Buspirone Hydrochloride

Product NDC: 55111-473
11-digit product format: 551110473
Labeler code: 55111
Product ID: 55111-473_e4f9b1c3-d3ff-9ba2-9232-758efe2752d4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Buspirone Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Dr. Reddy's Laboratories Limited
Application: ANDA078246
Marketing category: ANDA
Marketing start: 2009-03-04
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 · 6 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	55111-473		I	Inactivated by FDA	2026-08-07
excluded package	package	55111-473	55111-473-01	I	Inactivated by FDA	2026-08-07
excluded package	package	55111-473	55111-473-05	I	Inactivated by FDA	2026-08-07
excluded package	package	55111-473	55111-473-30	I	Inactivated by FDA	2026-08-07
excluded package	package	55111-473	55111-473-60	I	Inactivated by FDA	2026-08-07
excluded package	package	55111-473	55111-473-78	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 · 90 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	55111-473-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	55111-473-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	55111-473-78	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	55111-473-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	55111-473-01	`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	55111-473-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	55111-473-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	55111-473-78	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	55111-473-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	55111-473-01	`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	55111-473-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	55111-473-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	55111-473-78	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	55111-473-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	55111-473-01	`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	55111-473-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	55111-473-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	55111-473-78	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	55111-473-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	55111-473-01	`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	55111-473-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	55111-473-60	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	55111-473-78	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	55111-473-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	55111-473-01	`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	55111-473-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	55111-473-60	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	55111-473-78	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	55111-473-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	55111-473-01	`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	55111-473-30	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	55111-473-60	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	55111-473-78	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	55111-473-05	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	55111-473-01	`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	55111-473-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	55111-473-60	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	55111-473-78	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	55111-473-05	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	55111-473-01	`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	55111-473-30	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	55111-473-60	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	55111-473-78	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	55111-473-05	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	55111-473-01	`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	55111-473-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	55111-473-60	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	55111-473-78	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	55111-473-05	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	55111-473-01	`ad56d346431e…`	`cc804d4bbf1e…`

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
A078246-001	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2009-02-27
A078246-002	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2009-02-27
A078246-003	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2009-02-27
A078246-004	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2009-02-27
A078246-005	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2020-02-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078246-001	AB
A078246-002	AB
A078246-003	AB
A078246-004	AB
A078246-005	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 · 201 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	A078246-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2009-02-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078246-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2009-02-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078246-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2009-02-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078246-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2009-02-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078246-005	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2020-02-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078246-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2009-02-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078246-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2009-02-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078246-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2009-02-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078246-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2009-02-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078246-005	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2020-02-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078246-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2009-02-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078246-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2009-02-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078246-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2009-02-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078246-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2009-02-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078246-005	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2020-02-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078246-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2009-02-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078246-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2009-02-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078246-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2009-02-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078246-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2009-02-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078246-005	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2020-02-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078246-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2009-02-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078246-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2009-02-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078246-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2009-02-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078246-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2009-02-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078246-005	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2020-02-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078246-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2009-02-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078246-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2009-02-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078246-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2009-02-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078246-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2009-02-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078246-005	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2020-02-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078246-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2009-02-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078246-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2009-02-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078246-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2009-02-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078246-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2009-02-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078246-005	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2020-02-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078246-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2009-02-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078246-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2009-02-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078246-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2009-02-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078246-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2009-02-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078246-005	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2020-02-21	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 201 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	A078246-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078246-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078246-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078246-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078246-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078246-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078246-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078246-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078246-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078246-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078246-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078246-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078246-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078246-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078246-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078246-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078246-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078246-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078246-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078246-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078246-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078246-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078246-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078246-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078246-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078246-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078246-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078246-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078246-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078246-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078246-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078246-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078246-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078246-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078246-005	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078246-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078246-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078246-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078246-004	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078246-005	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, Related label table
NDC	Related label
55111-473-01	Buspirone Hydrochloride
55111-473-05	Buspirone Hydrochloride
55111-473-30	Buspirone Hydrochloride
55111-473-60	Buspirone Hydrochloride
55111-473-78	Buspirone Hydrochloride

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
55111-473-01	Buspirone Hydrochloride	100 in 1 BOTTLE	TABLET	100	2
55111-473-05	Buspirone Hydrochloride	500 in 1 BOTTLE	TABLET	500	2
55111-473-30	Buspirone Hydrochloride	30 in 1 BOTTLE	TABLET	30	2
55111-473-60	Buspirone Hydrochloride	60 in 1 BOTTLE	TABLET	60	2
55111-473-78	Buspirone Hydrochloride	10 in 1 CARTON	TABLET	10	2
55111-473-79	Buspirone Hydrochloride	10 in 1 BLISTER PACK	TABLET	10	2

