Buspirone Hydrochloride

Product NDC: 0904-7122
11-digit product format: 009047122
Labeler code: 0904
Product ID: 0904-7122_7e3f9aeb-2fcc-4f4d-921b-a4b96a932d19
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Buspirone Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Major Pharmaceuticals
Application: ANDA204582
Marketing category: ANDA
Marketing start: 2012-06-29
Substance: BUSPIRONE HYDROCHLORIDE
Active strength: 5 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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A204582-001	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-09-18
A204582-002	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-09-18
A204582-003	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2015-09-18
A204582-004	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2015-09-18

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A204582-001	AB
A204582-002	AB
A204582-003	AB
A204582-004	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 5 · 164 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	A204582-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-09-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204582-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-09-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204582-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2015-09-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204582-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2015-09-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204582-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-09-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204582-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-09-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204582-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2015-09-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204582-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2015-09-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204582-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-09-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204582-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-09-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204582-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2015-09-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204582-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2015-09-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204582-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-09-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204582-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-09-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204582-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2015-09-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204582-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2015-09-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204582-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-09-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204582-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-09-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204582-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2015-09-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204582-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2015-09-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204582-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-09-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204582-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-09-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204582-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2015-09-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204582-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2015-09-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204582-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-09-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204582-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-09-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204582-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2015-09-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204582-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2015-09-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204582-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-09-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204582-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-09-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204582-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2015-09-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204582-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2015-09-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204582-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-09-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204582-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-09-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204582-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2015-09-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204582-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2015-09-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204582-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-09-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204582-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-09-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204582-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2015-09-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204582-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2015-09-18	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 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	A204582-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204582-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204582-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204582-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204582-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204582-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204582-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204582-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204582-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204582-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204582-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204582-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204582-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204582-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204582-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204582-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204582-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204582-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204582-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204582-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204582-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204582-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204582-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204582-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204582-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204582-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204582-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204582-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204582-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204582-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204582-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204582-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204582-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204582-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204582-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204582-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204582-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204582-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204582-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204582-004	AB	1	`d06236e962d9…`

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	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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
866083	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
8dc1ee33-e5aa-4462-8fb9-9bbdf5463488	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
0904-7122-61	Buspirone Hydrochloride	100 in 1 CARTON	TABLET	100		4
0904-7122-61	Buspirone Hydrochloride	1 in 1 BLISTER PACK	TABLET	1		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0904-7122-61	EA - Each	0904-7122	5a463b59-c8f6-4d17-b42a-e6906c40b85a	1	2022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0904-7122	BUSPIRONE HYDROCHLORIDE TABLET [MAJOR PHARMACEUTICALS]	3	Current NDC, Legacy NDC, 2 package rows	20250210_8dc1ee33-e5aa-4462-8fb9-9bbdf5463488.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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	REMEDYREPACK INC.	fd05160d-24c6-4371-8b2c-c0f78c8b468e	2026-07-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204582 application number: ANDA204582
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	REMEDYREPACK INC.	a9fc7091-b3ce-45fd-8d89-aeebdd81c327	2026-07-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204582 application number: ANDA204582
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Bryant Ranch Prepack	225575f1-9635-4922-8286-d479d6480bf0	2026-05-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204582 application number: ANDA204582
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Bryant Ranch Prepack	eee7fa99-a9a1-4299-8a3d-6c2dd90948c9	2026-05-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204582 application number: ANDA204582
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Cardinal Health 107, LLC	5424f933-93e1-4480-acdf-bd8667ae50e9	2026-04-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204582 application number: ANDA204582
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Northwind Health Company, LLC	1d883a13-4877-c6c7-e063-6294a90a5137	2025-12-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204582 application number: ANDA204582
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	4ff72575-bd60-40ce-b3a8-fd92b79af674	2025-11-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204582 application number: ANDA204582
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Major Pharmaceuticals	8dc1ee33-e5aa-4462-8fb9-9bbdf5463488	2025-07-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204582 application number: ANDA204582 ndc (product): 0904-7122

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	5424f933-93e1-4480-acdf-bd8667ae50e9	7
866094	busPIRone HCl 5 MG Oral Tablet	PSN	5424f933-93e1-4480-acdf-bd8667ae50e9	7
866083	buspirone hydrochloride 10 MG Oral Tablet	SCD	5424f933-93e1-4480-acdf-bd8667ae50e9	7
866094	buspirone hydrochloride 5 MG Oral Tablet	SCD	5424f933-93e1-4480-acdf-bd8667ae50e9	7
866083	buspirone HCl 10 MG (buspirone 9.1 MG) Oral Tablet	SY	5424f933-93e1-4480-acdf-bd8667ae50e9	7
866094	buspirone hydrochloride 5 MG (buspirone 4.6 MG) Oral Tablet	SY	5424f933-93e1-4480-acdf-bd8667ae50e9	7
866083	busPIRone HCl 10 MG Oral Tablet	PSN	8dc1ee33-e5aa-4462-8fb9-9bbdf5463488	4
866094	busPIRone HCl 5 MG Oral Tablet	PSN	8dc1ee33-e5aa-4462-8fb9-9bbdf5463488	4
866083	buspirone hydrochloride 10 MG Oral Tablet	SCD	8dc1ee33-e5aa-4462-8fb9-9bbdf5463488	4
866094	buspirone hydrochloride 5 MG Oral Tablet	SCD	8dc1ee33-e5aa-4462-8fb9-9bbdf5463488	4
866083	buspirone HCl 10 MG (buspirone 9.1 MG) Oral Tablet	SY	8dc1ee33-e5aa-4462-8fb9-9bbdf5463488	4
866094	buspirone hydrochloride 5 MG (buspirone 4.6 MG) Oral Tablet	SY	8dc1ee33-e5aa-4462-8fb9-9bbdf5463488	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0904-7122-61	00904712261	100 BLISTER PACK in 1 CARTON (0904-7122-61) / 1 TABLET in 1 BLISTER PACK	100 blister pack	2012-06-29	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Buspirone Hydrochloride Tablets, USP Rx only	Cardinal Health 107, LLC	2026-04-15	HUMAN PRESCRIPTION DRUG LABEL	7
Buspirone Hydrochloride Tablets, USP Rx only	Major Pharmaceuticals	2025-07-03	HUMAN PRESCRIPTION DRUG LABEL	4