What is NDC 65219-646?

65219-646 is the product NDC for Protamine Sulfate, Protamine sulfate 10 mg/mL injection, solution, listed with the FDA by Fresenius Kabi USA, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

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 Protamine Sulfate?

4 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Protamine Sulfate NDC 65219-646 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)65219-646Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65219-0646Add 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 NDC	11-digit (billing)	Package	Copy
65219-646-05	65219064605	25 VIAL, SINGLE-DOSE in 1 TRAY (65219-646-05) / 5 mL in 1 VIAL, SINGLE-DOSE (65219-646-02)Marketed from Mar 28, 2025

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): Protamine Sulfate
Generic name (nonproprietary): protamine sulfate
Active ingredients: Protamine sulfate — 10 mg/mL
Dosage form: Injection, Solution
Route: Intravenous
Labeler: Fresenius Kabi USA, LLCNDC labeler code 65219
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 089454
Marketing start: Mar 28, 2025
Listing expires: Dec 31, 2026
Other FDA classes: Heparin Binding Activity (Mechanism)Reversed Anticoagulation Activity (Physiologic effect)
Identifiers: Product ID 65219-646_c76876da-b9a8-45d0-9278-7df3288d3a06SPL ID c76876da-b9a8-45d0-9278-7df3288d3a06SPL set ID c76876da-b9a8-45d0-9278-7df3288d3a06RxCUI 1796672UNII 0DE9724IHCUPC 0365219646020
Pharmacologic class: Heparin Reversal Agent

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

N465219064605 followed by a unit qualifier and the quantity

Package 65219-0646-05. 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 Apr 29, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE: Protamine Sulfate Injection, USP is indicated in the treatment of heparin overdosage.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 65219-646

What is NDC 65219-646?: 65219-646 is the product NDC for Protamine Sulfate, Protamine sulfate 10 mg/mL injection, solution, 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?: Protamine Sulfate.
What is the active ingredient?: Protamine sulfate.
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 Protamine Sulfate?: 4 other product NDCs are listed under this name. See all Protamine Sulfate 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 Protamine Sulfate NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Protamine Sulfate	Protamine sulfate 10 mg/mL	Injection, SolutionIntravenous	HF Acquisition Co LLC, DBA HealthFirst	51662-1414	51662-1414-0151662-1414-03
Protamine Sulfate	Protamine sulfate 10 mg/mL	Injection, SolutionIntravenous	Fresenius Kabi USA, LLC	63323-229	63323-0229-9463323-0229-95
Protamine Sulfate	Protamine sulfate 10 mg/mL	Injection, SolutionIntravenous	Fresenius Kabi USA, LLC	63323-229	63323-0229-0563323-0229-30
Protamine Sulfate	Protamine sulfate 10 mg/mL	Injection, SolutionIntravenous	Fresenius Kabi USA, LLC	63323-229	63323-0229-1563323-0229-35

Other NDCs under ANDA 089454

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

FDA NDC Directory listings under ANDA 089454
Product	Strength	Form · route	Labeler	Product NDC
Protamine Sulfate	Protamine sulfate 10 mg/mL	Injection, SolutionIntravenous	HF Acquisition Co LLC, DBA HealthFirst	51662-1414
Protamine Sulfate	Protamine sulfate 10 mg/mL	Injection, SolutionIntravenous	Fresenius Kabi USA, LLC	63323-229
Protamine Sulfate	Protamine sulfate 10 mg/mL	Injection, SolutionIntravenous	Fresenius Kabi USA, LLC	63323-229
Protamine Sulfate	Protamine sulfate 10 mg/mL	Injection, SolutionIntravenous	Fresenius Kabi USA, LLC	63323-229