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NDC 62135-0010-47 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 Chartwell RX, LLC. The primary component is AMANTADINE HYDROCHLORIDE.
Product Information
| NDC | 62135-0010 |
|---|---|
| Product ID | 62135-010_f1d7a3eb-c7dd-9b20-e053-2995a90a5f72 |
| Associated GPIs | |
| 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 | Chartwell RX, LLC |
| Pharmaceutical Class | Influenza A M2 Protein Inhibitor [EPC], M2 Protein Inhibitors [MoA] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA074028 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 62135-0010-47 (62135001047)
| NDC Package Code | 62135-010-47 |
|---|---|
| Billing NDC | 62135001047 |
| Package | 473 mL in 1 BOTTLE (62135-010-47) |
| Marketing Start Date | 2022-12-13 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |