Buspirone hydrochloride

Product NDC: 50268-135
11-digit product format: 502680135
Labeler code: 50268
Product ID: 50268-135_4c3657a8-f6bd-b2a4-e063-6394a90a741d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Buspirone hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: AvPAK
Application: ANDA078888
Marketing category: ANDA
Marketing start: 2020-10-21
Substance: BUSPIRONE HYDROCHLORIDE
Active strength: 15 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 42.

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
A078888-001	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-02-07
A078888-002	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-02-07
A078888-003	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2014-02-07
A078888-004	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2014-02-07
A078888-005	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2023-03-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078888-001	AB
A078888-002	AB
A078888-003	AB
A078888-004	AB
A078888-005	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 · 192 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
2026-08-18 06:07:40	2026-07	A078888-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-02-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078888-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-02-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078888-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2014-02-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078888-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2014-02-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078888-005	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2023-03-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078888-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-02-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078888-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-02-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078888-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2014-02-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078888-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2014-02-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078888-005	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2023-03-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078888-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-02-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078888-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-02-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078888-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2014-02-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078888-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2014-02-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078888-005	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2023-03-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078888-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-02-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078888-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-02-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078888-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2014-02-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078888-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2014-02-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078888-005	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2023-03-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078888-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-02-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078888-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-02-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078888-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2014-02-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078888-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2014-02-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078888-005	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2023-03-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078888-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-02-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078888-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-02-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078888-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2014-02-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078888-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2014-02-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078888-005	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2023-03-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078888-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-02-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078888-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-02-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078888-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2014-02-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078888-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2014-02-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078888-005	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2023-03-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078888-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-02-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078888-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-02-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078888-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2014-02-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078888-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2014-02-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078888-005	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2023-03-21	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 192 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A078888-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078888-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078888-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078888-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078888-005	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078888-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078888-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078888-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078888-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078888-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078888-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078888-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078888-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078888-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078888-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078888-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078888-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078888-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078888-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078888-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078888-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078888-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078888-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078888-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078888-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078888-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078888-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078888-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078888-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078888-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078888-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078888-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078888-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078888-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078888-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078888-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078888-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078888-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078888-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078888-005	AB	1	`2680178bc6a6…`

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	15 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
866018	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
b230197c-3d50-7874-e053-2a95a90af50f	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	Strength	SPL version
50268-135-11	Buspirone hydrochloride	1 in 1 BLISTER PACK	TABLET	1		6
50268-135-15	Buspirone hydrochloride	50 in 1 BOX	TABLET	50		6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50268-135	BUSPIRONE HYDROCHLORIDE TABLET [AVPAK]	4	Current NDC, Legacy NDC, 2 package rows	20240110_b230197c-3d50-7874-e053-2a95a90af50f.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 · 16 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Buspirone hydrochloride	BUSPIRONE HYDROCHLORIDE	Major Pharmaceuticals	a9bb9216-3dac-4e8a-9df9-f72c2eaef160	2026-06-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078888 application number: ANDA078888
Buspirone hydrochloride	BUSPIRONE HYDROCHLORIDE	Unit Dose Solutions, Inc.	544b8918-7175-655f-e063-6394a90a453a	2026-06-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078888 application number: ANDA078888
Buspirone hydrochloride	BUSPIRONE HYDROCHLORIDE	Coupler LLC	53e7576a-e2f4-042b-e063-6294a90ae035	2026-06-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078888 application number: ANDA078888
Buspirone hydrochloride	BUSPIRONE HYDROCHLORIDE	REMEDYREPACK INC.	fa3f9c0e-261d-4ceb-8cc7-e5e013563479	2026-06-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078888 application number: ANDA078888
Buspirone hydrochloride	BUSPIRONE HYDROCHLORIDE	Cardinal Health 107, LLC	1315494d-7a51-4395-bc7c-afb4bc5482c9	2026-04-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078888 application number: ANDA078888
Buspirone hydrochloride	BUSPIRONE HYDROCHLORIDE	AvPAK	b230197c-3d50-7874-e053-2a95a90af50f	2026-03-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078888 application number: ANDA078888 ndc (product): 50268-135
buspirone hydrochloride	BUSPIRONE HYDROCHLORIDE	Zydus Lifesciences Limited	1109dd63-6492-49b1-a383-3ab3a80cd6c7	2025-12-24		Exact identifier application applno (ANDA): 078888 application number: ANDA078888
Buspirone hydrochloride	BUSPIRONE HYDROCHLORIDE	Bryant Ranch Prepack	8c811d3a-8b2d-44f5-bc8f-8eb563f18c3f	2025-11-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078888 application number: ANDA078888
Buspirone hydrochloride	BUSPIRONE HYDROCHLORIDE	Bryant Ranch Prepack	08efb26e-488c-49d4-8432-98db855962e9	2025-03-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078888 application number: ANDA078888
Buspirone hydrochloride	BUSPIRONE HYDROCHLORIDE	Bryant Ranch Prepack	897dac69-a59b-423c-be16-6301c7e504d9	2025-03-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078888 application number: ANDA078888
Buspirone hydrochloride	BUSPIRONE HYDROCHLORIDE	Zydus Pharmaceuticals USA Inc.	14fd7c1c-778e-46d4-9024-89b319f15f39	2025-02-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078888 application number: ANDA078888
Buspirone hydrochloride	BUSPIRONE HYDROCHLORIDE	REMEDYREPACK INC.	7ac98a7f-0ded-427f-899a-c3f6d1997403	2025-01-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078888 application number: ANDA078888
Buspirone hydrochloride	BUSPIRONE HYDROCHLORIDE	American Health Packaging	e80d83a6-7c2a-478e-bdf1-c481824fc301	2024-06-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078888 application number: ANDA078888
Buspirone hydrochloride	BUSPIRONE HYDROCHLORIDE	Bryant Ranch Prepack	b07c0a91-892c-47f5-819e-a128e0ef1ed7	2023-12-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078888 application number: ANDA078888
Buspirone hydrochloride	BUSPIRONE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	7f6986a8-59dc-4dc3-bac0-b38cfc689f8f	2019-04-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078888 application number: ANDA078888
Buspirone hydrochloride	BUSPIRONE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	310c6bea-838b-43e4-87e0-a0050829c242	2018-12-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078888 application number: ANDA078888

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
866018	busPIRone HCl 15 MG Oral Tablet	PSN	b230197c-3d50-7874-e053-2a95a90af50f	6
866018	buspirone hydrochloride 15 MG Oral Tablet	SCD	b230197c-3d50-7874-e053-2a95a90af50f	6
866018	buspirone hydrochloride 15 MG (buspirone 13.7 MG) Oral Tablet	SY	b230197c-3d50-7874-e053-2a95a90af50f	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50268-135-11	50268013511	1 in 1 BLISTER PACK						Historical
50268-135-15	50268013515	50 BLISTER PACK in 1 BOX (50268-135-15) / 1 TABLET in 1 BLISTER PACK (50268-135-11)	50 blister pack	2020-10-21	0000-00-00	No	No	Current