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NDC 52427-0800-01 Comtan 200 mg/1 Details
Comtan 200 mg/1
Comtan 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 ENTACAPONE.
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: 52427-0800-01Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Entacapone
Product Information
| NDC | 52427-0800 |
|---|---|
| Product ID | 52427-800_08339349-877e-5342-c14a-6ebb83f3f063 |
| Associated GPIs | 73153030000320 |
| GCN Sequence Number | 041199 |
| GCN Sequence Number Description | entacapone TABLET 200 MG ORAL |
| HIC3 | H6A |
| HIC3 Description | ANTIPARKINSONISM DRUGS,OTHER |
| GCN | 95079 |
| HICL Sequence Number | 018950 |
| HICL Sequence Number Description | ENTACAPONE |
| Brand/Generic | Brand |
| Proprietary Name | Comtan |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | entacapone |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 200 |
| Active Ingredient Units | mg/1 |
| Substance Name | ENTACAPONE |
| Labeler Name | Almatica Pharma LLC |
| Pharmaceutical Class | Catechol O-Methyltransferase Inhibitors [MoA], Catechol-O-Methyltransferase Inhibitor [EPC] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA020796 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 52427-0800-01 (52427080001)
| NDC Package Code | 52427-800-01 |
|---|---|
| Billing NDC | 52427080001 |
| Package | 1 BOTTLE in 1 CARTON (52427-800-01) / 100 TABLET, FILM COATED in 1 BOTTLE |
| Marketing Start Date | 2020-10-05 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |