FDA.reportPublic FDA data

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

Additional Listing Data#

Finished product
Yes
Brand name base
SODIUM POLYSTYRENE SULFONATE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM POLYSTYRENE SULFONATE4.1 meq/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1699G8679Z
Rxcui2101899

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
95250459-30e4-45c1-b08a-993044f49109Product name220250805
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
a21a21e5-f36d-4c1f-8918-def921b8f7e3Product name320250124
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
a90f088a-9578-47a2-8f6e-0a9d32aafec6Product name120181030
f6c90bdc-1674-455a-aadd-1b1b59e5edebProduct name220181030
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508
f1ec5c2f-d01e-a277-5826-c7eba86ed99bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11534-166-15SODIUM POLYSTYRENE SULFONATE15 g in 1 BOTTLEPOWDER, FOR SUSPENSION154
11534-166-16SODIUM POLYSTYRENE SULFONATE15 g in 1 BOTTLEPOWDER, FOR SUSPENSION154
11534-166-44SODIUM POLYSTYRENE SULFONATE454 g in 1 JARPOWDER, FOR SUSPENSION4544

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11534-166-15GM - Gram11534-1664b2579c0-bcc6-4e38-bb74-e6360474d8e312017-03-06
11534-166-16GM - Gram11534-1660791b857-fa82-4ea3-8e0c-0512af95b27a12020-05-08
11534-166-44GM - Gram11534-166588bd26d-455d-4f46-bd81-5c11681b26e012017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11534-166SODIUM POLYSTYRENE SULFONATE POWDER, FOR SUSPENSION [SUNRISE PHARMACEUTICAL, INC.]4Current NDC, Legacy NDC, 3 package rows20221124_c73b9661-2378-4336-8be0-098e7c1ae522.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2101899sodium polystyrene sulfonate 15 GM Powder for SuspensionPSNfe1eaaea-0697-4790-8f14-b9db08d42257105
2101899sodium polystyrene sulfonate 15000 MG Powder for Oral SuspensionSCDfe1eaaea-0697-4790-8f14-b9db08d42257105
2101899sodium polystyrene sulfonate 15 to 60 GM Powder for Oral SuspensionSYfe1eaaea-0697-4790-8f14-b9db08d42257105
2101899sodium polystyrene sulfonate 30 to 50 GM Powder for Rectal SuspensionSYfe1eaaea-0697-4790-8f14-b9db08d42257105
2101899sodium polystyrene sulfonate 4.1 MEQ in 1 GM Powder for Oral SuspensionSYfe1eaaea-0697-4790-8f14-b9db08d42257105
2101899sodium polystyrene sulfonate 15 GM Powder for SuspensionPSN03a0b525-5e48-4e76-b1fa-700eab10d20a104
2101899sodium polystyrene sulfonate 15000 MG Powder for Oral SuspensionSCD03a0b525-5e48-4e76-b1fa-700eab10d20a104
2101899sodium polystyrene sulfonate 15 to 60 GM Powder for Oral SuspensionSY03a0b525-5e48-4e76-b1fa-700eab10d20a104
2101899sodium polystyrene sulfonate 30 to 50 GM Powder for Rectal SuspensionSY03a0b525-5e48-4e76-b1fa-700eab10d20a104
2101899sodium polystyrene sulfonate 4.1 MEQ in 1 GM Powder for Oral SuspensionSY03a0b525-5e48-4e76-b1fa-700eab10d20a104
2101899sodium polystyrene sulfonate 15 GM Powder for SuspensionPSNcae5e7d2-c6ca-485e-963e-1a147e5b11c3102
2101899sodium polystyrene sulfonate 15000 MG Powder for Oral SuspensionSCDcae5e7d2-c6ca-485e-963e-1a147e5b11c3102
2101899sodium polystyrene sulfonate 15 to 60 GM Powder for Oral SuspensionSYcae5e7d2-c6ca-485e-963e-1a147e5b11c3102
2101899sodium polystyrene sulfonate 30 to 50 GM Powder for Rectal SuspensionSYcae5e7d2-c6ca-485e-963e-1a147e5b11c3102
2101899sodium polystyrene sulfonate 4.1 MEQ in 1 GM Powder for Oral SuspensionSYcae5e7d2-c6ca-485e-963e-1a147e5b11c3102
2101899sodium polystyrene sulfonate 15 GM Powder for SuspensionPSN9a50c6d4-e619-438d-8af9-bb758ea7ba7e101
2101899sodium polystyrene sulfonate 15000 MG Powder for Oral SuspensionSCD9a50c6d4-e619-438d-8af9-bb758ea7ba7e101
2101899sodium polystyrene sulfonate 15 to 60 GM Powder for Oral SuspensionSY9a50c6d4-e619-438d-8af9-bb758ea7ba7e101
2101899sodium polystyrene sulfonate 30 to 50 GM Powder for Rectal SuspensionSY9a50c6d4-e619-438d-8af9-bb758ea7ba7e101
2101899sodium polystyrene sulfonate 4.1 MEQ in 1 GM Powder for Oral SuspensionSY9a50c6d4-e619-438d-8af9-bb758ea7ba7e101
2101899sodium polystyrene sulfonate 15 GM Powder for SuspensionPSNd6016e9d-dec6-4f14-b10b-7ec1aba3964a100
2101899sodium polystyrene sulfonate 15000 MG Powder for Oral SuspensionSCDd6016e9d-dec6-4f14-b10b-7ec1aba3964a100
2101899sodium polystyrene sulfonate 15 to 60 GM Powder for Oral SuspensionSYd6016e9d-dec6-4f14-b10b-7ec1aba3964a100
2101899sodium polystyrene sulfonate 30 to 50 GM Powder for Rectal SuspensionSYd6016e9d-dec6-4f14-b10b-7ec1aba3964a100
2101899sodium polystyrene sulfonate 4.1 MEQ in 1 GM Powder for Oral SuspensionSYd6016e9d-dec6-4f14-b10b-7ec1aba3964a100
2101899sodium polystyrene sulfonate 15 GM Powder for SuspensionPSNc73b9661-2378-4336-8be0-098e7c1ae5224
2101899sodium polystyrene sulfonate 15000 MG Powder for Oral SuspensionSCDc73b9661-2378-4336-8be0-098e7c1ae5224
2101899sodium polystyrene sulfonate 15 to 60 GM Powder for Oral SuspensionSYc73b9661-2378-4336-8be0-098e7c1ae5224
2101899sodium polystyrene sulfonate 30 to 50 GM Powder for Rectal SuspensionSYc73b9661-2378-4336-8be0-098e7c1ae5224
2101899sodium polystyrene sulfonate 4.1 MEQ in 1 GM Powder for Oral SuspensionSYc73b9661-2378-4336-8be0-098e7c1ae5224

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11534-166-151153401661515 g in 1 BOTTLE (11534-166-15) 15 g2017-01-240000-00-00NoNoCurrent
11534-166-161153401661615 g in 1 BOTTLE (11534-166-16) 15 g2017-01-240000-00-00NoNoCurrent
11534-166-4411534016644454 g in 1 JAR (11534-166-44) 454 g2017-01-240000-00-00NoNoCurrent