NDC codes

FDA NDC Directory
Product NDC (as listed)65219-512Labeler and product segments. Claims need a package NDC.
Product NDC at billing width65219-0512Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
65219-512-506521905125025 VIAL, PHARMACY BULK PACKAGE in 1 TRAY (65219-512-50) / 50 mL in 1 VIAL, PHARMACY BULK PACKAGE (65219-512-02)Marketed from Nov 27, 2024

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary)
Potassium Acetate
Generic name (nonproprietary)
potassium acetate
Active ingredients
Potassium acetate — 196 mg/mL
Dosage form
Injection, Solution, Concentrate
Route
Intravenous
Labeler
Fresenius Kabi USA, LLCNDC labeler code 65219
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 217515
Marketing start
Listing expires
Other FDA classes
Increased Large Intestinal Motility (Physiologic effect)Inhibition Large Intestine Fluid/Electrolyte Absorption (Physiologic effect)Osmotic Activity (Mechanism)Potassium Compounds (Chemical structure)
Identifiers
Product ID 65219-512_ea996741-0733-42bc-9ea6-4392cbfb2c37SPL ID ea996741-0733-42bc-9ea6-4392cbfb2c37SPL set ID 2f069f41-903a-4a57-b566-eda5c44367d8RxCUI 237381UNII M911911U02UPC 0365219512028
Pharmacologic class
Osmotic Laxative; Potassium Salt

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

Administration

Drug administration (CPT 96360–96549)

When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.

How CPT relates to drug billing

NDC on a medical claim

N465219051250 followed by a unit qualifier and the quantity

Package 65219-0512-50. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective .

Indications (excerpt from the label)

INDICATIONS AND USAGE Potassium Acetate Injection (2 mEq/mL) is indicated as a source of potassium, for the addition to large volume intravenous fluids, to prevent or correct hypokalemia in patients with restricted or no oral intake. It is also useful as an additive for preparing specific intravenous fluid formulas when the needs of the patient cannot be met by standard electrolyte or nutrient solutions.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 65219-512

What is NDC 65219-512?
65219-512 is the product NDC for Potassium Acetate, Potassium acetate 196 mg/mL injection, solution, concentrate, listed with the FDA by Fresenius Kabi USA, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Potassium Acetate.
What is the active ingredient?
Potassium acetate.
Who is the labeler?
Fresenius Kabi USA, LLC, NDC labeler code 65219. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Potassium Acetate?
4 other product NDCs are listed under this name. See all Potassium Acetate NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Potassium Acetate NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Potassium AcetatePotassium acetate 3.93 g/20mLInjection, Solution, ConcentrateIntravenousFresenius Kabi USA, LLC65219-51065219-0510-20
Potassium AcetatePotassium acetate 200 meq/100mLInjectionIntravenousExela Pharma Sciences, LLC51754-200451754-2004-04
Potassium AcetatePotassium acetate 3.93 g/20mLInjection, Solution, ConcentrateIntravenousHospira, Inc.0409-818300409-8183-25
Potassium AcetatePotassium acetate 196.3 mg/mLInjection, Solution, ConcentrateIntravenousHospira, Inc.0409-329400409-3294-51

Other NDCs under ANDA 217515

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 217515
ProductStrengthForm · routeLabelerProduct NDC
Potassium AcetatePotassium acetate 3.93 g/20mLInjection, Solution, ConcentrateIntravenousFresenius Kabi USA, LLC65219-510

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