Buspirone Hydrochloride

Product NDC: 71610-267
Requested package NDC: 71610-267-80
11-digit product format: 716100267
Labeler code: 71610
Product ID: 71610-267_52da6ae2-944a-4609-a3a0-07cfb06b31a2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Buspirone Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: ANDA204582
Marketing category: ANDA
Marketing start: 2012-06-29
Marketing end: 0000-00-00
Substance: BUSPIRONE HYDROCHLORIDE
Active strength: 5 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	71610-267	71610-267-80	D	Discontinued by firm		2026-08-10

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
A204582-001	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-09-18
A204582-002	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-09-18
A204582-003	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2015-09-18
A204582-004	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2015-09-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204582-001	AB
A204582-002	AB
A204582-003	AB
A204582-004	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	A204582-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-09-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204582-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-09-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204582-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2015-09-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204582-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2015-09-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204582-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-09-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204582-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-09-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204582-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2015-09-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204582-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2015-09-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204582-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-09-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204582-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-09-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204582-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2015-09-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204582-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2015-09-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204582-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-09-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204582-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-09-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204582-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2015-09-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204582-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2015-09-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204582-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-09-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204582-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-09-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204582-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2015-09-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204582-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2015-09-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204582-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-09-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204582-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-09-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204582-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2015-09-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204582-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2015-09-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204582-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-09-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204582-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-09-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204582-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2015-09-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204582-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2015-09-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204582-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-09-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204582-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-09-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204582-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2015-09-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204582-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2015-09-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204582-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-09-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204582-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-09-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204582-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2015-09-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204582-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2015-09-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204582-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-09-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204582-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-09-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204582-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2015-09-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204582-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2015-09-18	`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	A204582-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204582-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204582-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204582-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204582-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204582-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204582-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204582-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204582-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204582-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204582-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204582-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204582-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204582-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204582-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204582-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204582-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204582-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204582-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204582-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204582-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204582-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204582-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204582-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204582-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204582-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204582-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204582-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204582-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204582-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204582-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204582-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204582-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204582-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204582-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204582-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204582-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204582-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204582-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204582-004	AB	1	`d06236e962d9…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71610-267-53	EA - Each	71610-267	9050c523-e9d7-4158-9497-b553bfc7618a	1	2020-05-08
71610-267-60	EA - Each	71610-267	ae46eb70-a27a-4d1a-946f-83c7f354b7e1	1	2020-05-08
71610-267-80	EA - Each	71610-267	840403df-066e-406a-a9f7-11fbfaee834a	1	2020-05-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71610-267	BUSPIRONE HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1	Legacy NDC	20190515_b2266389-ab0f-484e-8099-4eaa19ac18c3.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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	REMEDYREPACK INC.	fd05160d-24c6-4371-8b2c-c0f78c8b468e	2026-07-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204582 application number: ANDA204582
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	REMEDYREPACK INC.	a9fc7091-b3ce-45fd-8d89-aeebdd81c327	2026-07-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204582 application number: ANDA204582
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Bryant Ranch Prepack	225575f1-9635-4922-8286-d479d6480bf0	2026-05-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204582 application number: ANDA204582
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Bryant Ranch Prepack	eee7fa99-a9a1-4299-8a3d-6c2dd90948c9	2026-05-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204582 application number: ANDA204582
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Cardinal Health 107, LLC	5424f933-93e1-4480-acdf-bd8667ae50e9	2026-04-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204582 application number: ANDA204582
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Northwind Health Company, LLC	1d883a13-4877-c6c7-e063-6294a90a5137	2025-12-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204582 application number: ANDA204582
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	4ff72575-bd60-40ce-b3a8-fd92b79af674	2025-11-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204582 application number: ANDA204582
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Major Pharmaceuticals	8dc1ee33-e5aa-4462-8fb9-9bbdf5463488	2025-07-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204582 application number: ANDA204582

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
207LT9J9OC	BUSPIRONE HYDROCHLORIDE	33386-08-2	BUSPIRONE HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71610-267-80	71610026780	180 TABLET in 1 BOTTLE (71610-267-80)	180 tablet	2019-05-01	0000-00-00	No	No	Current