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United States · US · US:62559-356_4d8f40b7-bd03-44af-8c72-641a31b76d26

Kionex

In shortageOrange BookUNIISPLATC V03AE01

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

Identification

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

Packs · 1

  • ndc11
    6255935601
    10 BOTTLE in 1 CASE (62559-356-01) / 60 mL in 1 BOTTLE (62559-356-60)

Annotations

UNII (FDA Substance ID)
1699G8679Z
SODIUM POLYSTYRENE SULFONATE
RxCUI 56512
Orange Book
A040028
AA
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Sodium Chloride 0.9% 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",
  "spl_meta": {
    "676c3d81-d575-43f6-8748-e04b7c0cafeb": {
      "match": "brand_token",
      "title": "KIONEX (SODIUM POLYSTYRENE SULFONATE) SUSPENSION [ANI PHARMACEUTICALS, INC.]",
      "spl_version": "2",
      "published_date": "2025-11-17"
    }
  },
  "productid": "62559-356_4d8f40b7-bd03-44af-8c72-641a31b76d26",
  "productndc": "62559-356",
  "dosage_form": "SUSPENSION",
  "orange_book": {
    "appl_no": "040028",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "15GM/60ML",
        "product_no": "001",
        "approval_date": "Sep 17, 2007"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "SODIUM POLYSTYRENE SULFONATE",
  "shortage_reason": "Sodium Chloride 0.9% Injection",
  "shortage_status": "current",
  "proprietary_name": "Kionex",
  "active_ingred_unit": "g/60mL",
  "application_number": "ANDA040028",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Sodium Polystyrene Sulfonate",
  "start_marketing_date": "20240503",
  "active_numerator_strength": "15"
}

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