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NDC 00121-4799-50 Levetiracetam 500 mg/5mL Details
Levetiracetam 500 mg/5mL
Levetiracetam is a ORAL SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by PAI Holdings, LLC. 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: 00121-4799-50Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Levetiracetam
Product Information
| NDC | 00121-4799 |
|---|---|
| Product ID | 0121-4799_abe070cf-8f58-41df-8b24-572a80d0a128 |
| Associated GPIs | 72600043002020 |
| GCN Sequence Number | 064819 |
| GCN Sequence Number Description | levetiracetam SOLUTION 500 MG/5ML ORAL |
| HIC3 | H4B |
| HIC3 Description | ANTICONVULSANTS |
| GCN | 16779 |
| HICL Sequence Number | 020952 |
| HICL Sequence Number Description | LEVETIRACETAM |
| Brand/Generic | Generic |
| Proprietary Name | Levetiracetam |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | LEVETIRACETAM |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | SOLUTION |
| Route | ORAL |
| Active Ingredient Strength | 500 |
| Active Ingredient Units | mg/5mL |
| Substance Name | LEVETIRACETAM |
| Labeler Name | PAI Holdings, LLC |
| Pharmaceutical Class | Decreased Central Nervous System Disorganized Electrical Activity [PE] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA201157 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00121-4799-50 (00121479950)
| NDC Package Code | 0121-4799-50 |
|---|---|
| Billing NDC | 00121479950 |
| Package | 5 TRAY in 1 CASE (0121-4799-50) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-4799-05) |
| Marketing Start Date | 2020-05-28 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |