Buspirone Hydrochloride

Product NDC: 71335-1605
11-digit product format: 713351605
Labeler code: 71335
Product ID: 71335-1605_c45202e2-c467-43ea-b93b-e54672271cc2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Buspirone Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA204582
Marketing category: ANDA
Marketing start: 2012-06-29
Substance: BUSPIRONE HYDROCHLORIDE
Active strength: 15 mg/1
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	71335-1605-2	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	71335-1605-6	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	71335-1605-5	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	71335-1605-4	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	71335-1605-1	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	71335-1605-3	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	71335-1605-7	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	71335-1605-2	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	71335-1605-6	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	71335-1605-5	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	71335-1605-4	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	71335-1605-1	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	71335-1605-3	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	71335-1605-7	`1332a3947898…`	`d4bfe170f9cd…`

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	Approval date
A204582-001	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-09-18
A204582-002	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-09-18
A204582-003	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2015-09-18
A204582-004	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2015-09-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204582-001	AB
A204582-002	AB
A204582-003	AB
A204582-004	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 5 · 164 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
2026-02-19 14:30 UTC	2026-02	A204582-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-09-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204582-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-09-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204582-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2015-09-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204582-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2015-09-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204582-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-09-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204582-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-09-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204582-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2015-09-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204582-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2015-09-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204582-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-09-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204582-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-09-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204582-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2015-09-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204582-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2015-09-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204582-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-09-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204582-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-09-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204582-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2015-09-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204582-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2015-09-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204582-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-09-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204582-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-09-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204582-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2015-09-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204582-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2015-09-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204582-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-09-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204582-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-09-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204582-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2015-09-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204582-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2015-09-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204582-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-09-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204582-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-09-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204582-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2015-09-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204582-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2015-09-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204582-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-09-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204582-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-09-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204582-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2015-09-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204582-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2015-09-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204582-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-09-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204582-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-09-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204582-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2015-09-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204582-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2015-09-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204582-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-09-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204582-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-09-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204582-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2015-09-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204582-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2015-09-18	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 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	A204582-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204582-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204582-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204582-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204582-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204582-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204582-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204582-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204582-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204582-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204582-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204582-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204582-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204582-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204582-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204582-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204582-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204582-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204582-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204582-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204582-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204582-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204582-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204582-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204582-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204582-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204582-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204582-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204582-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204582-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204582-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204582-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204582-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204582-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204582-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204582-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204582-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204582-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204582-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204582-004	AB	1	`d06236e962d9…`

