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NDC 55150-0246-47 Levetiracetam 500 mg/100mL Details
Levetiracetam 500 mg/100mL
Levetiracetam is a INTRAVENOUS INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Eugia US LLC. 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: 55150-0246-47Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Levetiracetam Injection
Product Information
| NDC | 55150-0246 |
|---|---|
| Product ID | 55150-246_c2b8749d-192a-44e6-8389-04352ab9c3eb |
| Associated GPIs | 72600043052020 |
| GCN Sequence Number | 068393 |
| GCN Sequence Number Description | levetiracetam in NaCl (iso-os) PIGGYBACK 500MG/0.1L INTRAVEN |
| HIC3 | H4B |
| HIC3 Description | ANTICONVULSANTS |
| GCN | 31167 |
| HICL Sequence Number | 038373 |
| HICL Sequence Number Description | LEVETIRACETAM IN SODIUM CHLORIDE, ISO-OSMOTIC |
| Brand/Generic | Generic |
| Proprietary Name | Levetiracetam |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Levetiracetam in sodium chloride |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, SOLUTION |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 500 |
| Active Ingredient Units | mg/100mL |
| Substance Name | LEVETIRACETAM |
| Labeler Name | Eugia US LLC |
| Pharmaceutical Class | Decreased Central Nervous System Disorganized Electrical Activity [PE] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA207160 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 55150-0246-47 (55150024647)
| NDC Package Code | 55150-246-47 |
|---|---|
| Billing NDC | 55150024647 |
| Package | 10 POUCH in 1 CARTON (55150-246-47) / 1 BAG in 1 POUCH / 100 mL in 1 BAG |
| Marketing Start Date | 2017-01-04 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |