Tembexa

Product NDC: 79622-010
11-digit product format: 796220010
Labeler code: 79622
Product ID: 79622-010_179ef983-ea03-496a-be62-7ce509cea793
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Brincidofovir
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Chimerix, Inc.
Application: NDA214461
Marketing category: NDA
Marketing start: 2022-04-20
Marketing end: 0000-00-00
Substance: BRINCIDOFOVIR
Active strength: 100 mg/1
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	79622-010		I	Inactivated by FDA	2026-08-17
excluded package	package	79622-010	79622-010-04	I	Inactivated by FDA	2026-08-17
excluded package	package	79622-010	79622-010-10	I	Inactivated by FDA	2026-08-17

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 · 6 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	79622-010-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	79622-010-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	79622-010-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	79622-010-04	`f5e01cc5f278…`	`a2eaf40c39c3…`

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	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-08-18 06:07:40	2026-07	N214461-001	ODE-354	2028-06-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N214461-001	ODE-354	2028-06-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214461-001	ODE-354	2028-06-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214461-001	ODE-354	2028-06-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214461-001	ODE-354	2028-06-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214461-001	ODE-354	2028-06-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214461-001	NP	2024-06-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214461-001	ODE-354	2028-06-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214461-001	NP	2024-06-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214461-001	ODE-354	2028-06-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214461-001	NP	2024-06-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214461-001	ODE-354	2028-06-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214461-001	NP	2024-06-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214461-001	ODE-354	2028-06-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N214461-001	NP	2024-06-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N214461-001	ODE-354	2028-06-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214461-001	NP	2024-06-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214461-001	ODE-354	2028-06-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214461-001	NP	2024-06-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214461-001	ODE-354	2028-06-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N214461-001	NP	2024-06-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N214461-001	ODE-354	2028-06-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N214461-001	NP	2024-06-04	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N214461-001	ODE-354	2028-06-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N214461-001	NP	2024-06-04	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N214461-001	ODE-354	2028-06-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N214461-001	NP	2024-06-04	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N214461-001	ODE-354	2028-06-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N214461-001	NP	2024-06-04	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N214461-001	ODE-354	2028-06-04	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N214461-001	NP	2024-06-04	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N214461-001	ODE-354	2028-06-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N214461-001	NP	2024-06-04	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N214461-001	ODE-354	2028-06-04	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N214461-001	NP	2024-06-04	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N214461-001	ODE-354	2028-06-04	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N214461-001	NP	2024-06-04	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N214461-001	ODE-354	2028-06-04	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N214461-001	NP	2024-06-04	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N214461-001	ODE-354	2028-06-04	`ea1830bbd6c7…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
1625e783-d316-4f61-a95a-9e96a8159086	Product name	1	20220118
cff38427-72e6-4268-92d0-25b276bf1896	Product name	1	20220118
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
79622-010-04	2025-09-02	These highlights do not include all the information needed to use TEMBEXA ® safely and effectively. See full prescribing information for TEMBEXA. TEMBEXA (brincidofovir) tablets, for oral use TEMBEXA (brincidofovir) oral suspension Initial U.S. Approval: 1996
79622-010-10	2025-09-02	These highlights do not include all the information needed to use TEMBEXA ® safely and effectively. See full prescribing information for TEMBEXA. TEMBEXA (brincidofovir) tablets, for oral use TEMBEXA (brincidofovir) oral suspension Initial U.S. Approval: 1996
79622-010-04	2025-07-29	These highlights do not include all the information needed to use TEMBEXA ® safely and effectively. See full prescribing information for TEMBEXA. TEMBEXA (brincidofovir) tablets, for oral use TEMBEXA (brincidofovir) oral suspension Initial U.S. Approval: 1996
79622-010-10	2025-07-29	These highlights do not include all the information needed to use TEMBEXA ® safely and effectively. See full prescribing information for TEMBEXA. TEMBEXA (brincidofovir) tablets, for oral use TEMBEXA (brincidofovir) oral suspension Initial U.S. Approval: 1996

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
79622-010-04	Tembexa	4 in 1 BLISTER PACK	TABLET, FILM COATED	4	4
79622-010-04	Tembexa	1 in 1 CARTON	TABLET, FILM COATED	1	4
79622-010-10	Tembexa	1 in 1 CARTON	TABLET, FILM COATED	1	4
79622-010-10	Tembexa	4 in 1 BLISTER PACK	TABLET, FILM COATED	4	4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
79622-010-04	EA - Each	79622-010	bd25b1e5-df49-489b-9fc0-8ecb089e8f45	1	2023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
79622-010	TEMBEXA (BRINCIDOFOVIR) TABLET, FILM COATED [CHIMERIX, INC.]	4	Legacy NDC, 4 package rows	20220422_31d6fa29-791e-4988-8758-e7e4d5b6a352.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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
6794O900AX	BRINCIDOFOVIR	444805-28-1	BRINCIDOFOVIR

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2599541	{4 (brincidofovir 100 MG Oral Tablet [Tembexa]) } Pack [Tembexa 4 Tablet Pack]	BPCK	31d6fa29-791e-4988-8758-e7e4d5b6a352	4
2599540	{4 (brincidofovir 100 MG Oral Tablet) } Pack	GPCK	31d6fa29-791e-4988-8758-e7e4d5b6a352	4
2599535	brincidofovir 100 MG Oral Tablet	PSN	31d6fa29-791e-4988-8758-e7e4d5b6a352	4
2599540	brincidofovir 4 Tablet Pack	PSN	31d6fa29-791e-4988-8758-e7e4d5b6a352	4
2599539	TEMBEXA 100 MG Oral Tablet	PSN	31d6fa29-791e-4988-8758-e7e4d5b6a352	4
2599541	TEMBEXA 4 Tablet Pack	PSN	31d6fa29-791e-4988-8758-e7e4d5b6a352	4
2599539	brincidofovir 100 MG Oral Tablet [Tembexa]	SBD	31d6fa29-791e-4988-8758-e7e4d5b6a352	4
2599535	brincidofovir 100 MG Oral Tablet	SCD	31d6fa29-791e-4988-8758-e7e4d5b6a352	4
2599540	brincidofovir 4 Tablet Pack	SY	31d6fa29-791e-4988-8758-e7e4d5b6a352	4
2599539	Tembexa 100 MG Oral Tablet	SY	31d6fa29-791e-4988-8758-e7e4d5b6a352	4
2599541	Tembexa 4 Tablet Pack	SY	31d6fa29-791e-4988-8758-e7e4d5b6a352	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
79622-010-04	79622001004	1 BLISTER PACK in 1 CARTON (79622-010-04) > 4 TABLET, FILM COATED in 1 BLISTER PACK	1 blister pack	2022-04-20	0000-00-00	No	No	Current
79622-010-10	79622001010	1 BLISTER PACK in 1 CARTON (79622-010-10) > 4 TABLET, FILM COATED in 1 BLISTER PACK	1 blister pack	2022-04-20	0000-00-00	No	No	Current