Tembexa

Product NDC: 64678-012
11-digit product format: 646780012
Labeler code: 64678
Product ID: 64678-012_8ce2edcc-3c73-4a58-b96e-c7ba5408d3c9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Brincidofovir
Dosage form: SUSPENSION
Route: ORAL
Labeler: Emergent BioDefense Operations Lansing LLC
Application: NDA214460
Marketing category: NDA
Marketing start: 2022-04-20
Substance: BRINCIDOFOVIR
Active strength: 10 mg/mL
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 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
N214460-001	TEMBEXA	BRINCIDOFOVIR	10MG/ML	SUSPENSION / ORAL		RLD, RS	2021-06-04

Orange Book patents#

Current patent rows page 1 of 1 · 1 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N214460-001	9303051	2034-07-30	U-3165	Drug substance, 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
N214460-001	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	N214460-001	TEMBEXA	10MG/ML	SUSPENSION / ORAL	RLD, RS	2021-06-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N214460-001	TEMBEXA	10MG/ML	SUSPENSION / ORAL	RLD, RS	2021-06-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214460-001	TEMBEXA	10MG/ML	SUSPENSION / ORAL	RLD, RS	2021-06-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214460-001	TEMBEXA	10MG/ML	SUSPENSION / ORAL	RLD, RS	2021-06-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214460-001	TEMBEXA	10MG/ML	SUSPENSION / ORAL	RLD, RS	2021-06-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214460-001	TEMBEXA	10MG/ML	SUSPENSION / ORAL	RLD, RS	2021-06-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214460-001	TEMBEXA	10MG/ML	SUSPENSION / ORAL	RLD, RS	2021-06-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214460-001	TEMBEXA	10MG/ML	SUSPENSION / ORAL	RLD, RS	2021-06-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214460-001	TEMBEXA	10MG/ML	SUSPENSION / ORAL	RLD, RS	2021-06-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214460-001	TEMBEXA	10MG/ML	SUSPENSION / ORAL	RLD, RS	2021-06-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N214460-001	TEMBEXA	10MG/ML	SUSPENSION / ORAL	RLD, RS	2021-06-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214460-001	TEMBEXA	10MG/ML	SUSPENSION / ORAL	RLD, RS	2021-06-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214460-001	TEMBEXA	10MG/ML	SUSPENSION / ORAL	RLD, RS	2021-06-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N214460-001	TEMBEXA	10MG/ML	SUSPENSION / ORAL	RLD, RS	2021-06-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N214460-001	TEMBEXA	10MG/ML	SUSPENSION / ORAL	RLD, RS	2021-06-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N214460-001	TEMBEXA	10MG/ML	SUSPENSION / ORAL	RLD, RS	2021-06-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N214460-001	TEMBEXA	10MG/ML	SUSPENSION / ORAL	RLD, RS	2021-06-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N214460-001	TEMBEXA	10MG/ML	SUSPENSION / ORAL	RLD, RS	2021-06-04	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N214460-001	TEMBEXA	10MG/ML	SUSPENSION / ORAL	RLD, RS	2021-06-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N214460-001	TEMBEXA	10MG/ML	SUSPENSION / ORAL	RLD, RS	2021-06-04	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N214460-001	TEMBEXA	10MG/ML	SUSPENSION / ORAL	RLD, RS	2021-06-04	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N214460-001	TEMBEXA	10MG/ML	SUSPENSION / ORAL	RLD, RS	2021-06-04	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N214460-001	TEMBEXA	10MG/ML	SUSPENSION / ORAL	RLD, RS	2021-06-04	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N214460-001	TEMBEXA	10MG/ML	SUSPENSION / ORAL	RLD, RS	2021-06-04	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N214460-001	TEMBEXA	10MG/ML	SUSPENSION / ORAL	RLD, RS	2021-06-04	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N214460-001	TEMBEXA	10MG/ML	SUSPENSION / ORAL	RLD, RS	2021-06-04	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N214460-001	TEMBEXA	10MG/ML	SUSPENSION / ORAL	RLD, RS	2021-06-04	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N214460-001	TEMBEXA	10MG/ML	SUSPENSION / ORAL	RLD, RS	2021-06-04	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N214460-001	TEMBEXA	10MG/ML	SUSPENSION / ORAL	RLD, RS	2021-06-04	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N214460-001	TEMBEXA	10MG/ML	SUSPENSION / ORAL	RLD, RS	2021-06-04	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N214460-001	TEMBEXA	10MG/ML	SUSPENSION / ORAL	RLD, RS	2021-06-04	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N214460-001	TEMBEXA	10MG/ML	SUSPENSION / ORAL	RLD, RS	2021-06-04	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N214460-001	TEMBEXA	10MG/ML	SUSPENSION / ORAL	RLD, RS	2021-06-04	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N214460-001	TEMBEXA	10MG/ML	SUSPENSION / ORAL	RLD, RS	2021-06-04	`a50c72e98297…`

Observed Orange Book patent history#

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	N214460-001	9303051	2034-07-30	U-3165	Drug substance, Drug product	2021-07-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N214460-001	9303051	2031-08-31	U-3165	Drug substance, Drug product	2021-07-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214460-001	9303051	2031-08-31	U-3165	Drug substance, Drug product	2021-07-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214460-001	9303051	2031-08-31	U-3165	Drug substance, Drug product	2021-07-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214460-001	9303051	2031-08-31	U-3165	Drug substance, Drug product	2021-07-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214460-001	9303051	2031-08-31	U-3165	Drug substance, Drug product	2021-07-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214460-001	9303051	2031-08-31	U-3165	Drug substance, Drug product	2021-07-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214460-001	9303051	2031-08-31	U-3165	Drug substance, Drug product	2021-07-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214460-001	9303051	2031-08-31	U-3165	Drug substance, Drug product	2021-07-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214460-001	9303051	2031-08-31	U-3165	Drug substance, Drug product	2021-07-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N214460-001	9303051	2031-08-31	U-3165	Drug substance, Drug product	2021-07-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214460-001	9303051	2031-08-31	U-3165	Drug substance, Drug product	2021-07-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214460-001	9303051	2031-08-31	U-3165	Drug substance, Drug product	2021-07-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N214460-001	9303051	2031-08-31	U-3165	Drug substance, Drug product	2021-07-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N214460-001	9303051	2031-08-31	U-3165	Drug substance, Drug product	2021-07-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N214460-001	9303051	2031-08-31	U-3165	Drug substance, Drug product	2021-07-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N214460-001	9303051	2031-08-31	U-3165	Drug substance, Drug product	2021-07-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N214460-001	9303051	2031-08-31	U-3165	Drug substance, Drug product	2021-07-02	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N214460-001	9303051	2031-08-31	U-3165	Drug substance, Drug product	2021-07-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N214460-001	9303051	2031-08-31	U-3165	Drug substance, Drug product	2021-07-02	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N214460-001	9303051	2031-08-31	U-3165	Drug substance, Drug product	2021-07-02	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N214460-001	9303051	2031-08-31	U-3165	Drug substance, Drug product	2021-07-02	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N214460-001	9303051	2031-08-31	U-3165	Drug substance, Drug product	2021-07-02	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N214460-001	9303051	2031-08-31	U-3165	Drug substance, Drug product	2021-07-02	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N214460-001	9303051	2031-08-31	U-3165	Drug substance, Drug product	2021-07-02	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N214460-001	9303051	2031-08-31	U-3165	Drug substance, Drug product	2021-07-02	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N214460-001	9303051	2031-08-31	U-3165	Drug substance, Drug product	2021-07-02	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N214460-001	9303051	2031-08-31	U-3165	Drug substance, Drug product	2021-07-02	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N214460-001	9303051	2031-08-31	U-3165	Drug substance, Drug product	2021-07-02	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N214460-001	9303051	2031-08-31	U-3165	Drug substance, Drug product	2021-07-02	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N214460-001	9303051	2031-08-31	U-3165	Drug substance, Drug product	2021-07-02	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N214460-001	9303051	2031-08-31	U-3165	Drug substance, Drug product	2021-07-02	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N214460-001	9303051	2031-08-31	U-3165	Drug substance, Drug product	2021-07-02	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N214460-001	9303051	2034-07-30	U-3165	Drug substance, Drug product	2021-07-02	`a50c72e98297…`

