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NDC 00121-0646-10 AMANTADINE HYDROCHLORIDE 50 mg/5mL Details
AMANTADINE HYDROCHLORIDE 50 mg/5mL
AMANTADINE HYDROCHLORIDE is a ORAL SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by PAI Holdings, LLC. The primary component is AMANTADINE HYDROCHLORIDE.
MedlinePlus Drug Summary
Amantadine is used to treat the symptoms of Parkinson's disease (PD; a disorder of the nervous system that causes difficulties with movement, muscle control, and balance) and other similar conditions. It is also used to control movement problems that are a side effect of certain medications used to treat Parkinson's disease. Amantadine extended-release capsules (Gocovri) are used along with the combination of levodopa and carbidopa (Rytary, Sinemet) to treat ''off'' episodes (times of difficulty moving, walking, and speaking that may happen when other medications wear off) in people with Parkinson's disease. It also is used to prevent symptoms of influenza A virus infection and for treatment of respiratory infections caused by influenza A virus. Amantadine is in a class of medications called adamantanes. It is thought to work to control movement problems by increasing the amount of dopamine in certain parts of the body. It works against influenza A virus by stopping the spread of the virus in the body.
Related Packages: 00121-0646-10Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Amantadine
Product Information
| NDC | 00121-0646 |
|---|---|
| Product ID | 0121-0646_0bb9609d-2d23-44e8-9134-03515a2f00a9 |
| Associated GPIs | 73200010102005 |
| GCN Sequence Number | 004576 |
| GCN Sequence Number Description | amantadine HCl SOLUTION 50 MG/5 ML ORAL |
| HIC3 | H6A |
| HIC3 Description | ANTIPARKINSONISM DRUGS,OTHER |
| GCN | 17530 |
| HICL Sequence Number | 001898 |
| HICL Sequence Number Description | AMANTADINE HCL |
| Brand/Generic | Generic |
| Proprietary Name | AMANTADINE HYDROCHLORIDE |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | AMANTADINE HYDROCHLORIDE |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | SOLUTION |
| Route | ORAL |
| Active Ingredient Strength | 50 |
| Active Ingredient Units | mg/5mL |
| Substance Name | AMANTADINE HYDROCHLORIDE |
| Labeler Name | PAI Holdings, LLC |
| Pharmaceutical Class | Influenza A M2 Protein Inhibitor [EPC], M2 Protein Inhibitors [MoA] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA074509 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00121-0646-10 (00121064610)
| NDC Package Code | 0121-0646-10 |
|---|---|
| Billing NDC | 00121064610 |
| Package | 10 TRAY in 1 CASE (0121-0646-10) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE |
| Marketing Start Date | 1995-07-17 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |