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NDC 59676-0701-01 SIRTURO 100 mg/1 Details
SIRTURO 100 mg/1
SIRTURO is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Janssen Products, LP. The primary component is BEDAQUILINE FUMARATE.
MedlinePlus Drug Summary
Bedaquiline is used along with at least three other medications to treat multi-drug resistant tuberculosis (MDR-TB; a serious infection that affects the lungs and other parts of the body and that cannot be treated with other medications that are usually used to treat the condition) in adults and children 5 years and older who weigh at least 33 lbs (15 kg) that has affected the lungs. Bedaquiline should not be used to treat TB that mainly affects other parts of the body. Bedaquiline is in a class of medications called anti-mycobacterials. It works by killing the bacteria that cause MDR-TB.
Related Packages: 59676-0701-01Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Bedaquiline
Product Information
| NDC | 59676-0701 |
|---|---|
| Product ID | 59676-701_07ec67e8-a3f2-a416-e063-6294a90a881e |
| Associated GPIs | 09000015100320 |
| GCN Sequence Number | 070413 |
| GCN Sequence Number Description | bedaquiline fumarate TABLET 100 MG ORAL |
| HIC3 | W1G |
| HIC3 Description | ANTITUBERCULAR ANTIBIOTICS |
| GCN | 33934 |
| HICL Sequence Number | 039895 |
| HICL Sequence Number Description | BEDAQUILINE FUMARATE |
| Brand/Generic | Brand |
| Proprietary Name | SIRTURO |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Bedaquiline Fumarate |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET |
| Route | ORAL |
| Active Ingredient Strength | 100 |
| Active Ingredient Units | mg/1 |
| Substance Name | BEDAQUILINE FUMARATE |
| Labeler Name | Janssen Products, LP |
| Pharmaceutical Class | Diarylquinoline Antimycobacterial [EPC], Diarylquinolines [CS] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA204384 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 59676-0701-01 (59676070101)
| NDC Package Code | 59676-701-01 |
|---|---|
| Billing NDC | 59676070101 |
| Package | 188 TABLET in 1 BOTTLE (59676-701-01) |
| Marketing Start Date | 2012-12-28 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |