What is NDC 72189-535?

72189-535 is the product NDC for Amantadine HCL, Amantadine hydrochloride 100 mg/1 tablet, listed with the FDA by Direct_Rx. It has 2 package NDCs, shown above in 10- and 11-digit form.

Direct_Rx, NDC labeler code 72189. 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 HCL?

5 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Amantadine HCL NDC 72189-535 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)72189-535Labeler and product segments. Claims need a package NDC.

Product NDC at billing width72189-0535Add 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
72189-535-30	7218905353072189053530	30 TABLET in 1 BOTTLE (72189-535-30)Marketed from Feb 23, 2024
72189-535-90	7218905359072189053590	90 TABLET in 1 BOTTLE (72189-535-90)Marketed from Feb 23, 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 HCL
Generic name (nonproprietary): amantadine hcl
Active ingredients: Amantadine hydrochloride — 100 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Direct_RxNDC labeler code 72189
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 209035
Marketing start: Feb 23, 2024
Listing expires: Dec 31, 2026
Other FDA classes: M2 Protein Inhibitors (Mechanism)
Identifiers: Product ID 72189-535_12894d87-0c1f-831b-e063-6294a90af11dSPL ID 12894d87-0c1f-831b-e063-6294a90af11dSPL set ID 1211ebf4-3169-20ca-e063-6294a90aee4dRxCUI 849395UNII 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

N472189053530 followed by a unit qualifier and the quantity

Package 72189-0535-30. 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 Feb 29, 2024.

Indications (excerpt from the label)

Amantadine Hydrochloride Tablets are indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza A virus. Amantadine Hydrochloride Tablets are also indicated in the treatment of parkinsonism and drug-induced extrapyramidal reactions. Influenza A Prophylaxis Amantadine Hydrochloride Tablets are indicated for chemoprophylaxis against signs and symptoms of influenza A virus infection. Because Amantadine Hydrochloride Tablets do 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 later exposed…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 72189-535

What is NDC 72189-535?: 72189-535 is the product NDC for Amantadine HCL, Amantadine hydrochloride 100 mg/1 tablet, listed with the FDA by Direct_Rx. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Amantadine HCL.
What is the active ingredient?: Amantadine hydrochloride.
Who is the labeler?: Direct_Rx, NDC labeler code 72189. 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 HCL?: 5 other product NDCs are listed under this name. See all Amantadine HCL 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 HCL NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Amantadine HCL	Amantadine hydrochloride 100 mg/1	CapsuleOral	Direct RX	72189-657	72189-0657-30
Amantadine HCL	Amantadine hydrochloride 100 mg/1	CapsuleOral	Direct_Rx	72189-412	72189-0412-30
Amantadine HClamantadine hydrochloride	Amantadine hydrochloride 100 mg/1	Capsule, Liquid filledOral	Bionpharma Inc.	69452-142	69452-0142-2069452-0142-30
Amantadine HClamantadine hydrochloride	Amantadine hydrochloride 100 mg/1	Capsule, Liquid filledOral	AvPAK	50268-069	50268-0069-15
Amantadine HClamantadine hydrochloride	Amantadine hydrochloride 100 mg/1	Capsule, Liquid filledOral	AvKARE	42291-125	42291-0125-50

Other NDCs under ANDA 209035

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

FDA NDC Directory listings under ANDA 209035
Product	Strength	Form · route	Labeler	Product NDC
Amantadine Hydrochloride	Amantadine hydrochloride 100 mg/1	TabletOral	Strides Pharma Inc.	42543-497
Amantadine Hydrochloride	Amantadine hydrochloride 100 mg/1	TabletOral	Coupler LLC	67046-1452