Buspirone Hydrochloride

Product NDC: 68071-2995
11-digit product format: 680712995
Labeler code: 68071
Product ID: 68071-2995_2d53e84a-506a-e4c8-e063-6294a90a3f8d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Buspirone Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA210907
Marketing category: ANDA
Marketing start: 2019-11-14
Substance: BUSPIRONE HYDROCHLORIDE
Active strength: 5 mg/1
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Observed NDC auxiliary status history#

Observed captured status history: Rows come only from successfully parsed FDA auxiliary ZIP captures. They show the state present in that artifact, not a continuous regulatory timeline. Absence before, after, or between captures is not proof of status, and a known non-data HTTP 403 capture is preserved in backfill provenance but cannot produce a status row.

Historic NDC status page 1 of 1 · 6 matching rows.

Browse every current auxiliary row. · Browse the complete NDC auxiliary source catalog.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product	68071-2995		U	Excluded because listing certification expired	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68071-2995	68071-2995-3	U	Excluded because listing certification expired	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product	68071-2995		U	Excluded because listing certification expired	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68071-2995	68071-2995-3	U	Excluded because listing certification expired	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product	68071-2995		U	Excluded because listing certification expired	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68071-2995	68071-2995-3	U	Excluded because listing certification expired	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`

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	RLD / RS	Approval date
A210907-001	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2019-11-14
A210907-002	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2019-11-14
A210907-003	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	RS	2019-11-14
A210907-004	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB		2019-11-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210907-001	AB
A210907-002	AB
A210907-003	AB
A210907-004	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 4 · 156 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A210907-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2019-11-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210907-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2019-11-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210907-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	RS	2019-11-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210907-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB		2019-11-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210907-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2019-11-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210907-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2019-11-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210907-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	RS	2019-11-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210907-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB		2019-11-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210907-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2019-11-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210907-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2019-11-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210907-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	RS	2019-11-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210907-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB		2019-11-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210907-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2019-11-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210907-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2019-11-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210907-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB		2019-11-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210907-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB		2019-11-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210907-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2019-11-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210907-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2019-11-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210907-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB		2019-11-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210907-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB		2019-11-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210907-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2019-11-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210907-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2019-11-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210907-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB		2019-11-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210907-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB		2019-11-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210907-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2019-11-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210907-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2019-11-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210907-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB		2019-11-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210907-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB		2019-11-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210907-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2019-11-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210907-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2019-11-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210907-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB		2019-11-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210907-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB		2019-11-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210907-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2019-11-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210907-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2019-11-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210907-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB		2019-11-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210907-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB		2019-11-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210907-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2019-11-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210907-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2019-11-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210907-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB		2019-11-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210907-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB		2019-11-14	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 156 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	A210907-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210907-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210907-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210907-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210907-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210907-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210907-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210907-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210907-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210907-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210907-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210907-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210907-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210907-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210907-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210907-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210907-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210907-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210907-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210907-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210907-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210907-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210907-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210907-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210907-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210907-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210907-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210907-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210907-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210907-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210907-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210907-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210907-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210907-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210907-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210907-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210907-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210907-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210907-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210907-004	AB	1	`d06236e962d9…`

