Prescription drug · ANDA
Amantadine HCl (Amantadine hydrochloride) NDC 69452-142
Amantadine hydrochloride 100 mg/1 · Capsule, Liquid filled · Oral · Bionpharma Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69452-142-20 | 6945201422069452014220 | 100 CAPSULE, LIQUID FILLED in 1 BOTTLE (69452-142-20)Marketed from Aug 15, 2016 | |
| 69452-142-30 | 6945201423069452014230 | 500 CAPSULE, LIQUID FILLED in 1 BOTTLE (69452-142-30)Marketed from Aug 15, 2016 |
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 HCl
- Generic name (nonproprietary)
- amantadine hydrochloride
- Active ingredients
- Amantadine hydrochloride — 100 mg/1
- Dosage form
- Capsule, Liquid filled
- Route
- Oral
- Labeler
- Bionpharma Inc.NDC labeler code 69452
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078720
- Marketing start
- Listing expires
- Other FDA classes
- M2 Protein Inhibitors (Mechanism)
- Identifiers
- Product ID 69452-142_372af940-7fe9-4525-e063-6294a90ab417SPL ID 372af940-7fe9-4525-e063-6294a90ab417SPL set ID d6ca4d20-72c5-496c-9ac7-1f5cb407a742RxCUI 849389UNII M6Q1EO9TD0UPC 0369452142202
- 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
N469452014220followed by a unit qualifier and the quantityPackage 69452-0142-20. 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 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 …
Excerpt only. Read the full label for complete information.
About NDC 69452-142
- What is NDC 69452-142?
- 69452-142 is the product NDC for Amantadine HCl (amantadine hydrochloride), Amantadine hydrochloride 100 mg/1 capsule, liquid filled, listed with the FDA by Bionpharma Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Amantadine HCl (Amantadine hydrochloride).
- What is the active ingredient?
- Amantadine hydrochloride.
- Who is the labeler?
- Bionpharma Inc., NDC labeler code 69452. 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 HCl?
- 5 other product NDCs are listed under this name. See all Amantadine HCl NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Amantadine HCl 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 HCL | Amantadine hydrochloride 100 mg/1 | CapsuleOral | Direct RX | 72189-657 | 72189-0657-30 |
| Amantadine HCL | Amantadine hydrochloride 100 mg/1 | TabletOral | Direct_Rx | 72189-535 | 72189-0535-3072189-0535-90 |
| Amantadine HCL | Amantadine hydrochloride 100 mg/1 | CapsuleOral | Direct_Rx | 72189-412 | 72189-0412-30 |
| Amantadine HClamantadine hydrochloride | Amantadine hydrochloride 100 mg/1 | Capsule, Liquid filledOral | AvPAK | 50268-069 | 50268-0069-15 |
| Amantadine HClamantadine hydrochloride | Amantadine hydrochloride 100 mg/1 | Capsule, Liquid filledOral | AvKARE | 42291-125 | 42291-0125-50 |
Other NDCs under ANDA 078720
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 HClamantadine hydrochloride | Amantadine hydrochloride 100 mg/1 | Capsule, Liquid filledOral | AvKARE | 42291-125 |
| Amantadine HClamantadine hydrochloride | Amantadine hydrochloride 100 mg/1 | Capsule, Liquid filledOral | AvPAK | 50268-069 |