Buspirone Hydrochloride

Product NDC: 0093-0053
11-digit product format: 000930053
Labeler code: 0093
Product ID: 0093-0053_f2a05d58-ca70-4b89-aa19-6b63e85a57a5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Buspirone Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Teva Pharmaceuticals USA, Inc.
Application: ANDA075022
Marketing category: ANDA
Marketing start: 2002-02-28
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 42.

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
A075022-001	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2002-02-28
A075022-002	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2002-02-28
A075022-003	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2002-02-28
A075022-004	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2004-03-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075022-001	AB
A075022-002	AB
A075022-003	AB
A075022-004	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 · 168 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
2026-08-18 06:07:40	2026-07	A075022-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2002-02-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075022-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2002-02-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075022-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2002-02-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075022-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2004-03-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075022-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2002-02-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075022-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2002-02-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075022-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2002-02-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075022-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2004-03-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075022-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2002-02-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075022-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2002-02-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075022-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2002-02-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075022-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2004-03-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075022-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2002-02-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075022-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2002-02-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075022-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2002-02-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075022-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2004-03-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075022-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2002-02-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075022-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2002-02-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075022-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2002-02-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075022-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2004-03-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075022-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2002-02-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075022-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2002-02-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075022-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2002-02-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075022-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2004-03-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075022-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2002-02-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075022-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2002-02-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075022-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2002-02-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075022-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2004-03-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075022-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2002-02-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075022-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2002-02-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075022-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2002-02-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075022-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2004-03-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075022-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2002-02-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075022-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2002-02-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075022-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2002-02-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075022-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2004-03-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075022-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2002-02-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075022-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2002-02-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075022-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2002-02-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075022-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2004-03-25	`d8e5a09893c0…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A075022-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075022-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075022-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075022-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075022-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075022-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075022-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075022-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075022-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075022-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075022-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075022-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075022-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075022-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075022-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075022-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075022-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075022-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075022-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075022-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075022-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075022-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075022-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075022-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075022-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075022-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075022-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075022-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075022-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075022-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075022-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075022-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075022-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075022-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075022-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075022-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075022-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075022-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075022-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075022-004	AB	1	`d8e5a09893c0…`

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 · 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
6fac36b4-b223-479e-913f-f8c9cdb9e119	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
0093-0053-01	Buspirone Hydrochloride	100 in 1 BOTTLE	TABLET	100		19
0093-0053-05	Buspirone Hydrochloride	500 in 1 BOTTLE	TABLET	500		19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0093-0053-01	EA - Each	0093-0053	bd67eacb-3629-4cf3-bdc6-472a6db08d78	1	2012-07-24
0093-0053-05	EA - Each	0093-0053	e70d29ed-ae78-4b7f-834a-9929b58fab3c	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 [TEVA PHARMACEUTICALS USA INC]	11
BUSPIRONE	ACTIVE MOIETY	TK65WKS8HL	BUSPIRONE HYDROCHLORIDE TABLET [TEVA PHARMACEUTICALS USA INC]	11
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	BUSPIRONE HYDROCHLORIDE TABLET [TEVA PHARMACEUTICALS USA INC]	11
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	BUSPIRONE HYDROCHLORIDE TABLET [TEVA PHARMACEUTICALS USA INC]	11
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	BUSPIRONE HYDROCHLORIDE TABLET [TEVA PHARMACEUTICALS USA INC]	11
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	BUSPIRONE HYDROCHLORIDE TABLET [TEVA PHARMACEUTICALS USA INC]	11
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	BUSPIRONE HYDROCHLORIDE TABLET [TEVA PHARMACEUTICALS USA INC]	11
BUSPIRONE HYDROCHLORIDE	ACTIVE INGREDIENT	207LT9J9OC	BUSPIRONE HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	9
BUSPIRONE	ACTIVE MOIETY	TK65WKS8HL	BUSPIRONE HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	9
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	BUSPIRONE HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	9
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	BUSPIRONE HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	9
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	BUSPIRONE HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	9
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	BUSPIRONE HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	9
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	BUSPIRONE HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	9
BUSPIRONE HYDROCHLORIDE	ACTIVE INGREDIENT	207LT9J9OC	BUSPIRONE HYDROCHLORIDE TABLET [CARILION MATERIALS MANAGEMENT]	2
