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United States · US · US:35573-108_c4d9a8d2-f02d-4c55-b416-4a3d0c03835b
Sodium Polystyrene Sulfonate
In shortageOrange BookUNIISPLATC V03AE01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBurel Pharmaceuticals, LLC
CountryUS (United States)
ATC codeV03AE01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11355731081410 BOTTLE, UNIT-DOSE in 1 CARTON (35573-108-14) / 60 mL in 1 BOTTLE, UNIT-DOSE (35573-108-13)
Annotations
UNII (FDA Substance ID)
1699G8679Z
SODIUM POLYSTYRENE SULFONATE
RxCUI 56512
Orange Book
A214912
AA
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Sodium Acetate Injection
Raw payload (JSON)
{
"unii": {
"unii": "1699G8679Z",
"rxcui": "56512",
"inchikey": null,
"display_name": "SODIUM POLYSTYRENE SULFONATE",
"substance_type": "polymer",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL; RECTAL",
"spl_meta": {
"52430b12-4d5f-d1e1-e063-6394a90abd64": {
"match": "brand_token",
"title": "SODIUM FLUORIDE RINSE LIQUID [ROCKLAND COSMETICS, INC.]",
"spl_version": "1",
"published_date": "2026-05-21"
}
},
"productid": "35573-108_c4d9a8d2-f02d-4c55-b416-4a3d0c03835b",
"productndc": "35573-108",
"dosage_form": "SUSPENSION",
"orange_book": {
"appl_no": "214912",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "15GM/60ML",
"product_no": "001",
"approval_date": "Jun 10, 2025"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "SODIUM POLYSTYRENE SULFONATE",
"shortage_reason": "Sodium Acetate Injection",
"shortage_status": "current",
"proprietary_name": "Sodium Polystyrene Sulfonate",
"active_ingred_unit": "g/60mL",
"application_number": "ANDA214912",
"marketing_category": "ANDA",
"nonproprietary_name": "sodium polystyrene sulfonate",
"start_marketing_date": "20251218",
"active_numerator_strength": "15"
}Related drugs
Other records sharing ATC code V03AE01.
- PLCalcium ResoniumSanofi Winthrop Industrie
- IECalcium Resonium 99.934% Powder for oral or rectal suspensionSanofi-Aventis Ireland Limited T/A SANOFI
- NLCalciumpolystyreensulfonaat 1 g/g Focus Care, poeder voor suspensie voor oraal/rectaal gebruikFocus Care Pharmaceuticals B.V.
- DKCalciumpolystyrensulfonat CarefarmOrifarm A/S
- CAJAMP SODIUM POLYSTYRENE SULFONATEJAMP PHARMA CORPORATION
- CAKAYEXALATESANOFI-AVENTIS CANADA INC
- BEKayexalate Calcium 14.99 gSanofi Belgium
- BEKayexalate Sodium 14.99 gSanofi Belgium
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