BRENZAVVY

Product NDC: 82381-2174
11-digit product format: 823812174
Labeler code: 82381
Product ID: 82381-2174_e4847454-8b05-4a77-9ed8-0d1d273738fe
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Bexagliflozin
Dosage form: TABLET
Route: ORAL
Labeler: TheracosBio, LLC
Application: NDA214373
Marketing category: NDA
Marketing start: 2023-07-13
Substance: BEXAGLIFLOZIN
Active strength: 20 mg/1
Pharmacologic classes: Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]
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 43.

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
N214373-001	BRENZAVVY	BEXAGLIFLOZIN	20MG	TABLET / ORAL		RLD, RS	2023-01-20

Orange Book patents#

Current patent rows page 1 of 1 · 7 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N214373-001	8106021	2028-08-22	U-2214		2023-02-15
N214373-001	8802637	2028-08-22	U-2214	Drug substance, Drug product	2023-02-15
N214373-001	7838499	2029-01-30	U-2214	Drug substance, Drug product	2023-02-15
N214373-001	10981942	2031-06-13		Drug substance, Drug product	2023-02-15
N214373-001	10533032	2031-07-03	U-2214		2023-02-15
N214373-001	8987323	2032-05-14		Drug substance, Drug product	2023-02-15
N214373-001	12594243	2041-10-05		Drug product	2026-04-15

