What is NDC 49502-476?

49502-476 is the product NDC for Pretomanid, Pretomanid 200 mg/1 tablet, listed with the FDA by Viatris Specialty LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Viatris Specialty LLC, NDC labeler code 49502. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Pretomanid?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Pretomanid NDC 49502-476 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)49502-476Labeler and product segments. Claims need a package NDC.

Product NDC at billing width49502-0476Add 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
49502-476-26	49502047626	1 BOTTLE in 1 CARTON (49502-476-26) / 26 TABLET in 1 BOTTLEMarketed from Nov 7, 2019

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): Pretomanid
Generic name (nonproprietary): pretomanid
Active ingredients: Pretomanid — 200 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Viatris Specialty LLCNDC labeler code 49502
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 212862
Marketing start: Nov 7, 2019
Listing expires: Dec 31, 2026
Other FDA classes: Organic Anion Transporter 3 Inhibitors (Mechanism)
Identifiers: Product ID 49502-476_99ba96bb-da73-4082-bb81-c573f6019013SPL ID 99ba96bb-da73-4082-bb81-c573f6019013SPL set ID f1906fc9-cb3c-4e13-8a4a-da76100c1bf3RxCUI 2198370UNII 2XOI31YC4N
Pharmacologic class: 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

N449502047626 followed by a unit qualifier and the quantity

Package 49502-0476-26. 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 Nov 15, 2024.

Indications (excerpt from the label)

Limited Population: Pretomanid Tablet is indicated, as part of a combination regimen with bedaquiline and linezolid for the treatment of adults with pulmonary tuberculosis (TB) resistant to isoniazid, rifamycins, a fluoroquinolone and a second line injectable antibacterial drug OR adults with pulmonary TB resistant to isoniazid and rifampin, who are treatment-intolerant or nonresponsive to standard therapy. Approval of this indication is based on limited clinical safety and efficacy data. This drug is indicated for use in a limited and specific population of patients. Limitations of Use: • Pretomanid Tablets are not indicated in patients with: o Drug-sensitive (DS) TB o Latent infection due …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 49502-476

What is NDC 49502-476?: 49502-476 is the product NDC for Pretomanid, Pretomanid 200 mg/1 tablet, listed with the FDA by Viatris Specialty LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Pretomanid.
What is the active ingredient?: Pretomanid.
Who is the labeler?: Viatris Specialty LLC, NDC labeler code 49502. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Pretomanid?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.