Home NDC 50090-4657-1 busPIRone HCl
Product NDC 50090-4657
Requested package NDC 50090-4657-1
11-digit product format 500904657
Labeler code 50090
Product ID 50090-4657_fe45e4ea-89e8-4b2b-a3c8-814ddfe0c6ae
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name buspirone hydrochloride
Dosage form TABLET
Route ORAL
Labeler A-S Medication Solutions
Application ANDA208829
Marketing category ANDA
Marketing start 2017-05-24
Marketing end 0000-00-00
Substance BUSPIRONE HYDROCHLORIDE
Active strength 15 mg/1
NDC exclude flag No
Listing certified through 2022-12-31
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 · 15 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…
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 Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Action table NDC Effective Action Document Indexing SPL Related label 50090-4657-1 2023-01-30 C162847 48780-1 f386c64a-265c-0266-e053-dadaa90a7c1a Buspirone Hydrochloride Tablets, USP (5 mg, 7.5 mg, 10 mg, 15 mg or 30 mg) Rx only 50090-4657-3 2023-01-30 C162847 48780-1 f386c64a-265c-0266-e053-dadaa90a7c1a Buspirone Hydrochloride Tablets, USP (5 mg, 7.5 mg, 10 mg, 15 mg or 30 mg) Rx only
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50090-4657-1 busPIRone HCl 60 in 1 BOTTLE TABLET 60 6 50090-4657-3 busPIRone HCl 90 in 1 BOTTLE TABLET 90 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50090-4657 BUSPIRONE HCL (BUSPIRONE HYDROCHLORIDE) TABLET [A-S MEDICATION SOLUTIONS] 6 Legacy NDC, 2 package rows 20210615_130fac8c-27e2-4c67-8e03-63062e509992.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 50090-4657-1 50090465701 60 TABLET in 1 BOTTLE (50090-4657-1) 60 tablet 2019-10-28 0000-00-00 No No Current