Buspirone Hydrochloride

Product NDC: 71610-302
Requested package NDC: 71610-302-80
11-digit product format: 716100302
Labeler code: 71610
Product ID: 71610-302_5b93f505-a135-4d98-accc-67123d748256
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Buspirone Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: ANDA202330
Marketing category: ANDA
Marketing start: 2014-08-25
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	71610-302	71610-302-80	I	Inactivated by FDA		2026-10-05

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 · 16 matching rows.

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

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	E	Excluded after deficient or non-compliant submission was not corrected	`fb8cb913e6d1…`	`eb8c232b6be0…`

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

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
A202330-001	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-08-25
A202330-002	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-08-25
A202330-003	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2014-08-25
A202330-004	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2014-08-25
A202330-005	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2017-02-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202330-001	AB
A202330-002	AB
A202330-003	AB
A202330-004	AB
A202330-005	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 · 215 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	A202330-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-08-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202330-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-08-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202330-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2014-08-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202330-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2014-08-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202330-005	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2017-02-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202330-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-08-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202330-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-08-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202330-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2014-08-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202330-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2014-08-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202330-005	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2017-02-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202330-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-08-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202330-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-08-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202330-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2014-08-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202330-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2014-08-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202330-005	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2017-02-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202330-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-08-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202330-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-08-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202330-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2014-08-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202330-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2014-08-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202330-005	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2017-02-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202330-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-08-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202330-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-08-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202330-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2014-08-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202330-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2014-08-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202330-005	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2017-02-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202330-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-08-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202330-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-08-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202330-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2014-08-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202330-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2014-08-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202330-005	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2017-02-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202330-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-08-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202330-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-08-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202330-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2014-08-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202330-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2014-08-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202330-005	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2017-02-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202330-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-08-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202330-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-08-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202330-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2014-08-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202330-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2014-08-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202330-005	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2017-02-17	`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	A202330-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202330-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202330-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202330-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202330-005	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202330-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202330-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202330-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202330-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202330-005	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202330-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202330-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202330-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202330-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202330-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202330-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202330-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202330-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202330-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202330-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202330-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202330-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202330-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202330-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202330-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202330-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202330-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202330-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202330-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202330-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202330-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202330-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202330-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202330-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202330-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202330-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202330-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202330-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202330-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202330-005	AB	1	`03ed91905a0d…`

Reported adverse events (FAERS/openFDA)#

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

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
71610-302-53	2023-01-30	C162847	48780-1	f386c649-c332-0266-e053-dadaa90a7c1a	Buspirone Hydrochloride Tablets, USP
71610-302-60	2023-01-30	C162847	48780-1	f386c649-c332-0266-e053-dadaa90a7c1a	Buspirone Hydrochloride Tablets, USP
71610-302-80	2023-01-30	C162847	48780-1	f386c649-c332-0266-e053-dadaa90a7c1a	Buspirone Hydrochloride Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
71610-302-53	Buspirone Hydrochloride	60 in 1 BOTTLE	TABLET	60	1
71610-302-60	Buspirone Hydrochloride	90 in 1 BOTTLE	TABLET	90	1
71610-302-80	Buspirone Hydrochloride	180 in 1 BOTTLE	TABLET	180	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71610-302-53	EA - Each	71610-302	34fb0b43-b0dd-490f-b5d2-2c37a26e00d9	1	2019-08-06
71610-302-60	EA - Each	71610-302	bfa53a2e-ba23-46ad-a186-49499e319cb6	1	2019-08-06
71610-302-80	EA - Each	71610-302	70750be9-e3cd-40b1-ba35-cff7394ab611	1	2019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71610-302	BUSPIRONE HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1	Legacy NDC, 3 package rows	20190713_5975ba77-cf91-4696-98df-72b3ee33e3ba.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 · 19 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Golden State Medical Supply, Inc.	bcce49d3-c8eb-9f9b-e053-2995a90a67d9	2026-07-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202330 application number: ANDA202330
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Strides Pharma Inc.	cb0091ad-97f6-431b-b2b9-e03171eed274	2026-07-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202330 application number: ANDA202330
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	REMEDYREPACK INC.	b42cc365-6259-4d2e-9648-d37718b65e1e	2026-06-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202330 application number: ANDA202330
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	50b18368-d37c-374b-e063-6394a90a8114	2026-04-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202330 application number: ANDA202330
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	093b701d-4a43-4871-b726-c5820fa3ab95	2026-04-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202330 application number: ANDA202330
BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	DIRECT RX	bae98d45-e192-56e3-e053-2a95a90aadc3	2026-03-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202330 application number: ANDA202330
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	A-S Medication Solutions	ecdfd79e-7450-40ec-9561-cdda3a043990	2026-01-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202330 application number: ANDA202330
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	A-S Medication Solutions	4d1ae09a-3ead-4604-8d13-590f41f63b96	2026-01-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202330 application number: ANDA202330
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Northwind Health Company, LLC	d9de7cf1-c38d-8b3c-e053-2995a90aa26b	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202330 application number: ANDA202330
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Strides Pharma Science Limited	cff9f09a-1ea2-4968-b57b-e62bebaae238	2025-09-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202330 application number: ANDA202330
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	1790d63d-ecb1-da9d-e063-6294a90a50ba	2025-08-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202330 application number: ANDA202330
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Bryant Ranch Prepack	63e2d4e2-f1ab-480d-b0bb-79b6cdb57a5d	2025-05-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202330 application number: ANDA202330
Buspirone HCL	BUSPIRONE HCL	Direct_Rx	f83219c9-8081-fe55-e053-6394a90aa924	2025-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202330 application number: ANDA202330
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	NCS HealthCare of KY, LLC dba Vangard Labs	da6f4a74-a71e-4ccc-af2c-8de29e909c3b	2024-08-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202330 application number: ANDA202330
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Proficient Rx LP	24a95296-5fbe-49df-b1fe-4760d3a5ffe1	2022-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202330 application number: ANDA202330
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	0d46cf24-07e1-4bb7-8b5b-5ce12a030afd	2022-03-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202330 application number: ANDA202330
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	62e4345a-2c51-4f93-89f0-282895ced785	2021-11-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202330 application number: ANDA202330
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	fbab1056-b63e-473e-9259-ba099d884d2b	2021-10-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202330 application number: ANDA202330
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	fa8171d4-f73c-4a91-973d-cb46c5507081	2021-09-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202330 application number: ANDA202330

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	5975ba77-cf91-4696-98df-72b3ee33e3ba	1
866083	buspirone hydrochloride 10 MG Oral Tablet	SCD	5975ba77-cf91-4696-98df-72b3ee33e3ba	1
866083	buspirone HCl 10 MG (buspirone 9.1 MG) Oral Tablet	SY	5975ba77-cf91-4696-98df-72b3ee33e3ba	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71610-302-80	71610030280	180 TABLET in 1 BOTTLE (71610-302-80)	180 tablet	2019-07-10	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Buspirone Hydrochloride Tablets, USP	Aphena Pharma Solutions - Tennessee, LLC	2019-07-11	HUMAN PRESCRIPTION DRUG LABEL	1