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NDC 65162-0649-78 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.
MedlinePlus Drug Summary
Oxcarbazepine (Trileptal) is used alone or in combination with other medications to control certain types of seizures in adults and children. Oxcarbazepine extended-release tablets (Oxtellar XR) are used in combination with other medications to control certain types of seizures in adults and children 6 years of age and older. Oxcarbazepine is in a class of medications called anticonvulsants. It works by decreasing abnormal electrical activity in the brain.
Related Packages: 65162-0649-78Last Updated: 12/01/2022
MedLinePlus Full Drug Details: 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 65162-0649-78 (65162064978)
| NDC Package Code | 65162-649-78 |
|---|---|
| Billing NDC | 65162064978 |
| Package | 1 BOTTLE in 1 CARTON (65162-649-78) / 250 mL in 1 BOTTLE |
| Marketing Start Date | 2012-06-04 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 0.36019 |
| Pricing Unit | ML |
| Effective Date | 2024-02-21 |
| NDC Description | OXCARBAZEPINE 300 MG/5 ML SUSP |
| Pharmacy Type Indicator | C/I |
| OTC | N |
| Explanation Code | 1, 5 |
| Classification for Rate Setting | G |
| As of Date | 2024-02-21 |
This pricing file, entitled the NADAC (National Average Drug Acquisition
Cost) files, provide
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