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NDC 65162-0649-48 Oxcarbazepine 300 mg/5mL Details
Oxcarbazepine 300 mg/5mL
Oxcarbazepine is a ORAL SUSPENSION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Amneal Pharmaceuticals LLC. The primary component is OXCARBAZEPINE.
Product Information
| NDC | 65162-0649 |
|---|---|
| Product ID | 65162-649_eb6369e3-0722-4d90-995c-87b6e33012dc |
| Associated GPIs | 72600046001820 |
| GCN Sequence Number | 033724 |
| GCN Sequence Number Description | oxcarbazepine ORAL SUSP 300 MG/5ML ORAL |
| HIC3 | H4B |
| HIC3 Description | ANTICONVULSANTS |
| GCN | 21723 |
| HICL Sequence Number | 011735 |
| HICL Sequence Number Description | OXCARBAZEPINE |
| Brand/Generic | Generic |
| Proprietary Name | Oxcarbazepine |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Oxcarbazepine |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | SUSPENSION |
| Route | ORAL |
| Active Ingredient Strength | 300 |
| Active Ingredient Units | mg/5mL |
| Substance Name | OXCARBAZEPINE |
| Labeler Name | Amneal Pharmaceuticals LLC |
| Pharmaceutical Class | Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA202961 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 65162-0649-48 (65162064948)
| NDC Package Code | 65162-649-48 |
|---|---|
| Billing NDC | 65162064948 |
| Package | 10 CUP, UNIT-DOSE in 1 TRAY (65162-649-48) / 5 mL in 1 CUP, UNIT-DOSE (65162-649-43) |
| Marketing Start Date | 2012-06-04 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |