Home NDC 50072-200-42 TPOXX
Product NDC 50072-200
Requested package NDC 50072-200-42
11-digit product format 500720200
Labeler code 50072
Product ID 50072-200_474526fb-5357-880e-e063-6294a90a3296
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name tecovirimat monohydrate
Dosage form CAPSULE
Route ORAL
Labeler SIGA Technologies, Inc.
Application NDA208627
Marketing category NDA
Marketing start 2018-08-31
Substance TECOVIRIMAT MONOHYDRATE
Active strength 200 mg/1
Pharmacologic classes Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Orthopoxvirus VP37 Envelope Wrapping Protein Inhibitor [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 50072-200 50072-200-42 I Inactivated by FDA excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 50072-200 50072-200-42 I Inactivated by FDA excluded / ndc_excluded.zip f5e01cc5f278…a2eaf40c39c3…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 N208627-001 TPOXX TECOVIRIMAT 200MG CAPSULE / ORAL RLD, RS 2018-07-13
Orange Book patents# Current patent rows page 1 of 1 · 5 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N208627-001 8039504 2027-07-23 Drug product 2018-08-09 N208627-001 12433868 2031-03-23 Drug product 2025-10-17 N208627-001 9339466 2031-03-23 Drug substance, Drug product 2018-08-09 N208627-001 7737168 2031-09-04 U-2346 2018-08-09 N208627-001 11890270 2032-08-08 U-2346 2024-02-27
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 · 41 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 2026-02-19 14:30 UTC 2026-02 N208627-001 TPOXX 200MG CAPSULE / ORAL RLD, RS 2018-07-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208627-001 TPOXX 200MG CAPSULE / ORAL RLD, RS 2018-07-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N208627-001 TPOXX 200MG CAPSULE / ORAL RLD, RS 2018-07-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208627-001 TPOXX 200MG CAPSULE / ORAL RLD, RS 2018-07-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208627-001 TPOXX 200MG CAPSULE / ORAL RLD, RS 2018-07-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208627-001 TPOXX 200MG CAPSULE / ORAL RLD, RS 2018-07-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208627-001 TPOXX 200MG CAPSULE / ORAL RLD, RS 2018-07-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208627-001 TPOXX 200MG CAPSULE / ORAL RLD, RS 2018-07-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208627-001 TPOXX 200MG CAPSULE / ORAL RLD, RS 2018-07-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N208627-001 TPOXX 200MG CAPSULE / ORAL RLD, RS 2018-07-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N208627-001 TPOXX 200MG CAPSULE / ORAL RLD, RS 2018-07-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N208627-001 TPOXX 200MG CAPSULE / ORAL RLD, RS 2018-07-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N208627-001 TPOXX 200MG CAPSULE / ORAL RLD, RS 2018-07-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N208627-001 TPOXX 200MG CAPSULE / ORAL RLD, RS 2018-07-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N208627-001 TPOXX 200MG CAPSULE / ORAL RLD, RS 2018-07-13 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N208627-001 TPOXX 200MG CAPSULE / ORAL RLD, RS 2018-07-13 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N208627-001 TPOXX 200MG CAPSULE / ORAL RLD, RS 2018-07-13 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N208627-001 TPOXX 200MG CAPSULE / ORAL RLD, RS 2018-07-13 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N208627-001 TPOXX 200MG CAPSULE / ORAL RLD, RS 2018-07-13 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N208627-001 TPOXX 200MG CAPSULE / ORAL RLD, RS 2018-07-13 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N208627-001 TPOXX 200MG CAPSULE / ORAL RLD, RS 2018-07-13 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N208627-001 TPOXX 200MG CAPSULE / ORAL RLD, RS 2018-07-13 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N208627-001 TPOXX 200MG CAPSULE / ORAL RLD, RS 2018-07-13 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N208627-001 TPOXX 200MG CAPSULE / ORAL RLD, RS 2018-07-13 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N208627-001 TPOXX 200MG CAPSULE / ORAL RLD, RS 2018-07-13 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N208627-001 TPOXX 200MG CAPSULE / ORAL RLD, RS 2018-07-13 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N208627-001 TPOXX 200MG CAPSULE / ORAL RLD, RS 2018-07-13 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N208627-001 TPOXX 200MG CAPSULE / ORAL RLD, RS 2018-07-13 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N208627-001 TPOXX 200MG CAPSULE / ORAL RLD, RS 2018-07-13 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N208627-001 TPOXX 200MG CAPSULE / ORAL RLD, RS 2018-07-13 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N208627-001 TPOXX 200MG CAPSULE / ORAL RLD, RS 2018-07-13 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N208627-001 TPOXX 200MG CAPSULE / ORAL RLD, RS 2018-07-13 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N208627-001 TPOXX 200MG CAPSULE / ORAL RLD, RS 2018-07-13 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N208627-001 TPOXX 200MG CAPSULE / ORAL RLD, RS 2018-07-13 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N208627-001 TPOXX 200MG CAPSULE / ORAL RLD, RS 2018-07-13 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N208627-001 TPOXX 200MG CAPSULE / ORAL RLD, RS 2018-07-13 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N208627-001 TPOXX 200MG CAPSULE / ORAL RLD, RS 2018-07-13 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N208627-001 TPOXX 200MG CAPSULE / ORAL RLD, RS 2018-07-13 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N208627-001 TPOXX 200MG CAPSULE / ORAL RLD, RS 2018-07-13 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N208627-001 TPOXX 200MG CAPSULE / ORAL RLD, RS 2018-07-13 cb3db0bc1861…
