BUSPIRONE HYDROCHLORIDE

Product NDC: 50090-6188
11-digit product format: 500906188
Labeler code: 50090
Product ID: 50090-6188_93b18226-2169-4140-9639-9e10d3acfeea
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: BUSPIRONE HYDROCHLORIDE
Dosage form: TABLET
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA078246
Marketing category: ANDA
Marketing start: 2020-02-21
Substance: BUSPIRONE HYDROCHLORIDE
Active strength: 15 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 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A078246-001	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2009-02-27
A078246-002	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2009-02-27
A078246-003	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2009-02-27
A078246-004	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2009-02-27
A078246-005	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2020-02-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078246-001	AB
A078246-002	AB
A078246-003	AB
A078246-004	AB
A078246-005	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 · 201 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	A078246-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2009-02-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078246-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2009-02-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078246-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2009-02-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078246-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2009-02-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078246-005	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2020-02-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078246-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2009-02-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078246-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2009-02-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078246-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2009-02-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078246-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2009-02-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078246-005	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2020-02-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078246-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2009-02-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078246-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2009-02-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078246-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2009-02-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078246-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2009-02-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078246-005	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2020-02-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078246-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2009-02-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078246-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2009-02-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078246-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2009-02-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078246-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2009-02-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078246-005	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2020-02-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078246-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2009-02-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078246-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2009-02-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078246-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2009-02-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078246-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2009-02-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078246-005	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2020-02-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078246-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2009-02-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078246-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2009-02-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078246-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2009-02-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078246-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2009-02-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078246-005	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2020-02-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078246-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2009-02-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078246-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2009-02-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078246-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2009-02-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078246-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2009-02-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078246-005	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2020-02-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078246-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2009-02-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078246-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2009-02-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078246-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2009-02-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078246-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2009-02-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078246-005	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2020-02-21	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 201 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	A078246-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078246-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078246-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078246-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078246-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078246-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078246-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078246-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078246-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078246-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078246-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078246-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078246-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078246-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078246-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078246-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078246-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078246-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078246-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078246-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078246-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078246-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078246-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078246-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078246-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078246-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078246-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078246-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078246-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078246-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078246-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078246-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078246-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078246-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078246-005	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078246-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078246-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078246-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078246-004	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078246-005	AB	1	`5bbf6a4d5a75…`

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	15 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
866018	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
501b0406-f56e-44d3-906a-7625b936f075	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	SPL version
50090-6188-0	BUSPIRONE HYDROCHLORIDE	180 in 1 BOTTLE	TABLET	180	3
50090-6188-1	BUSPIRONE HYDROCHLORIDE	60 in 1 BOTTLE	TABLET	60	3
50090-6188-3	BUSPIRONE HYDROCHLORIDE	90 in 1 BOTTLE	TABLET	90	3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-6188-1	EA - Each	50090-6188	1ec93303-2d34-40df-a912-6bdefddfaa66	1	2022-12-07
50090-6188-3	EA - Each	50090-6188	45cf5d4b-25db-4a61-b55b-794849942824	1	2022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-6188	BUSPIRONE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS]	3	Current NDC, Legacy NDC, 3 package rows	20231102_501b0406-f56e-44d3-906a-7625b936f075.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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	REMEDYREPACK INC.	fa4d5cac-f687-4440-99d2-8bb27cf2f4ed	2025-08-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078246 application number: ANDA078246
BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	Advanced Rx Pharmacy of Tennessee, LLC	fc0f93c8-2078-b2ff-e053-6294a90aacdf	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078246 application number: ANDA078246
BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	A-S Medication Solutions	529ab1f9-534c-4a45-aa70-76e605247af1	2024-12-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078246 application number: ANDA078246
BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	Proficient Rx LP	75b1ae3f-e926-4555-a0e9-50323fc66cb2	2024-02-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078246 application number: ANDA078246
BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	Bryant Ranch Prepack	55e32128-711d-4e95-b58b-e86e0afa4983	2023-12-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078246 application number: ANDA078246
BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	Bryant Ranch Prepack	d47cde56-e1ab-41fe-832e-d3f33b884a5e	2023-11-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078246 application number: ANDA078246
BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	A-S Medication Solutions	501b0406-f56e-44d3-906a-7625b936f075	2023-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078246 application number: ANDA078246 ndc (product): 50090-6188
BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	Bryant Ranch Prepack	2bc87b32-bdb7-4ce6-8a51-aed623f7219e	2023-06-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078246 application number: ANDA078246
BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	Aurobindo Pharma Limited	05c006d2-44b9-431f-bce2-aff09c043ecb	2021-07-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078246 application number: ANDA078246

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
866018	busPIRone HCl 15 MG Oral Tablet	PSN	501b0406-f56e-44d3-906a-7625b936f075	3
866018	buspirone hydrochloride 15 MG Oral Tablet	SCD	501b0406-f56e-44d3-906a-7625b936f075	3
866018	buspirone hydrochloride 15 MG (buspirone 13.7 MG) Oral Tablet	SY	501b0406-f56e-44d3-906a-7625b936f075	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-6188-0	50090618800	180 TABLET in 1 BOTTLE (50090-6188-0)	180 tablet	2022-10-27	0000-00-00	No	No	Current
50090-6188-1	50090618801	60 TABLET in 1 BOTTLE (50090-6188-1)	60 tablet	2022-10-27	0000-00-00	No	No	Current
50090-6188-3	50090618803	90 TABLET in 1 BOTTLE (50090-6188-3)	90 tablet	2022-10-27	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Buspirone Hydrochloride Tablets, USP Rx only (Patient Instruction Sheet Included)	A-S Medication Solutions	2023-11-01	Human Prescription Drug Label	3