Home NDC 51079-960 Buspirone Hydrochloride
Product NDC 51079-960
11-digit product format 510790960
Labeler code 51079
Product ID 51079-960_3a3995cf-40e7-1867-e063-6294a90aa483
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name buspirone hydrochloride
Dosage form TABLET
Route ORAL
Labeler Mylan Institutional Inc.
Application ANDA076008
Marketing category ANDA
Marketing start 2001-04-15
Substance BUSPIRONE HYDROCHLORIDE
Active strength 15 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 · 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.
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 15 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 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 866018 Internal RxNorm lookup 866083 Internal RxNorm lookup 866090 Internal RxNorm lookup 866094 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 51079-960-01 Buspirone Hydrochloride 1 in 1 BLISTER PACK TABLET 1 22 51079-960-20 Buspirone Hydrochloride 100 in 1 CARTON TABLET 100 22
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51079-960 BUSPIRONE HYDROCHLORIDE TABLET [MYLAN INSTITUTIONAL INC.] 21 Current NDC, Legacy NDC, 2 package rows 20231228_91bb5fc9-5121-43c2-b2af-149240d4189a.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 51079-960-01 51079096001 1 in 1 BLISTER PACK Historical 51079-960-20 51079096020 100 BLISTER PACK in 1 CARTON (51079-960-20) / 1 TABLET in 1 BLISTER PACK (51079-960-01) 100 blister pack 2001-04-15 0000-00-00 No No Current