Buspirone hydrochloride

Product NDC: 71610-962
11-digit product format: 716100962
Labeler code: 71610
Product ID: 71610-962_47e30f25-1be3-1cd2-e063-6294a90ae97f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Buspirone hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: ANDA202087
Marketing category: ANDA
Marketing start: 2025-09-18
Substance: BUSPIRONE HYDROCHLORIDE
Active strength: 10 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 43.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A202087-001	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-12-16
A202087-002	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-12-16
A202087-003	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2015-12-16
A202087-004	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2015-12-16
A202087-005	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2025-07-03

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-product	TE code
A202087-001	AB
A202087-002	AB
A202087-003	AB
A202087-004	AB
A202087-005	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 5 · 178 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
2026-09-14 22:38:34	2026-08	A202087-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-12-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202087-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-12-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202087-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2015-12-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202087-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2015-12-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202087-005	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2025-07-03	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202087-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-12-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202087-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-12-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202087-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2015-12-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202087-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2015-12-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202087-005	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2025-07-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202087-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-12-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202087-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-12-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202087-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2015-12-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202087-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2015-12-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202087-005	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2025-07-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202087-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-12-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202087-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-12-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202087-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2015-12-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202087-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2015-12-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202087-005	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2025-07-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202087-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-12-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202087-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-12-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202087-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2015-12-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202087-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2015-12-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202087-005	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2025-07-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202087-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-12-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202087-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-12-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202087-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2015-12-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202087-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2015-12-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202087-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-12-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202087-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-12-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202087-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2015-12-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202087-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2015-12-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202087-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-12-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202087-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-12-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202087-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2015-12-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202087-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2015-12-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202087-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-12-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202087-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-12-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202087-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2015-12-16	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 178 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A202087-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202087-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202087-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202087-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202087-005	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202087-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202087-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202087-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202087-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202087-005	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202087-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202087-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202087-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202087-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202087-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202087-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202087-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202087-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202087-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202087-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202087-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202087-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202087-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202087-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202087-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202087-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202087-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202087-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202087-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202087-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202087-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202087-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202087-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202087-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202087-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202087-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202087-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202087-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202087-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202087-003	AB	1	`2680178bc6a6…`

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	10 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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
866083	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
427ad27e-6664-afee-e063-6394a90a1890	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
71610-962-53	Buspirone hydrochloride	60 in 1 BOTTLE	TABLET	60	3
71610-962-60	Buspirone hydrochloride	90 in 1 BOTTLE	TABLET	90	3
71610-962-70	Buspirone hydrochloride	120 in 1 BOTTLE	TABLET	120	3
71610-962-80	Buspirone hydrochloride	180 in 1 BOTTLE	TABLET	180	3
71610-962-92	Buspirone hydrochloride	270 in 1 BOTTLE	TABLET	270	3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71610-962-53	EA - Each	71610-962	bfb1b8db-331d-489e-81f1-0a98ac6f6cba	1	2025-12-16
71610-962-60	EA - Each	71610-962	6f97948d-c11e-4bb9-890a-758a29233ebd	1	2025-12-16
71610-962-70	EA - Each	71610-962	7159ec11-0418-47d0-81e1-d9f2eae2647a	1	2026-03-17
71610-962-80	EA - Each	71610-962	1baae621-d156-400f-a99c-bb66684ae259	1	2025-12-16
71610-962-92	EA - Each	71610-962	3087c88d-7408-4319-987c-cb651b46283b	1	2026-03-17

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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Buspirone hydrochloride	BUSPIRONE HYDROCHLORIDE	AiPing Pharmaceutical, Inc.	55810b17-4796-49d0-90e4-8e075d62eda4	2026-07-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202087 application number: ANDA202087
Buspirone hydrochloride	BUSPIRONE HYDROCHLORIDE	A-S Medication Solutions	7b222cb0-0061-4a3e-9d0f-e9f120e7f5d9	2026-07-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202087 application number: ANDA202087
Buspirone hydrochloride	BUSPIRONE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	427ad27e-6664-afee-e063-6394a90a1890	2026-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202087 application number: ANDA202087 ndc (product): 71610-962
Buspirone hydrochloride	BUSPIRONE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	45c637b7-3057-ea38-e063-6394a90a87b6	2025-12-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202087 application number: ANDA202087
Buspirone hydrochloride	BUSPIRONE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	424d81f0-b195-5bc2-e063-6394a90a2104	2025-12-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202087 application number: ANDA202087
Buspirone hydrochloride	BUSPIRONE HYDROCHLORIDE	Radha Pharmaceuticals, Inc.	3f66a3fe-9d73-180c-e063-6394a90aacca	2025-09-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202087 application number: ANDA202087
Buspirone hydrochloride	BUSPIRONE HYDROCHLORIDE	EPIC PHARMA, LLC	e8f43c66-f8de-419f-9ea9-43ddc4ec0798	2025-01-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202087 application number: ANDA202087

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	427ad27e-6664-afee-e063-6394a90a1890	3
866083	buspirone hydrochloride 10 MG Oral Tablet	SCD	427ad27e-6664-afee-e063-6394a90a1890	3
866083	buspirone HCl 10 MG (buspirone 9.1 MG) Oral Tablet	SY	427ad27e-6664-afee-e063-6394a90a1890	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
71610-962-53	71610096253	60 TABLET in 1 BOTTLE (71610-962-53)	60 tablet	2025-11-05	No	No	Current
71610-962-60	71610096260	90 TABLET in 1 BOTTLE (71610-962-60)	90 tablet	2025-10-31	No	No	Current
71610-962-70	71610096270	120 TABLET in 1 BOTTLE (71610-962-70)	120 tablet	2026-01-08	No	No	Current
71610-962-80	71610096280	180 TABLET in 1 BOTTLE (71610-962-80)	180 tablet	2025-11-05	No	No	Current
71610-962-92	71610096292	270 TABLET in 1 BOTTLE (71610-962-92)	270 tablet	2026-01-08	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
BUSPIRONE HYDROCHLORIDE TABLETS, USP (Patient Instruction Sheet Included) Rx only	Aphena Pharma Solutions - Tennessee, LLC	2026-01-08	HUMAN PRESCRIPTION DRUG LABEL	3