What is NDC 64380-862?

64380-862 is the product NDC for Amantadine Hydrochloride, Amantadine hydrochloride 100 mg/1 capsule, liquid filled, listed with the FDA by Strides Pharma Science Limited. It has 2 package NDCs, shown above in 10- and 11-digit form.

Strides Pharma Science Limited, NDC labeler code 64380. 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 64380-862

NDC codes

FDA NDC Directory

Product NDC (as listed)64380-862Labeler and product segments. Claims need a package NDC.

Product NDC at billing width64380-0862Add 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
64380-862-06	6438008620664380086206	100 CAPSULE, LIQUID FILLED in 1 BOTTLE (64380-862-06)Marketed from Dec 1, 2022
64380-862-07	6438008620764380086207	500 CAPSULE, LIQUID FILLED in 1 BOTTLE (64380-862-07)Marketed from Dec 1, 2022

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): Amantadine Hydrochloride
Generic name (nonproprietary): amantadine hydrochloride
Active ingredients: Amantadine hydrochloride — 100 mg/1
Dosage form: Capsule, Liquid filled
Route: Oral
Labeler: Strides Pharma Science LimitedNDC labeler code 64380
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 211354
Marketing start: Dec 1, 2022
Listing expires: Dec 31, 2027
Other FDA classes: M2 Protein Inhibitors (Mechanism)
Identifiers: Product ID 64380-862_cd49441d-853e-4400-90bb-8e9e81d96b9fSPL ID cd49441d-853e-4400-90bb-8e9e81d96b9fSPL set ID 20dad861-6ad1-4660-b315-8af57b294175RxCUI 849389UNII M6Q1EO9TD0UPC 0364380862062
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

N464380086206 followed by a unit qualifier and the quantity

Package 64380-0862-06. 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 Jul 17, 2023.

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, USP 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 protecte…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 64380-862

What is NDC 64380-862?: 64380-862 is the product NDC for Amantadine Hydrochloride, Amantadine hydrochloride 100 mg/1 capsule, liquid filled, listed with the FDA by Strides Pharma Science Limited. It has 2 package NDCs, 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?: Strides Pharma Science Limited, NDC labeler code 64380. 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	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
Amantadine Hydrochloride	Amantadine hydrochloride 100 mg/1	CapsuleOral	ST. MARY'S MEDICAL PARK PHARMACY	60760-779	60760-0779-30

All 41 Amantadine Hydrochloride NDCs