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	15 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
866018	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
225575f1-9635-4922-8286-d479d6480bf0	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, Related label table
NDC	Effective	Related label
71335-1605-1	2024-05-21	Buspirone Hydrochloride Tablets, USP Rx only
71335-1605-2	2024-05-21	Buspirone Hydrochloride Tablets, USP Rx only
71335-1605-3	2024-05-21	Buspirone Hydrochloride Tablets, USP Rx only
71335-1605-4	2024-05-21	Buspirone Hydrochloride Tablets, USP Rx only
71335-1605-5	2024-05-21	Buspirone Hydrochloride Tablets, USP Rx only
71335-1605-6	2024-05-21	Buspirone Hydrochloride Tablets, USP Rx only
71335-1605-7	2024-05-21	Buspirone Hydrochloride Tablets, USP Rx only
71335-1605-1	2024-01-30	Buspirone Hydrochloride Tablets, USP Rx only
71335-1605-2	2024-01-30	Buspirone Hydrochloride Tablets, USP Rx only
71335-1605-3	2024-01-30	Buspirone Hydrochloride Tablets, USP Rx only
71335-1605-4	2024-01-30	Buspirone Hydrochloride Tablets, USP Rx only
71335-1605-5	2024-01-30	Buspirone Hydrochloride Tablets, USP Rx only
71335-1605-6	2024-01-30	Buspirone Hydrochloride Tablets, USP Rx only
71335-1605-7	2024-01-30	Buspirone Hydrochloride Tablets, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
71335-1605-1	Buspirone Hydrochloride	30 in 1 BOTTLE	TABLET	30	7
71335-1605-2	Buspirone Hydrochloride	100 in 1 BOTTLE	TABLET	100	7
71335-1605-3	Buspirone Hydrochloride	60 in 1 BOTTLE	TABLET	60	7
71335-1605-4	Buspirone Hydrochloride	90 in 1 BOTTLE	TABLET	90	7
71335-1605-5	Buspirone Hydrochloride	120 in 1 BOTTLE	TABLET	120	7
71335-1605-6	Buspirone Hydrochloride	28 in 1 BOTTLE	TABLET	28	7
71335-1605-7	Buspirone Hydrochloride	180 in 1 BOTTLE	TABLET	180	7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71335-1605-3	EA - Each	71335-1605	a4b00f31-d523-4adb-b8f8-8669da5411fe	1	2020-07-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71335-1605	BUSPIRONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]	6	Current NDC, Legacy NDC, 7 package rows	20240522_225575f1-9635-4922-8286-d479d6480bf0.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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	REMEDYREPACK INC.	fd05160d-24c6-4371-8b2c-c0f78c8b468e	2026-07-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204582 application number: ANDA204582
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	REMEDYREPACK INC.	a9fc7091-b3ce-45fd-8d89-aeebdd81c327	2026-07-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204582 application number: ANDA204582
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Bryant Ranch Prepack	225575f1-9635-4922-8286-d479d6480bf0	2026-05-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204582 application number: ANDA204582 ndc (product): 71335-1605
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Bryant Ranch Prepack	eee7fa99-a9a1-4299-8a3d-6c2dd90948c9	2026-05-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204582 application number: ANDA204582
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Cardinal Health 107, LLC	5424f933-93e1-4480-acdf-bd8667ae50e9	2026-04-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204582 application number: ANDA204582
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Northwind Health Company, LLC	1d883a13-4877-c6c7-e063-6294a90a5137	2025-12-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204582 application number: ANDA204582
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	4ff72575-bd60-40ce-b3a8-fd92b79af674	2025-11-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204582 application number: ANDA204582
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Major Pharmaceuticals	8dc1ee33-e5aa-4462-8fb9-9bbdf5463488	2025-07-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204582 application number: ANDA204582

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
866018	busPIRone HCl 15 MG Oral Tablet	PSN	225575f1-9635-4922-8286-d479d6480bf0	7
866018	buspirone hydrochloride 15 MG Oral Tablet	SCD	225575f1-9635-4922-8286-d479d6480bf0	7
866018	buspirone hydrochloride 15 MG (buspirone 13.7 MG) Oral Tablet	SY	225575f1-9635-4922-8286-d479d6480bf0	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71335-1605-1	71335160501	30 TABLET in 1 BOTTLE (71335-1605-1)	30 tablet	2024-05-20	0000-00-00	No	No	Current
71335-1605-2	71335160502	100 TABLET in 1 BOTTLE (71335-1605-2)	100 tablet	2024-05-20	0000-00-00	No	No	Current
71335-1605-3	71335160503	60 TABLET in 1 BOTTLE (71335-1605-3)	60 tablet	2020-05-29	0000-00-00	No	No	Current
71335-1605-4	71335160504	90 TABLET in 1 BOTTLE (71335-1605-4)	90 tablet	2020-05-27	0000-00-00	No	No	Current
71335-1605-5	71335160505	120 TABLET in 1 BOTTLE (71335-1605-5)	120 tablet	2024-05-20	0000-00-00	No	No	Current
71335-1605-6	71335160506	28 TABLET in 1 BOTTLE (71335-1605-6)	28 tablet	2024-05-20	0000-00-00	No	No	Current
71335-1605-7	71335160507	180 TABLET in 1 BOTTLE (71335-1605-7)	180 tablet	2024-05-20	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Buspirone Hydrochloride Tablets, USP Rx only	Bryant Ranch Prepack	2026-05-13	HUMAN PRESCRIPTION DRUG LABEL	7