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United States · US · US:46287-006_233303fe-cee1-420f-bf82-aaeb7850b01f

Sodium Polystyrene Sulfonate

In shortageOrange BookUNIISPLATC V03AE01

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerCMP Pharma, Inc.
CountryUS (United States)
ATC codeV03AE01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    4628700601
    473 mL in 1 BOTTLE (46287-006-01)
  • ndc11
    4628700604
    120 mL in 1 BOTTLE (46287-006-04)
  • ndc11
    4628700660
    10 BOTTLE, UNIT-DOSE in 1 CARTON (46287-006-60) / 60 mL in 1 BOTTLE, UNIT-DOSE

Annotations

UNII (FDA Substance ID)
1699G8679Z
SODIUM POLYSTYRENE SULFONATE
RxCUI 56512
Orange Book
A087859
AA
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Sodium Oxybate Solution
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": "46287-006_233303fe-cee1-420f-bf82-aaeb7850b01f",
  "productndc": "46287-006",
  "dosage_form": "SUSPENSION",
  "orange_book": {
    "appl_no": "087859",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AA",
        "strength": "15GM/60ML",
        "product_no": "001",
        "approval_date": "Dec 8, 1982"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "SODIUM POLYSTYRENE SULFONATE",
  "shortage_reason": "Sodium Oxybate Solution",
  "shortage_status": "current",
  "proprietary_name": "Sodium Polystyrene Sulfonate",
  "active_ingred_unit": "g/60mL",
  "application_number": "ANDA087859",
  "marketing_category": "ANDA",
  "nonproprietary_name": "sodium polystyrene sulfonate",
  "start_marketing_date": "19821208",
  "active_numerator_strength": "15"
}

Related drugs

Other records sharing ATC code V03AE01.

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