Buspirone Hydrochloride

Product NDC: 71085-093
11-digit product format: 710850093
Labeler code: 71085
Product ID: 71085-093_54ce3b90-d11a-cd1e-e063-6294a90a2753
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Buspirone Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: IPG Pharmaceuticals, Inc
Application: ANDA208972
Marketing category: ANDA
Marketing start: 2026-05-29
Substance: BUSPIRONE HYDROCHLORIDE
Active strength: 2.5 mg/1
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 7 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A208972-001	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2019-04-16
A208972-002	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2019-04-16
A208972-003	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2019-04-16
A208972-004	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2019-04-16
A208972-005	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2019-04-16
A208972-006	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	2.5MG	TABLET / ORAL		2026-05-13
A208972-007	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	12.5MG	TABLET / ORAL		2026-05-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208972-001	AB
A208972-002	AB
A208972-003	AB
A208972-004	AB
A208972-005	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 · 221 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
2026-09-14 22:38:34	2026-08	A208972-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2019-04-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208972-002	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2019-04-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208972-003	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2019-04-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208972-004	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2019-04-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208972-005	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2019-04-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208972-006	BUSPIRONE HYDROCHLORIDE	2.5MG	TABLET / ORAL		2026-05-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208972-007	BUSPIRONE HYDROCHLORIDE	12.5MG	TABLET / ORAL		2026-05-13	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208972-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2019-04-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208972-002	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2019-04-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208972-003	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2019-04-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208972-004	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2019-04-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208972-005	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2019-04-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208972-006	BUSPIRONE HYDROCHLORIDE	2.5MG	TABLET / ORAL		2026-05-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208972-007	BUSPIRONE HYDROCHLORIDE	12.5MG	TABLET / ORAL		2026-05-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208972-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	BX	2019-04-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208972-002	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	BX	2019-04-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208972-003	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	BX	2019-04-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208972-004	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	BX	2019-04-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208972-005	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	BX	2019-04-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208972-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	BX	2019-04-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208972-002	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	BX	2019-04-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208972-003	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	BX	2019-04-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208972-004	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	BX	2019-04-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208972-005	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	BX	2019-04-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208972-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	BX	2019-04-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208972-002	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	BX	2019-04-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208972-003	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	BX	2019-04-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208972-004	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	BX	2019-04-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208972-005	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	BX	2019-04-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208972-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2019-04-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208972-002	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2019-04-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208972-003	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2019-04-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208972-004	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2019-04-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208972-005	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2019-04-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208972-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2019-04-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208972-002	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2019-04-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208972-003	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2019-04-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208972-004	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2019-04-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208972-005	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2019-04-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208972-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2019-04-16	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 215 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A208972-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208972-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208972-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208972-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208972-005	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208972-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208972-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208972-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208972-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208972-005	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208972-001	BX	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208972-002	BX	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208972-003	BX	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208972-004	BX	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208972-005	BX	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208972-001	BX	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208972-002	BX	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208972-003	BX	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208972-004	BX	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208972-005	BX	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208972-001	BX	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208972-002	BX	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208972-003	BX	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208972-004	BX	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208972-005	BX	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208972-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208972-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208972-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208972-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208972-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208972-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208972-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208972-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208972-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208972-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208972-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208972-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208972-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208972-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208972-005	AB	1	`03ed91905a0d…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Buspirone Hydrochloride
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BUSPIRONE HYDROCHLORIDE	2.5 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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2744290	Internal RxNorm lookup
2744292	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
2c516eec-65d9-4481-8823-ae6b6da84062	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

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	IPG Pharmaceuticals, Inc	2c516eec-65d9-4481-8823-ae6b6da84062	2026-06-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208972 application number: ANDA208972 ndc (product): 71085-093
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	27db85e9-68ef-4d43-a319-4e2ec8dbae05	2020-04-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208972 application number: ANDA208972
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Epic Pharma, LLC	02628a0c-bfdb-4a58-8e48-bcd8ca12d53b	2019-05-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208972 application number: ANDA208972

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	Sample	Exclude flag	Status
71085-093-60	71085009360	60 TABLET in 1 BOTTLE (71085-093-60)	60 tablet	2026-05-29	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Buspirone Hydrochloride Tablets, USP Rx Only (Patient Instruction Sheet Included)	IPG Pharmaceuticals, Inc	2026-06-21	HUMAN PRESCRIPTION DRUG LABEL	3