Buspirone Hydrochloride

Product NDC: 29300-478
11-digit product format: 293000478
Labeler code: 29300
Product ID: 29300-478_ef78a61a-865b-447a-9324-3044e41db506
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Buspirone Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Unichem Pharmaceuticals (USA), Inc.
Application: ANDA210907
Marketing category: ANDA
Marketing start: 2023-10-17
Substance: BUSPIRONE HYDROCHLORIDE
Active strength: 30 mg/1
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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	RLD / RS	Approval date
A210907-001	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2019-11-14
A210907-002	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2019-11-14
A210907-003	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	RS	2019-11-14
A210907-004	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB		2019-11-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210907-001	AB
A210907-002	AB
A210907-003	AB
A210907-004	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 4 · 156 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A210907-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2019-11-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210907-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2019-11-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210907-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	RS	2019-11-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210907-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB		2019-11-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210907-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2019-11-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210907-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2019-11-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210907-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	RS	2019-11-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210907-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB		2019-11-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210907-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2019-11-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210907-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2019-11-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210907-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	RS	2019-11-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210907-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB		2019-11-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210907-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2019-11-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210907-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2019-11-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210907-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB		2019-11-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210907-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB		2019-11-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210907-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2019-11-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210907-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2019-11-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210907-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB		2019-11-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210907-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB		2019-11-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210907-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2019-11-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210907-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2019-11-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210907-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB		2019-11-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210907-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB		2019-11-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210907-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2019-11-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210907-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2019-11-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210907-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB		2019-11-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210907-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB		2019-11-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210907-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2019-11-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210907-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2019-11-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210907-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB		2019-11-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210907-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB		2019-11-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210907-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2019-11-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210907-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2019-11-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210907-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB		2019-11-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210907-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB		2019-11-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210907-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2019-11-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210907-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2019-11-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210907-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB		2019-11-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210907-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB		2019-11-14	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 156 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	