Buspirone Hydrochloride

Product NDC: 70518-2987
11-digit product format: 705182987
Labeler code: 70518
Product ID: 70518-2987_4af2d002-47c4-b68f-e063-6294a90af7c1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: buspirone hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA075388
Marketing category: ANDA
Marketing start: 2021-01-12
Substance: BUSPIRONE HYDROCHLORIDE
Active strength: 15 mg/1
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	70518-2987	70518-2987-1	D	Discontinued by firm		2026-07-31

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

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A075388-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2002-05-09	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A075388-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2002-05-09	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A075388-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2002-05-09	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A075388-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A075388-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A075388-003	AB	1	`a50c72e98297…`

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 2 · 26 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	REMEDYREPACK INC.	8e0219e9-d305-4473-8229-aee0ee84caf6	2026-03-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075388 application number: ANDA075388
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	476f4f55-c6c1-4f39-950e-59236f499577	2026-03-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075388 application number: ANDA075388
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	A-S Medication Solutions	84621631-4c13-4147-ae3c-4ed30d4ebb37	2026-03-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075388 application number: ANDA075388
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	REMEDYREPACK INC.	3155e607-bc7f-4e90-9edf-8e862dd5737d	2026-02-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075388 application number: ANDA075388 ndc (product): 70518-2987
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Proficient Rx LP	1521109d-8386-472f-9483-f1fe9f7ed152	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075388 application number: ANDA075388
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	A-S Medication Solutions	338f3317-96c0-4b8a-8299-8ce2a10911ae	2025-12-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075388 application number: ANDA075388
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	A-S Medication Solutions	e4d44e49-eb8f-454e-a737-22caf30bda78	2025-12-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075388 application number: ANDA075388
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Bryant Ranch Prepack	49659ee7-ca08-4df1-8e6b-3a366a7839c7	2025-11-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075388 application number: ANDA075388
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Bryant Ranch Prepack	aba814f0-55ce-4480-99f1-b9ad1ba77d3f	2025-11-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075388 application number: ANDA075388
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Bryant Ranch Prepack	bee0edbf-3fc3-484b-9715-f13a329216ae	2025-11-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075388 application number: ANDA075388
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Bryant Ranch Prepack	4e7640d1-0a31-4f97-82bb-574cf1ff6e4a	2025-10-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075388 application number: ANDA075388
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	40d5813d-d040-002c-e063-6294a90a5f7a	2025-10-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075388 application number: ANDA075388
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	A-S Medication Solutions	7c7225a0-8237-4998-843a-bf10fa6ec65b	2025-10-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075388 application number: ANDA075388
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Bryant Ranch Prepack	2df0b238-14a4-40ca-a235-411f6c9b8338	2025-10-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075388 application number: ANDA075388
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Bryant Ranch Prepack	f85b59b7-b945-4440-8378-987bd287a655	2025-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075388 application number: ANDA075388
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	b217f341-7d51-475d-887f-f16786164c7b	2025-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075388 application number: ANDA075388
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	270398a0-21b8-407b-af76-4aeef90f72be	2025-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075388 application number: ANDA075388
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	3dd7f213-afd8-67d6-e063-6294a90ac108	2025-09-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075388 application number: ANDA075388
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Bryant Ranch Prepack	65c69118-36bb-4f0d-9669-b52556056ec5	2025-09-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075388 application number: ANDA075388
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Bryant Ranch Prepack	ed7e334a-cc4a-47b2-a4db-56495730b698	2025-09-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075388 application number: ANDA075388

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
3155e607-bc7f-4e90-9edf-8e862dd5737d	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, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
70518-2987-0	2023-03-14	C162847	48780-1	f386c64a-3d7a-0266-e053-dadaa90a7c1a	3155e607-bc7f-4e90-9edf-8e862dd5737d
70518-2987-1	2023-03-14	C162847	48780-1	f386c64a-3d7a-0266-e053-dadaa90a7c1a	3155e607-bc7f-4e90-9edf-8e862dd5737d
70518-2987-0	2023-01-30	C162847	48780-1	f386c64a-3d7a-0266-e053-dadaa90a7c1a	3155e607-bc7f-4e90-9edf-8e862dd5737d
70518-2987-1	2023-01-30	C162847	48780-1	f386c64a-3d7a-0266-e053-dadaa90a7c1a	3155e607-bc7f-4e90-9edf-8e862dd5737d

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
70518-2987-0	Buspirone Hydrochloride	30 in 1 BLISTER PACK	TABLET	30	7
70518-2987-1	Buspirone Hydrochloride	60 in 1 BOTTLE, PLASTIC	TABLET	60	7
70518-2987-2	Buspirone Hydrochloride	60 in 1 BLISTER PACK	TABLET	60	7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70518-2987-0	EA - Each	70518-2987	8ef615c8-44db-4a87-8f73-751dea38394c	1	2026-02-05

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	3155e607-bc7f-4e90-9edf-8e862dd5737d	7
866018	buspirone hydrochloride 15 MG Oral Tablet	SCD	3155e607-bc7f-4e90-9edf-8e862dd5737d	7
866018	buspirone hydrochloride 15 MG (buspirone 13.7 MG) Oral Tablet	SY	3155e607-bc7f-4e90-9edf-8e862dd5737d	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70518-2987-0	70518298700	30 TABLET in 1 BLISTER PACK (70518-2987-0)	30 tablet	2021-01-12	0000-00-00	No	No	Current
70518-2987-1	70518298701	60 TABLET in 1 BOTTLE, PLASTIC (70518-2987-1)	60 tablet	2021-02-15	0000-00-00	No	No	Current
70518-2987-2	70518298702	60 TABLET in 1 BLISTER PACK (70518-2987-2)	60 tablet	2025-07-12		No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Buspirone Hydrochloride - REMEDYREPACK INC.	REMEDYREPACK INC.	2026-02-16	HUMAN PRESCRIPTION DRUG LABEL	7