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N214373-001	NCE	2028-01-20

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
2026-09-14 22:38:34	2026-08	N214373-001	BRENZAVVY	20MG	TABLET / ORAL	RLD, RS	2023-01-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N214373-001	BRENZAVVY	20MG	TABLET / ORAL	RLD, RS	2023-01-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N214373-001	BRENZAVVY	20MG	TABLET / ORAL	RLD, RS	2023-01-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214373-001	BRENZAVVY	20MG	TABLET / ORAL	RLD, RS	2023-01-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214373-001	BRENZAVVY	20MG	TABLET / ORAL	RLD, RS	2023-01-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214373-001	BRENZAVVY	20MG	TABLET / ORAL	RLD, RS	2023-01-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214373-001	BRENZAVVY	20MG	TABLET / ORAL	RLD, RS	2023-01-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214373-001	BRENZAVVY	20MG	TABLET / ORAL	RLD, RS	2023-01-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214373-001	BRENZAVVY	20MG	TABLET / ORAL	RLD, RS	2023-01-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214373-001	BRENZAVVY	20MG	TABLET / ORAL	RLD, RS	2023-01-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214373-001	BRENZAVVY	20MG	TABLET / ORAL	RLD, RS	2023-01-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N214373-001	BRENZAVVY	20MG	TABLET / ORAL	RLD, RS	2023-01-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214373-001	BRENZAVVY	20MG	TABLET / ORAL	RLD, RS	2023-01-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214373-001	BRENZAVVY	20MG	TABLET / ORAL	RLD, RS	2023-01-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N214373-001	BRENZAVVY	20MG	TABLET / ORAL	RLD, RS	2023-01-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N214373-001	BRENZAVVY	20MG	TABLET / ORAL	RLD, RS	2023-01-20	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N214373-001	BRENZAVVY	20MG	TABLET / ORAL	RLD, RS	2023-01-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N214373-001	BRENZAVVY	20MG	TABLET / ORAL	RLD, RS	2023-01-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N214373-001	BRENZAVVY	20MG	TABLET / ORAL	RLD, RS	2023-01-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N214373-001	BRENZAVVY	20MG	TABLET / ORAL	RLD, RS	2023-01-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N214373-001	BRENZAVVY	20MG	TABLET / ORAL	RLD, RS	2023-01-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N214373-001	BRENZAVVY	20MG	TABLET / ORAL	RLD, RS	2023-01-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N214373-001	BRENZAVVY	20MG	TABLET / ORAL	RLD, RS	2023-01-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N214373-001	BRENZAVVY	20MG	TABLET / ORAL	RLD, RS	2023-01-20	`053a50430f4f…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N214373-001	BRENZAVVY	20MG	TABLET / ORAL	RLD, RS	2023-01-20	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 4 · 153 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N214373-001	8106021	2028-08-22	U-2214		2023-02-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214373-001	8802637	2028-08-22	U-2214	Drug substance, Drug product	2023-02-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214373-001	7838499	2029-01-30	U-2214	Drug substance, Drug product	2023-02-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214373-001	10981942	2031-06-13		Drug substance, Drug product	2023-02-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214373-001	10533032	2031-07-03	U-2214		2023-02-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214373-001	8987323	2032-05-14		Drug substance, Drug product	2023-02-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214373-001	12594243	2041-10-05		Drug product	2026-04-15	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N214373-001	8106021	2028-08-22	U-2214		2023-02-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214373-001	8802637	2028-08-22	U-2214	Drug substance, Drug product	2023-02-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214373-001	7838499	2029-01-30	U-2214	Drug substance, Drug product	2023-02-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214373-001	10981942	2031-06-13		Drug substance, Drug product	2023-02-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214373-001	10533032	2031-07-03	U-2214		2023-02-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214373-001	8987323	2032-05-14		Drug substance, Drug product	2023-02-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214373-001	12594243	2041-10-05		Drug product	2026-04-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N214373-001	8106021	2028-08-22	U-2214		2023-02-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214373-001	8802637	2028-08-22	U-2214	Drug substance, Drug product	2023-02-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214373-001	7838499	2029-01-30	U-2214	Drug substance, Drug product	2023-02-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214373-001	10981942	2031-06-13		Drug substance, Drug product	2023-02-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214373-001	10533032	2031-07-03	U-2214		2023-02-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214373-001	8987323	2032-05-14		Drug substance, Drug product	2023-02-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214373-001	8106021	2028-08-22	U-2214		2023-02-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214373-001	8802637	2028-08-22	U-2214	Drug substance, Drug product	2023-02-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214373-001	7838499	2029-01-30	U-2214	Drug substance, Drug product	2023-02-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214373-001	10981942	2031-06-13		Drug substance, Drug product	2023-02-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214373-001	10533032	2031-07-03	U-2214		2023-02-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214373-001	8987323	2032-05-14		Drug substance, Drug product	2023-02-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214373-001	8106021	2028-08-22	U-2214		2023-02-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214373-001	8802637	2028-08-22	U-2214	Drug substance, Drug product	2023-02-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214373-001	7838499	2029-01-30	U-2214	Drug substance, Drug product	2023-02-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214373-001	10981942	2031-06-13		Drug substance, Drug product	2023-02-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214373-001	10533032	2031-07-03	U-2214		2023-02-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214373-001	8987323	2032-05-14		Drug substance, Drug product	2023-02-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214373-001	8106021	2028-08-22	U-2214		2023-02-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214373-001	8802637	2028-08-22	U-2214	Drug substance, Drug product	2023-02-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214373-001	7838499	2029-01-30	U-2214	Drug substance, Drug product	2023-02-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214373-001	10981942	2031-06-13		Drug substance, Drug product	2023-02-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214373-001	10533032	2031-07-03	U-2214		2023-02-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214373-001	8987323	2032-05-14		Drug substance, Drug product	2023-02-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214373-001	8106021	2028-08-22	U-2214		2023-02-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214373-001	8802637	2028-08-22	U-2214	Drug substance, Drug product	2023-02-15	`b8a1b40f171c…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-09-14 22:38:34	2026-08	N214373-001	NCE	2028-01-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N214373-001	NCE	2028-01-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N214373-001	NCE	2028-01-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214373-001	NCE	2028-01-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214373-001	NCE	2028-01-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214373-001	NCE	2028-01-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214373-001	NCE	2028-01-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214373-001	NCE	2028-01-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214373-001	NCE	2028-01-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214373-001	NCE	2028-01-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214373-001	NCE	2028-01-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N214373-001	NCE	2028-01-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214373-001	NCE	2028-01-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214373-001	NCE	2028-01-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N214373-001	NCE	2028-01-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N214373-001	NCE	2028-01-20	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N214373-001	NCE	2028-01-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N214373-001	NCE	2028-01-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N214373-001	NCE	2028-01-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N214373-001	NCE	2028-01-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N214373-001	NCE	2028-01-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N214373-001	NCE	2028-01-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N214373-001	NCE	2028-01-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N214373-001	NCE	2028-01-20	`053a50430f4f…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N214373-001	NCE	2028-01-20	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: BRENZAVVY
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BEXAGLIFLOZIN	20 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
EY00JF42FV	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2637859	Internal RxNorm lookup
2637865	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
3cdf28fc-4194-4ad6-aa03-c9eaa68da83e	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
d6eaa6f7-9161-483b-a15d-3a50fbcf86c2	Product name	1	20230921
351abe41-466c-4dd8-840a-0fdb68318bd5	Product name	1	20230316
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
82381-2174-1	BRENZAVVY	30 in 1 BOTTLE	TABLET	30		8
82381-2174-2	BRENZAVVY	90 in 1 BOTTLE	TABLET	90		8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
82381-2174-1	EA - Each	82381-2174	a4a81c34-ba58-45f3-9e9a-048c79f0badd	1	2023-09-05
82381-2174-2	EA - Each	82381-2174	74b3eadb-9d91-41d0-9461-572a1fbcf1b7	1	2023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
82381-2174	BRENZAVVY (BEXAGLIFLOZIN) TABLET [THERACOSBIO, LLC]	7	Current NDC, 2 package rows	20250411_3cdf28fc-4194-4ad6-aa03-c9eaa68da83e.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Bexagliflozin	BEXAGLIFLOZIN	Golden State Medical Supply, Inc.	1a3ba9d5-1009-bad0-e063-6294a90ac4cc	2026-07-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 214373 application number: NDA214373
Bexagliflozin	BEXAGLIFLOZIN	TheracosBio, LLC	7f0ad5d2-3509-4057-904c-d27993de7408	2026-06-23	Warnings, Adverse reactions	Exact identifier application applno (NDA): 214373 application number: NDA214373
BRENZAVVY	BEXAGLIFLOZIN	TheracosBio, LLC	3cdf28fc-4194-4ad6-aa03-c9eaa68da83e	2026-06-10	Warnings, Adverse reactions	Exact identifier application applno (NDA): 214373 application number: NDA214373 ndc (product): 82381-2174

