BusPIRone Hydrochloride

Product NDC: 71610-281
Requested package NDC: 71610-281-80
11-digit product format: 716100281
Labeler code: 71610
Product ID: 71610-281_9f6bd1a3-3372-451d-a274-faf0a72e9235
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: BusPIRone Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: ANDA209696
Marketing category: ANDA
Marketing start: 2018-07-03
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	71610-281	71610-281-80	D	Discontinued by firm		2026-08-07

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A209696-001	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	BX	2018-05-03
A209696-002	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	BX	2018-05-03
A209696-003	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	BX	2018-05-03
A209696-004	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	BX	2018-05-03
A209696-005	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	BX	2018-05-03

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-product	TE code
A209696-001	BX
A209696-002	BX
A209696-003	BX
A209696-004	BX
A209696-005	BX

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 · 205 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	A209696-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	BX	2018-05-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209696-002	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	BX	2018-05-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209696-003	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	BX	2018-05-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209696-004	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	BX	2018-05-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209696-005	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	BX	2018-05-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209696-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	BX	2018-05-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209696-002	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	BX	2018-05-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209696-003	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	BX	2018-05-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209696-004	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	BX	2018-05-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209696-005	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	BX	2018-05-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209696-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	BX	2018-05-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209696-002	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	BX	2018-05-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209696-003	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	BX	2018-05-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209696-004	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	BX	2018-05-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209696-005	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	BX	2018-05-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209696-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2018-05-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209696-002	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2018-05-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209696-003	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2018-05-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209696-004	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2018-05-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209696-005	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2018-05-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209696-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2018-05-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209696-002	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2018-05-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209696-003	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2018-05-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209696-004	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2018-05-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209696-005	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2018-05-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209696-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2018-05-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209696-002	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2018-05-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209696-003	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2018-05-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209696-004	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2018-05-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209696-005	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2018-05-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209696-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2018-05-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209696-002	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2018-05-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209696-003	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2018-05-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209696-004	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2018-05-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209696-005	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2018-05-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209696-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2018-05-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209696-002	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2018-05-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209696-003	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2018-05-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209696-004	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2018-05-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209696-005	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2018-05-03	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 205 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	A209696-001	BX	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209696-002	BX	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209696-003	BX	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209696-004	BX	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209696-005	BX	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209696-001	BX	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209696-002	BX	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209696-003	BX	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209696-004	BX	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209696-005	BX	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209696-001	BX	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209696-002	BX	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209696-003	BX	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209696-004	BX	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209696-005	BX	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209696-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209696-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209696-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209696-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209696-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209696-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209696-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209696-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209696-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209696-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209696-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209696-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209696-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209696-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209696-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209696-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209696-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209696-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209696-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209696-005	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209696-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209696-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209696-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209696-004	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209696-005	AB	1	`5bbf6a4d5a75…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71610-281-53	EA - Each	71610-281	8e4ea6f8-a3fd-46ab-b46e-0dcfbe6696b0	1	2019-07-02
71610-281-60	EA - Each	71610-281	cd8513d1-2c24-4a2b-8499-2a63771501c5	1	2019-07-02
71610-281-80	EA - Each	71610-281	f714bf38-d061-4bb0-8726-a839a9df488e	1	2019-07-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71610-281	BUSPIRONE HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1	Legacy NDC	20190601_0a003a4f-6d72-4d6e-bb55-6e8e697d8f31.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Bryant Ranch Prepack	267d8897-90dd-4f8a-bbd8-8aa4e47c2905	2024-07-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209696 application number: ANDA209696
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	APNAR PHARMA LP	3c115eea-9dbc-4e2c-9d79-42e3388fde5a	2024-06-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209696 application number: ANDA209696
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Nivagen Pharmaceuticals Inc.	b08dd2e7-e808-4b51-b404-5009076b82eb	2021-02-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209696 application number: ANDA209696
BusPIRone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Proficient Rx LP	03efd618-8ca3-43d0-bbeb-55e53b5308e8	2020-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209696 application number: ANDA209696
BusPIRone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	e2c672b3-6130-4dd1-8066-0ce9451cb8c7	2019-06-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209696 application number: ANDA209696

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
71610-281-80	71610028180	180 TABLET in 1 BOTTLE (71610-281-80)	180 tablet	2019-05-23	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Buspirone Hydrochloride Tablets USP (Patient Instruction Sheet Included) Rx Only	Aphena Pharma Solutions - Tennessee, LLC	2019-05-29	HUMAN PRESCRIPTION DRUG LABEL	1