What is NDC 72189-412?

72189-412 is the product NDC for Amantadine HCL, Amantadine hydrochloride 100 mg/1 capsule, listed with the FDA by Direct_Rx. It has 1 package NDC, 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 72189-412 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)72189-412Labeler and product segments. Claims need a package NDC.

Product NDC at billing width72189-0412Add 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
72189-412-30	72189041230	30 CAPSULE in 1 BOTTLE (72189-412-30)Marketed from Jan 18, 2023

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: Capsule
Route: Oral
Labeler: Direct_RxNDC labeler code 72189
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 209047
Marketing start: Jan 18, 2023
Listing expires: Dec 31, 2026
Other FDA classes: M2 Protein Inhibitors (Mechanism)
Identifiers: Product ID 72189-412_2c4cfb73-b3b1-daf3-e063-6294a90af289SPL ID 2c4cfb73-b3b1-daf3-e063-6294a90af289SPL set ID f28c55c8-2754-a44d-e053-2a95a90ae798RxCUI 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

N472189041230 followed by a unit qualifier and the quantity

Package 72189-0412-30. 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 Jan 22, 2025.

Indications (excerpt from the label)

Amantadine hydrochloride capsules are indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza A virus. Amantadine hydrochloride capsules 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 when later exposed to antigenically…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 72189-412

What is NDC 72189-412?: 72189-412 is the product NDC for Amantadine HCL, Amantadine hydrochloride 100 mg/1 capsule, listed with the FDA by Direct_Rx. It has 1 package NDC, 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	TabletOral	Direct_Rx	72189-535	72189-0535-3072189-0535-90
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 209047

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

FDA NDC Directory listings under ANDA 209047
Product	Strength	Form · route	Labeler	Product NDC
Amantadine Hydrochloride	Amantadine hydrochloride 100 mg/1	CapsuleOral	Strides Pharma Inc.	42543-493
Amantadine Hydrochloride	Amantadine hydrochloride 100 mg/1	CapsuleOral	Proficient Rx LP	71205-223
Amantadine Hydrochloride	Amantadine hydrochloride 100 mg/1	CapsuleOral	Bryant Ranch Prepack	71335-9618