Buspirone Hydrochloride

Product NDC: 51655-796
11-digit product format: 516550796
Labeler code: 51655
Product ID: 51655-796_4ba8aa52-6d36-c075-e063-6294a90a25a0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Buspirone Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Northwind Health Company, LLC
Application: ANDA202330
Marketing category: ANDA
Marketing start: 2022-02-18
Substance: BUSPIRONE HYDROCHLORIDE
Active strength: 10 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 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
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 · 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	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…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202330-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-08-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202330-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-08-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202330-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2014-08-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202330-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2014-08-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202330-005	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2017-02-17	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 210 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	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…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202330-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202330-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202330-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202330-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202330-005	AB	1	`2680178bc6a6…`

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	10 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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
866083	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
d9de7cf1-c38d-8b3c-e053-2995a90aa26b	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
51655-796-26	2026-01-29	C162847	48780-1	49896155-afc4-586f-e063-e6dba90add90	Buspirone Hydrochloride Tablets, USP (Patient Instruction Sheet Included)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
51655-796-26	Buspirone Hydrochloride	90 in 1 BOTTLE, PLASTIC	TABLET	90		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51655-796	BUSPIRONE HYDROCHLORIDE TABLET [NORTHWIND PHARMACEUTICALS]	2	Current NDC, Legacy NDC, 1 package rows	20231219_d9de7cf1-c38d-8b3c-e053-2995a90aa26b.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	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	Golden State Medical Supply, Inc.	bcce49d3-c8eb-9f9b-e053-2995a90a67d9	2026-02-18	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 ndc (product): 51655-796
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	d9de7cf1-c38d-8b3c-e053-2995a90aa26b	4
866083	buspirone hydrochloride 10 MG Oral Tablet	SCD	d9de7cf1-c38d-8b3c-e053-2995a90aa26b	4
866083	buspirone HCl 10 MG (buspirone 9.1 MG) Oral Tablet	SY	d9de7cf1-c38d-8b3c-e053-2995a90aa26b	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
51655-796-26	51655079626	90 TABLET in 1 BOTTLE, PLASTIC (51655-796-26)	90 tablet	2022-02-18	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)	Northwind Health Company, LLC	2026-01-01	HUMAN PRESCRIPTION DRUG LABEL	4