Buspirone Hydrochloride

Product NDC: 43353-060
Requested package NDC: 43353-060-80
11-digit product format: 433530060
Labeler code: 43353
Product ID: 43353-060_fab5e5c3-4250-44c5-9a97-68a48e5330b2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: buspirone hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: ANDA076008
Marketing category: ANDA
Marketing start: 2015-02-09
Marketing end: 0000-00-00
Substance: BUSPIRONE HYDROCHLORIDE
Active strength: 10 mg/1
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	43353-060	43353-060-80	D	Discontinued by firm		2026-08-07

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43353-060	43353-060-80	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43353-060	43353-060-80	D	Discontinued by firm		excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A076008-001	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2001-06-28
A076008-002	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL		2013-07-08
A076008-003	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2002-03-01
A076008-004	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2002-03-01
A076008-005	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2001-03-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A076008-001	AB
A076008-003	AB
A076008-004	AB
A076008-005	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 6 · 205 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
2026-02-19 14:30 UTC	2026-02	A076008-001	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2001-06-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076008-002	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2013-07-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076008-003	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2002-03-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076008-004	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2002-03-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076008-005	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2001-03-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076008-001	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2001-06-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076008-002	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2013-07-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076008-003	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2002-03-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076008-004	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2002-03-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076008-005	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2001-03-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076008-001	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2001-06-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076008-002	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2013-07-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076008-003	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2002-03-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076008-004	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2002-03-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076008-005	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2001-03-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076008-001	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2001-06-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076008-002	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2013-07-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076008-003	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2002-03-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076008-004	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2002-03-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076008-005	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2001-03-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076008-001	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2001-06-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076008-002	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2013-07-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076008-003	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2002-03-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076008-004	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2002-03-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076008-005	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2001-03-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076008-001	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2001-06-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076008-002	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2013-07-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076008-003	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2002-03-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076008-004	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2002-03-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076008-005	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2001-03-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076008-001	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2001-06-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076008-002	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2013-07-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076008-003	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2002-03-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076008-004	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2002-03-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076008-005	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2001-03-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076008-001	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2001-06-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076008-002	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2013-07-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076008-003	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2002-03-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076008-004	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2002-03-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076008-005	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2001-03-28	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 204 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A076008-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076008-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076008-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076008-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076008-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076008-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076008-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076008-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076008-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076008-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076008-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076008-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076008-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076008-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076008-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076008-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076008-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076008-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076008-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076008-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076008-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076008-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076008-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076008-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076008-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076008-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076008-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076008-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076008-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076008-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076008-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076008-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076008-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076008-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076008-005	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076008-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076008-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076008-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076008-004	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076008-005	AB	1	`5bbf6a4d5a75…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43353-060-53	EA - Each	43353-060	b5af9f03-2bfa-4fd6-8388-54a5b67870e6	1	2016-07-19
43353-060-60	EA - Each	43353-060	e673f6bc-f1a9-490b-990e-d7e0a3d7b6ee	1	2016-07-19
43353-060-70	EA - Each	43353-060	745cdcaf-a5c5-4528-9c80-800ac14fbe51	1	2016-07-19
43353-060-80	EA - Each	43353-060	ac288f41-cdfa-4eeb-9372-0d981d6197d1	1	2016-07-19
43353-060-92	EA - Each	43353-060	c784c943-f570-47e9-9654-4115c1b51f77	1	2016-07-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43353-060	BUSPIRONE HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2	Legacy NDC	20160711_fb05be45-4973-4cb7-97b2-b4bcedd47f5a.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Cardinal Health 107, LLC	2acc7da1-d5b8-4404-a3c6-d51ed82cc4fd	2026-06-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076008 application number: ANDA076008
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Mylan Pharmaceuticals Inc.	7c9eafb9-9ce1-4b28-900c-8fcb4b23424e	2026-06-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076008 application number: ANDA076008
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Safecor Health, LLC	ebda05ee-d895-4636-bc28-d393e69c91b3	2026-02-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076008 application number: ANDA076008
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Mylan Institutional Inc.	91bb5fc9-5121-43c2-b2af-149240d4189a	2025-07-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076008 application number: ANDA076008

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	Marketing end	Sample	Exclude flag	Status
43353-060-80	43353006080	180 TABLET in 1 BOTTLE, PLASTIC (43353-060-80)	180 tablet	2015-07-12	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Buspirone Hydrochloride - Aphena Pharma Solutions - Tennessee, LLC	Aphena Pharma Solutions - Tennessee, LLC	2016-06-09	HUMAN PRESCRIPTION DRUG LABEL	2