Home NDC 71610-404 Buspirone Hydrochloride
Product NDC 71610-404
11-digit product format 716100404
Labeler code 71610
Product ID 71610-404_a93360e6-43f6-4652-a7ef-07087a718258
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Buspirone Hydrochloride
Dosage form TABLET
Route ORAL
Labeler Aphena Pharma Solutions - Tennessee, LLC
Application ANDA208972
Marketing category ANDA
Marketing start 2019-04-17
Substance BUSPIRONE HYDROCHLORIDE
Active strength 7.5 mg/1
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 7 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A208972-001 BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2019-04-16 A208972-002 BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2019-04-16 A208972-003 BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2019-04-16 A208972-004 BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2019-04-16 A208972-005 BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 30MG TABLET / ORAL AB 2019-04-16 A208972-006 BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 2.5MG TABLET / ORAL 2026-05-13 A208972-007 BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 12.5MG TABLET / ORAL 2026-05-13
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 5 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 · 207 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 A208972-001 BUSPIRONE HYDROCHLORIDE 5MG TABLET / ORAL BX 2019-04-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208972-002 BUSPIRONE HYDROCHLORIDE 7.5MG TABLET / ORAL BX 2019-04-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208972-003 BUSPIRONE HYDROCHLORIDE 10MG TABLET / ORAL BX 2019-04-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208972-004 BUSPIRONE HYDROCHLORIDE 15MG TABLET / ORAL BX 2019-04-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208972-005 BUSPIRONE HYDROCHLORIDE 30MG TABLET / ORAL BX 2019-04-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208972-001 BUSPIRONE HYDROCHLORIDE 5MG TABLET / ORAL BX 2019-04-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208972-002 BUSPIRONE HYDROCHLORIDE 7.5MG TABLET / ORAL BX 2019-04-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208972-003 BUSPIRONE HYDROCHLORIDE 10MG TABLET / ORAL BX 2019-04-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208972-004 BUSPIRONE HYDROCHLORIDE 15MG TABLET / ORAL BX 2019-04-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208972-005 BUSPIRONE HYDROCHLORIDE 30MG TABLET / ORAL BX 2019-04-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208972-001 BUSPIRONE HYDROCHLORIDE 5MG TABLET / ORAL BX 2019-04-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208972-002 BUSPIRONE HYDROCHLORIDE 7.5MG TABLET / ORAL BX 2019-04-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208972-003 BUSPIRONE HYDROCHLORIDE 10MG TABLET / ORAL BX 2019-04-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208972-004 BUSPIRONE HYDROCHLORIDE 15MG TABLET / ORAL BX 2019-04-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208972-005 BUSPIRONE HYDROCHLORIDE 30MG TABLET / ORAL BX 2019-04-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208972-001 BUSPIRONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2019-04-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208972-002 BUSPIRONE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2019-04-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208972-003 BUSPIRONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2019-04-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208972-004 BUSPIRONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2019-04-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208972-005 BUSPIRONE HYDROCHLORIDE 30MG TABLET / ORAL AB 2019-04-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208972-001 BUSPIRONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2019-04-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208972-002 BUSPIRONE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2019-04-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208972-003 BUSPIRONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2019-04-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208972-004 BUSPIRONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2019-04-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208972-005 BUSPIRONE HYDROCHLORIDE 30MG TABLET / ORAL AB 2019-04-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208972-001 BUSPIRONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2019-04-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208972-002 BUSPIRONE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2019-04-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208972-003 BUSPIRONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2019-04-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208972-004 BUSPIRONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2019-04-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208972-005 BUSPIRONE HYDROCHLORIDE 30MG TABLET / ORAL AB 2019-04-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208972-001 BUSPIRONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2019-04-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208972-002 BUSPIRONE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2019-04-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208972-003 BUSPIRONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2019-04-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208972-004 BUSPIRONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2019-04-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208972-005 BUSPIRONE HYDROCHLORIDE 30MG TABLET / ORAL AB 2019-04-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208972-001 BUSPIRONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2019-04-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208972-002 BUSPIRONE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2019-04-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208972-003 BUSPIRONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2019-04-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208972-004 BUSPIRONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2019-04-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208972-005 BUSPIRONE HYDROCHLORIDE 30MG TABLET / ORAL AB 2019-04-16 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 6 · 205 observed states.
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 3 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Buspirone Hydrochloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BUSPIRONE HYDROCHLORIDE 7.5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 207LT9J9OC Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 866111 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 71610-404-60 Buspirone Hydrochloride 90 in 1 BOTTLE TABLET 90 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71610-404 BUSPIRONE HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 Current NDC, Legacy NDC, 1 package rows 20200414_27db85e9-68ef-4d43-a319-4e2ec8dbae05.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 71610-404-60 71610040460 90 TABLET in 1 BOTTLE (71610-404-60) 90 tablet 2020-03-09 0000-00-00 No No Current