Home NDC 50072-010 TPOXX
Product NDC 50072-010
11-digit product format 500720010
Labeler code 50072
Product ID 50072-010_474526fb-5357-880e-e063-6294a90a3296
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name tecovirimat monohydrate
Dosage form INJECTION, SOLUTION, CONCENTRATE
Route INTRAVENOUS
Labeler SIGA Technologies, Inc.
Application NDA214518
Marketing category NDA
Marketing start 2022-05-31
Substance TECOVIRIMAT
Active strength 10 mg/mL
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 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 N214518-001 TPOXX TECOVIRIMAT 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-05-18
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 N214518-001 8039504 2027-07-23 Drug product 2022-06-10 N214518-001 10576165 2031-08-02 Drug product 2022-06-10 N214518-001 9233097 2031-08-02 Drug product 2022-06-10 N214518-001 9907859 2031-08-02 U-3377 2022-06-10 N214518-001 7737168 2031-09-04 U-3377 2022-06-10
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.
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 N214518-001 TPOXX 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-05-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214518-001 TPOXX 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-05-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N214518-001 TPOXX 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-05-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214518-001 TPOXX 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-05-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214518-001 TPOXX 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-05-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214518-001 TPOXX 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-05-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214518-001 TPOXX 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-05-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N214518-001 TPOXX 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-05-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N214518-001 TPOXX 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-05-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N214518-001 TPOXX 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-05-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N214518-001 TPOXX 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-05-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N214518-001 TPOXX 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-05-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N214518-001 TPOXX 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-05-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N214518-001 TPOXX 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-05-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N214518-001 TPOXX 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-05-18 5c6f7cd8ea54…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N214518-001 TPOXX 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-05-18 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N214518-001 TPOXX 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-05-18 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N214518-001 TPOXX 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-05-18 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N214518-001 TPOXX 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-05-18 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N214518-001 TPOXX 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-05-18 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N214518-001 TPOXX 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-05-18 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N214518-001 TPOXX 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-05-18 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N214518-001 TPOXX 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-05-18 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N214518-001 TPOXX 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-05-18 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N214518-001 TPOXX 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-05-18 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N214518-001 TPOXX 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-05-18 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N214518-001 TPOXX 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-05-18 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N214518-001 TPOXX 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-05-18 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N214518-001 TPOXX 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-05-18 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 6 · 202 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 N214518-001 8039504 2027-07-23 Drug product 2022-06-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214518-001 10576165 2031-08-02 Drug product 2022-06-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214518-001 9233097 2031-08-02 Drug product 2022-06-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214518-001 9907859 2031-08-02 U-3377 2022-06-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214518-001 7737168 2031-09-04 U-3377 2022-06-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214518-001 8039504 2027-07-23 Drug product 2022-06-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214518-001 10576165 2031-08-02 Drug product 2022-06-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214518-001 9233097 2031-08-02 Drug product 2022-06-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214518-001 9907859 2031-08-02 U-3377 2022-06-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214518-001 7737168 2031-09-04 U-3377 2022-06-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N214518-001 8039504 2027-07-23 Drug product 2022-06-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214518-001 10576165 2031-08-02 Drug product 2022-06-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214518-001 9233097 2031-08-02 Drug product 2022-06-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214518-001 9907859 2031-08-02 U-3377 2022-06-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214518-001 7737168 2031-09-04 U-3377 2022-06-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214518-001 8039504 2027-07-23 Drug product 2022-06-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214518-001 10576165 2031-08-02 Drug product 2022-06-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214518-001 9233097 2031-08-02 Drug product 2022-06-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214518-001 9907859 2031-08-02 U-3377 2022-06-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214518-001 7737168 2031-09-04 U-3377 2022-06-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214518-001 8039504 2027-07-23 Drug product 2022-06-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214518-001 10576165 2031-08-02 Drug product 2022-06-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214518-001 9233097 2031-08-02 Drug product 2022-06-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214518-001 9907859 2031-08-02 U-3377 2022-06-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214518-001 7737168 2031-09-04 U-3377 2022-06-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214518-001 8124643 2024-06-18 Drug substance, Drug product 2022-06-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214518-001 8039504 2027-07-23 Drug product 2022-06-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214518-001 10576165 2031-08-02 Drug product 2022-06-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214518-001 9233097 2031-08-02 Drug product 2022-06-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214518-001 9907859 2031-08-02 U-3377 2022-06-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214518-001 7737168 2031-09-04 U-3377 2022-06-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214518-001 8124643 2024-06-18 Drug substance, Drug product 2022-06-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214518-001 8039504 2027-07-23 Drug product 2022-06-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214518-001 10576165 2031-08-02 Drug product 2022-06-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214518-001 9233097 2031-08-02 Drug product 2022-06-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214518-001 9907859 2031-08-02 U-3377 2022-06-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214518-001 7737168 2031-09-04 U-3377 2022-06-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N214518-001 8124643 2024-06-18 Drug substance, Drug product 2022-06-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N214518-001 8530509 2024-06-18 Drug product 2022-06-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N214518-001 8802714 2024-06-18 U-3377 2022-06-10 5bbf6a4d5a75…
Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base TPOXX
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TECOVIRIMAT 10 mg/mL
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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50072-010-01 TPOXX 7 in 1 CARTON INJECTION, SOLUTION, CONCENTRATE 7 17 50072-010-30 TPOXX 20 mL in 1 VIAL INJECTION, SOLUTION, CONCENTRATE 20 17
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50072-010 TPOXX (TECOVIRIMAT MONOHYDRATE) INJECTION, SOLUTION, CONCENTRATE TPOXX (TECOVIRIMAT MONOHYDRATE) CAPSULE [SIGA TECHNOLOGIES, INC.] 16 Current NDC, Legacy NDC, 2 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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join TPOXX TECOVIRIMAT MONOHYDRATE SIGA Technologies, Inc. fce826ab-4d6a-4139-a2ee-a304a913a253 2025-12-31 Warnings, Adverse reactions Exact identifier application applno (NDA): 214518 application number: NDA214518 ndc (product): 50072-010
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 50072-010-01 50072001001 7 VIAL in 1 CARTON (50072-010-01) / 20 mL in 1 VIAL (50072-010-30) 7 vial 2022-05-31 0000-00-00 No No Current 50072-010-30 50072001030 20 mL in 1 VIAL 20 ml Historical