Buspirone Hydrochloride

Product NDC: 0093-5200
11-digit product format: 000935200
Labeler code: 0093
Product ID: 0093-5200_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: 2004-03-26
Substance: BUSPIRONE HYDROCHLORIDE
Active strength: 30 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 · 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 · 164 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	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…`
2024-10-29 15:01 UTC	2024-10	A075022-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2002-02-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075022-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2002-02-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075022-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2002-02-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075022-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2004-03-25	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 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	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…`
2024-10-29 15:01 UTC	2024-10	A075022-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075022-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075022-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075022-004	AB	1	`d06236e962d9…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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): 0093-5200
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

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	30 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
0093-5200-05	Buspirone Hydrochloride	500 in 1 BOTTLE	TABLET	500		19
0093-5200-06	Buspirone Hydrochloride	60 in 1 BOTTLE	TABLET	60		19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0093-5200-05	EA - Each	0093-5200	a2494f74-ca90-4d6f-a364-59b35083cc47	1	2012-07-24
0093-5200-06	EA - Each	0093-5200	ea46a296-cfa0-44a9-9005-a563a3398f6b	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 (BUSPIRONE HYDROCHLORIDE) TABLET [AVKARE, INC.]	2
BUSPIRONE HYDROCHLORIDE	ACTIVE INGREDIENT	207LT9J9OC	BUSPIRONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]	2
BUSPIRONE	ACTIVE MOIETY	TK65WKS8HL	BUSPIRONE HYDROCHLORIDE (BUSPIRONE HYDROCHLORIDE) TABLET [AVKARE, INC.]	2
BUSPIRONE	ACTIVE MOIETY	TK65WKS8HL	BUSPIRONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]	2
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	BUSPIRONE HYDROCHLORIDE (BUSPIRONE HYDROCHLORIDE) TABLET [AVKARE, INC.]	2
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	BUSPIRONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	BUSPIRONE HYDROCHLORIDE (BUSPIRONE HYDROCHLORIDE) TABLET [AVKARE, INC.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	BUSPIRONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	BUSPIRONE HYDROCHLORIDE (BUSPIRONE HYDROCHLORIDE) TABLET [AVKARE, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	BUSPIRONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	BUSPIRONE HYDROCHLORIDE (BUSPIRONE HYDROCHLORIDE) TABLET [AVKARE, INC.]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	BUSPIRONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	BUSPIRONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	BUSPIRONE HYDROCHLORIDE (BUSPIRONE HYDROCHLORIDE) TABLET [AVKARE, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0093-5200	BUSPIRONE HYDROCHLORIDE TABLET [TEVA PHARMACEUTICALS USA, INC.]	19	Current NDC, Legacy NDC, 2 package rows	20230731_6fac36b4-b223-479e-913f-f8c9cdb9e119.zip

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	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
866090	busPIRone HCl 30 MG Oral Tablet	PSN	4adc1750-b89e-473d-a18f-949423a2354f	9
866090	buspirone hydrochloride 30 MG Oral Tablet	SCD	4adc1750-b89e-473d-a18f-949423a2354f	9
866090	buspirone hydrochloride 30 MG (buspirone 27.4 MG) Oral Tablet	SY	4adc1750-b89e-473d-a18f-949423a2354f	9
866090	busPIRone HCl 30 MG Oral Tablet	PSN	58623499-9552-4101-bdf4-ce9227aa6bdc	7
866090	buspirone hydrochloride 30 MG Oral Tablet	SCD	58623499-9552-4101-bdf4-ce9227aa6bdc	7
866090	buspirone hydrochloride 30 MG (buspirone 27.4 MG) Oral Tablet	SY	58623499-9552-4101-bdf4-ce9227aa6bdc	7
866090	busPIRone HCl 30 MG Oral Tablet	PSN	d5fcc60d-5465-4075-948c-1aa4ff21af4c	2
866090	buspirone hydrochloride 30 MG Oral Tablet	SCD	d5fcc60d-5465-4075-948c-1aa4ff21af4c	2
866090	buspirone hydrochloride 30 MG (buspirone 27.4 MG) Oral Tablet	SY	d5fcc60d-5465-4075-948c-1aa4ff21af4c	2
866090	busPIRone HCl 30 MG Oral Tablet	PSN	a8720833-3bbc-4714-b9b8-716c5e55410d	1
866090	buspirone hydrochloride 30 MG Oral Tablet	SCD	a8720833-3bbc-4714-b9b8-716c5e55410d	1
866090	buspirone hydrochloride 30 MG (buspirone 27.4 MG) Oral Tablet	SY	a8720833-3bbc-4714-b9b8-716c5e55410d	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0093-5200-05	00093520005	500 TABLET in 1 BOTTLE (0093-5200-05)	500 tablet	2004-03-26	0000-00-00	No	No	Current
0093-5200-06	00093520006	60 TABLET in 1 BOTTLE (0093-5200-06)	60 tablet	2004-03-26	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
BusPIRone Hydrochloride Tablets, USP Rx only	A-S Medication Solutions	2025-01-08	HUMAN PRESCRIPTION DRUG LABEL	9
BusPIRone Hydrochloride Tablets, USP Rx only	Bryant Ranch Prepack	2024-10-21	HUMAN PRESCRIPTION DRUG LABEL	1
BusPIRone Hydrochloride Tablets, USP Rx only	NCS HealthCare of KY, LLC dba Vangard Labs	2024-09-27	HUMAN PRESCRIPTION DRUG LABEL	2
BusPIRone Hydrochloride Tablets, USP Rx only	Teva Pharmaceuticals USA, Inc.	2023-07-23	HUMAN PRESCRIPTION DRUG LABEL	19
BusPIRone Hydrochloride Tablets USP Rx only	RPK Pharmaceuticals, Inc.	2023-07-04	HUMAN PRESCRIPTION DRUG LABEL	7
BusPIRone HYDROCHLORIDE TABLETS USP Rx only	AvKARE	2022-01-13	HUMAN PRESCRIPTION DRUG LABEL	5
BusPIRone Hydrochloride Tablets USP 0053 0054 1003 5200 Rx only	REMEDYREPACK INC.	2021-01-19	HUMAN PRESCRIPTION DRUG LABEL	2
BusPIRone Hydrochloride Tablets USP 0053 0054 1003 5200 Rx only	REMEDYREPACK INC.	2019-10-30	HUMAN PRESCRIPTION DRUG LABEL	3
BusPIRone Hydrochloride Tablets USP 0053 0054 1003 5200 Rx only	Bryant Ranch Prepack	2019-06-11	HUMAN PRESCRIPTION DRUG LABEL	8