pretomanid

Generic: pretomanid

Labeler: viatris specialty llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name pretomanid
Generic Name pretomanid
Labeler viatris specialty llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

pretomanid 200 mg/1

Manufacturer
Viatris Specialty LLC

Identifiers & Regulatory

Product NDC 49502-476
Product ID 49502-476_99ba96bb-da73-4082-bb81-c573f6019013
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA212862
Listing Expiration 2026-12-31
Marketing Start 2019-11-07

Pharmacologic Class

Established (EPC)
antimycobacterial [epc]
Mechanism of Action
organic anion transporter 3 inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 49502476
Hyphenated Format 49502-476

Supplemental Identifiers

RxCUI
2198370
UNII
2XOI31YC4N
NUI
N0000175483 N0000190111

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name pretomanid (source: ndc)
Generic Name pretomanid (source: ndc)
Application Number NDA212862 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (49502-476-26) / 26 TABLET in 1 BOTTLE
source: ndc

Packages (1)

49502-476-26 1 BOTTLE in 1 CARTON (49502-476-26) / 26 TABLET in 1 BOTTLE

Ingredients (1)

pretomanid (200 mg/1)

Linked Drug Pages (1)

Pretomanid ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "99ba96bb-da73-4082-bb81-c573f6019013", "openfda": {"nui": ["N0000175483", "N0000190111"], "unii": ["2XOI31YC4N"], "rxcui": ["2198370"], "spl_set_id": ["f1906fc9-cb3c-4e13-8a4a-da76100c1bf3"], "pharm_class_epc": ["Antimycobacterial [EPC]"], "pharm_class_moa": ["Organic Anion Transporter 3 Inhibitors [MoA]"], "manufacturer_name": ["Viatris Specialty LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (49502-476-26)  / 26 TABLET in 1 BOTTLE", "package_ndc": "49502-476-26", "marketing_start_date": "20191107"}], "brand_name": "Pretomanid", "product_id": "49502-476_99ba96bb-da73-4082-bb81-c573f6019013", "dosage_form": "TABLET", "pharm_class": ["Antimycobacterial [EPC]", "Organic Anion Transporter 3 Inhibitors [MoA]"], "product_ndc": "49502-476", "generic_name": "Pretomanid", "labeler_name": "Viatris Specialty LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Pretomanid", "active_ingredients": [{"name": "PRETOMANID", "strength": "200 mg/1"}], "application_number": "NDA212862", "marketing_category": "NDA", "marketing_start_date": "20191107", "listing_expiration_date": "20261231"}