Buspirone Hydrochloride

Product NDC: 82804-964
11-digit product format: 828040964
Labeler code: 82804
Product ID: 82804-964_1521109d-8386-472f-9483-f1fe9f7ed152
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: buspirone hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Proficient Rx LP
Application: ANDA078302
Marketing category: ANDA
Marketing start: 2020-05-01
Substance: BUSPIRONE HYDROCHLORIDE
Active strength: 30 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 44.

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
A078302-001	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB		2007-12-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A078302-001	AB

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.

Product history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A078302-001	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-12-17	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A078302-001	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-12-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078302-001	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-12-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078302-001	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-12-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078302-001	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-12-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078302-001	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-12-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078302-001	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-12-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078302-001	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-12-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078302-001	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-12-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078302-001	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-12-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078302-001	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-12-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078302-001	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-12-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078302-001	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-12-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078302-001	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-12-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078302-001	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-12-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078302-001	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-12-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078302-001	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-12-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078302-001	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-12-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078302-001	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-12-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078302-001	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-12-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078302-001	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-12-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078302-001	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-12-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078302-001	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-12-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078302-001	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-12-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078302-001	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-12-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078302-001	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-12-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078302-001	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-12-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078302-001	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-12-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078302-001	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-12-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078302-001	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-12-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078302-001	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-12-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078302-001	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-12-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078302-001	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-12-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078302-001	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-12-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078302-001	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-12-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078302-001	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-12-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078302-001	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-12-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078302-001	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-12-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078302-001	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-12-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078302-001	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-12-17	`3a93d1ddd44b…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-10-28 04:53 UTC	2022-10	A078302-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078302-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078302-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A078302-001	AB	1	`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: Buspirone Hydrochloride
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BUSPIRONE HYDROCHLORIDE	30 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
207LT9J9OC	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
866018	Internal RxNorm lookup
866083	Internal RxNorm lookup
866090	Internal RxNorm lookup
866094	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
1521109d-8386-472f-9483-f1fe9f7ed152	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
a9968269-ddf2-400e-9170-7376dcf3545a	Product name	1	20251215
2cf3c2e9-d566-c982-009a-188fe4f776b9	Product name	8	20200428
4a9096ce-7b98-89e5-5942-15f48c4f7abf	Product name	5	20190711

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
82804-964-00	Buspirone Hydrochloride	100 in 1 BOTTLE	TABLET	100	1
82804-964-11	Buspirone Hydrochloride	1000 in 1 BOTTLE	TABLET	1000	1
82804-964-30	Buspirone Hydrochloride	30 in 1 BOTTLE	TABLET	30	1
82804-964-55	Buspirone Hydrochloride	500 in 1 BOTTLE	TABLET	500	1
82804-964-60	Buspirone Hydrochloride	60 in 1 BOTTLE	TABLET	60	1
82804-964-72	Buspirone Hydrochloride	120 in 1 BOTTLE	TABLET	120	1
82804-964-90	Buspirone Hydrochloride	90 in 1 BOTTLE	TABLET	90	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
82804-964-00	EA - Each	82804-964	85434db2-49ff-4506-bcfa-aaabf0234a5d	1	2026-02-05
82804-964-11	EA - Each	82804-964	f24e9d8e-0873-4685-8645-c2fd22df9a64	1	2026-02-05
82804-964-30	EA - Each	82804-964	5f82aa24-2f21-48be-8313-99e3e0f922f6	1	2026-02-05
82804-964-55	EA - Each	82804-964	ff82dbdf-84eb-4563-b3c0-39d2ae102c84	1	2026-02-05
82804-964-60	EA - Each	82804-964	8d7ca41e-c0b6-45f9-83d8-f3c96c008388	1	2026-02-05
82804-964-72	EA - Each	82804-964	12fd51f4-6e01-447a-a045-b543f602596c	1	2026-02-05
82804-964-90	EA - Each	82804-964	5fbdabad-5d4c-47a9-9831-c6761bbf6060	1	2026-02-05