A210907-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210907-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210907-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210907-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210907-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210907-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210907-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210907-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210907-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210907-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210907-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210907-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210907-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210907-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210907-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210907-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210907-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210907-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210907-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210907-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210907-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210907-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210907-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210907-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210907-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210907-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210907-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210907-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210907-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210907-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210907-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210907-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210907-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210907-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210907-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210907-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210907-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210907-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210907-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210907-004	AB	1	`d06236e962d9…`

Additional Listing Data#

Finished product: Yes
Brand name base: Buspirone Hydrochloride
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BUSPIRONE HYDROCHLORIDE	30 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 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
866018	Internal RxNorm lookup
866083	Internal RxNorm lookup
866090	Internal RxNorm lookup
866094	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
a6bdf140-075e-445e-a62d-633a4b97f3a8	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
29300-478-01	Buspirone Hydrochloride	100 in 1 BOTTLE, PLASTIC	TABLET	100	7
29300-478-05	Buspirone Hydrochloride	500 in 1 BOTTLE, PLASTIC	TABLET	500	7
29300-478-16	Buspirone Hydrochloride	60 in 1 BOTTLE, PLASTIC	TABLET	60	7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
29300-478-05	EA - Each	29300-478	ecfea214-5e17-40f6-b2af-4d93a29b3b59	1	2024-04-05
29300-478-16	EA - Each	29300-478	415f7c03-3edb-4334-a655-06f4a3905703	1	2024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
29300-478	BUSPIRONE HYDROCHLORIDE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.]	7	Current NDC, 3 package rows	20231223_a6bdf140-075e-445e-a62d-633a4b97f3a8.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 2 · 34 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Unit Dose Solutions, Inc.	544a4570-bd7f-72bb-e063-6394a90ab8d6	2026-06-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210907 application number: ANDA210907
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	REMEDYREPACK INC.	fbff8248-b73c-474e-907e-449f8316c629	2026-06-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210907 application number: ANDA210907
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Asclemed USA, Inc.	97f2d082-0931-4e4f-a5be-7792e399e42b	2026-05-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210907 application number: ANDA210907
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Coupler LLC	510120d3-c922-a071-e063-6294a90af6a7	2026-05-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210907 application number: ANDA210907
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	REMEDYREPACK INC.	5b4da3f8-a5ce-4699-92e1-37fb95e0af2d	2026-04-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210907 application number: ANDA210907
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	REMEDYREPACK INC.	6c6db7a9-a728-406a-81af-edd89e1cc26f	2026-04-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210907 application number: ANDA210907
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	824c80e6-d508-405f-8a4f-2f10df5a9dc8	2026-03-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210907 application number: ANDA210907
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	187c315b-9c2c-485f-aa63-e399e0796e78	2026-03-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210907 application number: ANDA210907
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	068ee1a0-a77a-4803-bad9-18117d7fb358	2026-03-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210907 application number: ANDA210907
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	18ddef0b-1451-4bea-94fb-b6ec27f4744b	2026-01-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210907 application number: ANDA210907
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	REMEDYREPACK INC.	ed2b56fe-e02f-46bc-808a-352f9bbb5b57	2025-09-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210907 application number: ANDA210907
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	A-S Medication Solutions	48b4e52d-d4c4-4d24-a0ac-24316371cef0	2025-09-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210907 application number: ANDA210907
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Proficient Rx LP	801803eb-be17-4064-8813-7ccf52316cde	2025-08-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210907 application number: ANDA210907
