Buspirone Hydrochloride

Product NDC: 70518-4443
11-digit product format: 705184443
Labeler code: 70518
Product ID: 70518-4443_5b352984-3a88-7ee7-e063-6294a90a48fe
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: buspirone hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA075388
Marketing category: ANDA
Marketing start: 2025-08-14
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 44.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A075388-001	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2002-05-09
A075388-002	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2002-05-09
A075388-003	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2002-05-09

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A075388-001	AB
A075388-002	AB
A075388-003	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 · 132 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
2026-10-15 13:18:30	2026-09	A075388-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2002-05-09	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A075388-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2002-05-09	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A075388-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2002-05-09	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A075388-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2002-05-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075388-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2002-05-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075388-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2002-05-09	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075388-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2002-05-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075388-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2002-05-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075388-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2002-05-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075388-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2002-05-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075388-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2002-05-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075388-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2002-05-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075388-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2002-05-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075388-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2002-05-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075388-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2002-05-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075388-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2002-05-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075388-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2002-05-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075388-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2002-05-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075388-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2002-05-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075388-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2002-05-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075388-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2002-05-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075388-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2002-05-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075388-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2002-05-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075388-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2002-05-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075388-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2002-05-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075388-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2002-05-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075388-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2002-05-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075388-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2002-05-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075388-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2002-05-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075388-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2002-05-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075388-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2002-05-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075388-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2002-05-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075388-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2002-05-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075388-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2002-05-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075388-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2002-05-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075388-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2002-05-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075388-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2002-05-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075388-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2002-05-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075388-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2002-05-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075388-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2002-05-09	`79d66fd596c7…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 120 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A075388-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A075388-002	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A075388-003	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A075388-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075388-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075388-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075388-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075388-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075388-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075388-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075388-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075388-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075388-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075388-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075388-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075388-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075388-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075388-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075388-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075388-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075388-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075388-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075388-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075388-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075388-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075388-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075388-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075388-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075388-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075388-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075388-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075388-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075388-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075388-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075388-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075388-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075388-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075388-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075388-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075388-001	AB	1	`79d66fd596c7…`

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	10 mg/1

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	Strength	SPL version
70518-4443-0	Buspirone Hydrochloride	30 in 1 BLISTER PACK	TABLET	30		1

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 2 of 2 · 25 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	5d93a30e-3544-44e7-ab6a-dc9dc79d7c71	2025-09-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075388 application number: ANDA075388
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Oxford Pharmaceuticals, LLC	97fcebc1-6615-4b9d-b0f3-6434850f407c	2025-08-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075388 application number: ANDA075388
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Bryant Ranch Prepack	ad651fd5-fd91-4517-8de7-6fafd15ac7eb	2024-11-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075388 application number: ANDA075388
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Bryant Ranch Prepack	2a8b3b75-5d93-4a9e-a583-49ccddd65650	2024-04-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075388 application number: ANDA075388
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Bryant Ranch Prepack	a738c103-134a-401f-b14c-49a599130b8d	2024-04-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075388 application number: ANDA075388

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	ef8fc378-7fee-4d20-81ec-31211e34dc6e	1
866083	buspirone hydrochloride 10 MG Oral Tablet	SCD	ef8fc378-7fee-4d20-81ec-31211e34dc6e	1
866083	buspirone HCl 10 MG (buspirone 9.1 MG) Oral Tablet	SY	ef8fc378-7fee-4d20-81ec-31211e34dc6e	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
70518-4443-0	70518444300	30 TABLET in 1 BLISTER PACK (70518-4443-0)	30 tablet	2025-08-14	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Buspirone Hydrochloride - REMEDYREPACK INC.	REMEDYREPACK INC.	2026-09-11	HUMAN PRESCRIPTION DRUG LABEL	2