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	N214460-001	ODE-354	2028-06-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N214460-001	ODE-354	2028-06-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214460-001	ODE-354	2028-06-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214460-001	ODE-354	2028-06-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214460-001	ODE-354	2028-06-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214460-001	ODE-354	2028-06-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214460-001	NP	2024-06-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214460-001	ODE-354	2028-06-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214460-001	NP	2024-06-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214460-001	ODE-354	2028-06-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214460-001	NP	2024-06-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214460-001	ODE-354	2028-06-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214460-001	NP	2024-06-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214460-001	ODE-354	2028-06-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N214460-001	NP	2024-06-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N214460-001	ODE-354	2028-06-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214460-001	NP	2024-06-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214460-001	ODE-354	2028-06-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214460-001	NP	2024-06-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214460-001	ODE-354	2028-06-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N214460-001	NP	2024-06-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N214460-001	ODE-354	2028-06-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N214460-001	NP	2024-06-04	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N214460-001	ODE-354	2028-06-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N214460-001	NP	2024-06-04	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N214460-001	ODE-354	2028-06-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N214460-001	NP	2024-06-04	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N214460-001	ODE-354	2028-06-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N214460-001	NP	2024-06-04	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N214460-001	ODE-354	2028-06-04	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N214460-001	NP	2024-06-04	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N214460-001	ODE-354	2028-06-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N214460-001	NP	2024-06-04	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N214460-001	ODE-354	2028-06-04	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N214460-001	NP	2024-06-04	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N214460-001	ODE-354	2028-06-04	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N214460-001	NP	2024-06-04	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N214460-001	ODE-354	2028-06-04	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N214460-001	NP	2024-06-04	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N214460-001	ODE-354	2028-06-04	`ea1830bbd6c7…`

Additional Listing Data#

Finished product: Yes
Brand name base: Tembexa
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BRINCIDOFOVIR	10 mg/mL

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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2599525	Internal RxNorm lookup
2599531	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
0784838e-00bd-4b14-9b7e-653b7fbb7eea	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
1625e783-d316-4f61-a95a-9e96a8159086	Product name	1	20220118
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
cff38427-72e6-4268-92d0-25b276bf1896	Product name	1	20220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
64678-012-01	Tembexa	65 mL in 1 BOTTLE	SUSPENSION	65	2
64678-012-02	Tembexa	65 mL in 1 BOTTLE	SUSPENSION	65	2
64678-012-03	Tembexa	45 mL in 1 BOTTLE	SUSPENSION	45	2
64678-012-03	Tembexa	1 in 1 CARTON	SUSPENSION	1	2
64678-012-04	Tembexa	1 in 1 CARTON	SUSPENSION	1	2
64678-012-04	Tembexa	45 mL in 1 BOTTLE	SUSPENSION	45	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
64678-012	TEMBEXA (BRINCIDOFOVIR) SUSPENSION [EMERGENT BIODEFENSE OPERATIONS LANSING LLC]	1	Current NDC, 6 package rows	20230603_0784838e-00bd-4b14-9b7e-653b7fbb7eea.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	0784838e-00bd-4b14-9b7e-653b7fbb7eea	2025-07-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 214460 application number: NDA214460 ndc (product): 64678-012

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
2599525	brincidofovir 10 MG/mL Oral Suspension	PSN	0784838e-00bd-4b14-9b7e-653b7fbb7eea	2
2599531	TEMBEXA 10 MG/mL Oral Suspension	PSN	0784838e-00bd-4b14-9b7e-653b7fbb7eea	2
2599531	brincidofovir 10 MG/ML Oral Suspension [Tembexa]	SBD	0784838e-00bd-4b14-9b7e-653b7fbb7eea	2
2599525	brincidofovir 10 MG/ML Oral Suspension	SCD	0784838e-00bd-4b14-9b7e-653b7fbb7eea	2
2599531	Tembexa 10 MG/ML Oral Suspension	SY	0784838e-00bd-4b14-9b7e-653b7fbb7eea	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
64678-012-01	64678001201	65 mL in 1 BOTTLE (64678-012-01)	65 ml	2022-04-20	No	No	Current
64678-012-02	64678001202	65 mL in 1 BOTTLE (64678-012-02)	65 ml	2022-04-20	No	No	Current
64678-012-03	64678001203	1 BOTTLE in 1 CARTON (64678-012-03) / 45 mL in 1 BOTTLE	1 bottle	2025-07-23	No	No	Current
64678-012-04	64678001204	1 BOTTLE in 1 CARTON (64678-012-04) / 45 mL in 1 BOTTLE	1 bottle	2025-07-23	No	No	Current