Buspirone Hydrochloride

Product NDC: 0378-1165
11-digit product format: 003781165
Labeler code: 0378
Product ID: 0378-1165_bf3ebca4-75bb-4f84-a906-06a1337e190f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: buspirone hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Mylan Pharmaceuticals Inc.
Application: ANDA076008
Marketing category: ANDA
Marketing start: 2001-03-28
Substance: BUSPIRONE HYDROCHLORIDE
Active strength: 15 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
A076008-001	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2001-06-28
A076008-002	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL		2013-07-08
A076008-003	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2002-03-01
A076008-004	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2002-03-01
A076008-005	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2001-03-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076008-001	AB
A076008-003	AB
A076008-004	AB
A076008-005	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A076008-001	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2001-06-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076008-002	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2013-07-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076008-003	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2002-03-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076008-004	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2002-03-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076008-005	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2001-03-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076008-001	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2001-06-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076008-002	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2013-07-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076008-003	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2002-03-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076008-004	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2002-03-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076008-005	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2001-03-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076008-001	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2001-06-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076008-002	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2013-07-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076008-003	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2002-03-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076008-004	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2002-03-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076008-005	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2001-03-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076008-001	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2001-06-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076008-002	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2013-07-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076008-003	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2002-03-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076008-004	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2002-03-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076008-005	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2001-03-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076008-001	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2001-06-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076008-002	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2013-07-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076008-003	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2002-03-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076008-004	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2002-03-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076008-005	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2001-03-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076008-001	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2001-06-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076008-002	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2013-07-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076008-003	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2002-03-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076008-004	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2002-03-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076008-005	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2001-03-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076008-001	