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NDC 43485-0104-60 Spritam 1000 mg/1 Details
Spritam 1000 mg/1
Spritam is a ORAL TABLET, FOR SUSPENSION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Aprecia Pharmaceuticals, 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: 43485-0104-60Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Levetiracetam
Product Information
| NDC | 43485-0104 |
|---|---|
| Product ID | 43485-104_46576ffa-6af6-4d6c-8e83-62df0bbd7ca0 |
| Associated GPIs | 7260004300G850 |
| GCN Sequence Number | 075622 |
| GCN Sequence Number Description | levetiracetam TAB SUSP 1000 MG ORAL |
| HIC3 | H4B |
| HIC3 Description | ANTICONVULSANTS |
| GCN | 36266 |
| HICL Sequence Number | 020952 |
| HICL Sequence Number Description | LEVETIRACETAM |
| Brand/Generic | Brand |
| Proprietary Name | Spritam |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | levetiracetam |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, FOR SUSPENSION |
| Route | ORAL |
| Active Ingredient Strength | 1000 |
| Active Ingredient Units | mg/1 |
| Substance Name | LEVETIRACETAM |
| Labeler Name | Aprecia Pharmaceuticals, LLC |
| Pharmaceutical Class | Decreased Central Nervous System Disorganized Electrical Activity [PE] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA207958 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 43485-0104-60 (43485010460)
| NDC Package Code | 43485-104-60 |
|---|---|
| Billing NDC | 43485010460 |
| Package | 60 BLISTER PACK in 1 CARTON (43485-104-60) / 1 TABLET, FOR SUSPENSION in 1 BLISTER PACK (43485-104-01) |
| Marketing Start Date | 2016-02-05 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |