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NDC 75834-0245-05 Levetiracetam Extended Release 500 mg/1 Details
Levetiracetam Extended Release 500 mg/1
Levetiracetam Extended Release is a ORAL TABLET, FILM COATED, EXTENDED RELEASE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Nivagen Pharmaceuticals, Inc.. The primary component is LEVETIRACETAM.
MedlinePlus Drug Summary
Levetiracetam is used alone and along with other medications to control partial-onset seizures (seizures that involve only one part of the brain) in adults, children, and infants 1 month of age or older. Levetiracetam is also used in combination with other medications to treat seizure in adults and children 12 years of age or older with juvenile myoclonic epilepsy. Levetiracetam is also used in combination with other medications to treat primary generalized tonic-clonic seizures (formerly known as a grand mal seizure; seizure that involves the entire body) in adults and children 6 years of age or older with epilepsy. Levetiracetam is in a class of medications called anticonvulsants. It works by decreasing abnormal excitement in the brain.
Related Packages: 75834-0245-05Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Levetiracetam
Product Information
| NDC | 75834-0245 |
|---|---|
| Product ID | 75834-245_fb43800c-896d-4333-8854-37e4d14c7390 |
| Associated GPIs | 72600043007520 |
| GCN Sequence Number | 064416 |
| GCN Sequence Number Description | levetiracetam TAB ER 24H 500 MG ORAL |
| HIC3 | H4B |
| HIC3 Description | ANTICONVULSANTS |
| GCN | 14305 |
| HICL Sequence Number | 020952 |
| HICL Sequence Number Description | LEVETIRACETAM |
| Brand/Generic | Generic |
| Proprietary Name | Levetiracetam Extended Release |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Levetiracetam |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, FILM COATED, EXTENDED RELEASE |
| Route | ORAL |
| Active Ingredient Strength | 500 |
| Active Ingredient Units | mg/1 |
| Substance Name | LEVETIRACETAM |
| Labeler Name | Nivagen Pharmaceuticals, Inc. |
| Pharmaceutical Class | Decreased Central Nervous System Disorganized Electrical Activity [PE] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA201464 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 75834-0245-05 (75834024505)
| NDC Package Code | 75834-245-05 |
|---|---|
| Billing NDC | 75834024505 |
| Package | 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (75834-245-05) |
| Marketing Start Date | 2020-09-16 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |