Buspirone Hydrochloride

Product NDC: 69584-092
11-digit product format: 695840092
Labeler code: 69584
Product ID: 69584-092_8c9f66ca-78a9-418c-b11e-ba4391843257
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: buspirone hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Oxford Pharmaceuticals, LLC
Application: ANDA075388
Marketing category: ANDA
Marketing start: 2020-07-27
Substance: BUSPIRONE HYDROCHLORIDE
Active strength: 10 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 · 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 4 · 123 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	A075388-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2002-05-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075388-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2002-05-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075388-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2002-05-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075388-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2002-05-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075388-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2002-05-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075388-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2002-05-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075388-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2002-05-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075388-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2002-05-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075388-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2002-05-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075388-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2002-05-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075388-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2002-05-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075388-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2002-05-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075388-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2002-05-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075388-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2002-05-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075388-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2002-05-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075388-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2002-05-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075388-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2002-05-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075388-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2002-05-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075388-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2002-05-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075388-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2002-05-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075388-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2002-05-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075388-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2002-05-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075388-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2002-05-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075388-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2002-05-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075388-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2002-05-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075388-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2002-05-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075388-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2002-05-09	`d8e5a09893c0…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 111 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	A075388-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075388-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075388-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075388-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075388-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075388-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075388-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075388-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075388-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075388-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075388-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075388-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075388-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075388-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