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
EY00JF42FV	BEXAGLIFLOZIN	1118567-05-7	BEXAGLIFLOZIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2637859	bexagliflozin 20 MG Oral Tablet	PSN	3cdf28fc-4194-4ad6-aa03-c9eaa68da83e	8
2637865	Brenzavvy 20 MG Oral Tablet	PSN	3cdf28fc-4194-4ad6-aa03-c9eaa68da83e	8
2637865	bexagliflozin 20 MG Oral Tablet [Brenzavvy]	SBD	3cdf28fc-4194-4ad6-aa03-c9eaa68da83e	8
2637859	bexagliflozin 20 MG Oral Tablet	SCD	3cdf28fc-4194-4ad6-aa03-c9eaa68da83e	8
2637859	bexagliflozin 20 MG Oral Tablet	SY	3cdf28fc-4194-4ad6-aa03-c9eaa68da83e	8
2637865	Brenzavvy 20 MG Oral Tablet	SY	3cdf28fc-4194-4ad6-aa03-c9eaa68da83e	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
82381-2174-1	82381217401	30 TABLET in 1 BOTTLE (82381-2174-1)	30 tablet	2023-07-13	No	No	Current
82381-2174-2	82381217402	90 TABLET in 1 BOTTLE (82381-2174-2)	90 tablet	2023-07-13	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
BRENZAVVY	TheracosBio, LLC \| Piramal Healthcare UK Ltd \| Theracos Holdings Limited	2026-06-10	Human Prescription Drug Label	9
Brenzavvy	Golden State Medical Supply, Inc.	2023-10-09	HUMAN PRESCRIPTION DRUG LABEL	2