What is NDC 0615-8263?

0615-8263 is the product NDC for Amantadine Hydrochloride, Amantadine hydrochloride 100 mg/1 capsule, listed with the FDA by NCS HealthCare of KY, LLC dba Vangard Labs. It has 1 package NDC, shown above in 10- and 11-digit form.

NCS HealthCare of KY, LLC dba Vangard Labs, NDC labeler code 0615. 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 Hydrochloride?

40 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Amantadine Hydrochloride NDC 0615-8263

NDC codes

FDA NDC Directory

Product NDC (as listed)0615-8263Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00615-8263Add 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
0615-8263-39	00615826339	30 CAPSULE in 1 BLISTER PACK (0615-8263-39)Marketed from Jan 10, 2019

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 Hydrochloride
Generic name (nonproprietary): amantadine hydrochloride
Active ingredients: Amantadine hydrochloride — 100 mg/1
Dosage form: Capsule
Route: Oral
Labeler: NCS HealthCare of KY, LLC dba Vangard LabsNDC labeler code 0615
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 209171
Marketing start: Jan 1, 2017
Listing expires: Dec 31, 2026
Other FDA classes: M2 Protein Inhibitors (Mechanism)
Identifiers: Product ID 0615-8263_056d9ef2-8e38-40eb-8d3a-0d753e018030SPL ID 056d9ef2-8e38-40eb-8d3a-0d753e018030SPL set ID b54064bc-b3e1-4d83-be40-fcaddd2e99d0RxCUI 849389UNII M6Q1EO9TD0
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

N400615826339 followed by a unit qualifier and the quantity

Package 00615-8263-39. 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 Aug 5, 2024.

Indications (excerpt from the label)

INDICATIONS AND USAGE Amantadine hydrochloride capsules, USP are indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza A virus. Amantadine hydrochloride capsules, USP are also indicated in the treatment of parkinsonism and drug-induced extrapyramidal reactions. Influenza A Prophylaxis Amantadine hydrochloride capsules are indicated for chemoprophylaxis against signs and symptoms of influenza A virus infection. Because amantadine 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 whe…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0615-8263

What is NDC 0615-8263?: 0615-8263 is the product NDC for Amantadine Hydrochloride, Amantadine hydrochloride 100 mg/1 capsule, listed with the FDA by NCS HealthCare of KY, LLC dba Vangard Labs. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Amantadine Hydrochloride.
What is the active ingredient?: Amantadine hydrochloride.
Who is the labeler?: NCS HealthCare of KY, LLC dba Vangard Labs, NDC labeler code 0615. 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 Hydrochloride?: 40 other product NDCs are listed under this name. See all Amantadine Hydrochloride 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 Hydrochloride NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
amantadine hydrochloride	Amantadine hydrochloride 100 mg/1	CapsuleOral	AvKARE	73190-094	73190-0094-50
Amantadine Hydrochloride	Amantadine hydrochloride 50 mg/5mL	SolutionOral	BAJAJ MEDICAL, LLC	61037-484	61037-0484-03
Amantadine Hydrochloride	Amantadine hydrochloride 100 mg/1	TabletOral	Coupler LLC	67046-1452	67046-1452-03
amantadine hydrochloride	Amantadine hydrochloride 100 mg/1	CapsuleOral	Coupler LLC	67046-1508	67046-1508-03
Amantadine Hydrochloride	Amantadine hydrochloride 100 mg/1	TabletOral	Zhejiang Jutai Pharmaceutical Co., Ltd.	71765-009	71765-0009-01
Amantadine Hydrochloride	Amantadine hydrochloride 50 mg/5mL	SolutionOral	American Health Packaging	60687-797	60687-0797-56
Amantadine Hydrochloride	Amantadine hydrochloride 50 mg/5mL	SolutionOral	Patrin Pharma, Inc.	39328-530	39328-0530-1639328-0530-99
Amantadine Hydrochloride	Amantadine hydrochloride 100 mg/1	Capsule, Liquid filledOral	Strides Pharma Science Limited	64380-862	64380-0862-0664380-0862-07
Amantadine Hydrochloride	Amantadine hydrochloride 100 mg/1	CapsuleOral	Rising Pharma Holdings, Inc.	16571-834	16571-0834-0116571-0834-50
amantadine hydrochloride	Amantadine hydrochloride 100 mg/1	CapsuleOral	EPIC PHARMA LLC	42806-716	42806-0716-0542806-0716-11

All 41 Amantadine Hydrochloride NDCs

Other NDCs under ANDA 209171

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

FDA NDC Directory listings under ANDA 209171
Product	Strength	Form · route	Labeler	Product NDC
Amantadine Hydrochloride	Amantadine hydrochloride 100 mg/1	CapsuleOral	Major Pharmaceuticals	0904-7042
Amantadine Hydrochloride	Amantadine hydrochloride 100 mg/1	CapsuleOral	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-362
Amantadine Hydrochloride	Amantadine hydrochloride 100 mg/1	CapsuleOral	Chartwell RX, LLC	62135-609
Amantadine Hydrochloride	Amantadine hydrochloride 100 mg/1	CapsuleOral	Bryant Ranch Prepack	71335-2664
Amantadine Hydrochloride	Amantadine hydrochloride 100 mg/1	CapsuleOral	Bryant Ranch Prepack	71335-2919
Amantadine Hydrochloride	Amantadine hydrochloride 100 mg/1	CapsuleOral	Bryant Ranch Prepack	71335-2959
Amantadine Hydrochloride	Amantadine hydrochloride 100 mg/1	CapsuleOral	Bryant Ranch Prepack	72162-2408