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2001-06-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076008-002	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2013-07-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076008-003	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2002-03-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076008-004	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2002-03-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076008-005	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2001-03-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076008-001	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2001-06-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076008-002	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2013-07-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076008-003	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2002-03-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076008-004	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2002-03-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076008-005	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2001-03-28	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 204 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	A076008-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076008-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076008-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076008-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076008-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076008-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076008-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076008-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076008-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076008-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076008-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076008-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076008-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076008-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076008-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076008-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076008-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076008-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076008-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076008-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076008-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076008-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076008-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076008-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076008-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076008-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076008-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076008-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076008-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076008-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076008-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076008-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076008-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076008-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076008-005	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076008-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076008-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076008-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076008-004	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076008-005	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	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 · 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
7c9eafb9-9ce1-4b28-900c-8fcb4b23424e	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
0378-1165-05	Buspirone Hydrochloride	500 in 1 BOTTLE, PLASTIC	TABLET	500	22
0378-1165-80	Buspirone Hydrochloride	180 in 1 BOTTLE, PLASTIC	TABLET	180	22
0378-1165-91	Buspirone Hydrochloride	60 in 1 BOTTLE, PLASTIC	TABLET	60	22

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0378-1165-05	EA - Each	0378-1165	43200e06-bee3-41c4-9eb0-bbf706351ee9	1	2012-07-24
0378-1165-80	EA - Each	0378-1165	74abe190-c387-434d-937c-74596af7f3db	1	2012-07-24
0378-1165-91	EA - Each	0378-1165	11eefa3f-ba28-4673-9616-4cfe300ee5b8	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BUSPIRONE HYDROCHLORIDE	ACTIVE INGREDIENT	207LT9J9OC	BUSPIRONE HYDROCHLORIDE TABLET [MYLAN PHARMACEUTICALS INC.]	12
BUSPIRONE	ACTIVE MOIETY	TK65WKS8HL	BUSPIRONE HYDROCHLORIDE TABLET [MYLAN PHARMACEUTICALS INC.]	12
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	BUSPIRONE HYDROCHLORIDE TABLET [MYLAN PHARMACEUTICALS INC.]	12
