Buspirone HCl

Product NDC: 63187-645
11-digit product format: 631870645
Labeler code: 63187
Product ID: 63187-645_17bf8148-e593-4cf3-948a-4a3bed8266f8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Buspirone hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Proficient Rx LP
Application: ANDA074253
Marketing category: ANDA
Marketing start: 2001-03-28
Marketing end: 0000-00-00
Substance: BUSPIRONE HYDROCHLORIDE
Active strength: 15 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	63187-645		D	Discontinued by firm	2026-10-15
excluded package	package	63187-645	63187-645-30	D	Discontinued by firm	2026-10-15
excluded package	package	63187-645	63187-645-60	D	Discontinued by firm	2026-10-15
excluded package	package	63187-645	63187-645-72	D	Discontinued by firm	2026-10-15
excluded package	package	63187-645	63187-645-78	D	Discontinued by firm	2026-10-15
excluded package	package	63187-645	63187-645-90	D	Discontinued by firm	2026-10-15

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 · 12 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	63187-645-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63187-645-72	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63187-645-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63187-645-90	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63187-645-78	`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	63187-645-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63187-645-72	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63187-645-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63187-645-90	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63187-645-78	`f5e01cc5f278…`	`a2eaf40c39c3…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A074253-001	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2001-03-28
A074253-002	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2001-03-28
A074253-003	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2002-03-13

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A074253-001	AB
A074253-002	AB
A074253-003	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 4 · 132 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
2026-10-15 13:18:30	2026-09	A074253-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2001-03-28	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A074253-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2001-03-28	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A074253-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2002-03-13	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A074253-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2001-03-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A074253-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2001-03-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A074253-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2002-03-13	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A074253-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2001-03-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074253-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2001-03-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074253-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2002-03-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074253-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2001-03-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074253-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2001-03-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074253-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2002-03-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074253-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2001-03-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074253-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2001-03-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074253-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2002-03-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074253-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2001-03-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074253-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2001-03-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074253-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2002-03-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074253-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2001-03-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074253-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2001-03-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074253-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2002-03-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074253-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2001-03-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074253-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2001-03-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074253-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2002-03-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074253-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2001-03-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074253-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2001-03-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074253-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2002-03-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074253-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2001-03-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074253-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2001-03-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074253-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2002-03-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074253-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2001-03-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074253-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2001-03-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074253-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2002-03-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074253-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2001-03-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074253-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2001-03-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074253-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2002-03-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074253-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2001-03-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074253-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2001-03-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074253-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2002-03-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074253-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2001-03-28	`79d66fd596c7…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074253-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074253-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074253-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074253-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074253-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074253-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074253-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074253-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074253-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A074253-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A074253-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074253-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074253-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074253-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074253-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A074253-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A074253-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074253-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A074253-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A074253-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074253-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A074253-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A074253-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074253-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A074253-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A074253-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074253-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A074253-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A074253-003	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074253-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074253-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074253-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074253-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A074253-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A074253-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074253-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A074253-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A074253-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074253-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A074253-002	AB	1	`c0c555d07b60…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63187-645	BUSPIRONE HCL (BUSPIRONE HYDROCHLORIDE) TABLET [PROFICIENT RX LP]	3	Legacy NDC	20191121_5e392834-2930-41b3-a9ad-d35d35974038.zip

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
63187-645-30	63187064530	30 TABLET in 1 BOTTLE, PLASTIC (63187-645-30)	30 tablet	2018-12-01	0000-00-00	No	No	Current
63187-645-60	63187064560	60 TABLET in 1 BOTTLE, PLASTIC (63187-645-60)	60 tablet	2018-12-01	0000-00-00	No	No	Current
63187-645-72	63187064572	120 TABLET in 1 BOTTLE, PLASTIC (63187-645-72)	120 tablet	2018-12-01	0000-00-00	No	No	Current
63187-645-78	63187064578	180 TABLET in 1 BOTTLE, PLASTIC (63187-645-78)	180 tablet	2018-12-01	0000-00-00	No	No	Current
63187-645-90	63187064590	90 TABLET in 1 BOTTLE, PLASTIC (63187-645-90)	90 tablet	2018-12-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Buspirone HCl Tablets USP Revised: November 2013 Rx only	Proficient Rx LP	2019-11-01	HUMAN PRESCRIPTION DRUG LABEL	3