BUSPIRONE HYDROCHLORIDE

Product NDC: 61919-166
11-digit product format: 619190166
Labeler code: 61919
Product ID: 61919-166_47e15246-5edb-3524-e063-6294a90a3fd4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: BUSPIRONE HYDROCHLORIDE
Dosage form: TABLET
Route: ORAL
Labeler: Direct_Rx
Application: ANDA202557
Marketing category: ANDA
Marketing start: 2019-07-26
Substance: BUSPIRONE HYDROCHLORIDE
Active strength: 5 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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	61919-166		I	Inactivated by FDA	2026-08-03
excluded product	product	61919-166		I	Inactivated by FDA	2026-08-03
excluded package	package	61919-166	61919-166-90	I	Inactivated by FDA	2026-08-03
excluded package	package	61919-166	61919-166-30	I	Inactivated by FDA	2026-08-03

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 2 · 82 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
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product	61919-166		I	Inactivated by FDA	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product	61919-166		I	Inactivated by FDA	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61919-166	61919-166-90	I	Inactivated by FDA	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61919-166	61919-166-30	I	Inactivated by FDA	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product	61919-166		I	Inactivated by FDA	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product	61919-166		I	Inactivated by FDA	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61919-166	61919-166-90	I	Inactivated by FDA	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61919-166	61919-166-30	I	Inactivated by FDA	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product	61919-166		I	Inactivated by FDA	excluded / ndc_excluded.zip	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product	61919-166		I	Inactivated by FDA	excluded / ndc_excluded.zip	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61919-166	61919-166-90	I	Inactivated by FDA	excluded / ndc_excluded.zip	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61919-166	61919-166-30	I	Inactivated by FDA	excluded / ndc_excluded.zip	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product	61919-166		I	Inactivated by FDA	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product	61919-166		I	Inactivated by FDA	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61919-166	61919-166-90	I	Inactivated by FDA	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61919-166	61919-166-30	I	Inactivated by FDA	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product	61919-166		I	Inactivated by FDA	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product	61919-166		I	Inactivated by FDA	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61919-166	61919-166-90	I	Inactivated by FDA	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61919-166	61919-166-30	I	Inactivated by FDA	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product	61919-166		I	Inactivated by FDA	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product	61919-166		I	Inactivated by FDA	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61919-166	61919-166-90	I	Inactivated by FDA	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61919-166	61919-166-30	I	Inactivated by FDA	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product	61919-166		I	Inactivated by FDA	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product	61919-166		I	Inactivated by FDA	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61919-166	61919-166-90	I	Inactivated by FDA	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61919-166	61919-166-30	I	Inactivated by FDA	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product	61919-166		I	Inactivated by FDA	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product	61919-166		I	Inactivated by FDA	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61919-166	61919-166-90	I	Inactivated by FDA	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61919-166	61919-166-30	I	Inactivated by FDA	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product	61919-166		I	Inactivated by FDA	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product	61919-166		I	Inactivated by FDA	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61919-166	61919-166-90	I	Inactivated by FDA	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61919-166	61919-166-30	I	Inactivated by FDA	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product	61919-166		I	Inactivated by FDA	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product	61919-166		I	Inactivated by FDA	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	61919-166	61919-166-90	I	Inactivated by FDA	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	61919-166	61919-166-30	I	Inactivated by FDA	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product	61919-166		I	Inactivated by FDA	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product	61919-166		I	Inactivated by FDA	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	61919-166	61919-166-90	I	Inactivated by FDA	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	61919-166	61919-166-30	I	Inactivated by FDA	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product	61919-166		I	Inactivated by FDA	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product	61919-166		I	Inactivated by FDA	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	61919-166	61919-166-90	I	Inactivated by FDA	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	61919-166	61919-166-30	I	Inactivated by FDA	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product	61919-166		I	Inactivated by FDA	excluded / ndc_excluded.zip	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product	61919-166		I	Inactivated by FDA	excluded / ndc_excluded.zip	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	61919-166	61919-166-90	I	Inactivated by FDA	excluded / ndc_excluded.zip	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	61919-166	61919-166-30	I	Inactivated by FDA	excluded / ndc_excluded.zip	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product	61919-166		I	Inactivated by FDA	excluded / ndc_excluded.zip	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product	61919-166		I	Inactivated by FDA	excluded / ndc_excluded.zip	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	61919-166	61919-166-90	I	Inactivated by FDA	excluded / ndc_excluded.zip	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	61919-166	61919-166-30	I	Inactivated by FDA	excluded / ndc_excluded.zip	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product	61919-166		I	Inactivated by FDA	excluded / ndc_excluded.zip	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product	61919-166		I	Inactivated by FDA	excluded / ndc_excluded.zip	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	61919-166	61919-166-90	I	Inactivated by FDA	excluded / ndc_excluded.zip	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	61919-166	61919-166-30	I	Inactivated by FDA	excluded / ndc_excluded.zip	`1332a3947898…`	`d4bfe170f9cd…`

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

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
A202557-001	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-12-30
A202557-002	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2014-12-30
A202557-003	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-12-30
A202557-004	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2014-12-30
A202557-005	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2014-12-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202557-001	AB
A202557-002	AB
A202557-003	AB
A202557-004	AB
A202557-005	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 6 · 205 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	A202557-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2014-12-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202557-002	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB		2014-12-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202557-003	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2014-12-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202557-004	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB		2014-12-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202557-005	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB		2014-12-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202557-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2014-12-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202557-002	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB		2014-12-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202557-003	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2014-12-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202557-004	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB		2014-12-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202557-005	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB		2014-12-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202557-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2014-12-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202557-002	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB		2014-12-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202557-003	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2014-12-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202557-004	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB		2014-12-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202557-005	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB		2014-12-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202557-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2014-12-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202557-002	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB		2014-12-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202557-003	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2014-12-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202557-004	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	RS	2014-12-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202557-005	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB		2014-12-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202557-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2014-12-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202557-002	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB		2014-12-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202557-003	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2014-12-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202557-004	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	RS	2014-12-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202557-005	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB		2014-12-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202557-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2014-12-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202557-002	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB		2014-12-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202557-003	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2014-12-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202557-004	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	RS	2014-12-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202557-005	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB		2014-12-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202557-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2014-12-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202557-002	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB		2014-12-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202557-003	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2014-12-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202557-004	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	RS	2014-12-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202557-005	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB		2014-12-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202557-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2014-12-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202557-002	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB		2014-12-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202557-003	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2014-12-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202557-004	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	RS	2014-12-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202557-005	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB		2014-12-30	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 205 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	A202557-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202557-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202557-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202557-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202557-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202557-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202557-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202557-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202557-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202557-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202557-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202557-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202557-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202557-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202557-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202557-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202557-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202557-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202557-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202557-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202557-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202557-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202557-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202557-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202557-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202557-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202557-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202557-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202557-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202557-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202557-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202557-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202557-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202557-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202557-005	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202557-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202557-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202557-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202557-004	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202557-005	AB	1	`5bbf6a4d5a75…`

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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Bryant Ranch Prepack	66df7f74-5dea-46d6-9ef8-9bab37baf407	2026-05-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202557 application number: ANDA202557
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	7db10b76-4520-496e-b450-66a662cc95f6	2026-03-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202557 application number: ANDA202557
BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	DIRECT RX	bae98d45-e192-56e3-e053-2a95a90aadc3	2026-03-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202557 application number: ANDA202557
BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	Direct_Rx	8e9c0553-c994-f54a-e053-2a95a90a6fa3	2026-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202557 application number: ANDA202557 ndc (product): 61919-166
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Northwind Health Company, LLC	f318ba7b-121f-2e4f-e053-2a95a90a60c5	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202557 application number: ANDA202557
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Accord Healthcare Inc.	3da22999-f5fb-49fd-acde-c3006598e985	2025-10-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202557 application number: ANDA202557
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	540e9b7e-09ff-2cca-e054-00144ff8d46c	2024-07-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202557 application number: ANDA202557
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	A-S Medication Solutions	4ae45cb1-8612-4006-b12c-2440160132ac	2023-02-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202557 application number: ANDA202557
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	fac49d42-7bc0-435f-bce2-2548dcdd6de6	2018-12-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202557 application number: ANDA202557
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	8b6e7ae6-5b83-4a5a-ab45-cf4be4287d78	2018-10-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202557 application number: ANDA202557