BUSPIRONE	ACTIVE MOIETY	TK65WKS8HL	BUSPIRONE HYDROCHLORIDE TABLET [CARILION MATERIALS MANAGEMENT]	2
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	BUSPIRONE HYDROCHLORIDE TABLET [CARILION MATERIALS MANAGEMENT]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	BUSPIRONE HYDROCHLORIDE TABLET [CARILION MATERIALS MANAGEMENT]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	BUSPIRONE HYDROCHLORIDE TABLET [CARILION MATERIALS MANAGEMENT]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	BUSPIRONE HYDROCHLORIDE TABLET [CARILION MATERIALS MANAGEMENT]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	BUSPIRONE HYDROCHLORIDE TABLET [CARILION MATERIALS MANAGEMENT]	2
BUSPIRONE HYDROCHLORIDE	ACTIVE INGREDIENT	207LT9J9OC	BUSPIRONE HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	1
BUSPIRONE	ACTIVE MOIETY	TK65WKS8HL	BUSPIRONE HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	BUSPIRONE HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	BUSPIRONE HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	BUSPIRONE HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	BUSPIRONE HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	BUSPIRONE HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0093-0053	BUSPIRONE HYDROCHLORIDE TABLET [TEVA PHARMACEUTICALS USA, INC.]	19	Current NDC, Legacy NDC, 2 package rows	20230731_6fac36b4-b223-479e-913f-f8c9cdb9e119.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 · 19 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Redpharm Drug	5718bc19-07b2-b61d-e063-6394a90a6e80	2026-07-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075022 application number: ANDA075022
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	459cc50d-0b18-ac1d-e063-6294a90ae7c4	2026-03-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075022 application number: ANDA075022
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Northwind Health Company, LLC	ff02c7cb-f96a-4a3b-99a2-812cd78b345c	2025-12-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075022 application number: ANDA075022
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Boswell Pharmacy Services LLC d/b/a BPS Wholesale	438f5c4d-a009-b851-e063-6394a90a084a	2025-11-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075022 application number: ANDA075022
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	3b41fd76-c3cc-77f0-e063-6294a90aa778	2025-07-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075022 application number: ANDA075022
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	A-S Medication Solutions	4adc1750-b89e-473d-a18f-949423a2354f	2025-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075022 application number: ANDA075022
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Bryant Ranch Prepack	a8720833-3bbc-4714-b9b8-716c5e55410d	2024-10-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075022 application number: ANDA075022
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	NCS HealthCare of KY, LLC dba Vangard Labs	d5fcc60d-5465-4075-948c-1aa4ff21af4c	2024-09-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075022 application number: ANDA075022
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	NCS HealthCare of KY, LLC dba Vangard Labs	72bff09c-826e-4394-a7e7-41d56ce9605b	2024-09-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075022 application number: ANDA075022
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Bryant Ranch Prepack	db32a7ec-5b50-4305-8952-df22e7e871e2	2024-07-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075022 application number: ANDA075022
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	A-S Medication Solutions	cff1c7b2-4edb-4b5a-9626-2f7b8671b015	2024-05-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075022 application number: ANDA075022
Buspirone Hydrochloride	BUSPIRONE	Boswell Pharmacy Services d/b/a BPS Wholesale	18e90d65-4a3a-864e-e063-6294a90ae99d	2024-05-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075022 application number: ANDA075022
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	A-S Medication Solutions	96789fdc-f3a0-4441-b9f4-2be2d9c6273b	2023-10-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075022 application number: ANDA075022
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Teva Pharmaceuticals USA, Inc.	6fac36b4-b223-479e-913f-f8c9cdb9e119	2023-07-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075022 application number: ANDA075022 ndc (product): 0093-0053
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Proficient Rx LP	864ddd0c-80e5-4b4b-84e9-7d66214464ae	2023-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075022 application number: ANDA075022
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Proficient Rx LP	9a702362-39cb-4171-8d64-f37fa7e1f638	2022-08-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075022 application number: ANDA075022
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Proficient Rx LP	69eb15e9-c33e-40a3-82d8-497dad13068d	2022-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075022 application number: ANDA075022
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	efa03f52-430e-455a-bdca-7f9d422b7b19	2019-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075022 application number: ANDA075022
