Buspirone Hydrochloride

Product NDC: 67046-149
Requested package NDC: 67046-149-07
11-digit product format: 670460149
Labeler code: 67046
Product ID: 67046-149_598c39b1-0816-5895-e053-2991aa0a53b1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: buspirone hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Contract Pharmacy Services-PA
Application: ANDA076008
Marketing category: ANDA
Marketing start: 2017-09-19
Marketing end: 0000-00-00
Substance: BUSPIRONE HYDROCHLORIDE
Active strength: 10 mg/1
NDC exclude flag: No
Listing certified through: 2020-12-31
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	67046-149	67046-149-07	I	Inactivated by FDA		2026-09-09

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 · 18 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	`bd6a592717d7…`	`303034d00443…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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 · 210 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	A076008-001	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2001-06-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076008-002	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL		2013-07-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076008-003	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2002-03-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076008-004	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2002-03-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076008-005	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2001-03-28	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 208 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	A076008-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076008-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076008-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076008-005	AB	1	`caaa826d4ba7…`
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…`

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, Related label table
NDC	Related label
67046-149-07	Buspirone 10 mg 149
67046-149-14	Buspirone 10 mg 149
67046-149-15	Buspirone 10 mg 149
67046-149-21	Buspirone 10 mg 149
67046-149-28	Buspirone 10 mg 149
67046-149-30	Buspirone 10 mg 149

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
67046-149-07	Buspirone Hydrochloride	7 in 1 BLISTER PACK	TABLET	7	1
67046-149-14	Buspirone Hydrochloride	14 in 1 BLISTER PACK	TABLET	14	1
67046-149-15	Buspirone Hydrochloride	15 in 1 BLISTER PACK	TABLET	15	1
67046-149-21	Buspirone Hydrochloride	21 in 1 BLISTER PACK	TABLET	21	1
67046-149-28	Buspirone Hydrochloride	28 in 1 BLISTER PACK	TABLET	28	1
67046-149-30	Buspirone Hydrochloride	30 in 1 BLISTER PACK	TABLET	30	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67046-149	BUSPIRONE HYDROCHLORIDE TABLET [CONTRACT PHARMACY SERVICES-PA]	1	Legacy NDC, 6 package rows	20170919_598c39b1-0815-5895-e053-2991aa0a53b1.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	2026-07-29	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
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	598c39b1-0815-5895-e053-2991aa0a53b1	1
866083	buspirone hydrochloride 10 MG Oral Tablet	SCD	598c39b1-0815-5895-e053-2991aa0a53b1	1
866083	buspirone HCl 10 MG (buspirone 9.1 MG) Oral Tablet	SY	598c39b1-0815-5895-e053-2991aa0a53b1	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
67046-149-07	67046014907	7 TABLET in 1 BLISTER PACK (67046-149-07)	7 tablet	2017-09-19	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Buspirone 10 mg 149	Contract Pharmacy Services-PA \| Coupler Enterprises	2017-09-19	HUMAN PRESCRIPTION DRUG LABEL	1