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United States · US · US:65219-512_ea996741-0733-42bc-9ea6-4392cbfb2c37

Potassium Acetate

In shortageOrange BookUNIISPLATC B05XA17

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

Identification

ManufacturerFresenius Kabi USA, LLC
CountryUS (United States)
ATC codeB05XA17
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6521951250
    25 VIAL, PHARMACY BULK PACKAGE in 1 TRAY (65219-512-50) / 50 mL in 1 VIAL, PHARMACY BULK PACKAGE (65219-512-02)

Annotations

UNII (FDA Substance ID)
M911911U02
POTASSIUM ACETATE
RxCUI 54987
Orange Book
A217515
AP
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Potassium Chloride Tablet, Extended Release
Raw payload (JSON)
{
  "unii": {
    "unii": "M911911U02",
    "rxcui": "54987",
    "inchikey": "SCVFZCLFOSHCOH-UHFFFAOYSA-M",
    "display_name": "POTASSIUM ACETATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "ff67f638-5b53-406a-962a-87773a91fc48": {
      "match": "brand_token",
      "title": "POTASSIUM CITRATE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]",
      "spl_version": "104",
      "published_date": "2026-05-28"
    }
  },
  "productid": "65219-512_ea996741-0733-42bc-9ea6-4392cbfb2c37",
  "productndc": "65219-512",
  "dosage_form": "INJECTION, SOLUTION, CONCENTRATE",
  "orange_book": {
    "appl_no": "217515",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "2MEQ/ML",
        "product_no": "001",
        "approval_date": "Nov 27, 2024"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "POTASSIUM ACETATE",
  "shortage_reason": "Potassium Chloride Tablet, Extended Release",
  "shortage_status": "current",
  "proprietary_name": "Potassium Acetate",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA217515",
  "marketing_category": "ANDA",
  "nonproprietary_name": "POTASSIUM ACETATE",
  "start_marketing_date": "20241127",
  "active_numerator_strength": "196"
}

Related drugs

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