	POWDER / ORAL, RECTAL			2015-04-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040905-001	KALEXATE	454GM/BOT	POWDER / ORAL, RECTAL	AA	RS	2009-03-30	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040905-002	KALEXATE	15GM/BOT	POWDER / ORAL, RECTAL			2015-04-03	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A040905-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040905-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040905-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040905-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040905-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040905-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040905-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040905-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040905-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040905-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040905-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040905-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040905-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040905-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040905-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040905-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040905-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040905-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040905-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040905-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040905-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040905-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040905-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040905-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040905-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040905-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040905-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040905-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040905-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040905-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040905-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040905-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040905-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040905-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040905-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040905-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040905-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040905-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040905-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040905-001	AA	1	`e64feba35796…`

Additional Listing Data#

Finished product: Yes
Brand name base: Sodium Polystyrene Sulfonate
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SODIUM POLYSTYRENE SULFONATE	1 g/g

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2101899	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
905c3ee5-d1a7-4deb-a345-4a42296704fa	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
10702-036-15	Sodium Polystyrene Sulfonate	15 g in 1 BOTTLE	POWDER	15		9
10702-036-45	Sodium Polystyrene Sulfonate	454 g in 1 JAR	POWDER	454		9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
10702-036-15	GM - Gram	10702-036	1d6615b3-fe37-4592-a536-54061557bdf5	1	2013-02-13
10702-036-45	GM - Gram	10702-036	8b55760e-d30a-4723-b73d-3db7b813046a	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
SODIUM POLYSTYRENE SULFONATE	ACTIVE INGREDIENT	1699G8679Z	SODIUM POLYSTYRENE SULFONATE POWDER [KVK-TECH, INC.]	4
POLYSTYRENE SULFONIC ACID	ACTIVE MOIETY	70KO0R01RY	SODIUM POLYSTYRENE SULFONATE POWDER [KVK-TECH, INC.]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10702-036	SODIUM POLYSTYRENE SULFONATE POWDER [KVK-TECH, INC.]	9	Current NDC, Legacy NDC, 2 package rows	20240224_905c3ee5-d1a7-4deb-a345-4a42296704fa.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
Sodium Polystyrene Sulfonate	SODIUM POLYSTYRENE SULFONATE	KVK-Tech, Inc.	905c3ee5-d1a7-4deb-a345-4a42296704fa	2024-02-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040905 application number: ANDA040905 ndc (product): 10702-036

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
2101899	sodium polystyrene sulfonate 15 GM Powder for Suspension	PSN	905c3ee5-d1a7-4deb-a345-4a42296704fa	9
2101899	sodium polystyrene sulfonate 15000 MG Powder for Oral Suspension	SCD	905c3ee5-d1a7-4deb-a345-4a42296704fa	9
2101899	sodium polystyrene sulfonate 15 to 60 GM Powder for Oral Suspension	SY	905c3ee5-d1a7-4deb-a345-4a42296704fa	9
2101899	sodium polystyrene sulfonate 30 to 50 GM Powder for Rectal Suspension	SY	905c3ee5-d1a7-4deb-a345-4a42296704fa	9
2101899	sodium polystyrene sulfonate 4.1 MEQ in 1 GM Powder for Oral Suspension	SY	905c3ee5-d1a7-4deb-a345-4a42296704fa	9
2101899	sodium polystyrene sulfonate 15 GM Powder for Suspension	PSN	e148d6d4-5abc-47c0-a365-8a14d03597a5	4
2101899	sodium polystyrene sulfonate 15000 MG Powder for Oral Suspension	SCD	e148d6d4-5abc-47c0-a365-8a14d03597a5	4
2101899	sodium polystyrene sulfonate 15 to 60 GM Powder for Oral Suspension	SY	e148d6d4-5abc-47c0-a365-8a14d03597a5	4
2101899	sodium polystyrene sulfonate 30 to 50 GM Powder for Rectal Suspension	SY	e148d6d4-5abc-47c0-a365-8a14d03597a5	4
2101899	sodium polystyrene sulfonate 4.1 MEQ in 1 GM Powder for Oral Suspension	SY	e148d6d4-5abc-47c0-a365-8a14d03597a5	4
2101899	sodium polystyrene sulfonate 15 GM Powder for Suspension	PSN	34fe6cd2-70f1-4ea3-adb7-a3e37defc886	2
2101899	sodium polystyrene sulfonate 15000 MG Powder for Oral Suspension	SCD	34fe6cd2-70f1-4ea3-adb7-a3e37defc886	2
2101899	sodium polystyrene sulfonate 15 to 60 GM Powder for Oral Suspension	SY	34fe6cd2-70f1-4ea3-adb7-a3e37defc886	2
2101899	sodium polystyrene sulfonate 30 to 50 GM Powder for Rectal Suspension	SY	34fe6cd2-70f1-4ea3-adb7-a3e37defc886	2
2101899	sodium polystyrene sulfonate 4.1 MEQ in 1 GM Powder for Oral Suspension	SY	34fe6cd2-70f1-4ea3-adb7-a3e37defc886	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
10702-036-15	10702003615	15 g in 1 BOTTLE (10702-036-15)	15 g	2015-04-03	0000-00-00	No	No	Current
10702-036-45	10702003645	454 g in 1 JAR (10702-036-45)	454 g	2012-07-25	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Sodium Polystyrene Sulfonate	KVK-Tech, Inc.	2024-02-23	HUMAN PRESCRIPTION DRUG LABEL	9
SODIUM POLYSTYRENE SULFONATE, USP	ATLANTIC BIOLOGICALS CORP	2019-09-25	HUMAN PRESCRIPTION DRUG LABEL	4
SODIUM POLYSTYRENE SULFONATE, USP	Atlantic Biologicals Corps	2016-05-04	HUMAN PRESCRIPTION DRUG LABEL	2