Observed Orange Book patent history# Patent history page 1 of 6 · 223 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N208627-001 8039504 2027-07-23 Drug product 2018-08-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208627-001 12433868 2031-03-23 Drug product 2025-10-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208627-001 9339466 2031-03-23 Drug substance, Drug product 2018-08-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208627-001 7737168 2031-09-04 U-2346 2018-08-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208627-001 11890270 2032-08-08 U-2346 2024-02-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208627-001 8039504 2027-07-23 Drug product 2018-08-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208627-001 12433868 2031-03-23 Drug product 2025-10-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208627-001 9339466 2031-03-23 Drug substance, Drug product 2018-08-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208627-001 7737168 2031-09-04 U-2346 2018-08-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208627-001 11890270 2032-08-08 U-2346 2024-02-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N208627-001 8039504 2027-07-23 Drug product 2018-08-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208627-001 9339466 2031-03-23 Drug substance, Drug product 2018-08-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208627-001 7737168 2031-09-04 U-2346 2018-08-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208627-001 11890270 2032-08-08 U-2346 2024-02-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208627-001 8039504 2027-07-23 Drug product 2018-08-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208627-001 9339466 2031-03-23 Drug substance, Drug product 2018-08-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208627-001 7737168 2031-09-04 U-2346 2018-08-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208627-001 11890270 2032-08-08 U-2346 2024-02-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208627-001 8039504 2027-07-23 Drug product 2018-08-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208627-001 9339466 2031-03-23 Drug substance, Drug product 2018-08-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208627-001 7737168 2031-09-04 U-2346 2018-08-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208627-001 11890270 2032-08-08 U-2346 2024-02-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208627-001 8124643 2024-06-18 Drug substance, Drug product 2018-08-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208627-001 8039504 2027-07-23 Drug product 2018-08-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208627-001 9339466 2031-03-23 Drug substance, Drug product 2018-08-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208627-001 7737168 2031-09-04 U-2346 2018-08-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208627-001 11890270 2032-08-08 U-2346 2024-02-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208627-001 8124643 2024-06-18 Drug substance, Drug product 2018-08-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208627-001 8039504 2027-07-23 Drug product 2018-08-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208627-001 9339466 2031-03-23 Drug substance, Drug product 2018-08-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208627-001 7737168 2031-09-04 U-2346 2018-08-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208627-001 11890270 2032-08-08 U-2346 2024-02-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208627-001 8124643 2024-06-18 Drug substance, Drug product 2018-08-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208627-001 8039504 2027-07-23 Drug product 2018-08-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208627-001 9339466 2031-03-23 Drug substance, Drug product 2018-08-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208627-001 7737168 2031-09-04 U-2346 2018-08-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208627-001 11890270 2032-08-08 U-2346 2024-02-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208627-001 8124643 2024-06-18 Drug substance, Drug product 2018-08-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208627-001 8039504 2027-07-23 Drug product 2018-08-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208627-001 9339466 2031-03-23 Drug substance, Drug product 2018-08-09 d8e5a09893c0…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 63 observed states.
Additional Listing Data#
Finished product Yes
Brand name base TPOXX
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TECOVIRIMAT MONOHYDRATE 200 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination F925RR824R Internal UNII lookup SB96YO2BR8 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2055109 Internal RxNorm lookup 2055115 Internal RxNorm lookup 2602126 Internal RxNorm lookup 2602131 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50072-200-42 TPOXX 42 in 1 BOTTLE CAPSULE 42 17
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50072-200 TPOXX (TECOVIRIMAT MONOHYDRATE) INJECTION, SOLUTION, CONCENTRATE TPOXX (TECOVIRIMAT MONOHYDRATE) CAPSULE [SIGA TECHNOLOGIES, INC.] 16 Current NDC, Legacy NDC, 1 package rows 20240718_fce826ab-4d6a-4139-a2ee-a304a913a253.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 50072-200-42 50072020042 42 CAPSULE in 1 BOTTLE (50072-200-42) 42 capsule 2018-08-31 0000-00-00 No No Current