Buspirone HCL	BUSPIRONE HCL	Direct_Rx	3246dd4d-f787-2f62-e063-6294a90a9cd2	2025-06-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210907 application number: ANDA210907
Buspirone HCL	BUSPIRONE HCL	Direct_Rx	37780596-3b6f-8d00-e063-6294a90ad4ad	2025-06-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210907 application number: ANDA210907
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	335107c9-5799-c4df-e063-6294a90a5ca0	2025-04-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210907 application number: ANDA210907
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Bryant Ranch Prepack	b6352207-e708-44a7-8a63-93b96613e1e7	2025-03-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210907 application number: ANDA210907
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Advanced Rx of Tennessee, LLC	30c93022-4126-db8c-e063-6394a90a7579	2025-03-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210907 application number: ANDA210907
Buspirone HCL	BUSPIRONE HCL	Direct_Rx	f71e019b-3928-f8eb-e053-6394a90a871e	2025-02-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210907 application number: ANDA210907
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	f98d258d-6479-253a-e053-6394a90acbb3	2025-02-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210907 application number: ANDA210907

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
866090	busPIRone HCl 30 MG Oral Tablet	PSN	48b4e52d-d4c4-4d24-a0ac-24316371cef0	9
866090	buspirone hydrochloride 30 MG Oral Tablet	SCD	48b4e52d-d4c4-4d24-a0ac-24316371cef0	9
866090	buspirone hydrochloride 30 MG (buspirone 27.4 MG) Oral Tablet	SY	48b4e52d-d4c4-4d24-a0ac-24316371cef0	9
866083	busPIRone HCl 10 MG Oral Tablet	PSN	a6bdf140-075e-445e-a62d-633a4b97f3a8	7
866018	busPIRone HCl 15 MG Oral Tablet	PSN	a6bdf140-075e-445e-a62d-633a4b97f3a8	7
866090	busPIRone HCl 30 MG Oral Tablet	PSN	a6bdf140-075e-445e-a62d-633a4b97f3a8	7
866094	busPIRone HCl 5 MG Oral Tablet	PSN	a6bdf140-075e-445e-a62d-633a4b97f3a8	7
866083	buspirone hydrochloride 10 MG Oral Tablet	SCD	a6bdf140-075e-445e-a62d-633a4b97f3a8	7
866018	buspirone hydrochloride 15 MG Oral Tablet	SCD	a6bdf140-075e-445e-a62d-633a4b97f3a8	7
866090	buspirone hydrochloride 30 MG Oral Tablet	SCD	a6bdf140-075e-445e-a62d-633a4b97f3a8	7
866094	buspirone hydrochloride 5 MG Oral Tablet	SCD	a6bdf140-075e-445e-a62d-633a4b97f3a8	7
866083	buspirone HCl 10 MG (buspirone 9.1 MG) Oral Tablet	SY	a6bdf140-075e-445e-a62d-633a4b97f3a8	7
866018	buspirone hydrochloride 15 MG (buspirone 13.7 MG) Oral Tablet	SY	a6bdf140-075e-445e-a62d-633a4b97f3a8	7
866090	buspirone hydrochloride 30 MG (buspirone 27.4 MG) Oral Tablet	SY	a6bdf140-075e-445e-a62d-633a4b97f3a8	7
866094	buspirone hydrochloride 5 MG (buspirone 4.6 MG) Oral Tablet	SY	a6bdf140-075e-445e-a62d-633a4b97f3a8	7
866083	busPIRone HCl 10 MG Oral Tablet	PSN	97f2d082-0931-4e4f-a5be-7792e399e42b	2
866018	busPIRone HCl 15 MG Oral Tablet	PSN	97f2d082-0931-4e4f-a5be-7792e399e42b	2
866090	busPIRone HCl 30 MG Oral Tablet	PSN	97f2d082-0931-4e4f-a5be-7792e399e42b	2
866090	busPIRone HCl 30 MG Oral Tablet	PSN	ed2b56fe-e02f-46bc-808a-352f9bbb5b57	2
866094	busPIRone HCl 5 MG Oral Tablet	PSN	97f2d082-0931-4e4f-a5be-7792e399e42b	2
866083	buspirone hydrochloride 10 MG Oral Tablet	SCD	97f2d082-0931-4e4f-a5be-7792e399e42b	2
866018	buspirone hydrochloride 15 MG Oral Tablet	SCD	97f2d082-0931-4e4f-a5be-7792e399e42b	2
866090	buspirone hydrochloride 30 MG Oral Tablet	SCD	ed2b56fe-e02f-46bc-808a-352f9bbb5b57	2
866090	buspirone hydrochloride 30 MG Oral Tablet	SCD	97f2d082-0931-4e4f-a5be-7792e399e42b	2
866094	buspirone hydrochloride 5 MG Oral Tablet	SCD	97f2d082-0931-4e4f-a5be-7792e399e42b	2
866083	buspirone HCl 10 MG (buspirone 9.1 MG) Oral Tablet	SY	97f2d082-0931-4e4f-a5be-7792e399e42b	2
866018	buspirone hydrochloride 15 MG (buspirone 13.7 MG) Oral Tablet	SY	97f2d082-0931-4e4f-a5be-7792e399e42b	2
866090	buspirone hydrochloride 30 MG (buspirone 27.4 MG) Oral Tablet	SY	97f2d082-0931-4e4f-a5be-7792e399e42b	2
866090	buspirone hydrochloride 30 MG (buspirone 27.4 MG) Oral Tablet	SY	ed2b56fe-e02f-46bc-808a-352f9bbb5b57	2
866094	buspirone hydrochloride 5 MG (buspirone 4.6 MG) Oral Tablet	SY	97f2d082-0931-4e4f-a5be-7792e399e42b	2
866090	busPIRone HCl 30 MG Oral Tablet	PSN	38faa7cb-d858-4481-8649-35d228acbd38	1
866090	busPIRone HCl 30 MG Oral Tablet	PSN	26a5943c-1250-74d0-e063-6394a90ac646	1
866090	busPIRone HCl 30 MG Oral Tablet	PSN	1e1b68d1-40ac-a627-e063-6394a90ac167	1
866090	buspirone hydrochloride 30 MG Oral Tablet	SCD	1e1b68d1-40ac-a627-e063-6394a90ac167	1
866090	buspirone hydrochloride 30 MG Oral Tablet	SCD	38faa7cb-d858-4481-8649-35d228acbd38	1
866090	buspirone hydrochloride 30 MG Oral Tablet	SCD	26a5943c-1250-74d0-e063-6394a90ac646	1
866090	buspirone hydrochloride 30 MG (buspirone 27.4 MG) Oral Tablet	SY	38faa7cb-d858-4481-8649-35d228acbd38	1
866090	buspirone hydrochloride 30 MG (buspirone 27.4 MG) Oral Tablet	SY	26a5943c-1250-74d0-e063-6394a90ac646	1
866090	buspirone hydrochloride 30 MG (buspirone 27.4 MG) Oral Tablet	SY	1e1b68d1-40ac-a627-e063-6394a90ac167	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
29300-478-01	29300047801	100 TABLET in 1 BOTTLE, PLASTIC (29300-478-01)	100 tablet	2023-12-22	No	No	Current
29300-478-05	29300047805	500 TABLET in 1 BOTTLE, PLASTIC (29300-478-05)	500 tablet	2023-12-22	No	No	Current
29300-478-16	29300047816	60 TABLET in 1 BOTTLE, PLASTIC (29300-478-16)	60 tablet	2023-12-22	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Buspirone Hydrochloride Tablets, USP Rx Only	Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	2026-05-04	HUMAN PRESCRIPTION DRUG LABEL	2
Buspirone Hydrochloride Tablets, USP Rx Only	REMEDYREPACK INC.	2025-09-25	HUMAN PRESCRIPTION DRUG LABEL	2
Buspirone Hydrochloride Tablets, USP Rx Only	A-S Medication Solutions	2025-09-09	HUMAN PRESCRIPTION DRUG LABEL	9
Buspirone Hydrochloride Tablets, USP Rx Only	Coupler LLC	2024-11-11	HUMAN PRESCRIPTION DRUG LABEL	1
Buspirone Hydrochloride Tablets, USP Rx Only	Bryant Ranch Prepack	2024-08-20	HUMAN PRESCRIPTION DRUG LABEL	1
Buspirone Hydrochloride Tablets, USP Rx Only	RedPharm Drug	2024-07-25	HUMAN PRESCRIPTION DRUG LABEL	1
Buspirone Hydrochloride Tablets, USP Rx Only	Unichem Pharmaceuticals (USA), Inc.	2023-12-22	HUMAN PRESCRIPTION DRUG LABEL	7