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 42 .
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 · 214 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 2026-08-18 06:07:40 2026-07 A208972-001 BUSPIRONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2019-04-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A208972-002 BUSPIRONE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2019-04-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A208972-003 BUSPIRONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2019-04-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A208972-004 BUSPIRONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2019-04-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A208972-005 BUSPIRONE HYDROCHLORIDE 30MG TABLET / ORAL AB 2019-04-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A208972-006 BUSPIRONE HYDROCHLORIDE 2.5MG TABLET / ORAL 2026-05-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A208972-007 BUSPIRONE HYDROCHLORIDE 12.5MG TABLET / ORAL 2026-05-13 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 6 · 210 observed states.
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
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 · 3 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 71610-404-60 71610040460 90 TABLET in 1 BOTTLE (71610-404-60) 90 tablet 2020-03-09 0000-00-00 No No Current