Home NDC 64678-010 Tembexa
Product NDC 64678-010
11-digit product format 646780010
Labeler code 64678
Product ID 64678-010_bf0186cb-f9bf-49ea-904b-6f8dd72a2590
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Brincidofovir
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Emergent BioDefense Operations Lansing LLC
Application NDA214461
Marketing category NDA
Marketing start 2022-04-20
Substance BRINCIDOFOVIR
Active strength 100 mg/1
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 42 .
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 N214461-001 TEMBEXA BRINCIDOFOVIR 100MG TABLET / ORAL RLD, RS 2021-06-04
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 N214461-001 9303051 2034-07-30 U-3165 Drug substance, Drug product 2021-07-02 N214461-001 10112909 2034-10-10 U-3165 2021-07-02 N214461-001 10487061 2034-10-10 U-3165 Drug product 2021-07-02 N214461-001 8962829 2034-10-10 Drug substance, Drug product 2021-07-02 N214461-001 9371344 2034-10-10 Drug product 2021-07-02
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N214461-001 ODE-354 2028-06-04
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 2026-08-18 06:07:40 2026-07 N214461-001 TEMBEXA 100MG TABLET / ORAL RLD, RS 2021-06-04 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N214461-001 TEMBEXA 100MG TABLET / ORAL RLD, RS 2021-06-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214461-001 TEMBEXA 100MG TABLET / ORAL RLD, RS 2021-06-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N214461-001 TEMBEXA 100MG TABLET / ORAL RLD, RS 2021-06-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214461-001 TEMBEXA 100MG TABLET / ORAL RLD, RS 2021-06-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214461-001 TEMBEXA 100MG TABLET / ORAL RLD, RS 2021-06-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214461-001 TEMBEXA 100MG TABLET / ORAL RLD, RS 2021-06-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214461-001 TEMBEXA 100MG TABLET / ORAL RLD, RS 2021-06-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N214461-001 TEMBEXA 100MG TABLET / ORAL RLD, RS 2021-06-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N214461-001 TEMBEXA 100MG TABLET / ORAL RLD, RS 2021-06-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N214461-001 TEMBEXA 100MG TABLET / ORAL RLD, RS 2021-06-04 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N214461-001 TEMBEXA 100MG TABLET / ORAL RLD, RS 2021-06-04 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N214461-001 TEMBEXA 100MG TABLET / ORAL RLD, RS 2021-06-04 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N214461-001 TEMBEXA 100MG TABLET / ORAL RLD, RS 2021-06-04 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N214461-001 TEMBEXA 100MG TABLET / ORAL RLD, RS 2021-06-04 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N214461-001 TEMBEXA 100MG TABLET / ORAL RLD, RS 2021-06-04 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N214461-001 TEMBEXA 100MG TABLET / ORAL RLD, RS 2021-06-04 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N214461-001 TEMBEXA 100MG TABLET / ORAL RLD, RS 2021-06-04 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N214461-001 TEMBEXA 100MG TABLET / ORAL RLD, RS 2021-06-04 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N214461-001 TEMBEXA 100MG TABLET / ORAL RLD, RS 2021-06-04 782e0a99824c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N214461-001 TEMBEXA 100MG TABLET / ORAL RLD, RS 2021-06-04 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N214461-001 TEMBEXA 100MG TABLET / ORAL RLD, RS 2021-06-04 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N214461-001 TEMBEXA 100MG TABLET / ORAL RLD, RS 2021-06-04 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N214461-001 TEMBEXA 100MG TABLET / ORAL RLD, RS 2021-06-04 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N214461-001 TEMBEXA 100MG TABLET / ORAL RLD, RS 2021-06-04 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N214461-001 TEMBEXA 100MG TABLET / ORAL RLD, RS 2021-06-04 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N214461-001 TEMBEXA 100MG TABLET / ORAL RLD, RS 2021-06-04 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N214461-001 TEMBEXA 100MG TABLET / ORAL RLD, RS 2021-06-04 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N214461-001 TEMBEXA 100MG TABLET / ORAL RLD, RS 2021-06-04 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N214461-001 TEMBEXA 100MG TABLET / ORAL RLD, RS 2021-06-04 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N214461-001 TEMBEXA 100MG TABLET / ORAL RLD, RS 2021-06-04 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N214461-001 TEMBEXA 100MG TABLET / ORAL RLD, RS 2021-06-04 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N214461-001 TEMBEXA 100MG TABLET / ORAL RLD, RS 2021-06-04 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N214461-001 TEMBEXA 100MG TABLET / ORAL RLD, RS 2021-06-04 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 5 · 170 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N214461-001 9303051 2034-07-30 U-3165 Drug substance, Drug product 2021-07-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214461-001 10112909 2034-10-10 U-3165 2021-07-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214461-001 10487061 2034-10-10 U-3165 Drug product 2021-07-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214461-001 8962829 2034-10-10 Drug substance, Drug product 