Home NDC 49999-812 Buspirone Hydrochloride
Product NDC 49999-812
11-digit product format 499990812
Labeler code 49999
Product ID 49999-812_4245ef47-4a3e-46b9-a532-40ae32f4ffdb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Buspirone Hydrochloride
Dosage form TABLET
Route ORAL
Labeler Lake Erie Medical DBA Quality Care Products LLC
Application ANDA074253
Marketing category ANDA
Marketing start 2010-11-16
Marketing end 0000-00-00
Substance BUSPIRONE HYDROCHLORIDE
Active strength 10 mg/1
NDC exclude flag No
Listing certified through 2019-12-31
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 · 36 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 RLD / RS Approval date A074253-001 BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2001-03-28 A074253-002 BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2001-03-28 A074253-003 BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2002-03-13
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 · 132 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 2026-10-15 13:18:30 2026-09 A074253-001 BUSPIRONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2001-03-28 c2088c7a36db…2026-10-15 13:18:30 2026-09 A074253-002 BUSPIRONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2001-03-28 c2088c7a36db…2026-10-15 13:18:30 2026-09 A074253-003 BUSPIRONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2002-03-13 c2088c7a36db…2026-09-14 22:38:34 2026-08 A074253-001 BUSPIRONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2001-03-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 A074253-002 BUSPIRONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2001-03-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 A074253-003 BUSPIRONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2002-03-13 84e616aacf4f…2026-08-18 06:07:40 2026-07 A074253-001 BUSPIRONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2001-03-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A074253-002 BUSPIRONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2001-03-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A074253-003 BUSPIRONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2002-03-13 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A074253-001 BUSPIRONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2001-03-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A074253-002 BUSPIRONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2001-03-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A074253-003 BUSPIRONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2002-03-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074253-001 BUSPIRONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2001-03-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074253-002 BUSPIRONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2001-03-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074253-003 BUSPIRONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2002-03-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074253-001 BUSPIRONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2001-03-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A074253-002 BUSPIRONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2001-03-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A074253-003 BUSPIRONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2002-03-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074253-001 BUSPIRONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2001-03-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074253-002 BUSPIRONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2001-03-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074253-003 BUSPIRONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2002-03-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074253-001 BUSPIRONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2001-03-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074253-002 BUSPIRONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2001-03-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074253-003 BUSPIRONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2002-03-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074253-001 BUSPIRONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2001-03-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074253-002 BUSPIRONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2001-03-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074253-003 BUSPIRONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2002-03-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074253-001 BUSPIRONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2001-03-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074253-002 BUSPIRONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2001-03-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074253-003 BUSPIRONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2002-03-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074253-001 BUSPIRONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2001-03-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074253-002 BUSPIRONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2001-03-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074253-003 BUSPIRONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2002-03-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074253-001 BUSPIRONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2001-03-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074253-002 BUSPIRONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2001-03-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074253-003 BUSPIRONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2002-03-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074253-001 BUSPIRONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2001-03-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A074253-002 BUSPIRONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2001-03-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A074253-003 BUSPIRONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2002-03-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074253-001 BUSPIRONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2001-03-28 79d66fd596c7…
Observed Orange Book normalized TE history# Normalized TE history page 4 of 4 · 132 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.