075388-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075388-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075388-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075388-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075388-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075388-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075388-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075388-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075388-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075388-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075388-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075388-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075388-003	AB	1	`d8e5a09893c0…`
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…`

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	10 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 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
866018	Internal RxNorm lookup
866083	Internal RxNorm lookup
866090	Internal RxNorm lookup
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
97fcebc1-6615-4b9d-b0f3-6434850f407c	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
69584-092-10	Buspirone Hydrochloride	100 in 1 BOTTLE	TABLET	100		6
69584-092-50	Buspirone Hydrochloride	500 in 1 BOTTLE	TABLET	500		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69584-092-10	EA - Each	69584-092	0a6d6bec-991b-46fb-aafb-a10c683e783f	1	2020-09-14
69584-092-50	EA - Each	69584-092	fb5e6c4d-3c4b-4df9-9619-96822d2602f4	1	2020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69584-092	BUSPIRONE HYDROCHLORIDE TABLET [OXFORD PHARMACEUTICALS, LLC]	5	Current NDC, Legacy NDC, 2 package rows	20240207_97fcebc1-6615-4b9d-b0f3-6434850f407c.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 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
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

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	a738c103-134a-401f-b14c-49a599130b8d	104
866083	busPIRone HCl 10 MG Oral Tablet	PSN	ad651fd5-fd91-4517-8de7-6fafd15ac7eb	104
866083	buspirone hydrochloride 10 MG Oral Tablet	SCD	a738c103-134a-401f-b14c-49a599130b8d	104
866083	buspirone hydrochloride 10 MG Oral Tablet	SCD	ad651fd5-fd91-4517-8de7-6fafd15ac7eb	104
866083	buspirone HCl 10 MG (buspirone 9.1 MG) Oral Tablet	SY	a738c103-134a-401f-b14c-49a599130b8d	104
866083	buspirone HCl 10 MG (buspirone 9.1 MG) Oral Tablet	SY	ad651fd5-fd91-4517-8de7-6fafd15ac7eb	104
866083	busPIRone HCl 10 MG Oral Tablet	PSN	4e7640d1-0a31-4f97-82bb-574cf1ff6e4a	103
866083	busPIRone HCl 10 MG Oral Tablet	PSN	aba814f0-55ce-4480-99f1-b9ad1ba77d3f	103
866083	buspirone hydrochloride 10 MG Oral Tablet	SCD	4e7640d1-0a31-4f97-82bb-574cf1ff6e4a	103
866083	buspirone hydrochloride 10 MG Oral Tablet	SCD	aba814f0-55ce-4480-99f1-b9ad1ba77d3f	103
866083	buspirone HCl 10 MG (buspirone 9.1 MG) Oral Tablet	SY	4e7640d1-0a31-4f97-82bb-574cf1ff6e4a	103
866083	buspirone HCl 10 MG (buspirone 9.1 MG) Oral Tablet	SY	aba814f0-55ce-4480-99f1-b9ad1ba77d3f	103
866083	busPIRone HCl 10 MG Oral Tablet	PSN	476f4f55-c6c1-4f39-950e-59236f499577	18
866018	busPIRone HCl 15 MG Oral Tablet	PSN	476f4f55-c6c1-4f39-950e-59236f499577	18
866090	busPIRone HCl 30 MG Oral Tablet	PSN	476f4f55-c6c1-4f39-950e-59236f499577	18
866094	busPIRone HCl 5 MG Oral Tablet	PSN	476f4f55-c6c1-4f39-950e-59236f499577	18
866083	buspirone hydrochloride 10 MG Oral Tablet	SCD	476f4f55-c6c1-4f39-950e-59236f499577	18
866018	buspirone hydrochloride 15 MG Oral Tablet	SCD	476f4f55-c6c1-4f39-950e-59236f499577	18
866090	buspirone hydrochloride 30 MG Oral Tablet	SCD	476f4f55-c6c1-4f39-950e-59236f499577	18
866094	buspirone hydrochloride 5 MG Oral Tablet	SCD	476f4f55-c6c1-4f39-950e-59236f499577	18
866083	buspirone HCl 10 MG (buspirone 9.1 MG) Oral Tablet	SY	476f4f55-c6c1-4f39-950e-59236f499577	18
866018	buspirone hydrochloride 15 MG (buspirone 13.7 MG) Oral Tablet	SY	476f4f55-c6c1-4f39-950e-59236f499577	18
866090	buspirone hydrochloride 30 MG (buspirone 27.4 MG) Oral Tablet	SY	476f4f55-c6c1-4f39-950e-59236f499577	18
866094	buspirone hydrochloride 5 MG (buspirone 4.6 MG) Oral Tablet	SY	476f4f55-c6c1-4f39-950e-59236f499577	18
866083	busPIRone HCl 10 MG Oral Tablet	PSN	b217f341-7d51-475d-887f-f16786164c7b	11
866083	buspirone hydrochloride 10 MG Oral Tablet	SCD	b217f341-7d51-475d-887f-f16786164c7b	11
866083	buspirone HCl 10 MG (buspirone 9.1 MG) Oral Tablet	SY	b217f341-7d51-475d-887f-f16786164c7b	11
866083	busPIRone HCl 10 MG Oral Tablet	PSN	97fcebc1-6615-4b9d-b0f3-6434850f407c	6
866018	busPIRone HCl 15 MG Oral Tablet	PSN	97fcebc1-6615-4b9d-b0f3-6434850f407c	6
866090	busPIRone HCl 30 MG Oral Tablet	PSN	97fcebc1-6615-4b9d-b0f3-6434850f407c	6
866094	busPIRone HCl 5 MG Oral Tablet	PSN	97fcebc1-6615-4b9d-b0f3-6434850f407c	6
