SODIUM POLYSTYRENE SULFONATE

Product NDC: 11534-166
11-digit product format: 115340166
Labeler code: 11534
Product ID: 11534-166_c5432731-23bc-44cf-bfcc-e59d16437db2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: sodium polystyrene sulfonate
Dosage form: POWDER, FOR SUSPENSION
Route: ORAL; RECTAL
Labeler: SUNRISE PHARMACEUTICAL, INC.
Application: ANDA204071
Marketing category: ANDA
Marketing start: 2017-01-24
Substance: SODIUM POLYSTYRENE SULFONATE
Active strength: 4.1 meq/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 1.

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
A204071-001	SODIUM POLYSTYRENE SULFONATE	SODIUM POLYSTYRENE SULFONATE	454GM/BOT	POWDER / ORAL, RECTAL	AA		2014-11-28
A204071-002	SODIUM POLYSTYRENE SULFONATE	SODIUM POLYSTYRENE SULFONATE	15GM/BOT	POWDER / ORAL, RECTAL			2014-11-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204071-001	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 · 82 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
2026-02-19 14:30 UTC	2026-02	A204071-001	SODIUM POLYSTYRENE SULFONATE	454GM/BOT	POWDER / ORAL, RECTAL	AA	2014-11-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204071-002	SODIUM POLYSTYRENE SULFONATE	15GM/BOT	POWDER / ORAL, RECTAL		2014-11-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204071-001	SODIUM POLYSTYRENE SULFONATE	454GM/BOT	POWDER / ORAL, RECTAL	AA	2014-11-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204071-002	SODIUM POLYSTYRENE SULFONATE	15GM/BOT	POWDER / ORAL, RECTAL		2014-11-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204071-001	SODIUM POLYSTYRENE SULFONATE	454GM/BOT	POWDER / ORAL, RECTAL	AA	2014-11-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204071-002	SODIUM POLYSTYRENE SULFONATE	15GM/BOT	POWDER / ORAL, RECTAL		2014-11-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204071-001	SODIUM POLYSTYRENE SULFONATE	454GM/BOT	POWDER / ORAL, RECTAL	AA	2014-11-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204071-002	SODIUM POLYSTYRENE SULFONATE	15GM/BOT	POWDER / ORAL, RECTAL		2014-11-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204071-001	SODIUM POLYSTYRENE SULFONATE	454GM/BOT	POWDER / ORAL, RECTAL	AA	2014-11-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204071-002	SODIUM POLYSTYRENE SULFONATE	15GM/BOT	POWDER / ORAL, RECTAL		2014-11-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204071-001	SODIUM POLYSTYRENE SULFONATE	454GM/BOT	POWDER / ORAL, RECTAL	AA	2014-11-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204071-002	SODIUM POLYSTYRENE SULFONATE	15GM/BOT	POWDER / ORAL, RECTAL		2014-11-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204071-001	SODIUM POLYSTYRENE SULFONATE	454GM/BOT	POWDER / ORAL, RECTAL	AA	2014-11-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204071-002	SODIUM POLYSTYRENE SULFONATE	15GM/BOT	POWDER / ORAL, RECTAL		2014-11-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204071-001	SODIUM POLYSTYRENE SULFONATE	454GM/BOT	POWDER / ORAL, RECTAL	AA	2014-11-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204071-002	SODIUM POLYSTYRENE SULFONATE	15GM/BOT	POWDER / ORAL, RECTAL		2014-11-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204071-001	SODIUM POLYSTYRENE SULFONATE	454GM/BOT	POWDER / ORAL, RECTAL	AA	2014-11-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204071-002	SODIUM POLYSTYRENE SULFONATE	15GM/BOT	POWDER / ORAL, RECTAL		2014-11-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204071-001	SODIUM POLYSTYRENE SULFONATE	454GM/BOT	POWDER / ORAL, RECTAL	AA	2014-11-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204071-002	SODIUM POLYSTYRENE SULFONATE	15GM/BOT	POWDER / ORAL, RECTAL		2014-11-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204071-001	SODIUM POLYSTYRENE SULFONATE	454GM/BOT	POWDER / ORAL, RECTAL	AA	2014-11-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204071-002	SODIUM POLYSTYRENE SULFONATE	15GM/BOT	POWDER / ORAL, RECTAL		2014-11-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204071-001	SODIUM POLYSTYRENE SULFONATE	454GM/BOT	POWDER / ORAL, RECTAL	AA	2014-11-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204071-002	SODIUM POLYSTYRENE SULFONATE	15GM/BOT	POWDER / ORAL, RECTAL		2014-11-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204071-001	