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United States · US · US:62135-340_06fcec70-ae79-a194-e063-6394a90a6ffa

Sodium Polystyrene Sulfonate

In shortageOrange BookUNIISPLATC V03AE01

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

Identification

ManufacturerChartwell RX, LLC
CountryUS (United States)
ATC codeV03AE01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    6213534011
    10 BOTTLE in 1 BOX (62135-340-11) / 15 g in 1 BOTTLE
  • ndc11
    6213534053
    453.6 g in 1 BOTTLE (62135-340-53)
  • ndc11
    6213534062
    15 g in 1 BOTTLE (62135-340-62)

Annotations

UNII (FDA Substance ID)
1699G8679Z
SODIUM POLYSTYRENE SULFONATE
RxCUI 56512
Orange Book
A206815
AA
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Sodium Bicarbonate 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": "62135-340_06fcec70-ae79-a194-e063-6394a90a6ffa",
  "productndc": "62135-340",
  "dosage_form": "POWDER, FOR SUSPENSION",
  "orange_book": {
    "appl_no": "206815",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "454GM/BOT",
        "product_no": "001",
        "approval_date": "Feb 18, 2016"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "SODIUM POLYSTYRENE SULFONATE",
  "shortage_reason": "Sodium Bicarbonate Injection",
  "shortage_status": "current",
  "proprietary_name": "Sodium Polystyrene Sulfonate",
  "active_ingred_unit": "meq/g",
  "application_number": "ANDA206815",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Sodium Polystyrene Sulfonate",
  "start_marketing_date": "20160218",
  "active_numerator_strength": "4.1"
}

Related drugs

Other records sharing ATC code V03AE01.

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