Prescription drug · ANDA
Amantadine NDC 0615-8605
Amantadine hydrochloride 100 mg/1 · Tablet · Oral · NCS HealthCare of KY, LLC dba Vangard Labs
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0615-8605-39 | 0061586053900615860539 | 30 TABLET in 1 BLISTER PACK (0615-8605-39)Marketed from Jan 20, 2026 |
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
- Generic name (nonproprietary)
- amantadine
- Active ingredients
- Amantadine hydrochloride — 100 mg/1
- Dosage form
- Tablet
- 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 214284
- Marketing start
- Listing expires
- Other FDA classes
- M2 Protein Inhibitors (Mechanism)
- Identifiers
- Product ID 0615-8605_a8ae3043-8fe8-4e56-9829-a53b597c4910SPL ID a8ae3043-8fe8-4e56-9829-a53b597c4910SPL set ID 2ff05131-f634-4688-86e9-9bc33a8d11c4RxCUI 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
N400615860539followed by a unit qualifier and the quantityPackage 00615-8605-39. 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 .
Indications (excerpt from the label)
INDICATIONS AND USAGE 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 protec…
Excerpt only. Read the full label for complete information.
About NDC 0615-8605
- What is NDC 0615-8605?
- 0615-8605 is the product NDC for Amantadine, Amantadine hydrochloride 100 mg/1 tablet, 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.
- 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?
- 9 other product NDCs are listed under this name. See all Amantadine NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Amantadine products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Amantadine | Amantadine hydrochloride 50 mg/5mL | SolutionOral | AvPAK | 50268-036 | 50268-0036-14 |
| Amantadine | Amantadine hydrochloride 100 mg/1 | TabletOral | Coupler LLC | 67046-1531 | 67046-1531-03 |
| Amantadine | Amantadine hydrochloride 50 mg/5mL | SolutionOral | Xttrium Laboratories, Inc | 0116-4010 | 00116-4010-1600116-4010-41 |
| Amantadine | Amantadine hydrochloride 100 mg/1 | TabletOral | Alembic Pharmaceuticals Limited | 46708-586 | 46708-0586-3146708-0586-71 |
| Amantadine | Amantadine hydrochloride 100 mg/1 | TabletOral | Alembic Pharmaceuticals Inc. | 62332-586 | 62332-0586-3162332-0586-71 |
| Amantadine | Amantadine hydrochloride 100 mg/1 | TabletOral | Proficient Rx LP | 82804-267 | 82804-0267-20 |
| Amantadine | Amantadine hydrochloride 100 mg/1 | CapsuleOral | American Health Packaging | 60687-422 | 60687-0422-01 |
| amantadine | Amantadine hydrochloride 100 mg/1 | CapsuleOral | Alembic Pharmaceuticals Limited | 46708-246 | 46708-0246-3046708-0246-3146708-0246-71+1 more |
| amantadine | Amantadine hydrochloride 100 mg/1 | CapsuleOral | Alembic Pharmaceuticals Inc. | 62332-246 | 62332-0246-3062332-0246-3162332-0246-71+1 more |
Other NDCs under ANDA 214284
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Amantadine | Amantadine hydrochloride 100 mg/1 | TabletOral | Alembic Pharmaceuticals Limited | 46708-586 |
| Amantadine | Amantadine hydrochloride 100 mg/1 | TabletOral | Alembic Pharmaceuticals Inc. | 62332-586 |
| Amantadine | Amantadine hydrochloride 100 mg/1 | TabletOral | Coupler LLC | 67046-1531 |
| Amantadine | Amantadine hydrochloride 100 mg/1 | TabletOral | Proficient Rx LP | 82804-267 |