Buspirone hydrochloride

Product NDC: 68382-623
11-digit product format: 683820623
Labeler code: 68382
Product ID: 68382-623_8692aee8-7eb4-4cbb-8a31-3ecc49660195
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Buspirone hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Zydus Pharmaceuticals USA Inc.
Application: ANDA078888
Marketing category: ANDA
Marketing start: 2023-03-21
Substance: BUSPIRONE HYDROCHLORIDE
Active strength: 7.5 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 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A078888-001	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-02-07
A078888-002	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-02-07
A078888-003	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2014-02-07
A078888-004	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2014-02-07
A078888-005	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2023-03-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078888-001	AB
A078888-002	AB
A078888-003	AB
A078888-004	AB
A078888-005	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 5 · 187 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	A078888-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-02-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078888-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-02-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078888-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2014-02-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078888-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2014-02-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078888-005	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2023-03-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078888-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-02-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078888-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-02-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078888-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2014-02-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078888-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2014-02-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078888-005	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2023-03-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078888-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-02-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078888-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-02-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078888-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2014-02-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078888-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2014-02-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078888-005	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2023-03-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078888-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-02-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078888-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-02-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078888-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2014-02-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078888-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2014-02-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078888-005	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2023-03-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078888-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-02-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078888-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-02-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078888-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2014-02-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078888-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2014-02-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078888-005	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2023-03-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078888-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-02-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078888-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-02-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078888-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2014-02-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078888-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2014-02-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078888-005	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2023-03-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078888-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-02-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078888-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-02-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078888-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2014-02-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078888-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2014-02-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078888-005	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2023-03-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078888-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-02-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078888-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-02-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078888-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2014-02-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078888-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2014-02-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078888-005	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2023-03-21	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 187 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	