SODIUM POLYSTYRENE SULFONATE	454GM/BOT	POWDER / ORAL, RECTAL	AA	2014-11-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204071-002	SODIUM POLYSTYRENE SULFONATE	15GM/BOT	POWDER / ORAL, RECTAL		2014-11-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204071-001	SODIUM POLYSTYRENE SULFONATE	454GM/BOT	POWDER / ORAL, RECTAL	AA	2014-11-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204071-002	SODIUM POLYSTYRENE SULFONATE	15GM/BOT	POWDER / ORAL, RECTAL		2014-11-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204071-001	SODIUM POLYSTYRENE SULFONATE	454GM/BOT	POWDER / ORAL, RECTAL	AA	2014-11-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204071-002	SODIUM POLYSTYRENE SULFONATE	15GM/BOT	POWDER / ORAL, RECTAL		2014-11-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204071-001	SODIUM POLYSTYRENE SULFONATE	454GM/BOT	POWDER / ORAL, RECTAL	AA	2014-11-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204071-002	SODIUM POLYSTYRENE SULFONATE	15GM/BOT	POWDER / ORAL, RECTAL		2014-11-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204071-001	SODIUM POLYSTYRENE SULFONATE	454GM/BOT	POWDER / ORAL, RECTAL	AA	2014-11-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204071-002	SODIUM POLYSTYRENE SULFONATE	15GM/BOT	POWDER / ORAL, RECTAL		2014-11-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204071-001	SODIUM POLYSTYRENE SULFONATE	454GM/BOT	POWDER / ORAL, RECTAL	AA	2014-11-28	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204071-002	SODIUM POLYSTYRENE SULFONATE	15GM/BOT	POWDER / ORAL, RECTAL		2014-11-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204071-001	SODIUM POLYSTYRENE SULFONATE	454GM/BOT	POWDER / ORAL, RECTAL	AA	2014-11-28	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204071-002	SODIUM POLYSTYRENE SULFONATE	15GM/BOT	POWDER / ORAL, RECTAL		2014-11-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204071-001	SODIUM POLYSTYRENE SULFONATE	454GM/BOT	POWDER / ORAL, RECTAL	AA	2014-11-28	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A204071-002	SODIUM POLYSTYRENE SULFONATE	15GM/BOT	POWDER / ORAL, RECTAL		2014-11-28	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A204071-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204071-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204071-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204071-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204071-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204071-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204071-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204071-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204071-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204071-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204071-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204071-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204071-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204071-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204071-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204071-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204071-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204071-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204071-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204071-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204071-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204071-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204071-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204071-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204071-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204071-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204071-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204071-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204071-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204071-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204071-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204071-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204071-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204071-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204071-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204071-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204071-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204071-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204071-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A204071-001	AA	1	`cb3db0bc1861…`

