potassium acetate

Generic: potassium acetate

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name potassium acetate
Generic Name potassium acetate
Labeler fresenius kabi usa, llc
Dosage Form INJECTION, SOLUTION, CONCENTRATE
Routes
INTRAVENOUS
Active Ingredients

potassium acetate 196 mg/mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 65219-512
Product ID 65219-512_ea996741-0733-42bc-9ea6-4392cbfb2c37
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217515
Listing Expiration 2026-12-31
Marketing Start 2024-11-27

Pharmacologic Class

Classes
increased large intestinal motility [pe] inhibition large intestine fluid/electrolyte absorption [pe] osmotic activity [moa] osmotic laxative [epc] potassium compounds [cs] potassium salt [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65219512
Hyphenated Format 65219-512

Supplemental Identifiers

RxCUI
237381
UPC
0365219512028
UNII
M911911U02

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name potassium acetate (source: ndc)
Generic Name potassium acetate (source: ndc)
Application Number ANDA217515 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 196 mg/mL
source: ndc
Packaging
  • 25 VIAL, PHARMACY BULK PACKAGE in 1 TRAY (65219-512-50) / 50 mL in 1 VIAL, PHARMACY BULK PACKAGE (65219-512-02)
source: ndc

Packages (1)

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

Ingredients (1)

potassium acetate (196 mg/mL)

Linked Drug Pages (1)

Potassium Acetate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "ea996741-0733-42bc-9ea6-4392cbfb2c37", "openfda": {"upc": ["0365219512028"], "unii": ["M911911U02"], "rxcui": ["237381"], "spl_set_id": ["2f069f41-903a-4a57-b566-eda5c44367d8"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL, PHARMACY BULK PACKAGE in 1 TRAY (65219-512-50)  / 50 mL in 1 VIAL, PHARMACY BULK PACKAGE (65219-512-02)", "package_ndc": "65219-512-50", "marketing_start_date": "20241127"}], "brand_name": "Potassium Acetate", "product_id": "65219-512_ea996741-0733-42bc-9ea6-4392cbfb2c37", "dosage_form": "INJECTION, SOLUTION, CONCENTRATE", "pharm_class": ["Increased Large Intestinal Motility [PE]", "Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]", "Osmotic Activity [MoA]", "Osmotic Laxative [EPC]", "Potassium Compounds [CS]", "Potassium Salt [EPC]"], "product_ndc": "65219-512", "generic_name": "POTASSIUM ACETATE", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Potassium Acetate", "active_ingredients": [{"name": "POTASSIUM ACETATE", "strength": "196 mg/mL"}], "application_number": "ANDA217515", "marketing_category": "ANDA", "marketing_start_date": "20241127", "listing_expiration_date": "20261231"}