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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	476f4f55-c6c1-4f39-950e-59236f499577	2026-03-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078302 application number: ANDA078302
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Proficient Rx LP	1521109d-8386-472f-9483-f1fe9f7ed152	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078302 application number: ANDA078302 ndc (product): 82804-964
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Bryant Ranch Prepack	eb072818-3ca8-430b-91a1-e7fedd37990c	2025-11-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078302 application number: ANDA078302
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	A-S Medication Solutions	38677cd0-2ee6-4c8f-8553-36310b2813a1	2025-11-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078302 application number: ANDA078302
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Bryant Ranch Prepack	790b6159-c03b-4a3a-be6b-add35a3114a4	2025-10-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078302 application number: ANDA078302
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Oxford Pharmaceuticals, LLC	97fcebc1-6615-4b9d-b0f3-6434850f407c	2025-08-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078302 application number: ANDA078302
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Bryant Ranch Prepack	696911d8-e97a-4c8e-9341-782b4c63bf03	2024-08-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078302 application number: ANDA078302
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Bryant Ranch Prepack	8bb7991e-ab09-4602-b49d-0a72a501685b	2024-08-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078302 application number: ANDA078302

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
207LT9J9OC	BUSPIRONE HYDROCHLORIDE	33386-08-2	BUSPIRONE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
866083	busPIRone HCl 10 MG Oral Tablet	PSN	1521109d-8386-472f-9483-f1fe9f7ed152	1
866018	busPIRone HCl 15 MG Oral Tablet	PSN	1521109d-8386-472f-9483-f1fe9f7ed152	1
866090	busPIRone HCl 30 MG Oral Tablet	PSN	1521109d-8386-472f-9483-f1fe9f7ed152	1
866094	busPIRone HCl 5 MG Oral Tablet	PSN	1521109d-8386-472f-9483-f1fe9f7ed152	1
866083	buspirone hydrochloride 10 MG Oral Tablet	SCD	1521109d-8386-472f-9483-f1fe9f7ed152	1
866018	buspirone hydrochloride 15 MG Oral Tablet	SCD	1521109d-8386-472f-9483-f1fe9f7ed152	1
866090	buspirone hydrochloride 30 MG Oral Tablet	SCD	1521109d-8386-472f-9483-f1fe9f7ed152	1
866094	buspirone hydrochloride 5 MG Oral Tablet	SCD	1521109d-8386-472f-9483-f1fe9f7ed152	1
866083	buspirone HCl 10 MG (buspirone 9.1 MG) Oral Tablet	SY	1521109d-8386-472f-9483-f1fe9f7ed152	1
866018	buspirone hydrochloride 15 MG (buspirone 13.7 MG) Oral Tablet	SY	1521109d-8386-472f-9483-f1fe9f7ed152	1
866090	buspirone hydrochloride 30 MG (buspirone 27.4 MG) Oral Tablet	SY	1521109d-8386-472f-9483-f1fe9f7ed152	1
866094	buspirone hydrochloride 5 MG (buspirone 4.6 MG) Oral Tablet	SY	1521109d-8386-472f-9483-f1fe9f7ed152	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
82804-964-00	82804096400	100 TABLET in 1 BOTTLE (82804-964-00)	100 tablet	2026-01-12	No	No	Current
82804-964-11	82804096411	1000 TABLET in 1 BOTTLE (82804-964-11)	1000 tablet	2026-01-12	No	No	Current
82804-964-30	82804096430	30 TABLET in 1 BOTTLE (82804-964-30)	30 tablet	2026-01-12	No	No	Current
82804-964-55	82804096455	500 TABLET in 1 BOTTLE (82804-964-55)	500 tablet	2026-01-12	No	No	Current
82804-964-60	82804096460	60 TABLET in 1 BOTTLE (82804-964-60)	60 tablet	2026-01-12	No	No	Current
82804-964-72	82804096472	120 TABLET in 1 BOTTLE (82804-964-72)	120 tablet	2026-01-12	No	No	Current
82804-964-90	82804096490	90 TABLET in 1 BOTTLE (82804-964-90)	90 tablet	2026-01-12	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Buspirone Hydrochloride - Proficient Rx LP	Proficient Rx LP	2026-01-01	HUMAN PRESCRIPTION DRUG LABEL	1