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	BUSPIRONE HYDROCHLORIDE TABLET [MYLAN PHARMACEUTICALS INC.]	12
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	BUSPIRONE HYDROCHLORIDE TABLET [MYLAN PHARMACEUTICALS INC.]	12
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	BUSPIRONE HYDROCHLORIDE TABLET [MYLAN PHARMACEUTICALS INC.]	12
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	BUSPIRONE HYDROCHLORIDE TABLET [MYLAN PHARMACEUTICALS INC.]	12
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	BUSPIRONE HYDROCHLORIDE TABLET [MYLAN PHARMACEUTICALS INC.]	12
BUSPIRONE HYDROCHLORIDE	ACTIVE INGREDIENT	207LT9J9OC	BUSPIRONE HYDROCHLORIDE TABLET [MYLAN INSTITUTIONAL INC.]	9
BUSPIRONE	ACTIVE MOIETY	TK65WKS8HL	BUSPIRONE HYDROCHLORIDE TABLET [MYLAN INSTITUTIONAL INC.]	9
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	BUSPIRONE HYDROCHLORIDE TABLET [MYLAN INSTITUTIONAL INC.]	9
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	BUSPIRONE HYDROCHLORIDE TABLET [MYLAN INSTITUTIONAL INC.]	9
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	BUSPIRONE HYDROCHLORIDE TABLET [MYLAN INSTITUTIONAL INC.]	9
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	BUSPIRONE HYDROCHLORIDE TABLET [MYLAN INSTITUTIONAL INC.]	9
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	BUSPIRONE HYDROCHLORIDE TABLET [MYLAN INSTITUTIONAL INC.]	9
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	BUSPIRONE HYDROCHLORIDE TABLET [MYLAN INSTITUTIONAL INC.]	9
BUSPIRONE HYDROCHLORIDE	ACTIVE INGREDIENT	207LT9J9OC	BUSPIRONE HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
BUSPIRONE HYDROCHLORIDE	ACTIVE INGREDIENT	207LT9J9OC	BUSPIRONE HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
BUSPIRONE	ACTIVE MOIETY	TK65WKS8HL	BUSPIRONE HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
BUSPIRONE	ACTIVE MOIETY	TK65WKS8HL	BUSPIRONE HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	BUSPIRONE HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	BUSPIRONE HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	BUSPIRONE HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	BUSPIRONE HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	BUSPIRONE HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	BUSPIRONE HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	BUSPIRONE HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	BUSPIRONE HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	BUSPIRONE HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	BUSPIRONE HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	BUSPIRONE HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	BUSPIRONE HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0378-1165	BUSPIRONE HYDROCHLORIDE TABLET [MYLAN PHARMACEUTICALS INC.]	20	Current NDC, Legacy NDC, 3 package rows	20240606_7c9eafb9-9ce1-4b28-900c-8fcb4b23424e.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Cardinal Health 107, LLC	2acc7da1-d5b8-4404-a3c6-d51ed82cc4fd	2026-06-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076008 application number: ANDA076008
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Mylan Pharmaceuticals Inc.	7c9eafb9-9ce1-4b28-900c-8fcb4b23424e	2026-06-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076008 application number: ANDA076008 ndc (product): 0378-1165
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Safecor Health, LLC	ebda05ee-d895-4636-bc28-d393e69c91b3	2026-02-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076008 application number: ANDA076008
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Mylan Institutional Inc.	91bb5fc9-5121-43c2-b2af-149240d4189a	2025-07-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076008 application number: ANDA076008

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	91bb5fc9-5121-43c2-b2af-149240d4189a	22
866083	busPIRone HCl 10 MG Oral Tablet	PSN	7c9eafb9-9ce1-4b28-900c-8fcb4b23424e	22
866018	busPIRone HCl 15 MG Oral Tablet	PSN	91bb5fc9-5121-43c2-b2af-149240d4189a	22
866018	busPIRone HCl 15 MG Oral Tablet	PSN	7c9eafb9-9ce1-4b28-900c-8fcb4b23424e	22
866090	busPIRone HCl 30 MG Oral Tablet	PSN	91bb5fc9-5121-43c2-b2af-149240d4189a	22
866090	busPIRone HCl 30 MG Oral Tablet	PSN	7c9eafb9-9ce1-4b28-900c-8fcb4b23424e	22
866094	busPIRone HCl 5 MG Oral Tablet	PSN	91bb5fc9-5121-43c2-b2af-149240d4189a	22
866094	busPIRone HCl 5 MG Oral Tablet	PSN	7c9eafb9-9ce1-4b28-900c-8fcb4b23424e	22
866111	busPIRone HCl 7.5 MG Oral Tablet	PSN	7c9eafb9-9ce1-4b28-900c-8fcb4b23424e	22
866083	buspirone hydrochloride 10 MG Oral Tablet	SCD	91bb5fc9-5121-43c2-b2af-149240d4189a	22
866083	buspirone hydrochloride 10 MG Oral Tablet	SCD	7c9eafb9-9ce1-4b28-900c-8fcb4b23424e	22
866018	buspirone hydrochloride 15 MG Oral Tablet	SCD	91bb5fc9-5121-43c2-b2af-149240d4189a	22