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	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
8e9c0553-c994-f54a-e053-2a95a90a6fa3	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
61919-166-30	2021-01-29	C162847	48780-1	ba0f9c33-45b7-a910-e053-dadaa90a0b85	BUSPIRONE
61919-166-90	2020-01-31	C162847	48780-1	9d75b9d0-d9c3-f424-e053-dadaa90a57ce	BUSPIRONE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
61919-166-60	BUSPIRONE HYDROCHLORIDE	60 in 1 BOTTLE	TABLET	60	5
61919-166-30	BUSPIRONE HYDROCHLORIDE	30 in 1 BOTTLE	TABLET	30	1
61919-166-90	BUSPIRONE HYDROCHLORIDE	90 in 1 BOTTLE	TABLET	90	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61919-166-30	EA - Each	61919-166	0be21527-734d-43ff-aa03-f1947a01b4af	1	2019-09-05
61919-166-60	EA - Each	61919-166	9b6ec070-3e50-4928-bee2-5aa55f12b4c5	1	2019-09-05
61919-166-90	EA - Each	61919-166	145fabb3-4974-490f-ba8c-973c80b064fa	1	2019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61919-166	BUSPIRONE HYDROCHLORIDE TABLET [DIRECT_RX]	4	Current NDC, Legacy NDC, 1 package rows	20240110_8e9c0553-c994-f54a-e053-2a95a90a6fa3.zip
61919-166	BUSPIRONE HYDROCHLORIDE TABLET [DIRECT RX]	1	Current NDC, Legacy NDC, 1 package rows	20170512_4f5855b7-d3d4-3477-e054-00144ff8d46c.zip
61919-166	BUSPIRONE HYDROCHLORIDE TABLET [DIRECT_RX]	1	Current NDC, Legacy NDC, 1 package rows	20190726_8e85d869-fe78-3148-e053-2995a90a207c.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	8e9c0553-c994-f54a-e053-2a95a90a6fa3	5
866094	buspirone hydrochloride 5 MG Oral Tablet	SCD	8e9c0553-c994-f54a-e053-2a95a90a6fa3	5
866094	buspirone hydrochloride 5 MG (buspirone 4.6 MG) Oral Tablet	SY	8e9c0553-c994-f54a-e053-2a95a90a6fa3	5
866094	busPIRone HCl 5 MG Oral Tablet	PSN	4f5855b7-d3d4-3477-e054-00144ff8d46c	1
866094	busPIRone HCl 5 MG Oral Tablet	PSN	8e85d869-fe78-3148-e053-2995a90a207c	1
866094	buspirone hydrochloride 5 MG Oral Tablet	SCD	4f5855b7-d3d4-3477-e054-00144ff8d46c	1
866094	buspirone hydrochloride 5 MG Oral Tablet	SCD	8e85d869-fe78-3148-e053-2995a90a207c	1
866094	buspirone hydrochloride 5 MG (buspirone 4.6 MG) Oral Tablet	SY	4f5855b7-d3d4-3477-e054-00144ff8d46c	1
866094	buspirone hydrochloride 5 MG (buspirone 4.6 MG) Oral Tablet	SY	8e85d869-fe78-3148-e053-2995a90a207c	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
61919-166-30	61919016630	30 in 1 BOTTLE						Historical
61919-166-60	61919016660	60 TABLET in 1 BOTTLE (61919-166-60)	60 tablet	2019-07-26	0000-00-00	No	No	Current
61919-166-90	61919016690	90 in 1 BOTTLE						Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
BUSPIRONE	Direct_Rx	2026-01-08	HUMAN PRESCRIPTION DRUG LABEL	5
BUSPIRONE	Direct_Rx	2019-07-25	HUMAN PRESCRIPTION DRUG LABEL	1
BUSPIRONE	DIRECT RX	2017-05-12	HUMAN PRESCRIPTION DRUG LABEL	1