Home NDC 49502-476-26 Pretomanid
Product NDC 49502-476
Requested package NDC 49502-476-26
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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N212862-001 PRETOMANID PRETOMANID 200MG TABLET / ORAL RLD, RS 2019-08-14
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 4 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 2 · 42 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 N212862-001 PRETOMANID 200MG TABLET / ORAL RLD, RS 2019-08-14 84e616aacf4f…2026-08-18 06:07:40 2026-07 N212862-001 PRETOMANID 200MG TABLET / ORAL RLD, RS 2019-08-14 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N212862-001 PRETOMANID 200MG TABLET / ORAL RLD, RS 2019-08-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212862-001 PRETOMANID 200MG TABLET / ORAL RLD, RS 2019-08-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N212862-001 PRETOMANID 200MG TABLET / ORAL RLD, RS 2019-08-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212862-001 PRETOMANID 200MG TABLET / ORAL RLD, RS 2019-08-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212862-001 PRETOMANID 200MG TABLET / ORAL RLD, RS 2019-08-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N212862-001 PRETOMANID 200MG TABLET / ORAL RLD, RS 2019-08-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N212862-001 PRETOMANID 200MG TABLET / ORAL RLD, RS 2019-08-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N212862-001 PRETOMANID 200MG TABLET / ORAL RLD, RS 2019-08-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N212862-001 PRETOMANID 200MG TABLET / ORAL RLD, RS 2019-08-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N212862-001 PRETOMANID 200MG TABLET / ORAL RLD, RS 2019-08-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N212862-001 PRETOMANID 200MG TABLET / ORAL RLD, RS 2019-08-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N212862-001 PRETOMANID 200MG TABLET / ORAL RLD, RS 2019-08-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N212862-001 PRETOMANID 200MG TABLET / ORAL RLD, RS 2019-08-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N212862-001 PRETOMANID 200MG TABLET / ORAL RLD, RS 2019-08-14 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N212862-001 PRETOMANID 200MG TABLET / ORAL RLD, RS 2019-08-14 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N212862-001 PRETOMANID 200MG TABLET / ORAL RLD, RS 2019-08-14 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N212862-001 PRETOMANID 200MG TABLET / ORAL RLD, RS 2019-08-14 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N212862-001 PRETOMANID 200MG TABLET / ORAL RLD, RS 2019-08-14 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N212862-001 PRETOMANID 200MG TABLET / ORAL RLD, RS 2019-08-14 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N212862-001 PRETOMANID 200MG TABLET / ORAL RLD, RS 2019-08-14 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N212862-001 PRETOMANID 200MG TABLET / ORAL RLD, RS 2019-08-14 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N212862-001 PRETOMANID 200MG TABLET / ORAL RLD, RS 2019-08-14 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N212862-001 PRETOMANID 200MG TABLET / ORAL RLD, RS 2019-08-14 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N212862-001 PRETOMANID 200MG TABLET / ORAL RLD, RS 2019-08-14 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N212862-001 PRETOMANID 200MG TABLET / ORAL RLD, RS 2019-08-14 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N212862-001 PRETOMANID 200MG TABLET / ORAL RLD, RS 2019-08-14 b00525d2431f…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N212862-001 PRETOMANID 200MG TABLET / ORAL RLD, RS 2019-08-14 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N212862-001 PRETOMANID 200MG TABLET / ORAL RLD, RS 2019-08-14 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N212862-001 PRETOMANID 200MG TABLET / ORAL RLD, RS 2019-08-14 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N212862-001 PRETOMANID 200MG TABLET / ORAL RLD, RS 2019-08-14 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N212862-001 PRETOMANID 200MG TABLET / ORAL RLD, RS 2019-08-14 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N212862-001 PRETOMANID 200MG TABLET / ORAL RLD, RS 2019-08-14 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N212862-001 PRETOMANID 200MG TABLET / ORAL RLD, RS 2019-08-14 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N212862-001 PRETOMANID 200MG TABLET / ORAL RLD, RS 2019-08-14 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N212862-001 PRETOMANID 200MG TABLET / ORAL RLD, RS 2019-08-14 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N212862-001 PRETOMANID 200MG TABLET / ORAL RLD, RS 2019-08-14 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N212862-001 PRETOMANID 200MG TABLET / ORAL RLD, RS 2019-08-14 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N212862-001 PRETOMANID 200MG TABLET / ORAL RLD, RS 2019-08-14 e64feba35796…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 4 · 126 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Pretomanid
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PRETOMANID 200 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2XOI31YC4N Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2198370 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 49502-476 PRETOMANID TABLET [VIATRIS SPECIALTY LLC] 13 Current NDC, Legacy NDC, 8 package rows 20250410_f1906fc9-cb3c-4e13-8a4a-da76100c1bf3.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 49502-476-26 49502047626 1 BOTTLE in 1 CARTON (49502-476-26) / 26 TABLET in 1 BOTTLE 1 bottle 2019-11-07 0000-00-00 No No Current