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Buspirone Hydrochloride	ACTIVE INGREDIENT	207LT9J9OC	BUSPIRONE HYDROCHLORIDE TABLET [DR. REDDY'S LABORATORIES LTD]	1
Buspirone	ACTIVE MOIETY	TK65WKS8HL	BUSPIRONE HYDROCHLORIDE TABLET [DR. REDDY'S LABORATORIES LTD]	1
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	BUSPIRONE HYDROCHLORIDE TABLET [DR. REDDY'S LABORATORIES LTD]	1
ferric oxide red	INACTIVE INGREDIENT	1K09F3G675	BUSPIRONE HYDROCHLORIDE TABLET [DR. REDDY'S LABORATORIES LTD]	1
lactose monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	BUSPIRONE HYDROCHLORIDE TABLET [DR. REDDY'S LABORATORIES LTD]	1
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	BUSPIRONE HYDROCHLORIDE TABLET [DR. REDDY'S LABORATORIES LTD]	1
silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	BUSPIRONE HYDROCHLORIDE TABLET [DR. REDDY'S LABORATORIES LTD]	1
sodium starch glycolate type A potato	INACTIVE INGREDIENT	5856J3G2A2	BUSPIRONE HYDROCHLORIDE TABLET [DR. REDDY'S LABORATORIES LTD]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55111-473	BUSPIRONE HYDROCHLORIDE TABLET [DR. REDDY'S LABORATORIES LIMITED]	2	Legacy NDC, 6 package rows	20171204_c78cf4ff-51b2-851e-89cc-98ea543e3865.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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	REMEDYREPACK INC.	fa4d5cac-f687-4440-99d2-8bb27cf2f4ed	2025-08-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078246 application number: ANDA078246
BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	Advanced Rx Pharmacy of Tennessee, LLC	fc0f93c8-2078-b2ff-e053-6294a90aacdf	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078246 application number: ANDA078246
BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	A-S Medication Solutions	529ab1f9-534c-4a45-aa70-76e605247af1	2024-12-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078246 application number: ANDA078246
BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	Proficient Rx LP	75b1ae3f-e926-4555-a0e9-50323fc66cb2	2024-02-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078246 application number: ANDA078246
BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	Bryant Ranch Prepack	55e32128-711d-4e95-b58b-e86e0afa4983	2023-12-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078246 application number: ANDA078246
BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	Bryant Ranch Prepack	d47cde56-e1ab-41fe-832e-d3f33b884a5e	2023-11-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078246 application number: ANDA078246
BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	A-S Medication Solutions	501b0406-f56e-44d3-906a-7625b936f075	2023-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078246 application number: ANDA078246
BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	Bryant Ranch Prepack	2bc87b32-bdb7-4ce6-8a51-aed623f7219e	2023-06-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078246 application number: ANDA078246
BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	Aurobindo Pharma Limited	05c006d2-44b9-431f-bce2-aff09c043ecb	2021-07-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078246 application number: ANDA078246

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	c78cf4ff-51b2-851e-89cc-98ea543e3865	2
866018	busPIRone HCl 15 MG Oral Tablet	PSN	c78cf4ff-51b2-851e-89cc-98ea543e3865	2
866090	busPIRone HCl 30 MG Oral Tablet	PSN	c78cf4ff-51b2-851e-89cc-98ea543e3865	2
866094	busPIRone HCl 5 MG Oral Tablet	PSN	c78cf4ff-51b2-851e-89cc-98ea543e3865	2
866083	buspirone hydrochloride 10 MG Oral Tablet	SCD	c78cf4ff-51b2-851e-89cc-98ea543e3865	2
866018	buspirone hydrochloride 15 MG Oral Tablet	SCD	c78cf4ff-51b2-851e-89cc-98ea543e3865	2
866090	buspirone hydrochloride 30 MG Oral Tablet	SCD	c78cf4ff-51b2-851e-89cc-98ea543e3865	2
866094	buspirone hydrochloride 5 MG Oral Tablet	SCD	c78cf4ff-51b2-851e-89cc-98ea543e3865	2
866083	buspirone HCl 10 MG (buspirone 9.1 MG) Oral Tablet	SY	c78cf4ff-51b2-851e-89cc-98ea543e3865	2
866018	buspirone hydrochloride 15 MG (buspirone 13.7 MG) Oral Tablet	SY	c78cf4ff-51b2-851e-89cc-98ea543e3865	2
866090	buspirone hydrochloride 30 MG (buspirone 27.4 MG) Oral Tablet	SY	c78cf4ff-51b2-851e-89cc-98ea543e3865	2
866094	buspirone hydrochloride 5 MG (buspirone 4.6 MG) Oral Tablet	SY	c78cf4ff-51b2-851e-89cc-98ea543e3865	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
55111-473-01	55111047301	100 TABLET in 1 BOTTLE (55111-473-01)	100 tablet	2009-03-04	0000-00-00	No	No	Current
55111-473-05	55111047305	500 TABLET in 1 BOTTLE (55111-473-05)	500 tablet	2009-03-04	0000-00-00	No	No	Current
55111-473-30	55111047330	30 TABLET in 1 BOTTLE (55111-473-30)	30 tablet	2009-03-04	0000-00-00	No	No	Current
55111-473-60	55111047360	60 TABLET in 1 BOTTLE (55111-473-60)	60 tablet	2009-03-04	0000-00-00	No	No	Current
55111-473-78	55111047378	10 BLISTER PACK in 1 CARTON (55111-473-78) > 10 TABLET in 1 BLISTER PACK (55111-473-79)	10 blister pack	2009-03-04	0000-00-00	No	No	Current
55111-473-79	55111047379	10 in 1 BLISTER PACK						Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Buspirone Hydrochloride	Dr. Reddy's Laboratories Limited \| Dr. Reddy's Laboratories Limited - FTO III	2010-11-25	HUMAN PRESCRIPTION DRUG LABEL	2