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NDC 52427-0816-01 Stalevo 25; 200; 100 mg/1; mg/1; mg/1 Details
Stalevo 25; 200; 100 mg/1; mg/1; mg/1
Stalevo is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Almatica Pharma LLC. The primary component is CARBIDOPA; ENTACAPONE; LEVODOPA.
MedlinePlus Drug Summary
Entacapone is an inhibitor of catechol-O-methyltransferase (COMT). It is used in combination with levodopa and carbidopa (Sinemet) to treat the end-of-dose 'wearing-off' symptoms of Parkinson's disease. Entacapone helps the levodopa and carbidopa work better by allowing more of it to reach the brain, where it has its effects. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.
Related Packages: 52427-0816-01Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Entacapone
The combination of levodopa and carbidopa is used to treat the symptoms of Parkinson's disease and Parkinson's-like symptoms that may develop after encephalitis (swelling of the brain) or injury to the nervous system caused by carbon monoxide poisoning or manganese poisoning. Parkinson's symptoms, including tremors (shaking), stiffness, and slowness of movement, are caused by a lack of dopamine, a natural substance usually found in the brain. Levodopa is in a class of medications called central nervous system agents. It works by being converted to dopamine in the brain. Carbidopa is in a class of medications called decarboxylase inhibitors. It works by preventing levodopa from being broken down before it reaches the brain. This allows for a lower dose of levodopa, which causes less nausea and vomiting.
Related Packages: 52427-0816-01Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Levodopa and Carbidopa
Product Information
| NDC | 52427-0816 |
|---|---|
| Product ID | 52427-816_3fb120cb-9592-2622-1136-949cddf4edca |
| Associated GPIs | 73209903300330 |
| GCN Sequence Number | 052881 |
| GCN Sequence Number Description | carbidopa/levodopa/entacapone TABLET 25-100-200 ORAL |
| HIC3 | H6A |
| HIC3 Description | ANTIPARKINSONISM DRUGS,OTHER |
| GCN | 20146 |
| HICL Sequence Number | 025476 |
| HICL Sequence Number Description | CARBIDOPA/LEVODOPA/ENTACAPONE |
| Brand/Generic | Brand |
| Proprietary Name | Stalevo |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | carbidopa, levodopa, and entacapone |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 25; 200; 100 |
| Active Ingredient Units | mg/1; mg/1; mg/1 |
| Substance Name | CARBIDOPA; ENTACAPONE; LEVODOPA |
| Labeler Name | Almatica Pharma LLC |
| Pharmaceutical Class | Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC], Catechol O-Methyltransferase Inhibitors [MoA], Catechol-O-Methyltransferase Inhibitor [EPC] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA021485 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 52427-0816-01 (52427081601)
| NDC Package Code | 52427-816-01 |
|---|---|
| Billing NDC | 52427081601 |
| Package | 1 BOTTLE in 1 CARTON (52427-816-01) / 100 TABLET, FILM COATED in 1 BOTTLE |
| Marketing Start Date | 2020-10-05 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |