Home NDC 55700-803 busPIRone HCl
Product NDC 55700-803
11-digit product format 557000803
Labeler code 55700
Product ID 55700-803_67dcfccf-988c-4554-b9a6-1d05602eb15e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name buspirone hydrochloride
Dosage form TABLET
Route ORAL
Labeler Quality Care Products, LLC
Application ANDA208829
Marketing category ANDA
Marketing start 2019-10-11
Marketing end 0000-00-00
Substance BUSPIRONE HYDROCHLORIDE
Active strength 15 mg/1
NDC exclude flag No
Listing certified through 2020-12-31
Current FDA listing Historical FDA.report record
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 · 38 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 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 55700-803-60 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 55700-803-60 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 55700-803-60 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 55700-803-60 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 55700-803-60 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 55700-803-60 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 55700-803-60 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 55700-803-60 D Discontinued by firm 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 55700-803-60 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 55700-803-60 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 55700-803-60 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 55700-803-60 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 55700-803-60 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 55700-803-60 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 55700-803-60 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 55700-803-60 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 55700-803-60 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 55700-803-60 I Inactivated by FDA bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 55700-803-60 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 RLD / RS Approval date A208829-001 BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 5MG TABLET / ORAL 2017-05-24 A208829-002 BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 7.5MG TABLET / ORAL 2017-05-24 A208829-003 BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 10MG TABLET / ORAL 2017-05-24 A208829-004 BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 15MG TABLET / ORAL 2017-05-24 A208829-005 BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 30MG TABLET / ORAL 2017-05-24
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 · 215 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 2026-09-14 22:38:34 2026-08 A208829-001 BUSPIRONE HYDROCHLORIDE 5MG TABLET / ORAL 2017-05-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 A208829-002 BUSPIRONE HYDROCHLORIDE 7.5MG TABLET / ORAL 2017-05-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 A208829-003 BUSPIRONE HYDROCHLORIDE 10MG TABLET / ORAL 2017-05-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 A208829-004 BUSPIRONE HYDROCHLORIDE 15MG TABLET / ORAL 2017-05-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 A208829-005 BUSPIRONE HYDROCHLORIDE 30MG TABLET / ORAL 2017-05-24 84e616aacf4f…2026-08-18 06:07:40 2026-07 A208829-001 BUSPIRONE HYDROCHLORIDE 5MG TABLET / ORAL 2017-05-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A208829-002 BUSPIRONE HYDROCHLORIDE 7.5MG TABLET / ORAL 2017-05-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A208829-003 BUSPIRONE HYDROCHLORIDE 10MG TABLET / ORAL 2017-05-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A208829-004 BUSPIRONE HYDROCHLORIDE 15MG TABLET / ORAL 2017-05-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A208829-005 BUSPIRONE HYDROCHLORIDE 30MG TABLET / ORAL 2017-05-24 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A208829-001 BUSPIRONE HYDROCHLORIDE 5MG TABLET / ORAL 2017-05-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208829-002 BUSPIRONE HYDROCHLORIDE 7.5MG TABLET / ORAL 2017-05-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208829-003 BUSPIRONE HYDROCHLORIDE 10MG TABLET / ORAL 2017-05-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208829-004 BUSPIRONE HYDROCHLORIDE 15MG TABLET / ORAL 2017-05-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208829-005 BUSPIRONE HYDROCHLORIDE 30MG TABLET / ORAL 2017-05-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208829-001 BUSPIRONE HYDROCHLORIDE 5MG TABLET / ORAL 2017-05-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208829-002 BUSPIRONE HYDROCHLORIDE 7.5MG TABLET / ORAL 2017-05-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208829-003 BUSPIRONE HYDROCHLORIDE 10MG TABLET / ORAL 2017-05-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208829-004 BUSPIRONE HYDROCHLORIDE 15MG TABLET / ORAL 2017-05-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208829-005 BUSPIRONE HYDROCHLORIDE 30MG TABLET / ORAL 2017-05-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208829-001 BUSPIRONE HYDROCHLORIDE 5MG TABLET / ORAL 2017-05-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208829-002 BUSPIRONE HYDROCHLORIDE 7.5MG TABLET / ORAL 2017-05-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208829-003 BUSPIRONE HYDROCHLORIDE 10MG TABLET / ORAL 2017-05-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208829-004 BUSPIRONE HYDROCHLORIDE 15MG TABLET / ORAL 2017-05-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208829-005 BUSPIRONE HYDROCHLORIDE 30MG TABLET / ORAL 2017-05-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208829-001 BUSPIRONE HYDROCHLORIDE 5MG TABLET / ORAL 2017-05-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208829-002 BUSPIRONE HYDROCHLORIDE 7.5MG TABLET / ORAL 2017-05-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208829-003 BUSPIRONE HYDROCHLORIDE 10MG TABLET / ORAL 2017-05-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208829-004 BUSPIRONE HYDROCHLORIDE 15MG TABLET / ORAL 2017-05-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208829-005 BUSPIRONE HYDROCHLORIDE 30MG TABLET / ORAL 2017-05-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208829-001 BUSPIRONE HYDROCHLORIDE 5MG TABLET / ORAL 2017-05-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208829-002 BUSPIRONE HYDROCHLORIDE 7.5MG TABLET / ORAL 2017-05-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208829-003 BUSPIRONE HYDROCHLORIDE 10MG TABLET / ORAL 2017-05-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208829-004 BUSPIRONE HYDROCHLORIDE 15MG TABLET / ORAL 2017-05-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208829-005 BUSPIRONE HYDROCHLORIDE 30MG TABLET / ORAL 2017-05-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208829-001 BUSPIRONE HYDROCHLORIDE 5MG TABLET / ORAL 2017-05-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208829-002 BUSPIRONE HYDROCHLORIDE 7.5MG TABLET / ORAL 2017-05-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208829-003 BUSPIRONE HYDROCHLORIDE 10MG TABLET / ORAL 2017-05-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208829-004 BUSPIRONE HYDROCHLORIDE 15MG TABLET / ORAL 2017-05-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208829-005 BUSPIRONE HYDROCHLORIDE 30MG TABLET / ORAL 2017-05-24 03ed91905a0d…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 130 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing#