What is NDC 0116-4010?

0116-4010 is the product NDC for Amantadine, Amantadine hydrochloride 50 mg/5mL solution, listed with the FDA by Xttrium Laboratories, Inc. It has 2 package NDCs, shown above in 10- and 11-digit form.

Xttrium Laboratories, Inc, NDC labeler code 0116. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Amantadine?

9 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Amantadine NDC 0116-4010 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0116-4010Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00116-4010Add 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
0116-4010-16	0011640101600116401016	473 mL in 1 BOTTLE (0116-4010-16)Marketed from Nov 5, 2024
0116-4010-41	0011640104100116401041	100 TRAY in 1 CASE (0116-4010-41) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0116-4010-10)Marketed from Nov 5, 2024

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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): Amantadine
Generic name (nonproprietary): amantadine
Active ingredients: Amantadine hydrochloride — 50 mg/5mL
Dosage form: Solution
Route: Oral
Labeler: Xttrium Laboratories, IncNDC labeler code 0116
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 075060
Marketing start: Nov 5, 2024
Listing expires: Dec 31, 2027
Other FDA classes: M2 Protein Inhibitors (Mechanism)
Identifiers: Product ID 0116-4010_3479947d-22a8-67e8-e063-6294a90ae41cSPL ID 3479947d-22a8-67e8-e063-6294a90ae41cSPL set ID 25dd8a3c-6b11-2ea1-e063-6294a90a50cfRxCUI 849385UNII M6Q1EO9TD0UPC 0001164010164
Pharmacologic class: Influenza A M2 Protein Inhibitor

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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N400116401016 followed by a unit qualifier and the quantity

Package 00116-4010-16. 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 May 21, 2025.

Indications (excerpt from the label)

Indications and Usage Amantadine Hydrochloride Oral Solution, USP is indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza A virus. Amantadine hydrochloride is also indicated in the treatment of parkinsonism and drug-induced extrapyramidal reactions. Influenza A Prophylaxis: Amantadine hydrochloride is indicated for chemoprophylaxis against signs and symptoms of influenza A virus infection. Because amantadine hydrochloride does not completely prevent the host immune response to influenza A infection, individuals who take this drug may still develop immune responses to natural disease or vaccination and may be protected when late…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0116-4010

What is NDC 0116-4010?: 0116-4010 is the product NDC for Amantadine, Amantadine hydrochloride 50 mg/5mL solution, listed with the FDA by Xttrium Laboratories, Inc. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Amantadine.
What is the active ingredient?: Amantadine hydrochloride.
Who is the labeler?: Xttrium Laboratories, Inc, NDC labeler code 0116. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Amantadine?: 9 other product NDCs are listed under this name. See all Amantadine 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 Amantadine NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Amantadine	Amantadine hydrochloride 50 mg/5mL	SolutionOral	AvPAK	50268-036	50268-0036-14
Amantadine	Amantadine hydrochloride 100 mg/1	TabletOral	Coupler LLC	67046-1531	67046-1531-03
Amantadine	Amantadine hydrochloride 100 mg/1	TabletOral	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8605	00615-8605-39
Amantadine	Amantadine hydrochloride 100 mg/1	TabletOral	Alembic Pharmaceuticals Limited	46708-586	46708-0586-3146708-0586-71
Amantadine	Amantadine hydrochloride 100 mg/1	TabletOral	Alembic Pharmaceuticals Inc.	62332-586	62332-0586-3162332-0586-71
Amantadine	Amantadine hydrochloride 100 mg/1	TabletOral	Proficient Rx LP	82804-267	82804-0267-20
Amantadine	Amantadine hydrochloride 100 mg/1	CapsuleOral	American Health Packaging	60687-422	60687-0422-01
amantadine	Amantadine hydrochloride 100 mg/1	CapsuleOral	Alembic Pharmaceuticals Limited	46708-246	46708-0246-3046708-0246-3146708-0246-71+1 more
amantadine	Amantadine hydrochloride 100 mg/1	CapsuleOral	Alembic Pharmaceuticals Inc.	62332-246	62332-0246-3062332-0246-3162332-0246-71+1 more

Other NDCs under ANDA 075060

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

FDA NDC Directory listings under ANDA 075060
Product	Strength	Form · route	Labeler	Product NDC
Amantadine	Amantadine hydrochloride 50 mg/5mL	SolutionOral	AvPAK	50268-036