Buspirone Hydrochloride

Product NDC: 53002-1017
Requested package NDC: 53002-1017-3
11-digit product format: 530021017
Labeler code: 53002
Product ID: 53002-1017_309352d9-0436-40d6-ae20-a051cfe85acc
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Buspirone Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: RPK Pharmaceuticals, Inc.
Application: ANDA075022
Marketing category: ANDA
Marketing start: 2002-02-28
Marketing end: 0000-00-00
Substance: BUSPIRONE HYDROCHLORIDE
Active strength: 10 mg/1
NDC exclude flag: No
Listing certified through: 2021-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	53002-1017	53002-1017-3	I	Inactivated by FDA		2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 11 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53002-1017	53002-1017-3	I	Inactivated by FDA	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53002-1017	53002-1017-3	I	Inactivated by FDA	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53002-1017	53002-1017-3	I	Inactivated by FDA	excluded / ndc_excluded.zip	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53002-1017	53002-1017-3	I	Inactivated by FDA	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53002-1017	53002-1017-3	I	Inactivated by FDA	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53002-1017	53002-1017-3	I	Inactivated by FDA	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53002-1017	53002-1017-3	U	Excluded because listing certification expired	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53002-1017	53002-1017-3	U	Excluded because listing certification expired	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53002-1017	53002-1017-3	U	Excluded because listing certification expired	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	53002-1017	53002-1017-3	I	Inactivated by FDA	excluded / ndc_excluded.zip	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	53002-1017	53002-1017-3	I	Inactivated by FDA	excluded / ndc_excluded.zip	`9bebd1f3094a…`	`5416666fcb17…`

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#

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
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

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53002-1017-0	2025-01-30	C162847	48780-1	9d75b9d0-c703-f424-e053-dadaa90a57ce	BusPIRone Hydrochloride Tablets USP Rx only
53002-1017-3	2025-01-30	C162847	48780-1	9d75b9d0-c703-f424-e053-dadaa90a57ce	BusPIRone Hydrochloride Tablets USP Rx only
53002-1017-6	2025-01-30	C162847	48780-1	9d75b9d0-c703-f424-e053-dadaa90a57ce	BusPIRone Hydrochloride Tablets USP Rx only
53002-1017-0	2023-06-07	C162847	48780-1	9d75b9d0-c703-f424-e053-dadaa90a57ce	BusPIRone Hydrochloride Tablets USP Rx only
53002-1017-3	2023-06-07	C162847	48780-1	9d75b9d0-c703-f424-e053-dadaa90a57ce	BusPIRone Hydrochloride Tablets USP Rx only
53002-1017-6	2023-06-07	C162847	48780-1	9d75b9d0-c703-f424-e053-dadaa90a57ce	BusPIRone Hydrochloride Tablets USP Rx only
53002-1017-0	2023-01-30	C162847	48780-1	9d75b9d0-c703-f424-e053-dadaa90a57ce	BusPIRone Hydrochloride Tablets USP Rx only
53002-1017-3	2023-01-30	C162847	48780-1	9d75b9d0-c703-f424-e053-dadaa90a57ce	BusPIRone Hydrochloride Tablets USP Rx only
53002-1017-6	2023-01-30	C162847	48780-1	9d75b9d0-c703-f424-e053-dadaa90a57ce	BusPIRone Hydrochloride Tablets USP Rx only
53002-1017-0	2020-12-15	C162847	48780-1	9d75b9d0-c703-f424-e053-dadaa90a57ce	BusPIRone Hydrochloride Tablets USP Rx only
53002-1017-3	2020-12-15	C162847	48780-1	9d75b9d0-c703-f424-e053-dadaa90a57ce	BusPIRone Hydrochloride Tablets USP Rx only
53002-1017-6	2020-12-15	C162847	48780-1	9d75b9d0-c703-f424-e053-dadaa90a57ce	BusPIRone Hydrochloride Tablets USP Rx only
53002-1017-0	2020-01-31	C162847	48780-1	9d75b9d0-c703-f424-e053-dadaa90a57ce	BusPIRone Hydrochloride Tablets USP Rx only
53002-1017-3	2020-01-31	C162847	48780-1	9d75b9d0-c703-f424-e053-dadaa90a57ce	BusPIRone Hydrochloride Tablets USP Rx only
53002-1017-6	2020-01-31	C162847	48780-1	9d75b9d0-c703-f424-e053-dadaa90a57ce	BusPIRone Hydrochloride Tablets USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
53002-1017-0	Buspirone Hydrochloride	100 in 1 BOTTLE	TABLET	100	5
53002-1017-3	Buspirone Hydrochloride	30 in 1 BOTTLE	TABLET	30	5
53002-1017-6	Buspirone Hydrochloride	60 in 1 BOTTLE	TABLET	60	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53002-1017	BUSPIRONE HYDROCHLORIDE TABLET [RPK PHARMACEUTICALS, INC.]	5	Legacy NDC, 3 package rows	20230609_20e3c81a-ff4f-4691-bf1a-a4e522e7a56f.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	20e3c81a-ff4f-4691-bf1a-a4e522e7a56f	5
866083	buspirone hydrochloride 10 MG Oral Tablet	SCD	20e3c81a-ff4f-4691-bf1a-a4e522e7a56f	5
866083	buspirone HCl 10 MG (buspirone 9.1 MG) Oral Tablet	SY	20e3c81a-ff4f-4691-bf1a-a4e522e7a56f	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53002-1017-3	53002101703	30 TABLET in 1 BOTTLE (53002-1017-3)	30 tablet	2017-09-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
BusPIRone Hydrochloride Tablets USP Rx only	RPK Pharmaceuticals, Inc.	2023-06-07	HUMAN PRESCRIPTION DRUG LABEL	5