Buspirone Hydrochloride

Product NDC: 43353-609
11-digit product format: 433530609
Labeler code: 43353
Product ID: 43353-609_eb043003-31d8-4757-ac93-1bb8960cf7a4
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: 2002-03-21
Marketing end: 0000-00-00
Substance: BUSPIRONE HYDROCHLORIDE
Active strength: 5 mg/1
NDC exclude flag: No
Listing certified through: 2019-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	43353-609		I	Inactivated by FDA	2026-08-07
excluded package	package	43353-609	43353-609-53	I	Inactivated by FDA	2026-08-07
excluded package	package	43353-609	43353-609-60	I	Inactivated by FDA	2026-08-07
excluded package	package	43353-609	43353-609-80	I	Inactivated by FDA	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 2 · 84 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43353-609-80	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43353-609-53	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43353-609-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43353-609-80	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43353-609-53	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43353-609-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43353-609-80	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43353-609-53	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43353-609-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43353-609-80	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43353-609-53	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43353-609-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43353-609-80	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43353-609-53	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43353-609-60	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43353-609-80	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43353-609-53	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43353-609-60	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43353-609-80	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43353-609-53	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43353-609-60	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	43353-609-80	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	43353-609-53	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	43353-609-60	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	43353-609-80	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	43353-609-53	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	43353-609-60	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	43353-609-80	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	43353-609-53	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	43353-609-60	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	43353-609-80	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	43353-609-53	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	43353-609-60	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	43353-609-80	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	43353-609-53	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	43353-609-60	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	43353-609-80	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	43353-609-53	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	43353-609-60	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	43353-609-80	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	43353-609-53	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	43353-609-60	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	43353-609-80	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	43353-609-53	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	43353-609-60	`1332a3947898…`	`d4bfe170f9cd…`

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 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
43353-609-53	2020-01-31	C162847	48780-1	9d75b9d0-72eb-f424-e053-dadaa90a57ce	d0fea556-a015-45c9-98ef-a8b17da4c889
43353-609-60	2020-01-31	C162847	48780-1	9d75b9d0-72eb-f424-e053-dadaa90a57ce	d0fea556-a015-45c9-98ef-a8b17da4c889
43353-609-80	2020-01-31	C162847	48780-1	9d75b9d0-72eb-f424-e053-dadaa90a57ce	d0fea556-a015-45c9-98ef-a8b17da4c889

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
43353-609-53	Buspirone Hydrochloride	60 in 1 BOTTLE, PLASTIC	TABLET	60	1
43353-609-60	Buspirone Hydrochloride	90 in 1 BOTTLE, PLASTIC	TABLET	90	1
43353-609-80	Buspirone Hydrochloride	180 in 1 BOTTLE, PLASTIC	TABLET	180	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43353-609-53	EA - Each	43353-609	26fd952c-b239-4fc4-be00-00af4899a2fd	1	2014-07-02
43353-609-60	EA - Each	43353-609	a8d538b5-c474-4d68-b21e-cc63a189b209	1	2014-07-02
43353-609-80	EA - Each	43353-609	f08aca52-e728-4c8a-9619-f3a7b42bb6d2	1	2014-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BUSPIRONE HYDROCHLORIDE	ACTIVE INGREDIENT	207LT9J9OC	BUSPIRONE HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
BUSPIRONE	ACTIVE MOIETY	TK65WKS8HL	BUSPIRONE HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	BUSPIRONE HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	BUSPIRONE HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	BUSPIRONE HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	BUSPIRONE HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	BUSPIRONE HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	BUSPIRONE HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43353-609	BUSPIRONE HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1	Legacy NDC, 3 package rows	20140626_d0fea556-a015-45c9-98ef-a8b17da4c889.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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
866083	busPIRone HCl 10 MG Oral Tablet	PSN	d0fea556-a015-45c9-98ef-a8b17da4c889	1
866018	busPIRone HCl 15 MG Oral Tablet	PSN	d0fea556-a015-45c9-98ef-a8b17da4c889	1
866094	busPIRone HCl 5 MG Oral Tablet	PSN	d0fea556-a015-45c9-98ef-a8b17da4c889	1
866083	buspirone hydrochloride 10 MG Oral Tablet	SCD	d0fea556-a015-45c9-98ef-a8b17da4c889	1
866018	buspirone hydrochloride 15 MG Oral Tablet	SCD	d0fea556-a015-45c9-98ef-a8b17da4c889	1
866094	buspirone hydrochloride 5 MG Oral Tablet	SCD	d0fea556-a015-45c9-98ef-a8b17da4c889	1
866083	buspirone HCl 10 MG (buspirone 9.1 MG) Oral Tablet	SY	d0fea556-a015-45c9-98ef-a8b17da4c889	1
866018	buspirone hydrochloride 15 MG (buspirone 13.7 MG) Oral Tablet	SY	d0fea556-a015-45c9-98ef-a8b17da4c889	1
866094	buspirone hydrochloride 5 MG (buspirone 4.6 MG) Oral Tablet	SY	d0fea556-a015-45c9-98ef-a8b17da4c889	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
43353-609-53	43353060953	60 in 1 BOTTLE, PLASTIC	Historical
43353-609-60	43353060960	90 in 1 BOTTLE, PLASTIC	Historical
43353-609-80	43353060980	180 in 1 BOTTLE, PLASTIC	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Buspirone Hydrochloride - Aphena Pharma Solutions - Tennessee, LLC	Aphena Pharma Solutions - Tennessee, LLC	2014-06-18	HUMAN PRESCRIPTION DRUG LABEL	1