What is NDC 39328-530?

39328-530 is the product NDC for Amantadine Hydrochloride, Amantadine hydrochloride 50 mg/5mL solution, listed with the FDA by Patrin Pharma, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.

Patrin Pharma, Inc., NDC labeler code 39328. 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 39328-530

NDC codes

FDA NDC Directory

Product NDC (as listed)39328-530Labeler and product segments. Claims need a package NDC.

Product NDC at billing width39328-0530Add 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
39328-530-16	3932805301639328053016	473 mL in 1 BOTTLE, PLASTIC (39328-530-16)Marketed from Aug 11, 2023
39328-530-99	3932805309939328053099	10 TRAY in 1 CASE (39328-530-99) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (39328-530-10)Marketed from May 8, 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): Amantadine Hydrochloride
Generic name (nonproprietary): amantadine hydrochloride
Active ingredients: Amantadine hydrochloride — 50 mg/5mL
Dosage form: Solution
Route: Oral
Labeler: Patrin Pharma, Inc.NDC labeler code 39328
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 214178
Marketing start: Aug 11, 2023
Listing expires: Dec 31, 2026
Other FDA classes: M2 Protein Inhibitors (Mechanism)
Identifiers: Product ID 39328-530_f923b293-f2ac-4116-a122-9524fe748acaSPL ID f923b293-f2ac-4116-a122-9524fe748acaSPL set ID 0fcf5182-a666-4f38-879f-47f19de30dd5RxCUI 849385UNII 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

N439328053016 followed by a unit qualifier and the quantity

Package 39328-0530-16. 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 20, 2024.

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 Oral Solution USP is also indicated in the treatment of parkinsonism and drug-induced extrapyramidal reactions. Influenza A Prophylaxis Amantadine Hydrochloride Oral Solution USP is indicated for chemoprophylaxis against signs and symptoms of influenza A virus infection. Because Amantadine Hydrochloride Oral Solution USP does not completely prevent the host immune response to influenza A infection, individuals who take this drug may still develop immune responses to natural d…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 39328-530

What is NDC 39328-530?: 39328-530 is the product NDC for Amantadine Hydrochloride, Amantadine hydrochloride 50 mg/5mL solution, listed with the FDA by Patrin Pharma, Inc.. 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?: Patrin Pharma, Inc., NDC labeler code 39328. 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 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
Amantadine Hydrochloride	Amantadine hydrochloride 100 mg/1	CapsuleOral	ST. MARY'S MEDICAL PARK PHARMACY	60760-779	60760-0779-30

All 41 Amantadine Hydrochloride NDCs