Prescription drug · ANDA
amantadine hydrochloride NDC 71205-702
Amantadine hydrochloride 100 mg/1 · Capsule · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71205-702-20 | 71205070220 | 20 CAPSULE in 1 BOTTLE (71205-702-20)Marketed from Sep 29, 2022 | |
| 71205-702-30 | 71205070230 | 30 CAPSULE in 1 BOTTLE (71205-702-30)Marketed from Sep 29, 2022 | |
| 71205-702-60 | 71205070260 | 60 CAPSULE in 1 BOTTLE (71205-702-60)Marketed from Sep 29, 2022 | |
| 71205-702-90 | 71205070290 | 90 CAPSULE in 1 BOTTLE (71205-702-90)Marketed from Sep 29, 2022 |
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 — 100 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Proficient Rx LP
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208278
- Marketing start
- Listing expires
- Other FDA classes
- M2 Protein Inhibitors (Mechanism)
- Identifiers
- Product ID 71205-702_743d1b73-f47e-4bbf-bb52-45b1e7f17308SPL ID 743d1b73-f47e-4bbf-bb52-45b1e7f17308SPL set ID 743d1b73-f47e-4bbf-bb52-45b1e7f17308RxCUI 849389UNII M6Q1EO9TD0UPC 0371205702205
- 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
N471205070220followed by a unit qualifier and the quantityPackage 71205-0702-20. 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 capsules, USP are indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza A virus. Amantadine hydrochloride capsules, USP are also indicated in the treatment of parkinsonism and drug-induced extrapyramidal reactions. Influenza A Prophylaxis Amantadine hydrochloride capsules, USP 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 protecte…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 208278
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 hydrochloride | Amantadine hydrochloride 100 mg/1 | CapsuleOral | Zydus Pharmaceuticals (USA) Inc. | 68382-512 |
| amantadine hydrochloride | Amantadine hydrochloride 100 mg/1 | CapsuleOral | Coupler LLC | 67046-1508 |
| amantadine hydrochloride | Amantadine hydrochloride 100 mg/1 | CapsuleOral | AvKARE | 73190-094 |
| amantadine hydrochloride | Amantadine hydrochloride 100 mg/1 | CapsuleOral | Zydus Lifesciences Limited | 65841-835 |
| amantadine hydrochloride | Amantadine hydrochloride 100 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-0469 |