Buspirone Hydrochloride

Product NDC: 63629-2415
11-digit product format: 636292415
Labeler code: 63629
Product ID: 63629-2415_5f0a85ed-8b19-4276-b5cf-6436473af97d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: buspirone hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA078302
Marketing category: ANDA
Marketing start: 2020-05-01
Substance: BUSPIRONE HYDROCHLORIDE
Active strength: 30 mg/1
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A078302-001	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB		2007-12-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078302-001	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2025-01-19 17:59 UTC	2025-01	A078302-001	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-12-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078302-001	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-12-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078302-001	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-12-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078302-001	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-12-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078302-001	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-12-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078302-001	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-12-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078302-001	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-12-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078302-001	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-12-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078302-001	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-12-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078302-001	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-12-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078302-001	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-12-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078302-001	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-12-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078302-001	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-12-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078302-001	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-12-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078302-001	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-12-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078302-001	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-12-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078302-001	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-12-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078302-001	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-12-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078302-001	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-12-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078302-001	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-12-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078302-001	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-12-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078302-001	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-12-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078302-001	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-12-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078302-001	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-12-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078302-001	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-12-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078302-001	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-12-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078302-001	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-12-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078302-001	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-12-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078302-001	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-12-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078302-001	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-12-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078302-001	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-12-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078302-001	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-12-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078302-001	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-12-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078302-001	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-12-17	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078302-001	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-12-17	`cb3db0bc1861…`
2026-08-01 22:54:32	2026-06	A078302-001	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-12-17	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-01-19 17:59 UTC	2025-01	A078302-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078302-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078302-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078302-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078302-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078302-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078302-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078302-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078302-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078302-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078302-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078302-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078302-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078302-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078302-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078302-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078302-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078302-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078302-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078302-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078302-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078302-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078302-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078302-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078302-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078302-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078302-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078302-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078302-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078302-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078302-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078302-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078302-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078302-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078302-001	AB	1	`cb3db0bc1861…`
2026-08-01 22:54:32	2026-06	A078302-001	AB	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	476f4f55-c6c1-4f39-950e-59236f499577	2026-03-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078302 application number: ANDA078302
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Proficient Rx LP	1521109d-8386-472f-9483-f1fe9f7ed152	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078302 application number: ANDA078302
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Bryant Ranch Prepack	eb072818-3ca8-430b-91a1-e7fedd37990c	2025-11-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078302 application number: ANDA078302
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	A-S Medication Solutions	38677cd0-2ee6-4c8f-8553-36310b2813a1	2025-11-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078302 application number: ANDA078302
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Bryant Ranch Prepack	790b6159-c03b-4a3a-be6b-add35a3114a4	2025-10-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078302 application number: ANDA078302
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Oxford Pharmaceuticals, LLC	97fcebc1-6615-4b9d-b0f3-6434850f407c	2025-08-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078302 application number: ANDA078302
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Bryant Ranch Prepack	696911d8-e97a-4c8e-9341-782b4c63bf03	2024-08-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078302 application number: ANDA078302 ndc (product): 63629-2415
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Bryant Ranch Prepack	8bb7991e-ab09-4602-b49d-0a72a501685b	2024-08-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078302 application number: ANDA078302

Additional Listing Data#

Finished product: Yes
Brand name base: Buspirone Hydrochloride
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BUSPIRONE HYDROCHLORIDE	30 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
866090	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
696911d8-e97a-4c8e-9341-782b4c63bf03	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
63629-2415-1	Buspirone Hydrochloride	60 in 1 BOTTLE	TABLET	60		105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63629-2415-1	EA - Each	63629-2415	911e3bc6-cac3-47c8-a583-73c05f9ee4fa	1	2021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63629-2415	BUSPIRONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]	105	Current NDC, Legacy NDC, 1 package rows	20240814_696911d8-e97a-4c8e-9341-782b4c63bf03.zip

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
866090	busPIRone HCl 30 MG Oral Tablet	PSN	696911d8-e97a-4c8e-9341-782b4c63bf03	105
866090	buspirone hydrochloride 30 MG Oral Tablet	SCD	696911d8-e97a-4c8e-9341-782b4c63bf03	105
866090	buspirone hydrochloride 30 MG (buspirone 27.4 MG) Oral Tablet	SY	696911d8-e97a-4c8e-9341-782b4c63bf03	105

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-2415-1	63629241501	60 TABLET in 1 BOTTLE (63629-2415-1)	60 tablet	2021-02-24	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Buspirone Hydrochloride - Bryant Ranch Prepack	Bryant Ranch Prepack	2024-08-12	HUMAN PRESCRIPTION DRUG LABEL	105