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 · 34 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Unit Dose Solutions, Inc.	544a4570-bd7f-72bb-e063-6394a90ab8d6	2026-06-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210907 application number: ANDA210907
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	REMEDYREPACK INC.	fbff8248-b73c-474e-907e-449f8316c629	2026-06-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210907 application number: ANDA210907
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Asclemed USA, Inc.	97f2d082-0931-4e4f-a5be-7792e399e42b	2026-05-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210907 application number: ANDA210907
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Coupler LLC	510120d3-c922-a071-e063-6294a90af6a7	2026-05-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210907 application number: ANDA210907
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	REMEDYREPACK INC.	5b4da3f8-a5ce-4699-92e1-37fb95e0af2d	2026-04-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210907 application number: ANDA210907
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	REMEDYREPACK INC.	6c6db7a9-a728-406a-81af-edd89e1cc26f	2026-04-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210907 application number: ANDA210907
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	824c80e6-d508-405f-8a4f-2f10df5a9dc8	2026-03-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210907 application number: ANDA210907
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	187c315b-9c2c-485f-aa63-e399e0796e78	2026-03-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210907 application number: ANDA210907
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	068ee1a0-a77a-4803-bad9-18117d7fb358	2026-03-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210907 application number: ANDA210907
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	18ddef0b-1451-4bea-94fb-b6ec27f4744b	2026-01-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210907 application number: ANDA210907
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	REMEDYREPACK INC.	ed2b56fe-e02f-46bc-808a-352f9bbb5b57	2025-09-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210907 application number: ANDA210907
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	A-S Medication Solutions	48b4e52d-d4c4-4d24-a0ac-24316371cef0	2025-09-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210907 application number: ANDA210907
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Proficient Rx LP	801803eb-be17-4064-8813-7ccf52316cde	2025-08-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210907 application number: ANDA210907
Buspirone HCL	BUSPIRONE HCL	Direct_Rx	3246dd4d-f787-2f62-e063-6294a90a9cd2	2025-06-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210907 application number: ANDA210907
Buspirone HCL	BUSPIRONE HCL	Direct_Rx	37780596-3b6f-8d00-e063-6294a90ad4ad	2025-06-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210907 application number: ANDA210907
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	335107c9-5799-c4df-e063-6294a90a5ca0	2025-04-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210907 application number: ANDA210907
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Bryant Ranch Prepack	b6352207-e708-44a7-8a63-93b96613e1e7	2025-03-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210907 application number: ANDA210907
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Advanced Rx of Tennessee, LLC	30c93022-4126-db8c-e063-6394a90a7579	2025-03-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210907 application number: ANDA210907
Buspirone HCL	BUSPIRONE HCL	Direct_Rx	f71e019b-3928-f8eb-e053-6394a90a871e	2025-02-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210907 application number: ANDA210907
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	f98d258d-6479-253a-e053-6394a90acbb3	2025-02-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210907 application number: ANDA210907

Additional Listing Data#

Finished product: Yes
Brand name base: Buspirone Hydrochloride
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BUSPIRONE HYDROCHLORIDE	5 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
866094	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
fbd7f3fa-11f8-a319-e053-6294a90acae4	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
68071-2995-3	2025-02-04	C162847	48780-1	2cef2736-b47f-d83d-e063-dadaa90ab31f	Buspirone Hydrochloride Tablets, USP Rx Only
68071-2995-3	2025-01-30	C162847	48780-1	2cef2736-b47f-d83d-e063-dadaa90ab31f	Buspirone Hydrochloride Tablets, USP Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68071-2995-3	Buspirone Hydrochloride	30 in 1 BOTTLE, PLASTIC	TABLET	30		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-2995	BUSPIRONE HYDROCHLORIDE TABLET [NUCARE PHARMACEUTICALS,INC.]	2	Current NDC, 1 package rows	20250206_fbd7f3fa-11f8-a319-e053-6294a90acae4.zip

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	fbd7f3fa-11f8-a319-e053-6294a90acae4	2
866094	buspirone hydrochloride 5 MG Oral Tablet	SCD	fbd7f3fa-11f8-a319-e053-6294a90acae4	2
866094	buspirone hydrochloride 5 MG (buspirone 4.6 MG) Oral Tablet	SY	fbd7f3fa-11f8-a319-e053-6294a90acae4	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
68071-2995-3	68071299503	30 TABLET in 1 BOTTLE, PLASTIC (68071-2995-3)	30 tablet	2023-05-16	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Buspirone Hydrochloride Tablets, USP Rx Only	NuCare Pharmaceuticals,Inc.	2025-02-04	HUMAN PRESCRIPTION DRUG LABEL	2