Sirturo (bedaquiline fumarate) NDC 59676-702

NDC codes

FDA NDC Directory

Product NDC (as listed)59676-702Labeler and product segments. Claims need a package NDC.

Product NDC at billing width59676-0702Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
59676-702-60	59676070260	60 TABLET in 1 BOTTLE (59676-702-60)Marketed from May 27, 2020

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Sirturo
Generic name (nonproprietary): bedaquiline fumarate
Active ingredients: Bedaquiline fumarate — 20 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Janssen Products, LP
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 204384
Marketing start: May 27, 2020
Listing expires: Dec 31, 2026
Other FDA classes: Diarylquinolines (Chemical structure)
Identifiers: Product ID 59676-702_415acee9-3121-56fb-e063-6394a90a9d83SPL ID 415acee9-3121-56fb-e063-6394a90a9d83SPL set ID 1534c9ae-4948-4cf4-9f66-222a99db6d0eRxCUI 1364509, 1364515, 2373939, 2373941UNII P04QX2C1A5UPC 0359676701019, 0359676702603
Pharmacologic class: Diarylquinoline Antimycobacterial

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N459676070260 followed by a unit qualifier and the quantity

Package 59676-0702-60. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Oct 17, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

SIRTURO is a diarylquinoline antimycobacterial drug indicated as part of combination therapy in the treatment of adult and pediatric patients (2 years and older and weighing at least 8 kg) with pulmonary tuberculosis (TB) due to Mycobacterium tuberculosis resistant to at least rifampin and isoniazid. SIRTURO is a diarylquinoline antimycobacterial drug indicated as part of combination therapy in adult and pediatric patients (2 years and older and weighing at least 8 kg) with pulmonary tuberculosis (TB) due to Mycobacterium tuberculosis resistant to at least rifampin and isoniazid. ( 1 ) Limitations of Use : Do not use SIRTURO for the treatment of latent, extra-pulmonary or drug-sensitive TB o…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 204384

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 204384
Product	Strength	Form · route	Labeler	Product NDC
Sirturobedaquiline fumarate	Bedaquiline fumarate 100 mg/1	TabletOral	Janssen Products, LP	59676-701