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NDC 39822-4000-01 Levetiracetam 500 mg/5mL Details
Levetiracetam 500 mg/5mL
Levetiracetam is a INTRAVENOUS INJECTION, SOLUTION, CONCENTRATE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by XGen Pharmaceuticals DJB, Inc.. The primary component is LEVETIRACETAM.
MedlinePlus Drug Summary
Levetiracetam injection 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 who cannot take oral medications. Levetiracetam injection is also used in combination with other medications to treat seizures in adults and children 12 years of age or older with juvenile myoclonic epilepsy who cannot take oral medications. Levetiracetam injection 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 who cannot take oral medications. Levetiracetam is in a class of medications called anticonvulsants. It works by decreasing abnormal excitement in the brain.
Related Packages: 39822-4000-01Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Levetiracetam Injection
Product Information
| NDC | 39822-4000 |
|---|---|
| Product ID | 39822-4000_eedc47c0-5515-3069-e053-2995a90a0226 |
| Associated GPIs | 72600043002060 |
| GCN Sequence Number | 061005 |
| GCN Sequence Number Description | levetiracetam VIAL 500 MG/5ML INTRAVEN |
| HIC3 | H4B |
| HIC3 Description | ANTICONVULSANTS |
| GCN | 27163 |
| 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 | INJECTION, SOLUTION, CONCENTRATE |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 500 |
| Active Ingredient Units | mg/5mL |
| Substance Name | LEVETIRACETAM |
| Labeler Name | XGen Pharmaceuticals DJB, Inc. |
| Pharmaceutical Class | Decreased Central Nervous System Disorganized Electrical Activity [PE] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA091485 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 39822-4000-01 (39822400001)
| NDC Package Code | 39822-4000-1 |
|---|---|
| Billing NDC | 39822400001 |
| Package | 5 mL in 1 VIAL (39822-4000-1) |
| Marketing Start Date | 2011-08-05 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |