Buspirone hydrochloride

Product NDC: 67296-1520
11-digit product format: 672961520
Labeler code: 67296
Product ID: 67296-1520_d61b948d-1f22-7c00-e053-2a95a90a8802
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Buspirone hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: RedPharm Drug, Inc.
Application: ANDA078888
Marketing category: ANDA
Marketing start: 2014-05-03
Marketing end: 0000-00-00
Substance: BUSPIRONE HYDROCHLORIDE
Active strength: 5 mg/1
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	67296-1520		I	Inactivated by FDA		2026-08-17
excluded package	package	67296-1520	67296-1520-6	I	Inactivated by FDA		2026-08-17

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 · 32 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67296-1520-6	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67296-1520-6	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67296-1520-6	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67296-1520-6	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67296-1520-6	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	67296-1520-6	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	67296-1520-6	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	67296-1520-6	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	67296-1520-6	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	67296-1520-6	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	67296-1520-6	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	67296-1520-6	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	67296-1520-6	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	67296-1520-6	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	67296-1520-6	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	67296-1520-6	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

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
A078888-001	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-02-07
A078888-002	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-02-07
A078888-003	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2014-02-07
A078888-004	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2014-02-07
A078888-005	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2023-03-21

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-product	TE code
A078888-001	AB
A078888-002	AB
A078888-003	AB
A078888-004	AB
A078888-005	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 5 · 192 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	A078888-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-02-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078888-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-02-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078888-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2014-02-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078888-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2014-02-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078888-005	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2023-03-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078888-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-02-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078888-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-02-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078888-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2014-02-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078888-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2014-02-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078888-005	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2023-03-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078888-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-02-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078888-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-02-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078888-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2014-02-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078888-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2014-02-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078888-005	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2023-03-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078888-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-02-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078888-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-02-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078888-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2014-02-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078888-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2014-02-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078888-005	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2023-03-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078888-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-02-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078888-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-02-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078888-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2014-02-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078888-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2014-02-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078888-005	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2023-03-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078888-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-02-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078888-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-02-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078888-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2014-02-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078888-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2014-02-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078888-005	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2023-03-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078888-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-02-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078888-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-02-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078888-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2014-02-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078888-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2014-02-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078888-005	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2023-03-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078888-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-02-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078888-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-02-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078888-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2014-02-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078888-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2014-02-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078888-005	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2023-03-21	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 192 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	A078888-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078888-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078888-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078888-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078888-005	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078888-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078888-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078888-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078888-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078888-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078888-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078888-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078888-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078888-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078888-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078888-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078888-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078888-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078888-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078888-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078888-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078888-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078888-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078888-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078888-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078888-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078888-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078888-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078888-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078888-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078888-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078888-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078888-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078888-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078888-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078888-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078888-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078888-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078888-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078888-005	AB	1	`2680178bc6a6…`

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
67296-1520-6	2024-01-30	C162847	48780-1	1030e365-2bff-111a-e063-dadaa90a10e2	5179a29b-e8bf-6677-e054-00144ff88e88

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67296-1520-6	Buspirone hydrochloride	60 in 1 BOTTLE	TABLET	60		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67296-1520	BUSPIRONE HYDROCHLORIDE TABLET [REDPHARM DRUG, INC.]	3	Legacy NDC, 1 package rows	20220122_5179a29b-e8bf-6677-e054-00144ff88e88.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 · 16 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Buspirone hydrochloride	BUSPIRONE HYDROCHLORIDE	Major Pharmaceuticals	a9bb9216-3dac-4e8a-9df9-f72c2eaef160	2026-06-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078888 application number: ANDA078888
Buspirone hydrochloride	BUSPIRONE HYDROCHLORIDE	Unit Dose Solutions, Inc.	544b8918-7175-655f-e063-6394a90a453a	2026-06-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078888 application number: ANDA078888
Buspirone hydrochloride	BUSPIRONE HYDROCHLORIDE	Coupler LLC	53e7576a-e2f4-042b-e063-6294a90ae035	2026-06-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078888 application number: ANDA078888
Buspirone hydrochloride	BUSPIRONE HYDROCHLORIDE	REMEDYREPACK INC.	fa3f9c0e-261d-4ceb-8cc7-e5e013563479	2026-06-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078888 application number: ANDA078888
Buspirone hydrochloride	BUSPIRONE HYDROCHLORIDE	Cardinal Health 107, LLC	1315494d-7a51-4395-bc7c-afb4bc5482c9	2026-04-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078888 application number: ANDA078888
Buspirone hydrochloride	BUSPIRONE HYDROCHLORIDE	AvPAK	b230197c-3d50-7874-e053-2a95a90af50f	2026-03-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078888 application number: ANDA078888
buspirone hydrochloride	BUSPIRONE HYDROCHLORIDE	Zydus Lifesciences Limited	1109dd63-6492-49b1-a383-3ab3a80cd6c7	2025-12-24		Exact identifier application applno (ANDA): 078888 application number: ANDA078888
Buspirone hydrochloride	BUSPIRONE HYDROCHLORIDE	Bryant Ranch Prepack	8c811d3a-8b2d-44f5-bc8f-8eb563f18c3f	2025-11-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078888 application number: ANDA078888
Buspirone hydrochloride	BUSPIRONE HYDROCHLORIDE	Bryant Ranch Prepack	08efb26e-488c-49d4-8432-98db855962e9	2025-03-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078888 application number: ANDA078888
Buspirone hydrochloride	BUSPIRONE HYDROCHLORIDE	Bryant Ranch Prepack	897dac69-a59b-423c-be16-6301c7e504d9	2025-03-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078888 application number: ANDA078888
Buspirone hydrochloride	BUSPIRONE HYDROCHLORIDE	Zydus Pharmaceuticals USA Inc.	14fd7c1c-778e-46d4-9024-89b319f15f39	2025-02-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078888 application number: ANDA078888
Buspirone hydrochloride	BUSPIRONE HYDROCHLORIDE	REMEDYREPACK INC.	7ac98a7f-0ded-427f-899a-c3f6d1997403	2025-01-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078888 application number: ANDA078888
Buspirone hydrochloride	BUSPIRONE HYDROCHLORIDE	American Health Packaging	e80d83a6-7c2a-478e-bdf1-c481824fc301	2024-06-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078888 application number: ANDA078888
Buspirone hydrochloride	BUSPIRONE HYDROCHLORIDE	Bryant Ranch Prepack	b07c0a91-892c-47f5-819e-a128e0ef1ed7	2023-12-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078888 application number: ANDA078888
Buspirone hydrochloride	BUSPIRONE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	7f6986a8-59dc-4dc3-bac0-b38cfc689f8f	2019-04-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078888 application number: ANDA078888
Buspirone hydrochloride	BUSPIRONE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	310c6bea-838b-43e4-87e0-a0050829c242	2018-12-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078888 application number: ANDA078888

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
866094	busPIRone HCl 5 MG Oral Tablet	PSN	5179a29b-e8bf-6677-e054-00144ff88e88	3
866094	buspirone hydrochloride 5 MG Oral Tablet	SCD	5179a29b-e8bf-6677-e054-00144ff88e88	3
866094	buspirone hydrochloride 5 MG (buspirone 4.6 MG) Oral Tablet	SY	5179a29b-e8bf-6677-e054-00144ff88e88	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
67296-1520-6	67296152006	60 TABLET in 1 BOTTLE (67296-1520-6)	60 tablet	2014-05-03	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Buspirone hydrochloride - RedPharm Drug, Inc.	RedPharm Drug, Inc.	2022-01-21	HUMAN PRESCRIPTION DRUG LABEL	3