Home NDC 71610-360-60 Buspirone Hydrochloride
Product NDC 71610-360
Requested package NDC 71610-360-60
11-digit product format 716100360
Labeler code 71610
Product ID 71610-360_0953055a-c1a5-4b8e-ab92-615504d805f7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name buspirone hydrochloride
Dosage form TABLET
Route ORAL
Labeler Aphena Pharma Solutions - Tennessee, LLC
Application ANDA076008
Marketing category ANDA
Marketing start 2013-07-08
Marketing end 0000-00-00
Substance BUSPIRONE HYDROCHLORIDE
Active strength 8 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 · 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 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 RLD / RS Approval date A076008-001 BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 30MG TABLET / ORAL AB 2001-06-28 A076008-002 BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 7.5MG TABLET / ORAL 2013-07-08 A076008-003 BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2002-03-01 A076008-004 BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2002-03-01 A076008-005 BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2001-03-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 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 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 A076008-001 BUSPIRONE HYDROCHLORIDE 30MG TABLET / ORAL AB 2001-06-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076008-002 BUSPIRONE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2013-07-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076008-003 BUSPIRONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2002-03-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076008-004 BUSPIRONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2002-03-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076008-005 BUSPIRONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2001-03-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076008-001 BUSPIRONE HYDROCHLORIDE 30MG TABLET / ORAL AB 2001-06-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076008-002 BUSPIRONE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2013-07-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076008-003 BUSPIRONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2002-03-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076008-004 BUSPIRONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2002-03-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076008-005 BUSPIRONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2001-03-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076008-001 BUSPIRONE HYDROCHLORIDE 30MG TABLET / ORAL AB 2001-06-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076008-002 BUSPIRONE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2013-07-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076008-003 BUSPIRONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2002-03-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076008-004 BUSPIRONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2002-03-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076008-005 BUSPIRONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2001-03-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076008-001 BUSPIRONE HYDROCHLORIDE 30MG TABLET / ORAL AB 2001-06-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076008-002 BUSPIRONE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2013-07-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076008-003 BUSPIRONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2002-03-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076008-004 BUSPIRONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2002-03-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076008-005 BUSPIRONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2001-03-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076008-001 BUSPIRONE HYDROCHLORIDE 30MG TABLET / ORAL AB 2001-06-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076008-002 BUSPIRONE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2013-07-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076008-003 BUSPIRONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2002-03-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076008-004 BUSPIRONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2002-03-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076008-005 BUSPIRONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2001-03-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076008-001 BUSPIRONE HYDROCHLORIDE 30MG TABLET / ORAL AB 2001-06-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076008-002 BUSPIRONE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2013-07-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076008-003 BUSPIRONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2002-03-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076008-004 BUSPIRONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2002-03-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076008-005 BUSPIRONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2001-03-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076008-001 BUSPIRONE HYDROCHLORIDE 30MG TABLET / ORAL AB 2001-06-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076008-002 BUSPIRONE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2013-07-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076008-003 BUSPIRONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2002-03-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076008-004 BUSPIRONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2002-03-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076008-005 BUSPIRONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2001-03-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076008-001 BUSPIRONE HYDROCHLORIDE 30MG TABLET / ORAL AB 2001-06-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076008-002 BUSPIRONE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2013-07-08 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076008-003 BUSPIRONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2002-03-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076008-004 BUSPIRONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2002-03-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076008-005 BUSPIRONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2001-03-28 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 6 · 204 observed states.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 71610-360-60 Buspirone Hydrochloride 90 in 1 BOTTLE, PLASTIC TABLET 90 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71610-360 BUSPIRONE HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 Legacy NDC, 1 package rows 20191128_ea4fc29e-35f6-43ca-aeb1-f323b2d926f9.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 4 matching rows.
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 71610-360-60 71610036060 90 TABLET in 1 BOTTLE, PLASTIC (71610-360-60) 90 tablet 2019-11-01 0000-00-00 No No Current