Prescription drug · ANDA
Amantadine Hydrochloride NDC 10135-693
Amantadine hydrochloride 100 mg/1 · Capsule, Gelatin coated · Oral · Marlex Pharmaceuticals Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 10135-693-01 | 1013506930110135069301 | 100 CAPSULE, GELATIN COATED in 1 BOTTLE (10135-693-01)Marketed from Mar 1, 2020 | |
| 10135-693-05 | 1013506930510135069305 | 500 CAPSULE, GELATIN COATED in 1 BOTTLE (10135-693-05)Marketed from Mar 1, 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 Hydrochloride
- Generic name (nonproprietary)
- amantadine hydrochloride
- Active ingredients
- Amantadine hydrochloride — 100 mg/1
- Dosage form
- Capsule, Gelatin coated
- Route
- Oral
- Labeler
- Marlex Pharmaceuticals IncNDC labeler code 10135
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210129
- Marketing start
- Listing expires
- Other FDA classes
- M2 Protein Inhibitors (Mechanism)
- Identifiers
- Product ID 10135-693_3e752827-026e-d525-e063-6394a90a7e80SPL ID 3e752827-026e-d525-e063-6394a90a7e80SPL set ID 25af52ee-9b29-4c07-a383-62d4537b63e0RxCUI 849389, 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
N410135069301followed by a unit qualifier and the quantityPackage 10135-0693-01. 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 are indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza A virus. Amantadine Hydrochloride are also indicated in the treatment of Parkinsonism and drug-induced extrapyramidal reactions. Influenza a Prophylaxis Amantadine Hydrochloride are indicated for chemoprophylaxis against signs and symptoms of influenza a virus infection. Because Amantadine Hydrochloride 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 protected when later exposed to antige…
Excerpt only. Read the full label for complete information.
About NDC 10135-693
- What is NDC 10135-693?
- 10135-693 is the product NDC for Amantadine Hydrochloride, Amantadine hydrochloride 100 mg/1 capsule, gelatin coated, listed with the FDA by Marlex Pharmaceuticals 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?
- Marlex Pharmaceuticals Inc, NDC labeler code 10135. 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 210129
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 | 72189-657 |
| Amantadine Hydrochloride | Amantadine hydrochloride 100 mg/1 | CapsuleOral | Rising Pharma Holdings, Inc. | 16571-834 |