Home NDC 0591-0658 Buspirone HCl
Product NDC 0591-0658
11-digit product format 005910658
Labeler code 0591
Product ID 0591-0658_71a042fc-d5d4-4190-b309-81bc1b95be02
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Buspirone hydrochloride
Dosage form TABLET
Route ORAL
Labeler Actavis Pharma, Inc.
Application ANDA074253
Marketing category ANDA
Marketing start 2001-03-28
Marketing end 2019-03-31
Substance BUSPIRONE HYDRO
Active strength 10 mg/1
NDC exclude flag No
Listing certified through 0000-00-00
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 · 48 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A074253-001 BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2001-03-28 A074253-002 BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2001-03-28 A074253-003 BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2002-03-13
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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 4 · 123 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 A074253-001 BUSPIRONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2001-03-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A074253-002 BUSPIRONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2001-03-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A074253-003 BUSPIRONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2002-03-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074253-001 BUSPIRONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2001-03-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074253-002 BUSPIRONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2001-03-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074253-003 BUSPIRONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2002-03-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074253-001 BUSPIRONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2001-03-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A074253-002 BUSPIRONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2001-03-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A074253-003 BUSPIRONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2002-03-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074253-001 BUSPIRONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2001-03-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074253-002 BUSPIRONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2001-03-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074253-003 BUSPIRONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2002-03-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074253-001 BUSPIRONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2001-03-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074253-002 BUSPIRONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2001-03-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074253-003 BUSPIRONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2002-03-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074253-001 BUSPIRONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2001-03-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074253-002 BUSPIRONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2001-03-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074253-003 BUSPIRONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2002-03-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074253-001 BUSPIRONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2001-03-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074253-002 BUSPIRONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2001-03-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074253-003 BUSPIRONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2002-03-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074253-001 BUSPIRONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2001-03-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074253-002 BUSPIRONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2001-03-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074253-003 BUSPIRONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2002-03-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074253-001 BUSPIRONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2001-03-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074253-002 BUSPIRONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2001-03-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074253-003 BUSPIRONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2002-03-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074253-001 BUSPIRONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2001-03-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A074253-002 BUSPIRONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2001-03-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A074253-003 BUSPIRONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2002-03-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074253-001 BUSPIRONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2001-03-28 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074253-002 BUSPIRONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2001-03-28 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074253-003 BUSPIRONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2002-03-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074253-001 BUSPIRONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2001-03-28 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074253-002 BUSPIRONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2001-03-28 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074253-003 BUSPIRONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2002-03-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074253-001 BUSPIRONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2001-03-28 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074253-002 BUSPIRONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2001-03-28 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074253-003 BUSPIRONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2002-03-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A074253-001 BUSPIRONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2001-03-28 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 observed states.
