Prescription drug · ANDA
Amantadine Hydrochloride NDC 42543-493
Amantadine hydrochloride 100 mg/1 · Capsule · Oral · Strides Pharma Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42543-493-01 | 4254304930142543049301 | 100 CAPSULE in 1 BOTTLE (42543-493-01)Marketed from Jul 31, 2017 | |
| 42543-493-05 | 4254304930542543049305 | 500 CAPSULE in 1 BOTTLE (42543-493-05)Marketed from Jul 31, 2017 |
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
- Strides Pharma Inc.NDC labeler code 42543
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209047
- Marketing start
- Listing expires
- Other FDA classes
- M2 Protein Inhibitors (Mechanism)
- Identifiers
- Product ID 42543-493_20218de3-d4e9-4f7d-b1f5-bfb66e22420dSPL ID 20218de3-d4e9-4f7d-b1f5-bfb66e22420dSPL set ID e4d8f36f-d668-4728-8dca-b1c22bd9aedbRxCUI 849389UNII M6Q1EO9TD0UPC 0342543493018
- 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
N442543049301followed by a unit qualifier and the quantityPackage 42543-0493-01. 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 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 ex…
Excerpt only. Read the full label for complete information.
About NDC 42543-493
- What is NDC 42543-493?
- 42543-493 is the product NDC for Amantadine Hydrochloride, Amantadine hydrochloride 100 mg/1 capsule, listed with the FDA by Strides Pharma Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Amantadine Hydrochloride.
- What is the active ingredient?
- Amantadine hydrochloride.
- Who is the labeler?
- Strides Pharma Inc., NDC labeler code 42543. 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 Hydrochloride?
- 40 other product NDCs are listed under this name. See all Amantadine Hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Amantadine Hydrochloride 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 hydrochloride | Amantadine hydrochloride 100 mg/1 | CapsuleOral | AvKARE | 73190-094 | 73190-0094-50 |
| Amantadine Hydrochloride | Amantadine hydrochloride 50 mg/5mL | SolutionOral | BAJAJ MEDICAL, LLC | 61037-484 | 61037-0484-03 |
| Amantadine Hydrochloride | Amantadine hydrochloride 100 mg/1 | TabletOral | Coupler LLC | 67046-1452 | 67046-1452-03 |
| amantadine hydrochloride | Amantadine hydrochloride 100 mg/1 | CapsuleOral | Coupler LLC | 67046-1508 | 67046-1508-03 |
| Amantadine Hydrochloride | Amantadine hydrochloride 100 mg/1 | TabletOral | Zhejiang Jutai Pharmaceutical Co., Ltd. | 71765-009 | 71765-0009-01 |
| Amantadine Hydrochloride | Amantadine hydrochloride 50 mg/5mL | SolutionOral | American Health Packaging | 60687-797 | 60687-0797-56 |
| Amantadine Hydrochloride | Amantadine hydrochloride 50 mg/5mL | SolutionOral | Patrin Pharma, Inc. | 39328-530 | 39328-0530-1639328-0530-99 |
| Amantadine Hydrochloride | Amantadine hydrochloride 100 mg/1 | Capsule, Liquid filledOral | Strides Pharma Science Limited | 64380-862 | 64380-0862-0664380-0862-07 |
| Amantadine Hydrochloride | Amantadine hydrochloride 100 mg/1 | CapsuleOral | Rising Pharma Holdings, Inc. | 16571-834 | 16571-0834-0116571-0834-50 |
| amantadine hydrochloride | Amantadine hydrochloride 100 mg/1 | CapsuleOral | EPIC PHARMA LLC | 42806-716 | 42806-0716-0542806-0716-11 |
Other NDCs under ANDA 209047
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 HCL | Amantadine hydrochloride 100 mg/1 | CapsuleOral | Direct_Rx | 72189-412 |
| 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 |