Buspirone Hydrochloride

Product NDC: 43063-785
11-digit product format: 430630785
Labeler code: 43063
Product ID: 43063-785_4d5246b2-a725-6fc4-e063-6294a90a3219
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Buspirone Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: PD-Rx Pharmaceuticals, Inc.
Application: ANDA202557
Marketing category: ANDA
Marketing start: 2016-12-15
Substance: BUSPIRONE HYDROCHLORIDE
Active strength: 10 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 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A202557-001	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-12-30
A202557-002	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2014-12-30
A202557-003	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-12-30
A202557-004	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2014-12-30
A202557-005	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2014-12-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-product	TE code
A202557-001	AB
A202557-002	AB
A202557-003	AB
A202557-004	AB
A202557-005	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 6 · 205 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A202557-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2014-12-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202557-002	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB		2014-12-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202557-003	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2014-12-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202557-004	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB		2014-12-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202557-005	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB		2014-12-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202557-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2014-12-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202557-002	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB		2014-12-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202557-003	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2014-12-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202557-004	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB		2014-12-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202557-005	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB		2014-12-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202557-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2014-12-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202557-002	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB		2014-12-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202557-003	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2014-12-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202557-004	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB		2014-12-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202557-005	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB		2014-12-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202557-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2014-12-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202557-002	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB		2014-12-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202557-003	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2014-12-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202557-004	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	RS	2014-12-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202557-005	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB		2014-12-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202557-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2014-12-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202557-002	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB		2014-12-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202557-003	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2014-12-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202557-004	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	RS	2014-12-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202557-005	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB		2014-12-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202557-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2014-12-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202557-002	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB		2014-12-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202557-003	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2014-12-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202557-004	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	RS	2014-12-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202557-005	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB		2014-12-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202557-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2014-12-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202557-002	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB		2014-12-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202557-003	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2014-12-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202557-004	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	RS	2014-12-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202557-005	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB		2014-12-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202557-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2014-12-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202557-002	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB		2014-12-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202557-003	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2014-12-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202557-004	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	RS	2014-12-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202557-005	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB		2014-12-30	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 205 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	A202557-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202557-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202557-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202557-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202557-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202557-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202557-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202557-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202557-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202557-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202557-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202557-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202557-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202557-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202557-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202557-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202557-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202557-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202557-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202557-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202557-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202557-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202557-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202557-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202557-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202557-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202557-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202557-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202557-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202557-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202557-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202557-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202557-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202557-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202557-005	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202557-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202557-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202557-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202557-004	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202557-005	AB	1	`5bbf6a4d5a75…`

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	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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
866083	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
7db10b76-4520-496e-b450-66a662cc95f6	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
43063-785-90	Buspirone Hydrochloride	90 in 1 BOTTLE, PLASTIC	TABLET	90		20

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43063-785-90	EA - Each	43063-785	3d541dc9-a73e-4938-adf4-f3f28b432d38	1	2017-10-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43063-785	BUSPIRONE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]	18	Current NDC, Legacy NDC, 1 package rows	20240820_7db10b76-4520-496e-b450-66a662cc95f6.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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Bryant Ranch Prepack	66df7f74-5dea-46d6-9ef8-9bab37baf407	2026-05-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202557 application number: ANDA202557
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	7db10b76-4520-496e-b450-66a662cc95f6	2026-03-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202557 application number: ANDA202557 ndc (product): 43063-785
BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	DIRECT RX	bae98d45-e192-56e3-e053-2a95a90aadc3	2026-03-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202557 application number: ANDA202557
BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	Direct_Rx	8e9c0553-c994-f54a-e053-2a95a90a6fa3	2026-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202557 application number: ANDA202557
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Northwind Health Company, LLC	f318ba7b-121f-2e4f-e053-2a95a90a60c5	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202557 application number: ANDA202557
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Accord Healthcare Inc.	3da22999-f5fb-49fd-acde-c3006598e985	2025-10-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202557 application number: ANDA202557
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	540e9b7e-09ff-2cca-e054-00144ff8d46c	2024-07-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202557 application number: ANDA202557
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	A-S Medication Solutions	4ae45cb1-8612-4006-b12c-2440160132ac	2023-02-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202557 application number: ANDA202557
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	fac49d42-7bc0-435f-bce2-2548dcdd6de6	2018-12-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202557 application number: ANDA202557
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	8b6e7ae6-5b83-4a5a-ab45-cf4be4287d78	2018-10-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202557 application number: ANDA202557

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	7db10b76-4520-496e-b450-66a662cc95f6	20
866083	buspirone hydrochloride 10 MG Oral Tablet	SCD	7db10b76-4520-496e-b450-66a662cc95f6	20
866083	buspirone HCl 10 MG (buspirone 9.1 MG) Oral Tablet	SY	7db10b76-4520-496e-b450-66a662cc95f6	20

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
43063-785-30	43063078530	90 TABLET in 1 BOTTLE, PLASTIC (43063-785-30)	90 tablet	2017-08-31	0000-00-00	No	No	Current
43063-785-90	43063078590	90 TABLET in 1 BOTTLE, PLASTIC (43063-785-90)	90 tablet	2022-12-20	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
BusPIRone Hydrochloride Tablets Rx only	PD-Rx Pharmaceuticals, Inc.	2026-03-18	HUMAN PRESCRIPTION DRUG LABEL	20