Buspirone Hydrochloride

Product NDC: 42806-833
Requested package NDC: 42806-833-18
11-digit product format: 428060833
Labeler code: 42806
Product ID: 42806-833_160f52d2-2e08-4969-80c3-c653767652f0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Buspirone Hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: EPIC PHARMA, LLC
Application: ANDA218628
Marketing category: ANDA
Marketing start: 2025-03-13
Substance: BUSPIRONE
Active strength: 15 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 43.

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	RLD / RS	Approval date
A218628-001	BUCAPSOL	BUSPIRONE HYDROCHLORIDE	7.5MG	CAPSULE / ORAL		2025-03-13
A218628-002	BUCAPSOL	BUSPIRONE HYDROCHLORIDE	10MG	CAPSULE / ORAL		2025-03-13
A218628-003	BUCAPSOL	BUSPIRONE HYDROCHLORIDE	15MG	CAPSULE / ORAL	RS	2025-03-13
A218628-004	BUCAPSOL	BUSPIRONE HYDROCHLORIDE	5MG	CAPSULE / ORAL		2026-04-29

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A218628-001	BUCAPSOL	7.5MG	CAPSULE / ORAL		2025-03-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A218628-002	BUCAPSOL	10MG	CAPSULE / ORAL		2025-03-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A218628-003	BUCAPSOL	15MG	CAPSULE / ORAL	RS	2025-03-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A218628-004	BUCAPSOL	5MG	CAPSULE / ORAL		2026-04-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A218628-001	BUCAPSOL	7.5MG	CAPSULE / ORAL		2025-03-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218628-002	BUCAPSOL	10MG	CAPSULE / ORAL		2025-03-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218628-003	BUCAPSOL	15MG	CAPSULE / ORAL	RS	2025-03-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218628-004	BUCAPSOL	5MG	CAPSULE / ORAL		2026-04-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A218628-001	BUCAPSOL	7.5MG	CAPSULE / ORAL		2025-03-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218628-002	BUCAPSOL	10MG	CAPSULE / ORAL		2025-03-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218628-003	BUCAPSOL	15MG	CAPSULE / ORAL	RS	2025-03-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218628-001	BUCAPSOL	7.5MG	CAPSULE / ORAL		2025-03-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218628-002	BUCAPSOL	10MG	CAPSULE / ORAL		2025-03-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218628-003	BUCAPSOL	15MG	CAPSULE / ORAL	RS	2025-03-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A218628-001	BUSPIRONE HYDROCHLORIDE	7.5MG	CAPSULE / ORAL		2025-03-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A218628-002	BUSPIRONE HYDROCHLORIDE	10MG	CAPSULE / ORAL		2025-03-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A218628-003	BUSPIRONE HYDROCHLORIDE	15MG	CAPSULE / ORAL		2025-03-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218628-001	BUSPIRONE HYDROCHLORIDE	7.5MG	CAPSULE / ORAL		2025-03-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218628-002	BUSPIRONE HYDROCHLORIDE	10MG	CAPSULE / ORAL		2025-03-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218628-003	BUSPIRONE HYDROCHLORIDE	15MG	CAPSULE / ORAL		2025-03-13	`fd3edfee7708…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218628-001	BUCAPSOL	7.5MG	CAPSULE / ORAL		2025-03-13	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218628-002	BUCAPSOL	10MG	CAPSULE / ORAL		2025-03-13	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218628-003	BUCAPSOL	15MG	CAPSULE / ORAL	RS	2025-03-13	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218628-004	BUCAPSOL	5MG	CAPSULE / ORAL		2026-04-29	`a50c72e98297…`

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: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BUSPIRONE	15 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
TK65WKS8HL	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2708991	Internal RxNorm lookup
2708993	Internal RxNorm lookup
2708994	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
160f52d2-2e08-4969-80c3-c653767652f0	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	Strength	SPL version
42806-833-18	Buspirone Hydrochloride	180 in 1 BOTTLE	CAPSULE	180		1
42806-833-60	Buspirone Hydrochloride	60 in 1 BOTTLE	CAPSULE	60		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42806-833	BUSPIRONE HYDROCHLORIDE CAPSULE [EPIC PHARMA, LLC]	1	Current NDC, 2 package rows	20250323_160f52d2-2e08-4969-80c3-c653767652f0.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Bucapsol	BUSPIRONE HYDROCHLORIDE	PANGEA PHARMACEUTICALS, LLC	f101c5f3-d533-474d-a8bf-90d054933d16	2026-07-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218628 application number: ANDA218628
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	EPIC PHARMA, LLC	160f52d2-2e08-4969-80c3-c653767652f0	2025-03-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218628 application number: ANDA218628 ndc (package): 42806-833-18 ndc (product): 42806-833 ndc11 (package): 42806083318

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
TK65WKS8HL	BUSPIRONE	36505-84-7	BUSPIRONE
207LT9J9OC	BUSPIRONE HYDROCHLORIDE	33386-08-2	Buspirone Hydrochloride

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2708991	busPIRone HCl 10 MG Oral Capsule	PSN	160f52d2-2e08-4969-80c3-c653767652f0	1
2708993	busPIRone HCl 15 MG Oral Capsule	PSN	160f52d2-2e08-4969-80c3-c653767652f0	1
2708994	busPIRone HCl 7.5 MG Oral Capsule	PSN	160f52d2-2e08-4969-80c3-c653767652f0	1
2708991	buspirone hydrochloride 10 MG Oral Capsule	SCD	160f52d2-2e08-4969-80c3-c653767652f0	1
2708993	buspirone hydrochloride 15 MG Oral Capsule	SCD	160f52d2-2e08-4969-80c3-c653767652f0	1
2708994	buspirone hydrochloride 7.5 MG Oral Capsule	SCD	160f52d2-2e08-4969-80c3-c653767652f0	1
2708991	buspirone HCl 10 MG (equivalent to buspirone 9.1 MG) Oral Capsule	SY	160f52d2-2e08-4969-80c3-c653767652f0	1
2708991	buspirone HCl 10 MG Oral Capsule	SY	160f52d2-2e08-4969-80c3-c653767652f0	1
2708993	buspirone HCl 15 MG (equivalent to buspirone 13.7 MG) Oral Capsule	SY	160f52d2-2e08-4969-80c3-c653767652f0	1
2708993	buspirone HCl 15 MG Oral Capsule	SY	160f52d2-2e08-4969-80c3-c653767652f0	1
2708994	buspirone HCl 7.5 MG (equivalent to buspirone 6.8 MG) Oral Capsule	SY	160f52d2-2e08-4969-80c3-c653767652f0	1
2708994	buspirone HCl 7.5 MG Oral Capsule	SY	160f52d2-2e08-4969-80c3-c653767652f0	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
42806-833-18	42806083318	180 CAPSULE in 1 BOTTLE (42806-833-18)	180 capsule	2025-03-13	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Buspirone Hydrochloride Capsules Rx Only	EPIC PHARMA, LLC	2025-03-21	HUMAN PRESCRIPTION DRUG LABEL	1