Product NDC: | 54092-173 |
Proprietary Name: | Carbatrol |
Non Proprietary Name: | carbamazepine |
Active Ingredient(s): | 300 mg/1 & nbsp; carbamazepine |
Administration Route(s): | ORAL |
Dosage Form(s): | CAPSULE, EXTENDED RELEASE |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 54092-173 |
Labeler Name: | Shire US Manufacturing Inc. |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | NDA020712 |
Marketing Category: | NDA |
Start Marketing Date: | 19970930 |
Package NDC: | 54092-173-12 |
Package Description: | 120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (54092-173-12) |
NDC Code | 54092-173-12 |
Proprietary Name | Carbatrol |
Package Description | 120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (54092-173-12) |
Product NDC | 54092-173 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | carbamazepine |
Dosage Form Name | CAPSULE, EXTENDED RELEASE |
Route Name | ORAL |
Start Marketing Date | 19970930 |
Marketing Category Name | NDA |
Labeler Name | Shire US Manufacturing Inc. |
Substance Name | CARBAMAZEPINE |
Strength Number | 300 |
Strength Unit | mg/1 |
Pharmaceutical Classes | Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] |