Buspirone Hydrochloride

Product NDC: 70518-4586
11-digit product format: 705184586
Labeler code: 70518
Product ID: 70518-4586_4d65f61c-3cb9-e901-e063-6294a90acbec
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: buspirone hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA075388
Marketing category: ANDA
Marketing start: 2026-03-19
Substance: BUSPIRONE HYDROCHLORIDE
Active strength: 5 mg/1
NDC exclude flag: No
Listing certified through: 2027-12-31
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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A075388-001	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2002-05-09
A075388-002	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2002-05-09
A075388-003	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2002-05-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075388-001	AB
A075388-002	AB
A075388-003	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 3 · 96 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
2024-10-29 15:01 UTC	2024-10	A075388-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2002-05-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075388-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2002-05-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075388-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2002-05-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075388-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2002-05-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075388-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2002-05-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075388-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2002-05-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075388-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2002-05-09	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075388-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2002-05-09	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075388-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2002-05-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075388-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2002-05-09	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075388-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2002-05-09	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075388-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2002-05-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075388-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2002-05-09	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075388-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2002-05-09	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075388-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2002-05-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075388-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2002-05-09	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075388-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2002-05-09	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075388-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2002-05-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075388-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2002-05-09	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075388-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2002-05-09	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075388-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2002-05-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075388-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2002-05-09	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075388-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2002-05-09	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075388-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2002-05-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075388-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL		2002-05-09	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075388-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL		2002-05-09	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075388-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL		2002-05-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075388-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2002-05-09	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075388-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2002-05-09	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075388-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2002-05-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075388-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2002-05-09	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075388-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2002-05-09	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075388-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2002-05-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075388-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2002-05-09	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075388-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2002-05-09	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075388-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2002-05-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075388-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2002-05-09	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A075388-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2002-05-09	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A075388-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2002-05-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075388-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2002-05-09	`8869cabd3fbd…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-10-29 15:01 UTC	2024-10	A075388-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075388-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075388-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075388-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075388-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075388-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075388-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075388-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075388-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075388-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075388-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075388-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075388-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075388-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075388-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075388-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075388-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075388-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075388-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075388-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075388-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075388-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075388-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075388-003	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A075388-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075388-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075388-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075388-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075388-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075388-003	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075388-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075388-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075388-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075388-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A075388-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A075388-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075388-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A075388-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A075388-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075388-001	AB	1	`c0c555d07b60…`

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 2 · 26 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	REMEDYREPACK INC.	8e0219e9-d305-4473-8229-aee0ee84caf6	2026-03-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075388 application number: ANDA075388 ndc (product): 70518-4586
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	476f4f55-c6c1-4f39-950e-59236f499577	2026-03-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075388 application number: ANDA075388
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	A-S Medication Solutions	84621631-4c13-4147-ae3c-4ed30d4ebb37	2026-03-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075388 application number: ANDA075388
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	REMEDYREPACK INC.	3155e607-bc7f-4e90-9edf-8e862dd5737d	2026-02-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075388 application number: ANDA075388
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Proficient Rx LP	1521109d-8386-472f-9483-f1fe9f7ed152	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075388 application number: ANDA075388
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	A-S Medication Solutions	338f3317-96c0-4b8a-8299-8ce2a10911ae	2025-12-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075388 application number: ANDA075388
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	A-S Medication Solutions	e4d44e49-eb8f-454e-a737-22caf30bda78	2025-12-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075388 application number: ANDA075388
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Bryant Ranch Prepack	49659ee7-ca08-4df1-8e6b-3a366a7839c7	2025-11-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075388 application number: ANDA075388
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Bryant Ranch Prepack	aba814f0-55ce-4480-99f1-b9ad1ba77d3f	2025-11-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075388 application number: ANDA075388
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Bryant Ranch Prepack	bee0edbf-3fc3-484b-9715-f13a329216ae	2025-11-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075388 application number: ANDA075388
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Bryant Ranch Prepack	4e7640d1-0a31-4f97-82bb-574cf1ff6e4a	2025-10-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075388 application number: ANDA075388
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	40d5813d-d040-002c-e063-6294a90a5f7a	2025-10-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075388 application number: ANDA075388
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	A-S Medication Solutions	7c7225a0-8237-4998-843a-bf10fa6ec65b	2025-10-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075388 application number: ANDA075388
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Bryant Ranch Prepack	2df0b238-14a4-40ca-a235-411f6c9b8338	2025-10-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075388 application number: ANDA075388
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Bryant Ranch Prepack	f85b59b7-b945-4440-8378-987bd287a655	2025-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075388 application number: ANDA075388
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	b217f341-7d51-475d-887f-f16786164c7b	2025-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075388 application number: ANDA075388
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	270398a0-21b8-407b-af76-4aeef90f72be	2025-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075388 application number: ANDA075388
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	3dd7f213-afd8-67d6-e063-6294a90ac108	2025-09-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075388 application number: ANDA075388
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Bryant Ranch Prepack	65c69118-36bb-4f0d-9669-b52556056ec5	2025-09-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075388 application number: ANDA075388
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Bryant Ranch Prepack	ed7e334a-cc4a-47b2-a4db-56495730b698	2025-09-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075388 application number: ANDA075388

Additional Listing Data#

Finished product: Yes
Brand name base: Buspirone Hydrochloride
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BUSPIRONE HYDROCHLORIDE	5 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
866094	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
8e0219e9-d305-4473-8229-aee0ee84caf6	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
70518-4586-0	Buspirone Hydrochloride	30 in 1 BLISTER PACK	TABLET	30		1

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
866094	busPIRone HCl 5 MG Oral Tablet	PSN	8e0219e9-d305-4473-8229-aee0ee84caf6	1
866094	buspirone hydrochloride 5 MG Oral Tablet	SCD	8e0219e9-d305-4473-8229-aee0ee84caf6	1
866094	buspirone hydrochloride 5 MG (buspirone 4.6 MG) Oral Tablet	SY	8e0219e9-d305-4473-8229-aee0ee84caf6	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
70518-4586-0	70518458600	30 TABLET in 1 BLISTER PACK (70518-4586-0)	30 tablet	2026-03-19	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Buspirone Hydrochloride - REMEDYREPACK INC.	REMEDYREPACK INC.	2026-03-19	HUMAN PRESCRIPTION DRUG LABEL	1