866018	buspirone hydrochloride 15 MG Oral Tablet	SCD	7c9eafb9-9ce1-4b28-900c-8fcb4b23424e	22
866090	buspirone hydrochloride 30 MG Oral Tablet	SCD	7c9eafb9-9ce1-4b28-900c-8fcb4b23424e	22
866090	buspirone hydrochloride 30 MG Oral Tablet	SCD	91bb5fc9-5121-43c2-b2af-149240d4189a	22
866094	buspirone hydrochloride 5 MG Oral Tablet	SCD	7c9eafb9-9ce1-4b28-900c-8fcb4b23424e	22
866094	buspirone hydrochloride 5 MG Oral Tablet	SCD	91bb5fc9-5121-43c2-b2af-149240d4189a	22
866111	buspirone hydrochloride 7.5 MG Oral Tablet	SCD	7c9eafb9-9ce1-4b28-900c-8fcb4b23424e	22
866083	buspirone HCl 10 MG (buspirone 9.1 MG) Oral Tablet	SY	7c9eafb9-9ce1-4b28-900c-8fcb4b23424e	22
866083	buspirone HCl 10 MG (buspirone 9.1 MG) Oral Tablet	SY	91bb5fc9-5121-43c2-b2af-149240d4189a	22
866111	buspirone HCl 7.5 MG (buspirone 6.9 MG) Oral Tablet	SY	7c9eafb9-9ce1-4b28-900c-8fcb4b23424e	22
866018	buspirone hydrochloride 15 MG (buspirone 13.7 MG) Oral Tablet	SY	7c9eafb9-9ce1-4b28-900c-8fcb4b23424e	22
866018	buspirone hydrochloride 15 MG (buspirone 13.7 MG) Oral Tablet	SY	91bb5fc9-5121-43c2-b2af-149240d4189a	22
866090	buspirone hydrochloride 30 MG (buspirone 27.4 MG) Oral Tablet	SY	7c9eafb9-9ce1-4b28-900c-8fcb4b23424e	22
866090	buspirone hydrochloride 30 MG (buspirone 27.4 MG) Oral Tablet	SY	91bb5fc9-5121-43c2-b2af-149240d4189a	22
866094	buspirone hydrochloride 5 MG (buspirone 4.6 MG) Oral Tablet	SY	7c9eafb9-9ce1-4b28-900c-8fcb4b23424e	22
866094	buspirone hydrochloride 5 MG (buspirone 4.6 MG) Oral Tablet	SY	91bb5fc9-5121-43c2-b2af-149240d4189a	22
866083	busPIRone HCl 10 MG Oral Tablet	PSN	ebda05ee-d895-4636-bc28-d393e69c91b3	3
866018	busPIRone HCl 15 MG Oral Tablet	PSN	ebda05ee-d895-4636-bc28-d393e69c91b3	3
866090	busPIRone HCl 30 MG Oral Tablet	PSN	ebda05ee-d895-4636-bc28-d393e69c91b3	3
866094	busPIRone HCl 5 MG Oral Tablet	PSN	ebda05ee-d895-4636-bc28-d393e69c91b3	3
866083	buspirone hydrochloride 10 MG Oral Tablet	SCD	ebda05ee-d895-4636-bc28-d393e69c91b3	3
866018	buspirone hydrochloride 15 MG Oral Tablet	SCD	ebda05ee-d895-4636-bc28-d393e69c91b3	3
866090	buspirone hydrochloride 30 MG Oral Tablet	SCD	ebda05ee-d895-4636-bc28-d393e69c91b3	3
866094	buspirone hydrochloride 5 MG Oral Tablet	SCD	ebda05ee-d895-4636-bc28-d393e69c91b3	3
866083	buspirone HCl 10 MG (buspirone 9.1 MG) Oral Tablet	SY	ebda05ee-d895-4636-bc28-d393e69c91b3	3
866018	buspirone hydrochloride 15 MG (buspirone 13.7 MG) Oral Tablet	SY	ebda05ee-d895-4636-bc28-d393e69c91b3	3
866090	buspirone hydrochloride 30 MG (buspirone 27.4 MG) Oral Tablet	SY	ebda05ee-d895-4636-bc28-d393e69c91b3	3
866094	buspirone hydrochloride 5 MG (buspirone 4.6 MG) Oral Tablet	SY	ebda05ee-d895-4636-bc28-d393e69c91b3	3
866083	busPIRone HCl 10 MG Oral Tablet	PSN	d0fea556-a015-45c9-98ef-a8b17da4c889	1
866018	busPIRone HCl 15 MG Oral Tablet	PSN	d0fea556-a015-45c9-98ef-a8b17da4c889	1
866094	busPIRone HCl 5 MG Oral Tablet	PSN	d0fea556-a015-45c9-98ef-a8b17da4c889	1
866083	buspirone hydrochloride 10 MG Oral Tablet	SCD	d0fea556-a015-45c9-98ef-a8b17da4c889	1
866018	buspirone hydrochloride 15 MG Oral Tablet	SCD	d0fea556-a015-45c9-98ef-a8b17da4c889	1
866094	buspirone hydrochloride 5 MG Oral Tablet	SCD	d0fea556-a015-45c9-98ef-a8b17da4c889	1
866083	buspirone HCl 10 MG (buspirone 9.1 MG) Oral Tablet	SY	d0fea556-a015-45c9-98ef-a8b17da4c889	1
866018	buspirone hydrochloride 15 MG (buspirone 13.7 MG) Oral Tablet	SY	d0fea556-a015-45c9-98ef-a8b17da4c889	1
866094	buspirone hydrochloride 5 MG (buspirone 4.6 MG) Oral Tablet	SY	d0fea556-a015-45c9-98ef-a8b17da4c889	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0378-1165-05	00378116505	500 TABLET in 1 BOTTLE, PLASTIC (0378-1165-05)	500 tablet	2001-03-29	0000-00-00	No	No	Current
0378-1165-80	00378116580	180 TABLET in 1 BOTTLE, PLASTIC (0378-1165-80)	180 tablet	2001-03-29	2026-09-30	No	No	Current
0378-1165-91	00378116591	60 TABLET in 1 BOTTLE, PLASTIC (0378-1165-91)	60 tablet	2001-03-28	2026-09-30	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Buspirone Hydrochloride - Mylan Pharmaceuticals Inc.	Mylan Pharmaceuticals Inc.	2026-06-15	HUMAN PRESCRIPTION DRUG LABEL	23
Buspirone Hydrochloride - Safecor Health, LLC	Safecor Health, LLC	2026-02-20	HUMAN PRESCRIPTION DRUG LABEL	3
Buspirone Hydrochloride - Mylan Institutional Inc.	Mylan Institutional Inc.	2025-07-18	HUMAN PRESCRIPTION DRUG LABEL	22
Buspirone Hydrochloride - REMEDYREPACK INC.	REMEDYREPACK INC.	2022-06-16	HUMAN PRESCRIPTION DRUG LABEL	6
Buspirone Hydrochloride - REMEDYREPACK INC.	REMEDYREPACK INC.	2021-01-05	HUMAN PRESCRIPTION DRUG LABEL	6
Buspirone Hydrochloride Tablets, USP	Golden State Medical Supply, Inc.	2020-03-19	HUMAN PRESCRIPTION DRUG LABEL	6
Buspirone Hydrochloride - Aphena Pharma Solutions - Tennessee, LLC	Aphena Pharma Solutions - Tennessee, LLC	2014-06-18	HUMAN PRESCRIPTION DRUG LABEL	1