2021-07-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214461-001 9371344 2034-10-10 Drug product 2021-07-02 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N214461-001 9303051 2031-08-31 U-3165 Drug substance, Drug product 2021-07-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214461-001 10112909 2034-10-10 U-3165 2021-07-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214461-001 10487061 2034-10-10 U-3165 Drug product 2021-07-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214461-001 8962829 2034-10-10 Drug substance, Drug product 2021-07-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214461-001 9371344 2034-10-10 Drug product 2021-07-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214461-001 9303051 2031-08-31 U-3165 Drug substance, Drug product 2021-07-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214461-001 10112909 2034-10-10 U-3165 2021-07-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214461-001 10487061 2034-10-10 U-3165 Drug product 2021-07-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214461-001 8962829 2034-10-10 Drug substance, Drug product 2021-07-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214461-001 9371344 2034-10-10 Drug product 2021-07-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N214461-001 9303051 2031-08-31 U-3165 Drug substance, Drug product 2021-07-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214461-001 10112909 2034-10-10 U-3165 2021-07-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214461-001 10487061 2034-10-10 U-3165 Drug product 2021-07-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214461-001 8962829 2034-10-10 Drug substance, Drug product 2021-07-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214461-001 9371344 2034-10-10 Drug product 2021-07-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214461-001 9303051 2031-08-31 U-3165 Drug substance, Drug product 2021-07-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214461-001 10112909 2034-10-10 U-3165 2021-07-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214461-001 10487061 2034-10-10 U-3165 Drug product 2021-07-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214461-001 8962829 2034-10-10 Drug substance, Drug product 2021-07-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214461-001 9371344 2034-10-10 Drug product 2021-07-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214461-001 9303051 2031-08-31 U-3165 Drug substance, Drug product 2021-07-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214461-001 10112909 2034-10-10 U-3165 2021-07-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214461-001 10487061 2034-10-10 U-3165 Drug product 2021-07-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214461-001 8962829 2034-10-10 Drug substance, Drug product 2021-07-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214461-001 9371344 2034-10-10 Drug product 2021-07-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214461-001 9303051 2031-08-31 U-3165 Drug substance, Drug product 2021-07-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214461-001 10112909 2034-10-10 U-3165 2021-07-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214461-001 10487061 2034-10-10 U-3165 Drug product 2021-07-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214461-001 8962829 2034-10-10 Drug substance, Drug product 2021-07-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214461-001 9371344 2034-10-10 Drug product 2021-07-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214461-001 9303051 2031-08-31 U-3165 Drug substance, Drug product 2021-07-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214461-001 10112909 2034-10-10 U-3165 2021-07-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214461-001 10487061 2034-10-10 U-3165 Drug product 2021-07-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214461-001 8962829 2034-10-10 Drug substance, Drug product 2021-07-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214461-001 9371344 2034-10-10 Drug product 2021-07-02 2680178bc6a6…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 61 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Tembexa
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BRINCIDOFOVIR 100 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 6794O900AX Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2599535 Internal RxNorm lookup 2599539 Internal RxNorm lookup 2599540 Internal RxNorm lookup 2599541 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 64678-010-01 Tembexa 4 in 1 BLISTER PACK TABLET, FILM COATED 4 2 64678-010-02 Tembexa 4 in 1 BLISTER PACK TABLET, FILM COATED 4 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 64678-010 TEMBEXA (BRINCIDOFOVIR) TABLET, FILM COATED [EMERGENT BIODEFENSE OPERATIONS LANSING LLC] 1 Current NDC, 2 package rows 20230603_209aa94b-c613-4880-ad89-41be83d12c0a.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 Tembexa BRINCIDOFOVIR Emergent BioDefense Operations Lansing LLC 209aa94b-c613-4880-ad89-41be83d12c0a 2025-07-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 214461 application number: NDA214461 ndc (product): 64678-010
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 64678-010-01 64678001001 4 TABLET, FILM COATED in 1 BLISTER PACK (64678-010-01) 2022-04-20 No No Current 64678-010-02 64678001002 4 TABLET, FILM COATED in 1 BLISTER PACK (64678-010-02) 2022-04-20 No No Current