Home NDC 69238-1119 busPIRone HCl
Product NDC 69238-1119
11-digit product format 692381119
Labeler code 69238
Product ID 69238-1119_f697167a-4d7c-42fb-91c0-7c1f877bf54a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name buspirone hydrochloride
Dosage form TABLET
Route ORAL
Labeler Amneal Pharmaceuticals NY LLC
Application ANDA208829
Marketing category ANDA
Marketing start 2017-05-24
Marketing end 0000-00-00
Substance BUSPIRONE HYDROCHLORIDE
Active strength 30 mg/1
NDC exclude flag No
Listing certified through 2023-12-31
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 · 3 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product 69238-1119 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 69238-1119 69238-1119-5 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 69238-1119 69238-1119-6 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…
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.
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69238-1119 BUSPIRONE HCL (BUSPIRONE HYDROCHLORIDE) TABLET [AMNEAL PHARMACEUTICALS NY LLC] 8 Legacy NDC 20241205_33999f17-f689-40a1-955a-fb19c0590e0e.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 69238-1119-5 69238111905 500 TABLET in 1 BOTTLE (69238-1119-5) 500 tablet 2017-05-24 0000-00-00 No No Current 69238-1119-6 69238111906 60 TABLET in 1 BOTTLE (69238-1119-6) 60 tablet 2017-05-24 0000-00-00 No No Current