FDA.reportPublic FDA data

Sodium Polystyrene Sulfonate

Product NDC
35573-108
11-digit product format
355730108
Labeler code
35573
Product ID
35573-108_c4d9a8d2-f02d-4c55-b416-4a3d0c03835b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sodium polystyrene sulfonate
Dosage form
SUSPENSION
Route
ORAL; RECTAL
Labeler
Burel Pharmaceuticals, LLC
Application
ANDA214912
Marketing category
ANDA
Marketing start
2025-12-18
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A214912-001SODIUM POLYSTYRENE SULFONATESODIUM POLYSTYRENE SULFONATE15GM/60MLSUSPENSION / ORAL, RECTALAA2025-06-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A214912-001AA

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A214912-001SODIUM POLYSTYRENE SULFONATE15GM/60MLSUSPENSION / ORAL, RECTALAA2025-06-10caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A214912-001SODIUM POLYSTYRENE SULFONATE15GM/60MLSUSPENSION / ORAL, RECTALAA2025-06-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214912-001SODIUM POLYSTYRENE SULFONATE15GM/60MLSUSPENSION / ORAL, RECTALAA2025-06-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08A214912-001SODIUM POLYSTYRENE SULFONATE15GM/60MLSUSPENSION / ORAL, RECTALAA2025-06-106a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A214912-001SODIUM POLYSTYRENE SULFONATE15GM/60MLSUSPENSION / ORAL, RECTALAA2025-06-10a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A214912-001AA1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A214912-001AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214912-001AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A214912-001AA16a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A214912-001AA1a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
Sodium Polystyrene Sulfonate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM POLYSTYRENE SULFONATE15 g/60mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1699G8679ZInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
313072Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8bbeae67-a7ff-4fa6-b21e-fb8617cd9197Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a90f088a-9578-47a2-8f6e-0a9d32aafec6Product name120181030
f6c90bdc-1674-455a-aadd-1b1b59e5edebProduct name220181030
f1ec5c2f-d01e-a277-5826-c7eba86ed99bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
35573-108-13Sodium Polystyrene Sulfonate60 mL in 1 BOTTLE, UNIT-DOSESUSPENSION601
35573-108-14Sodium Polystyrene Sulfonate10 in 1 CARTONSUSPENSION101
35573-108-57Sodium Polystyrene Sulfonate473 mL in 1 BOTTLESUSPENSION4731

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
35573-108-13ML - Milliliter35573-1081d4e7346-d462-49a3-b0ce-9e71f5cb177912026-01-08
35573-108-14ML - Milliliter35573-1086a9ccb31-9790-448a-8c72-f64640de9cab12026-01-08

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sodium Polystyrene SulfonateSODIUM POLYSTYRENE SULFONATEBurel Pharmaceuticals, LLC8bbeae67-a7ff-4fa6-b21e-fb8617cd91972025-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214912
application number: ANDA214912
ndc (product): 35573-108

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313072sodium polystyrene sulfonate 15 GM in 60 mL Oral or Rectal SuspensionPSN8bbeae67-a7ff-4fa6-b21e-fb8617cd91971
313072sodium polystyrene sulfonate 250 MG/ML Oral SuspensionSCD8bbeae67-a7ff-4fa6-b21e-fb8617cd91971
313072sodium polystyrene sulfonate 15 GM per 60 ML Oral SuspensionSY8bbeae67-a7ff-4fa6-b21e-fb8617cd91971
313072sodium polystyrene sulfonate 30 GM per 120 ML Oral SuspensionSY8bbeae67-a7ff-4fa6-b21e-fb8617cd91971

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
35573-108-133557301081360 mL in 1 BOTTLE, UNIT-DOSE60 mlHistorical
35573-108-143557301081410 BOTTLE, UNIT-DOSE in 1 CARTON (35573-108-14) / 60 mL in 1 BOTTLE, UNIT-DOSE (35573-108-13) 2025-12-18NoNoCurrent
35573-108-5735573010857473 mL in 1 BOTTLE (35573-108-57)473 ml2026-06-190Current