A078888-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078888-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078888-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078888-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078888-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078888-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078888-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078888-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078888-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078888-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078888-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078888-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078888-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078888-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078888-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078888-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078888-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078888-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078888-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078888-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078888-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078888-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078888-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078888-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078888-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078888-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078888-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078888-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078888-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078888-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078888-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078888-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078888-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078888-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078888-005	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078888-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078888-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078888-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078888-004	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078888-005	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	7.5 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 · 5 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
866111	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
14fd7c1c-778e-46d4-9024-89b319f15f39	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
68382-623-01	Buspirone hydrochloride	100 in 1 BOTTLE	TABLET	100	11
68382-623-05	Buspirone hydrochloride	500 in 1 BOTTLE	TABLET	500	11
68382-623-10	Buspirone hydrochloride	1000 in 1 BOTTLE	TABLET	1000	11
68382-623-30	Buspirone hydrochloride	100 in 1 CARTON	TABLET	100	11
68382-623-30	Buspirone hydrochloride	10 in 1 BLISTER PACK	TABLET	10	11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68382-623-01	EA - Each	68382-623	cea9e7dc-633e-4067-833e-87011dadf8d6	1	2023-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BUSPIRONE HYDROCHLORIDE	ACTIVE INGREDIENT	207LT9J9OC	BUSPIRONE HYDROCHLORIDE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]	3
BUSPIRONE	ACTIVE MOIETY	TK65WKS8HL	BUSPIRONE HYDROCHLORIDE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	BUSPIRONE HYDROCHLORIDE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]	3
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	BUSPIRONE HYDROCHLORIDE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]	3
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	BUSPIRONE HYDROCHLORIDE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	BUSPIRONE HYDROCHLORIDE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]	3
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	BUSPIRONE HYDROCHLORIDE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68382-623	BUSPIRONE HYDROCHLORIDE TABLET [ZYDUS PHARMACEUTICALS USA INC.]	11	Current NDC, 5 package rows	20250214_14fd7c1c-778e-46d4-9024-89b319f15f39.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 · 16 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Buspirone hydrochloride	BUSPIRONE HYDROCHLORIDE	Major Pharmaceuticals	a9bb9216-3dac-4e8a-9df9-f72c2eaef160	2026-06-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078888 application number: ANDA078888
Buspirone hydrochloride	BUSPIRONE HYDROCHLORIDE	Unit Dose Solutions, Inc.	544b8918-7175-655f-e063-6394a90a453a	2026-06-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078888 application number: ANDA078888
Buspirone hydrochloride	BUSPIRONE HYDROCHLORIDE	Coupler LLC	53e7576a-e2f4-042b-e063-6294a90ae035	2026-06-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078888 application number: ANDA078888
Buspirone hydrochloride	BUSPIRONE HYDROCHLORIDE	REMEDYREPACK INC.	fa3f9c0e-261d-4ceb-8cc7-e5e013563479	2026-06-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078888 application number: ANDA078888
Buspirone hydrochloride	BUSPIRONE HYDROCHLORIDE	Cardinal Health 107, LLC	1315494d-7a51-4395-bc7c-afb4bc5482c9	2026-04-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078888 application number: ANDA078888
Buspirone hydrochloride	BUSPIRONE HYDROCHLORIDE	AvPAK	b230197c-3d50-7874-e053-2a95a90af50f	2026-03-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078888 application number: ANDA078888
buspirone hydrochloride	BUSPIRONE HYDROCHLORIDE	Zydus Lifesciences Limited	1109dd63-6492-49b1-a383-3ab3a80cd6c7	2025-12-24		Exact identifier application applno (ANDA): 078888 application number: ANDA078888
Buspirone hydrochloride	BUSPIRONE HYDROCHLORIDE	Bryant Ranch Prepack	8c811d3a-8b2d-44f5-bc8f-8eb563f18c3f	2025-11-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078888 application number: ANDA078888
Buspirone hydrochloride	BUSPIRONE HYDROCHLORIDE	Bryant Ranch Prepack	08efb26e-488c-49d4-8432-98db855962e9	2025-03-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078888 application number: ANDA078888
Buspirone hydrochloride	BUSPIRONE HYDROCHLORIDE	Bryant Ranch Prepack	897dac69-a59b-423c-be16-6301c7e504d9	2025-03-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078888 application number: ANDA078888
Buspirone hydrochloride	BUSPIRONE HYDROCHLORIDE	Zydus Pharmaceuticals USA Inc.	14fd7c1c-778e-46d4-9024-89b319f15f39	2025-02-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078888 application number: ANDA078888 ndc (product): 68382-623
Buspirone hydrochloride	BUSPIRONE HYDROCHLORIDE	REMEDYREPACK INC.	7ac98a7f-0ded-427f-899a-c3f6d1997403	2025-01-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078888 application number: ANDA078888
Buspirone hydrochloride	BUSPIRONE HYDROCHLORIDE	American Health Packaging	e80d83a6-7c2a-478e-bdf1-c481824fc301	2024-06-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078888 application number: ANDA078888
Buspirone hydrochloride	BUSPIRONE HYDROCHLORIDE	Bryant Ranch Prepack	b07c0a91-892c-47f5-819e-a128e0ef1ed7	2023-12-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078888 application number: ANDA078888
Buspirone hydrochloride	BUSPIRONE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	7f6986a8-59dc-4dc3-bac0-b38cfc689f8f	2019-04-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078888 application number: ANDA078888
Buspirone hydrochloride	BUSPIRONE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	310c6bea-838b-43e4-87e0-a0050829c242	2018-12-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078888 application number: ANDA078888

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
866111	busPIRone HCl 7.5 MG Oral Tablet	PSN	08efb26e-488c-49d4-8432-98db855962e9	102
866111	buspirone hydrochloride 7.5 MG Oral Tablet	SCD	08efb26e-488c-49d4-8432-98db855962e9	102
866111	buspirone HCl 7.5 MG (buspirone 6.9 MG) Oral Tablet	SY	08efb26e-488c-49d4-8432-98db855962e9	102
866111	busPIRone HCl 7.5 MG Oral Tablet	PSN	b07c0a91-892c-47f5-819e-a128e0ef1ed7	101
866111	buspirone hydrochloride 7.5 MG Oral Tablet	SCD	b07c0a91-892c-47f5-819e-a128e0ef1ed7	101
866111	buspirone HCl 7.5 MG (buspirone 6.9 MG) Oral Tablet	SY	b07c0a91-892c-47f5-819e-a128e0ef1ed7	101
866111	busPIRone HCl 7.5 MG Oral Tablet	PSN	8c811d3a-8b2d-44f5-bc8f-8eb563f18c3f	100
866111	buspirone hydrochloride 7.5 MG Oral Tablet	SCD	8c811d3a-8b2d-44f5-bc8f-8eb563f18c3f	100
866111	buspirone HCl 7.5 MG (buspirone 6.9 MG) Oral Tablet	SY	8c811d3a-8b2d-44f5-bc8f-8eb563f18c3f	100
866083	busPIRone HCl 10 MG Oral Tablet	PSN	14fd7c1c-778e-46d4-9024-89b319f15f39	11
866018	busPIRone HCl 15 MG Oral Tablet	PSN	14fd7c1c-778e-46d4-9024-89b319f15f39	11
866090	busPIRone HCl 30 MG Oral Tablet	PSN	14fd7c1c-778e-46d4-9024-89b319f15f39	11
866094	busPIRone HCl 5 MG Oral Tablet	PSN	14fd7c1c-778e-46d4-9024-89b319f15f39	11
866111	busPIRone HCl 7.5 MG Oral Tablet	PSN	14fd7c1c-778e-46d4-9024-89b319f15f39	11
866083	buspirone hydrochloride 10 MG Oral Tablet	SCD	14fd7c1c-778e-46d4-9024-89b319f15f39	11
866018	buspirone hydrochloride 15 MG Oral Tablet	SCD	14fd7c1c-778e-46d4-9024-89b319f15f39	11
866090	buspirone hydrochloride 30 MG Oral Tablet	SCD	14fd7c1c-778e-46d4-9024-89b319f15f39	11
866094	buspirone hydrochloride 5 MG Oral Tablet	SCD	14fd7c1c-778e-46d4-9024-89b319f15f39	11
866111	buspirone hydrochloride 7.5 MG Oral Tablet	SCD	14fd7c1c-778e-46d4-9024-89b319f15f39	11
866083	buspirone HCl 10 MG (buspirone 9.1 MG) Oral Tablet	SY	14fd7c1c-778e-46d4-9024-89b319f15f39	11
866111	buspirone HCl 7.5 MG (buspirone 6.9 MG) Oral Tablet	SY	14fd7c1c-778e-46d4-9024-89b319f15f39	11
866018	buspirone hydrochloride 15 MG (buspirone 13.7 MG) Oral Tablet	SY	14fd7c1c-778e-46d4-9024-89b319f15f39	11
866090	buspirone hydrochloride 30 MG (buspirone 27.4 MG) Oral Tablet	SY	14fd7c1c-778e-46d4-9024-89b319f15f39	11
866094	buspirone hydrochloride 5 MG (buspirone 4.6 MG) Oral Tablet	SY	14fd7c1c-778e-46d4-9024-89b319f15f39	11
866083	busPIRone HCl 10 MG Oral Tablet	PSN	e80d83a6-7c2a-478e-bdf1-c481824fc301	3
866018	busPIRone HCl 15 MG Oral Tablet	PSN	e80d83a6-7c2a-478e-bdf1-c481824fc301	3
866111	busPIRone HCl 7.5 MG Oral Tablet	PSN	fa3f9c0e-261d-4ceb-8cc7-e5e013563479	3
866111	busPIRone HCl 7.5 MG Oral Tablet	PSN	e80d83a6-7c2a-478e-bdf1-c481824fc301	3
866083	buspirone hydrochloride 10 MG Oral Tablet	SCD	e80d83a6-7c2a-478e-bdf1-c481824fc301	3
866018	buspirone hydrochloride 15 MG Oral Tablet	SCD	e80d83a6-7c2a-478e-bdf1-c481824fc301	3
866111	buspirone hydrochloride 7.5 MG Oral Tablet	SCD	fa3f9c0e-261d-4ceb-8cc7-e5e013563479	3
866111	buspirone hydrochloride 7.5 MG Oral Tablet	SCD	e80d83a6-7c2a-478e-bdf1-c481824fc301	3
866083	buspirone HCl 10 MG (buspirone 9.1 MG) Oral Tablet	SY	e80d83a6-7c2a-478e-bdf1-c481824fc301	3
866111	buspirone HCl 7.5 MG (buspirone 6.9 MG) Oral Tablet	SY	e80d83a6-7c2a-478e-bdf1-c481824fc301	3
866111	buspirone HCl 7.5 MG (buspirone 6.9 MG) Oral Tablet	SY	fa3f9c0e-261d-4ceb-8cc7-e5e013563479	3
866018	buspirone hydrochloride 15 MG (buspirone 13.7 MG) Oral Tablet	SY	e80d83a6-7c2a-478e-bdf1-c481824fc301	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
68382-623-01	68382062301	100 TABLET in 1 BOTTLE (68382-623-01)	100 tablet	2023-03-21	No	No	Current
68382-623-05	68382062305	500 TABLET in 1 BOTTLE (68382-623-05)	500 tablet	2023-03-21	No	No	Current
68382-623-10	68382062310	1000 TABLET in 1 BOTTLE (68382-623-10)	1000 tablet	2023-03-21	No	No	Current
68382-623-30	68382062330	100 BLISTER PACK in 1 CARTON (68382-623-30) / 10 TABLET in 1 BLISTER PACK	100 blister pack	2023-03-21	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Buspirone Hydrochloride Tablets, USP	REMEDYREPACK INC.	2026-06-10	HUMAN PRESCRIPTION DRUG LABEL	4
Buspirone Hydrochloride Tablets, USP	Coupler LLC \| Zydus Pharmaceuticals USA Inc.	2026-06-10	HUMAN PRESCRIPTION DRUG LABEL	1
Buspirone Hydrochloride Tablets, USP	Bryant Ranch Prepack	2025-11-10	HUMAN PRESCRIPTION DRUG LABEL	100
Buspirone Hydrochloride Tablets, USP	Bryant Ranch Prepack	2025-03-31	HUMAN PRESCRIPTION DRUG LABEL	102
Buspirone Hydrochloride Tablets, USP	Zydus Pharmaceuticals USA Inc. \| Zydus Lifesciences Limited	2025-02-12	HUMAN PRESCRIPTION DRUG LABEL	11
Buspirone Hydrochloride Tablets, USP Rx Only 8480121/1123F	American Health Packaging	2024-06-07	HUMAN PRESCRIPTION DRUG LABEL	3
Buspirone Hydrochloride Tablets, USP	Bryant Ranch Prepack	2023-12-15	HUMAN PRESCRIPTION DRUG LABEL	101