Product NDC: | 52015-080 |
Proprietary Name: | Dificid |
Non Proprietary Name: | fidaxomicin |
Active Ingredient(s): | 200 mg/1 & nbsp; fidaxomicin |
Administration Route(s): | ORAL |
Dosage Form(s): | TABLET, FILM COATED |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 52015-080 |
Labeler Name: | Optimer Pharmaceuticals, Inc. |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | NDA201699 |
Marketing Category: | NDA |
Start Marketing Date: | 20110527 |
Package NDC: | 52015-080-01 |
Package Description: | 1 BOTTLE in 1 CARTON (52015-080-01) > 20 TABLET, FILM COATED in 1 BOTTLE |
NDC Code | 52015-080-01 |
Proprietary Name | Dificid |
Package Description | 1 BOTTLE in 1 CARTON (52015-080-01) > 20 TABLET, FILM COATED in 1 BOTTLE |
Product NDC | 52015-080 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | fidaxomicin |
Dosage Form Name | TABLET, FILM COATED |
Route Name | ORAL |
Start Marketing Date | 20110527 |
Marketing Category Name | NDA |
Labeler Name | Optimer Pharmaceuticals, Inc. |
Substance Name | FIDAXOMICIN |
Strength Number | 200 |
Strength Unit | mg/1 |
Pharmaceutical Classes | Macrolides [Chemical/Ingredient],Macrolide Antibacterial [EPC] |