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SIRTURO
SIRTURO - 59676-701-01 - (Bedaquiline Fumarate)
Drug Information of SIRTURO
| Product NDC: | 59676-701 |
| Proprietary Name: | SIRTURO |
| Non Proprietary Name: | Bedaquiline Fumarate |
| Active Ingredient(s): | 100 mg/1 & nbsp; Bedaquiline Fumarate |
| Administration Route(s): | ORAL |
| Dosage Form(s): | TABLET |
| Coding System: | National Drug Codes(NDC) |
Labeler Information of SIRTURO
| Product NDC: | 59676-701 |
| Labeler Name: | Janssen Products, LP |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA204384 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20121228 |
Package Information of SIRTURO
| Package NDC: | 59676-701-01 |
| Package Description: | 188 TABLET in 1 BOTTLE (59676-701-01) |
NDC Information of SIRTURO
| NDC Code | 59676-701-01 |
| Proprietary Name | SIRTURO |
| Package Description | 188 TABLET in 1 BOTTLE (59676-701-01) |
| Product NDC | 59676-701 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | Bedaquiline Fumarate |
| Dosage Form Name | TABLET |
| Route Name | ORAL |
| Start Marketing Date | 20121228 |
| Marketing Category Name | NDA |
| Labeler Name | Janssen Products, LP |
| Substance Name | BEDAQUILINE FUMARATE |
| Strength Number | 100 |
| Strength Unit | mg/1 |
| Pharmaceutical Classes |