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	b7e3a98c-9ec5-4c21-9218-0d53a555a75c	2018-11-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075022 application number: ANDA075022

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	72bff09c-826e-4394-a7e7-41d56ce9605b	25
866018	busPIRone HCl 15 MG Oral Tablet	PSN	72bff09c-826e-4394-a7e7-41d56ce9605b	25
866094	busPIRone HCl 5 MG Oral Tablet	PSN	72bff09c-826e-4394-a7e7-41d56ce9605b	25
866083	buspirone hydrochloride 10 MG Oral Tablet	SCD	72bff09c-826e-4394-a7e7-41d56ce9605b	25
866018	buspirone hydrochloride 15 MG Oral Tablet	SCD	72bff09c-826e-4394-a7e7-41d56ce9605b	25
866094	buspirone hydrochloride 5 MG Oral Tablet	SCD	72bff09c-826e-4394-a7e7-41d56ce9605b	25
866083	buspirone HCl 10 MG (buspirone 9.1 MG) Oral Tablet	SY	72bff09c-826e-4394-a7e7-41d56ce9605b	25
866018	buspirone hydrochloride 15 MG (buspirone 13.7 MG) Oral Tablet	SY	72bff09c-826e-4394-a7e7-41d56ce9605b	25
866094	buspirone hydrochloride 5 MG (buspirone 4.6 MG) Oral Tablet	SY	72bff09c-826e-4394-a7e7-41d56ce9605b	25
866083	busPIRone HCl 10 MG Oral Tablet	PSN	6fac36b4-b223-479e-913f-f8c9cdb9e119	19
866018	busPIRone HCl 15 MG Oral Tablet	PSN	6fac36b4-b223-479e-913f-f8c9cdb9e119	19
866090	busPIRone HCl 30 MG Oral Tablet	PSN	6fac36b4-b223-479e-913f-f8c9cdb9e119	19
866094	busPIRone HCl 5 MG Oral Tablet	PSN	6fac36b4-b223-479e-913f-f8c9cdb9e119	19
866083	buspirone hydrochloride 10 MG Oral Tablet	SCD	6fac36b4-b223-479e-913f-f8c9cdb9e119	19
866018	buspirone hydrochloride 15 MG Oral Tablet	SCD	6fac36b4-b223-479e-913f-f8c9cdb9e119	19
866090	buspirone hydrochloride 30 MG Oral Tablet	SCD	6fac36b4-b223-479e-913f-f8c9cdb9e119	19
866094	buspirone hydrochloride 5 MG Oral Tablet	SCD	6fac36b4-b223-479e-913f-f8c9cdb9e119	19
866083	buspirone HCl 10 MG (buspirone 9.1 MG) Oral Tablet	SY	6fac36b4-b223-479e-913f-f8c9cdb9e119	19
866018	buspirone hydrochloride 15 MG (buspirone 13.7 MG) Oral Tablet	SY	6fac36b4-b223-479e-913f-f8c9cdb9e119	19
866090	buspirone hydrochloride 30 MG (buspirone 27.4 MG) Oral Tablet	SY	6fac36b4-b223-479e-913f-f8c9cdb9e119	19
866094	buspirone hydrochloride 5 MG (buspirone 4.6 MG) Oral Tablet	SY	6fac36b4-b223-479e-913f-f8c9cdb9e119	19
866083	busPIRone HCl 10 MG Oral Tablet	PSN	db32a7ec-5b50-4305-8952-df22e7e871e2	6
866094	busPIRone HCl 5 MG Oral Tablet	PSN	db32a7ec-5b50-4305-8952-df22e7e871e2	6
866083	buspirone hydrochloride 10 MG Oral Tablet	SCD	db32a7ec-5b50-4305-8952-df22e7e871e2	6
866094	buspirone hydrochloride 5 MG Oral Tablet	SCD	db32a7ec-5b50-4305-8952-df22e7e871e2	6
866083	buspirone HCl 10 MG (buspirone 9.1 MG) Oral Tablet	SY	db32a7ec-5b50-4305-8952-df22e7e871e2	6
866094	buspirone hydrochloride 5 MG (buspirone 4.6 MG) Oral Tablet	SY	db32a7ec-5b50-4305-8952-df22e7e871e2	6
866094	busPIRone HCl 5 MG Oral Tablet	PSN	1531bddc-eddd-4d7e-933c-66d4384e91f7	4
866094	busPIRone HCl 5 MG Oral Tablet	PSN	7871cdf8-cf8d-7370-e053-2991aa0af4dc	4
866094	buspirone hydrochloride 5 MG Oral Tablet	SCD	7871cdf8-cf8d-7370-e053-2991aa0af4dc	4
866094	buspirone hydrochloride 5 MG Oral Tablet	SCD	1531bddc-eddd-4d7e-933c-66d4384e91f7	4
866094	buspirone hydrochloride 5 MG (buspirone 4.6 MG) Oral Tablet	SY	7871cdf8-cf8d-7370-e053-2991aa0af4dc	4
866094	buspirone hydrochloride 5 MG (buspirone 4.6 MG) Oral Tablet	SY	1531bddc-eddd-4d7e-933c-66d4384e91f7	4
866094	busPIRone HCl 5 MG Oral Tablet	PSN	efa03f52-430e-455a-bdca-7f9d422b7b19	2
866094	buspirone hydrochloride 5 MG Oral Tablet	SCD	efa03f52-430e-455a-bdca-7f9d422b7b19	2
866094	buspirone hydrochloride 5 MG (buspirone 4.6 MG) Oral Tablet	SY	efa03f52-430e-455a-bdca-7f9d422b7b19	2
866094	busPIRone HCl 5 MG Oral Tablet	PSN	864ddd0c-80e5-4b4b-84e9-7d66214464ae	1
866094	buspirone hydrochloride 5 MG Oral Tablet	SCD	864ddd0c-80e5-4b4b-84e9-7d66214464ae	1
866094	buspirone hydrochloride 5 MG (buspirone 4.6 MG) Oral Tablet	SY	864ddd0c-80e5-4b4b-84e9-7d66214464ae	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0093-0053-01	00093005301	100 TABLET in 1 BOTTLE (0093-0053-01)	100 tablet	2002-02-28	0000-00-00	No	No	Current
0093-0053-05	00093005305	500 TABLET in 1 BOTTLE (0093-0053-05)	500 tablet	2002-03-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
BusPIRone Hydrochloride Tablets, USP Rx only	REMEDYREPACK INC.	2025-06-26	HUMAN PRESCRIPTION DRUG LABEL	7
BusPIRone Hydrochloride Tablets, USP Rx only	NCS HealthCare of KY, LLC dba Vangard Labs	2024-09-24	HUMAN PRESCRIPTION DRUG LABEL	25
BusPIRone Hydrochloride Tablets, USP Rx only	Bryant Ranch Prepack	2024-07-09	HUMAN PRESCRIPTION DRUG LABEL	6
BusPIRone Hydrochloride Tablets, USP Rx only	Teva Pharmaceuticals USA, Inc.	2023-07-23	HUMAN PRESCRIPTION DRUG LABEL	19
BusPIRone Hydrochloride Tablets USP Rx only	Proficient Rx LP	2023-05-01	HUMAN PRESCRIPTION DRUG LABEL	1
buspirone	RedPharm Drug, Inc.	2022-01-20	HUMAN PRESCRIPTION DRUG LABEL	4
BusPIRone Hydrochloride Tablets USP 0053 0054 1003 5200 Rx only	Aphena Pharma Solutions - Tennessee, LLC	2019-01-08	HUMAN PRESCRIPTION DRUG LABEL	2
BusPIRone Hydrochloride Tablets USP Rx only	Carilion Materials Management	2017-07-06	HUMAN PRESCRIPTION DRUG LABEL	4
BusPIRone HYDROCHLORIDE TABLETS USP 0053 0054 1003 5200 Rx only	NCS HealthCare of KY, Inc dba Vangard Labs	2011-04-15	HUMAN PRESCRIPTION DRUG LABEL	1