Prescription drug · ANDA
Amantadine Hydrochloride NDC 17856-0646
Amantadine hydrochloride 50 mg/5mL · Solution · Oral · ATLANTIC BIOLOGICALS CORP.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 17856-0646-1 | 1785606460117856064601 | 72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0646-1) / 10 mL in 1 CUP, UNIT-DOSE (17856-0646-3)Marketed from Apr 8, 2024 | |
| 17856-0646-2 | 1785606460217856064602 | 72 CUP, UNIT-DOSE in 1 PACKAGE (17856-0646-2) / 5 mL in 1 CUP, UNIT-DOSE (17856-0646-4)Marketed from Apr 8, 2024 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 50 mg/5mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- ATLANTIC BIOLOGICALS CORP.NDC labeler code 17856
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 074509
- Marketing start
- Listing expires
- Other FDA classes
- M2 Protein Inhibitors (Mechanism)
- Identifiers
- Product ID 17856-0646_34f3552c-a90d-da9a-e063-6294a90a65a3SPL ID 34f3552c-a90d-da9a-e063-6294a90a65a3SPL set ID 6311b46b-23cc-40c1-93c2-f7c92606386fRxCUI 849385UNII 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
N417856064601followed by a unit qualifier and the quantityPackage 17856-0646-01. 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 oral solution USP is indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza A virus. Amantadine hydrochloride is also indicated in the treatment of parkinsonism and drug-induced extrapyramidal reactions. Influenza A Prophylaxis Amantadine hydrochloride is indicated for chemoprophylaxis against signs and symptoms of influenza A virus infection. Because amantadine hydrochloride 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 …
Excerpt only. Read the full label for complete information.
About NDC 17856-0646
- What is NDC 17856-0646?
- 17856-0646 is the product NDC for Amantadine Hydrochloride, Amantadine hydrochloride 50 mg/5mL solution, listed with the FDA by ATLANTIC BIOLOGICALS CORP.. 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?
- ATLANTIC BIOLOGICALS CORP., NDC labeler code 17856. 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 074509
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 50 mg/5mL | SolutionOral | PAI Holdings, LLC dba PAI Pharma | 0121-0646 |
| Amantadine Hydrochloride | Amantadine hydrochloride 50 mg/5mL | SolutionOral | Cardinal Health 107, LLC | 55154-9444 |
| Amantadine Hydrochloride | Amantadine hydrochloride 50 mg/5mL | SolutionOral | American Health Packaging | 60687-797 |