Pretomanid

Product NDC
49502-476
11-digit product format
495020476
Labeler code
49502
Product ID
49502-476_99ba96bb-da73-4082-bb81-c573f6019013
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pretomanid
Dosage form
TABLET
Route
ORAL
Labeler
Viatris Specialty LLC
Application
NDA212862
Marketing category
NDA
Marketing start
2019-11-07
Substance
PRETOMANID
Active strength
200 mg/1
Pharmacologic classes
Antimycobacterial [EPC], Organic Anion Transporter 3 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Pretomanid
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PRETOMANID200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2XOI31YC4N
Rxcui2198370

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
455fcb39-5071-40c0-9e85-28c1336854f2Product name120200128

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49502-476-14Pretomanid14 in 1 CARTONTABLET1413
49502-476-26Pretomanid1 in 1 CARTONTABLET113
49502-476-26Pretomanid26 in 1 BOTTLETABLET2613
49502-476-29Pretomanid100 in 1 CARTONTABLET10013
49502-476-32Pretomanid1 in 1 BLISTER PACKTABLET113
49502-476-33Pretomanid1 in 1 BLISTER PACKTABLET113
49502-476-72Pretomanid1 in 1 CARTONTABLET113
49502-476-72Pretomanid182 in 1 BOTTLETABLET18213

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49502-476-26EA - Each49502-476d27a3da0-4e01-447d-9520-b16c66f1a99012019-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49502-476PRETOMANID TABLET [VIATRIS SPECIALTY LLC]13Current NDC, Legacy NDC, 8 package rows20250410_f1906fc9-cb3c-4e13-8a4a-da76100c1bf3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2198370pretomanid 200 MG Oral TabletPSNf1906fc9-cb3c-4e13-8a4a-da76100c1bf313
2198370pretomanid 200 MG Oral TabletSCDf1906fc9-cb3c-4e13-8a4a-da76100c1bf313

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49502-476-144950204761414 in 1 CARTONHistorical
49502-476-26495020476261 BOTTLE in 1 CARTON (49502-476-26) / 26 TABLET in 1 BOTTLE1 bottle2019-11-070000-00-00NoNoCurrent
49502-476-2949502047629100 in 1 CARTONHistorical
49502-476-32495020476321 in 1 BLISTER PACKHistorical
49502-476-33495020476331 in 1 BLISTER PACKHistorical
49502-476-72495020476721 in 1 CARTONHistorical