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	4.1 meq/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
c73b9661-2378-4336-8be0-098e7c1ae522	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
95250459-30e4-45c1-b08a-993044f49109	Product name	2	20250805
726062af-1135-4707-a1d7-57256991bbf9	Product name	2	20250226
a21a21e5-f36d-4c1f-8918-def921b8f7e3	Product name	3	20250124
fb7ab793-2c12-4079-b100-a64f73bef25a	Product name	4	20240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7	Product name	2	20230717
dc7c5daa-021f-40dd-b00d-63982cb2067a	Product name	1	20230426
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
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	5	20200925
e4870509-7e28-6f92-f0be-dd3dd889a9cf	Product name	5	20200810
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
a90f088a-9578-47a2-8f6e-0a9d32aafec6	Product name	1	20181030
f6c90bdc-1674-455a-aadd-1b1b59e5edeb	Product name	2	20181030
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
26acd337-b838-40ac-bcbc-05c3b81c8712	Product name	1	20170323
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	2	20160823
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
19c71a3d-ed9c-166b-a7e5-38c250c35631	Product name	1	20140508
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
597b1cfd-7b31-5048-62be-ca5cd740da2f	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
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508
f1ec5c2f-d01e-a277-5826-c7eba86ed99b	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
11534-166-15	SODIUM POLYSTYRENE SULFONATE	15 g in 1 BOTTLE	POWDER, FOR SUSPENSION	15	4
11534-166-16	SODIUM POLYSTYRENE SULFONATE	15 g in 1 BOTTLE	POWDER, FOR SUSPENSION	15	4
11534-166-44	SODIUM POLYSTYRENE SULFONATE	454 g in 1 JAR	POWDER, FOR SUSPENSION	454	4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
11534-166-15	GM - Gram	11534-166	4b2579c0-bcc6-4e38-bb74-e6360474d8e3	1	2017-03-06
11534-166-16	GM - Gram	11534-166	0791b857-fa82-4ea3-8e0c-0512af95b27a	1	2020-05-08
11534-166-44	GM - Gram	11534-166	588bd26d-455d-4f46-bd81-5c11681b26e0	1	2017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
11534-166	SODIUM POLYSTYRENE SULFONATE POWDER, FOR SUSPENSION [SUNRISE PHARMACEUTICAL, INC.]	4	Current NDC, Legacy NDC, 3 package rows	20221124_c73b9661-2378-4336-8be0-098e7c1ae522.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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SODIUM POLYSTYRENE SULFONATE	SODIUM POLYSTYRENE SULFONATE	Bryant Ranch Prepack	d6016e9d-dec6-4f14-b10b-7ec1aba3964a	2025-10-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204071 application number: ANDA204071
SODIUM POLYSTYRENE SULFONATE	SODIUM POLYSTYRENE SULFONATE	Bryant Ranch Prepack	9a50c6d4-e619-438d-8af9-bb758ea7ba7e	2025-05-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204071 application number: ANDA204071
SODIUM POLYSTYRENE SULFONATE	SODIUM POLYSTYRENE SULFONATE	Bryant Ranch Prepack	03a0b525-5e48-4e76-b1fa-700eab10d20a	2024-04-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204071 application number: ANDA204071
SODIUM POLYSTYRENE SULFONATE	SODIUM POLYSTYRENE SULFONATE	Bryant Ranch Prepack	fe1eaaea-0697-4790-8f14-b9db08d42257	2024-03-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204071 application number: ANDA204071
SODIUM POLYSTYRENE SULFONATE	SODIUM POLYSTYRENE SULFONATE	Bryant Ranch Prepack	cae5e7d2-c6ca-485e-963e-1a147e5b11c3	2023-03-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204071 application number: ANDA204071
SODIUM POLYSTYRENE SULFONATE	SODIUM POLYSTYRENE SULFONATE	SUNRISE PHARMACEUTICAL, INC.	c73b9661-2378-4336-8be0-098e7c1ae522	2022-08-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204071 application number: ANDA204071 ndc (product): 11534-166

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	fe1eaaea-0697-4790-8f14-b9db08d42257	105
2101899	sodium polystyrene sulfonate 15000 MG Powder for Oral Suspension	SCD	fe1eaaea-0697-4790-8f14-b9db08d42257	105
