Buspirone hydrochloride

Product NDC: 50090-8018
Requested package NDC: 50090-8018-1
11-digit product format: 500908018
Labeler code: 50090
Product ID: 50090-8018_6c194e4a-6e28-4dd2-b133-c42460a507d3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Buspirone hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA202087
Marketing category: ANDA
Marketing start: 2025-09-26
Substance: BUSPIRONE HYDROCHLORIDE
Active strength: 5 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	5 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
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
7b222cb0-0061-4a3e-9d0f-e9f120e7f5d9	Available on FDA.report

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 ndc (package): 50090-8018-1 ndc (product): 50090-8018 ndc11 (package): 50090801801
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
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
50090-8018-1	50090801801	60 TABLET in 1 BOTTLE (50090-8018-1)	60 tablet	2026-07-20	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
BUSPIRONE HYDROCHLORIDE TABLETS, USP (Patient Instruction Sheet Included) Rx only	A-S Medication Solutions	2026-07-24	HUMAN PRESCRIPTION DRUG LABEL	2