866083	buspirone hydrochloride 10 MG Oral Tablet	SCD	97fcebc1-6615-4b9d-b0f3-6434850f407c	6
866018	buspirone hydrochloride 15 MG Oral Tablet	SCD	97fcebc1-6615-4b9d-b0f3-6434850f407c	6
866090	buspirone hydrochloride 30 MG Oral Tablet	SCD	97fcebc1-6615-4b9d-b0f3-6434850f407c	6
866094	buspirone hydrochloride 5 MG Oral Tablet	SCD	97fcebc1-6615-4b9d-b0f3-6434850f407c	6
866083	buspirone HCl 10 MG (buspirone 9.1 MG) Oral Tablet	SY	97fcebc1-6615-4b9d-b0f3-6434850f407c	6
866018	buspirone hydrochloride 15 MG (buspirone 13.7 MG) Oral Tablet	SY	97fcebc1-6615-4b9d-b0f3-6434850f407c	6
866090	buspirone hydrochloride 30 MG (buspirone 27.4 MG) Oral Tablet	SY	97fcebc1-6615-4b9d-b0f3-6434850f407c	6
866094	buspirone hydrochloride 5 MG (buspirone 4.6 MG) Oral Tablet	SY	97fcebc1-6615-4b9d-b0f3-6434850f407c	6
866083	busPIRone HCl 10 MG Oral Tablet	PSN	e4d44e49-eb8f-454e-a737-22caf30bda78	3
866083	buspirone hydrochloride 10 MG Oral Tablet	SCD	e4d44e49-eb8f-454e-a737-22caf30bda78	3
866083	buspirone HCl 10 MG (buspirone 9.1 MG) Oral Tablet	SY	e4d44e49-eb8f-454e-a737-22caf30bda78	3
866083	busPIRone HCl 10 MG Oral Tablet	PSN	338f3317-96c0-4b8a-8299-8ce2a10911ae	1
866083	busPIRone HCl 10 MG Oral Tablet	PSN	ef8fc378-7fee-4d20-81ec-31211e34dc6e	1
866083	busPIRone HCl 10 MG Oral Tablet	PSN	1521109d-8386-472f-9483-f1fe9f7ed152	1
866083	busPIRone HCl 10 MG Oral Tablet	PSN	40d5813d-d040-002c-e063-6294a90a5f7a	1
866018	busPIRone HCl 15 MG Oral Tablet	PSN	1521109d-8386-472f-9483-f1fe9f7ed152	1
866090	busPIRone HCl 30 MG Oral Tablet	PSN	1521109d-8386-472f-9483-f1fe9f7ed152	1
866094	busPIRone HCl 5 MG Oral Tablet	PSN	1521109d-8386-472f-9483-f1fe9f7ed152	1
866083	buspirone hydrochloride 10 MG Oral Tablet	SCD	40d5813d-d040-002c-e063-6294a90a5f7a	1
866083	buspirone hydrochloride 10 MG Oral Tablet	SCD	338f3317-96c0-4b8a-8299-8ce2a10911ae	1
866083	buspirone hydrochloride 10 MG Oral Tablet	SCD	1521109d-8386-472f-9483-f1fe9f7ed152	1
866083	buspirone hydrochloride 10 MG Oral Tablet	SCD	ef8fc378-7fee-4d20-81ec-31211e34dc6e	1
866018	buspirone hydrochloride 15 MG Oral Tablet	SCD	1521109d-8386-472f-9483-f1fe9f7ed152	1
866090	buspirone hydrochloride 30 MG Oral Tablet	SCD	1521109d-8386-472f-9483-f1fe9f7ed152	1
866094	buspirone hydrochloride 5 MG Oral Tablet	SCD	1521109d-8386-472f-9483-f1fe9f7ed152	1
866083	buspirone HCl 10 MG (buspirone 9.1 MG) Oral Tablet	SY	40d5813d-d040-002c-e063-6294a90a5f7a	1
866083	buspirone HCl 10 MG (buspirone 9.1 MG) Oral Tablet	SY	338f3317-96c0-4b8a-8299-8ce2a10911ae	1
866083	buspirone HCl 10 MG (buspirone 9.1 MG) Oral Tablet	SY	1521109d-8386-472f-9483-f1fe9f7ed152	1
866083	buspirone HCl 10 MG (buspirone 9.1 MG) Oral Tablet	SY	ef8fc378-7fee-4d20-81ec-31211e34dc6e	1
866018	buspirone hydrochloride 15 MG (buspirone 13.7 MG) Oral Tablet	SY	1521109d-8386-472f-9483-f1fe9f7ed152	1
866090	buspirone hydrochloride 30 MG (buspirone 27.4 MG) Oral Tablet	SY	1521109d-8386-472f-9483-f1fe9f7ed152	1
866094	buspirone hydrochloride 5 MG (buspirone 4.6 MG) Oral Tablet	SY	1521109d-8386-472f-9483-f1fe9f7ed152	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69584-092-10	69584009210	100 TABLET in 1 BOTTLE (69584-092-10)	100 tablet	2020-07-27	0000-00-00	No	No	Current
69584-092-50	69584009250	500 TABLET in 1 BOTTLE (69584-092-50)	500 tablet	2020-07-27	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Buspirone Hydrochloride - PD-Rx Pharmaceuticals, Inc.	PD-Rx Pharmaceuticals, Inc.	2026-03-18	HUMAN PRESCRIPTION DRUG LABEL	18
Buspirone Hydrochloride - Proficient Rx LP	Proficient Rx LP	2026-01-01	HUMAN PRESCRIPTION DRUG LABEL	1
Buspirone Hydrochloride - A-S Medication Solutions	A-S Medication Solutions	2025-12-02	HUMAN PRESCRIPTION DRUG LABEL	1
Buspirone Hydrochloride - A-S Medication Solutions	A-S Medication Solutions	2025-12-01	HUMAN PRESCRIPTION DRUG LABEL	3
Buspirone Hydrochloride - Bryant Ranch Prepack	Bryant Ranch Prepack	2025-11-03	HUMAN PRESCRIPTION DRUG LABEL	103
Buspirone Hydrochloride - Bryant Ranch Prepack	Bryant Ranch Prepack	2025-10-28	HUMAN PRESCRIPTION DRUG LABEL	103
Buspirone Hydrochloride - Aphena Pharma Solutions - Tennessee, LLC	Aphena Pharma Solutions - Tennessee, LLC	2025-10-10	HUMAN PRESCRIPTION DRUG LABEL	1
Buspirone Hydrochloride - PD-Rx Pharmaceuticals, Inc.	PD-Rx Pharmaceuticals, Inc.	2025-10-01	HUMAN PRESCRIPTION DRUG LABEL	11
Buspirone Hydrochloride - Oxford Pharmaceuticals, LLC	Oxford Pharmaceuticals, LLC	2025-08-14	HUMAN PRESCRIPTION DRUG LABEL	6
Buspirone Hydrochloride - REMEDYREPACK INC.	REMEDYREPACK INC.	2025-08-14	HUMAN PRESCRIPTION DRUG LABEL	1
Buspirone Hydrochloride - Bryant Ranch Prepack	Bryant Ranch Prepack	2024-11-20	HUMAN PRESCRIPTION DRUG LABEL	104
Buspirone Hydrochloride - Bryant Ranch Prepack	Bryant Ranch Prepack	2024-04-03	HUMAN PRESCRIPTION DRUG LABEL	104