DailyMed Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded BUSPIRONE HYDROCHLORIDE ACTIVE INGREDIENT 207LT9J9OC BUSPIRONE HCL (BUSPIRONE HYDROCHLORIDE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 5 BUSPIRONE HYDROCHLORIDE ACTIVE INGREDIENT 207LT9J9OC BUSPIRONE HYDROCHLORIDE (BUSPIRONE) TABLET [PHYSICIANS TOTAL CARE, INC.] 5 BUSPIRONE ACTIVE MOIETY TK65WKS8HL BUSPIRONE HCL (BUSPIRONE HYDROCHLORIDE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 5 BUSPIRONE ACTIVE MOIETY TK65WKS8HL BUSPIRONE HYDROCHLORIDE (BUSPIRONE) TABLET [PHYSICIANS TOTAL CARE, INC.] 5 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U BUSPIRONE HCL (BUSPIRONE HYDROCHLORIDE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 5 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U BUSPIRONE HYDROCHLORIDE (BUSPIRONE) TABLET [PHYSICIANS TOTAL CARE, INC.] 5 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X BUSPIRONE HCL (BUSPIRONE HYDROCHLORIDE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 5 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X BUSPIRONE HYDROCHLORIDE (BUSPIRONE) TABLET [PHYSICIANS TOTAL CARE, INC.] 5 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 BUSPIRONE HYDROCHLORIDE (BUSPIRONE) TABLET [PHYSICIANS TOTAL CARE, INC.] 5 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 BUSPIRONE HCL (BUSPIRONE HYDROCHLORIDE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 5 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 BUSPIRONE HYDROCHLORIDE (BUSPIRONE) TABLET [PHYSICIANS TOTAL CARE, INC.] 5 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 BUSPIRONE HCL (BUSPIRONE HYDROCHLORIDE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 5 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 BUSPIRONE HYDROCHLORIDE (BUSPIRONE) TABLET [PHYSICIANS TOTAL CARE, INC.] 5 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 BUSPIRONE HCL (BUSPIRONE HYDROCHLORIDE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 5 BUSPIRONE HYDROCHLORIDE ACTIVE INGREDIENT 207LT9J9OC BUSPIRONE HCL (BUSPIRONE HYDROCHLORIDE) TABLET [TYA PHARMACEUTICALS] 4 BUSPIRONE ACTIVE MOIETY TK65WKS8HL BUSPIRONE HCL (BUSPIRONE HYDROCHLORIDE) TABLET [TYA PHARMACEUTICALS] 4 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U BUSPIRONE HCL (BUSPIRONE HYDROCHLORIDE) TABLET [TYA PHARMACEUTICALS] 4 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X BUSPIRONE HCL (BUSPIRONE HYDROCHLORIDE) TABLET [TYA PHARMACEUTICALS] 4 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 BUSPIRONE HCL (BUSPIRONE HYDROCHLORIDE) TABLET [TYA PHARMACEUTICALS] 4 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 BUSPIRONE HCL (BUSPIRONE HYDROCHLORIDE) TABLET [TYA PHARMACEUTICALS] 4 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 BUSPIRONE HCL (BUSPIRONE HYDROCHLORIDE) TABLET [TYA PHARMACEUTICALS] 4 BUSPIRONE HYDROCHLORIDE ACTIVE INGREDIENT 207LT9J9OC BUSPIRONE HCL (BUSPIRONE HYDROCHLORIDE) TABLET [BLENHEIM PHARMACAL, INC.] 1 BUSPIRONE HYDROCHLORIDE ACTIVE INGREDIENT 207LT9J9OC BUSPIRONE HCL (BUSPIRONE HYDROCHLORIDE) TABLET [PROFICIENT RX LP] 1 Buspirone hydrochloride ACTIVE INGREDIENT 207LT9J9OC BUSPIRONE HCL (BUSPIRONE HYDROCHLORIDE) TABLET [REBEL DISTRIBUTORS CORP.] 1 BUSPIRONE HYDROCHLORIDE ACTIVE INGREDIENT 207LT9J9OC BUSPIRONE HCL (BUSPIRONE HYDROCHLORIDE) TABLET [DISPENSING SOLUTIONS, INC.] 1 Buspirone ACTIVE MOIETY TK65WKS8HL BUSPIRONE HCL (BUSPIRONE HYDROCHLORIDE) TABLET [REBEL DISTRIBUTORS CORP.] 1 BUSPIRONE ACTIVE MOIETY TK65WKS8HL BUSPIRONE HCL (BUSPIRONE HYDROCHLORIDE) TABLET [BLENHEIM PHARMACAL, INC.] 1 BUSPIRONE ACTIVE MOIETY TK65WKS8HL BUSPIRONE HCL (BUSPIRONE HYDROCHLORIDE) TABLET [PROFICIENT RX LP] 1 BUSPIRONE ACTIVE MOIETY TK65WKS8HL BUSPIRONE HCL (BUSPIRONE HYDROCHLORIDE) TABLET [DISPENSING SOLUTIONS, INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U BUSPIRONE HCL (BUSPIRONE HYDROCHLORIDE) TABLET [PROFICIENT RX LP] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U BUSPIRONE HCL (BUSPIRONE HYDROCHLORIDE) TABLET [BLENHEIM PHARMACAL, INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U BUSPIRONE HCL (BUSPIRONE HYDROCHLORIDE) TABLET [REBEL DISTRIBUTORS CORP.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U BUSPIRONE HCL (BUSPIRONE HYDROCHLORIDE) TABLET [DISPENSING SOLUTIONS, INC.] 1 COLLOIDAL SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 BUSPIRONE HCL (BUSPIRONE HYDROCHLORIDE) TABLET [DISPENSING SOLUTIONS, INC.] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X BUSPIRONE HCL (BUSPIRONE HYDROCHLORIDE) TABLET [PROFICIENT RX LP] 1 lactose monohydrate INACTIVE INGREDIENT EWQ57Q8I5X BUSPIRONE HCL (BUSPIRONE HYDROCHLORIDE) TABLET [REBEL DISTRIBUTORS CORP.] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X BUSPIRONE HCL (BUSPIRONE HYDROCHLORIDE) TABLET [DISPENSING SOLUTIONS, INC.] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X BUSPIRONE HCL (BUSPIRONE HYDROCHLORIDE) TABLET [BLENHEIM PHARMACAL, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 BUSPIRONE HCL (BUSPIRONE HYDROCHLORIDE) TABLET [PROFICIENT RX LP] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 BUSPIRONE HCL (BUSPIRONE HYDROCHLORIDE) TABLET [DISPENSING SOLUTIONS, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 BUSPIRONE HCL (BUSPIRONE HYDROCHLORIDE) TABLET [BLENHEIM PHARMACAL, INC.] 1 magnesium stearate INACTIVE INGREDIENT 70097M6I30 BUSPIRONE HCL (BUSPIRONE HYDROCHLORIDE) TABLET [REBEL DISTRIBUTORS CORP.] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 BUSPIRONE HCL (BUSPIRONE HYDROCHLORIDE) TABLET [REBEL DISTRIBUTORS CORP.] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 BUSPIRONE HCL (BUSPIRONE HYDROCHLORIDE) TABLET [BLENHEIM PHARMACAL, INC.] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 BUSPIRONE HCL (BUSPIRONE HYDROCHLORIDE) TABLET [PROFICIENT RX LP] 1 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 BUSPIRONE HCL (BUSPIRONE HYDROCHLORIDE) TABLET [BLENHEIM PHARMACAL, INC.] 1 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 BUSPIRONE HCL (BUSPIRONE HYDROCHLORIDE) TABLET [REBEL DISTRIBUTORS CORP.] 1 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 BUSPIRONE HCL (BUSPIRONE HYDROCHLORIDE) TABLET [PROFICIENT RX LP] 1 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 BUSPIRONE HCL (BUSPIRONE HYDROCHLORIDE) TABLET [DISPENSING SOLUTIONS, INC.] 1
DailyMed RxNorm Mappings#