Buspirone Hydrochloride

Product NDC: 70518-2830
11-digit product format: 705182830
Labeler code: 70518
Product ID: 70518-2830_d76e5c2f-a85e-51dc-e053-2a95a90a5242
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Buspirone Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA208972
Marketing category: ANDA
Marketing start: 2020-08-10
Marketing end: 0000-00-00
Substance: BUSPIRONE HYDROCHLORIDE
Active strength: 8 mg/1
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	70518-2830		D	Discontinued by firm	2026-08-03
excluded package	package	70518-2830	70518-2830-0	D	Discontinued by firm	2026-08-03
excluded package	package	70518-2830	70518-2830-1	D	Discontinued by firm	2026-08-03

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 7 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A208972-001	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2019-04-16
A208972-002	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2019-04-16
A208972-003	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2019-04-16
A208972-004	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2019-04-16
A208972-005	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2019-04-16
A208972-006	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	2.5MG	TABLET / ORAL		2026-05-13
A208972-007	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	12.5MG	TABLET / ORAL		2026-05-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208972-001	AB
A208972-002	AB
A208972-003	AB
A208972-004	AB
A208972-005	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 · 162 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
2024-10-29 15:01 UTC	2024-10	A208972-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2019-04-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208972-002	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2019-04-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208972-003	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2019-04-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208972-004	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2019-04-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208972-005	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2019-04-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208972-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2019-04-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208972-002	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2019-04-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208972-003	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2019-04-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208972-004	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2019-04-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208972-005	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2019-04-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208972-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2019-04-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208972-002	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2019-04-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208972-003	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2019-04-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208972-004	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2019-04-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208972-005	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2019-04-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208972-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2019-04-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208972-002	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2019-04-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208972-003	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2019-04-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208972-004	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2019-04-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208972-005	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2019-04-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208972-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2019-04-16	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A208972-002	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2019-04-16	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A208972-003	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2019-04-16	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A208972-004	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2019-04-16	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A208972-005	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2019-04-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208972-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2019-04-16	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208972-002	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2019-04-16	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208972-003	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2019-04-16	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208972-004	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2019-04-16	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208972-005	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2019-04-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208972-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2019-04-16	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A208972-002	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2019-04-16	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A208972-003	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2019-04-16	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A208972-004	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2019-04-16	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A208972-005	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2019-04-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208972-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2019-04-16	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A208972-002	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2019-04-16	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A208972-003	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2019-04-16	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A208972-004	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2019-04-16	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A208972-005	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2019-04-16	`4b0b4de00fa7…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 160 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-10-29 15:01 UTC	2024-10	A208972-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208972-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208972-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208972-004	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208972-005	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208972-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208972-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208972-003	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208972-004	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208972-005	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208972-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208972-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208972-003	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208972-004	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208972-005	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208972-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208972-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208972-003	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208972-004	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208972-005	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208972-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A208972-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A208972-003	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A208972-004	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A208972-005	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208972-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208972-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208972-003	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208972-004	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208972-005	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208972-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A208972-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A208972-003	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A208972-004	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A208972-005	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208972-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A208972-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A208972-003	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A208972-004	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A208972-005	AB	1	`4b0b4de00fa7…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	IPG Pharmaceuticals, Inc	2c516eec-65d9-4481-8823-ae6b6da84062	2026-06-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208972 application number: ANDA208972
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	27db85e9-68ef-4d43-a319-4e2ec8dbae05	2020-04-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208972 application number: ANDA208972
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Epic Pharma, LLC	02628a0c-bfdb-4a58-8e48-bcd8ca12d53b	2019-05-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208972 application number: ANDA208972

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
70518-2830-0	2022-02-07	C162847	48780-1	d6a99b39-4565-a426-e053-dadaa90af4c2	Buspirone Hydrochloride Tablets, USP Rx Only (Patient Instruction Sheet Included)
70518-2830-0	2022-01-28	C162847	48780-1	d6a99b39-4565-a426-e053-dadaa90af4c2	Buspirone Hydrochloride Tablets, USP Rx Only (Patient Instruction Sheet Included)

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
207LT9J9OC	BUSPIRONE HYDROCHLORIDE	33386-08-2	BUSPIRONE HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70518-2830-0	70518283000	30 TABLET in 1 BLISTER PACK (70518-2830-0)	30 tablet	2020-08-10	0000-00-00	No	No	Current
70518-2830-1	70518283001	30 TABLET in 1 BLISTER PACK (70518-2830-1)	30 tablet	2021-01-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Buspirone Hydrochloride Tablets, USP Rx Only (Patient Instruction Sheet Included)	REMEDYREPACK INC.	2022-02-07	HUMAN PRESCRIPTION DRUG LABEL	2