Prescription drug · ANDA
Amantadine NDC 46708-586
Amantadine hydrochloride 100 mg/1 · Tablet · Oral · Alembic Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 46708-586-31 | 4670805863146708058631 | 100 TABLET in 1 BOTTLE (46708-586-31)Marketed from Oct 20, 2020 | |
| 46708-586-71 | 4670805867146708058671 | 500 TABLET in 1 BOTTLE (46708-586-71)Marketed from Oct 20, 2020 |
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
- Generic name (nonproprietary)
- amantadine
- Active ingredients
- Amantadine hydrochloride — 100 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Alembic Pharmaceuticals LimitedNDC labeler code 46708
- 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 46708-586_1ca812f6-6983-4d9a-b08e-a8f7e50054b8SPL ID 1ca812f6-6983-4d9a-b08e-a8f7e50054b8SPL set ID 48fa07c8-8b95-40d7-a0f5-132577dfb2c8RxCUI 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
N446708058631followed by a unit qualifier and the quantityPackage 46708-0586-31. 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 46708-586
- What is NDC 46708-586?
- 46708-586 is the product NDC for Amantadine, Amantadine hydrochloride 100 mg/1 tablet, listed with the FDA by Alembic Pharmaceuticals Limited. It has 2 package NDCs, 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?
- Alembic Pharmaceuticals Limited, NDC labeler code 46708. 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 | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8605 | 00615-8605-39 |
| 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 | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8605 |
| 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 |