2101899	sodium polystyrene sulfonate 15 to 60 GM Powder for Oral Suspension	SY	fe1eaaea-0697-4790-8f14-b9db08d42257	105
2101899	sodium polystyrene sulfonate 30 to 50 GM Powder for Rectal Suspension	SY	fe1eaaea-0697-4790-8f14-b9db08d42257	105
2101899	sodium polystyrene sulfonate 4.1 MEQ in 1 GM Powder for Oral Suspension	SY	fe1eaaea-0697-4790-8f14-b9db08d42257	105
2101899	sodium polystyrene sulfonate 15 GM Powder for Suspension	PSN	03a0b525-5e48-4e76-b1fa-700eab10d20a	104
2101899	sodium polystyrene sulfonate 15000 MG Powder for Oral Suspension	SCD	03a0b525-5e48-4e76-b1fa-700eab10d20a	104
2101899	sodium polystyrene sulfonate 15 to 60 GM Powder for Oral Suspension	SY	03a0b525-5e48-4e76-b1fa-700eab10d20a	104
2101899	sodium polystyrene sulfonate 30 to 50 GM Powder for Rectal Suspension	SY	03a0b525-5e48-4e76-b1fa-700eab10d20a	104
2101899	sodium polystyrene sulfonate 4.1 MEQ in 1 GM Powder for Oral Suspension	SY	03a0b525-5e48-4e76-b1fa-700eab10d20a	104
2101899	sodium polystyrene sulfonate 15 GM Powder for Suspension	PSN	cae5e7d2-c6ca-485e-963e-1a147e5b11c3	102
2101899	sodium polystyrene sulfonate 15000 MG Powder for Oral Suspension	SCD	cae5e7d2-c6ca-485e-963e-1a147e5b11c3	102
2101899	sodium polystyrene sulfonate 15 to 60 GM Powder for Oral Suspension	SY	cae5e7d2-c6ca-485e-963e-1a147e5b11c3	102
2101899	sodium polystyrene sulfonate 30 to 50 GM Powder for Rectal Suspension	SY	cae5e7d2-c6ca-485e-963e-1a147e5b11c3	102
2101899	sodium polystyrene sulfonate 4.1 MEQ in 1 GM Powder for Oral Suspension	SY	cae5e7d2-c6ca-485e-963e-1a147e5b11c3	102
2101899	sodium polystyrene sulfonate 15 GM Powder for Suspension	PSN	9a50c6d4-e619-438d-8af9-bb758ea7ba7e	101
2101899	sodium polystyrene sulfonate 15000 MG Powder for Oral Suspension	SCD	9a50c6d4-e619-438d-8af9-bb758ea7ba7e	101
2101899	sodium polystyrene sulfonate 15 to 60 GM Powder for Oral Suspension	SY	9a50c6d4-e619-438d-8af9-bb758ea7ba7e	101
2101899	sodium polystyrene sulfonate 30 to 50 GM Powder for Rectal Suspension	SY	9a50c6d4-e619-438d-8af9-bb758ea7ba7e	101
2101899	sodium polystyrene sulfonate 4.1 MEQ in 1 GM Powder for Oral Suspension	SY	9a50c6d4-e619-438d-8af9-bb758ea7ba7e	101
2101899	sodium polystyrene sulfonate 15 GM Powder for Suspension	PSN	d6016e9d-dec6-4f14-b10b-7ec1aba3964a	100
2101899	sodium polystyrene sulfonate 15000 MG Powder for Oral Suspension	SCD	d6016e9d-dec6-4f14-b10b-7ec1aba3964a	100
2101899	sodium polystyrene sulfonate 15 to 60 GM Powder for Oral Suspension	SY	d6016e9d-dec6-4f14-b10b-7ec1aba3964a	100
2101899	sodium polystyrene sulfonate 30 to 50 GM Powder for Rectal Suspension	SY	d6016e9d-dec6-4f14-b10b-7ec1aba3964a	100
2101899	sodium polystyrene sulfonate 4.1 MEQ in 1 GM Powder for Oral Suspension	SY	d6016e9d-dec6-4f14-b10b-7ec1aba3964a	100
2101899	sodium polystyrene sulfonate 15 GM Powder for Suspension	PSN	c73b9661-2378-4336-8be0-098e7c1ae522	4
2101899	sodium polystyrene sulfonate 15000 MG Powder for Oral Suspension	SCD	c73b9661-2378-4336-8be0-098e7c1ae522	4
2101899	sodium polystyrene sulfonate 15 to 60 GM Powder for Oral Suspension	SY	c73b9661-2378-4336-8be0-098e7c1ae522	4
2101899	sodium polystyrene sulfonate 30 to 50 GM Powder for Rectal Suspension	SY	c73b9661-2378-4336-8be0-098e7c1ae522	4
2101899	sodium polystyrene sulfonate 4.1 MEQ in 1 GM Powder for Oral Suspension	SY	c73b9661-2378-4336-8be0-098e7c1ae522	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
11534-166-15	11534016615	15 g in 1 BOTTLE (11534-166-15)	15 g	2017-01-24	0000-00-00	No	No	Current
11534-166-16	11534016616	15 g in 1 BOTTLE (11534-166-16)	15 g	2017-01-24	0000-00-00	No	No	Current
11534-166-44	11534016644	454 g in 1 JAR (11534-166-44)	454 g	2017-01-24	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
SODIUM POLYSTYRENE SULFONATE	Bryant Ranch Prepack	2025-10-21	HUMAN PRESCRIPTION DRUG LABEL	100
SODIUM POLYSTYRENE SULFONATE	Bryant Ranch Prepack	2025-05-12	HUMAN PRESCRIPTION DRUG LABEL	101
SODIUM POLYSTYRENE SULFONATE	Bryant Ranch Prepack	2024-04-12	HUMAN PRESCRIPTION DRUG LABEL	104
SODIUM POLYSTYRENE SULFONATE	Bryant Ranch Prepack	2024-03-15	HUMAN PRESCRIPTION DRUG LABEL	105
SODIUM POLYSTYRENE SULFONATE	Bryant Ranch Prepack	2023-03-15	HUMAN PRESCRIPTION DRUG LABEL	102
SODIUM POLYSTYRENE SULFONATE	SUNRISE PHARMACEUTICAL, INC. \| SUNRISE PHARMACEUTICAL INC.	2022-08-12	HUMAN PRESCRIPTION DRUG LABEL	4