Home NDC 10544-176 Buspirone HCl
Product NDC 10544-176
11-digit product format 105440176
Labeler code 10544
Product ID 10544-176_0f67e593-2c34-54d5-e054-00144ff88e88
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Buspirone hydrochloride
Dosage form TABLET
Route ORAL
Labeler Blenheim Pharmacal, Inc.
Application ANDA074253
Marketing category ANDA
Marketing start 2013-11-15
Marketing end 0000-00-00
Substance BUSPIRONE HYDROCHLORIDE
Active strength 10 mg/1
NDC exclude flag E
Listing certified through 2017-12-31
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 2 · 66 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 · 132 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 2026-10-15 13:18:30 2026-09 A074253-001 BUSPIRONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2001-03-28 c2088c7a36db…2026-10-15 13:18:30 2026-09 A074253-002 BUSPIRONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2001-03-28 c2088c7a36db…2026-10-15 13:18:30 2026-09 A074253-003 BUSPIRONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2002-03-13 c2088c7a36db…2026-09-14 22:38:34 2026-08 A074253-001 BUSPIRONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2001-03-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 A074253-002 BUSPIRONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2001-03-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 A074253-003 BUSPIRONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2002-03-13 84e616aacf4f…2026-08-18 06:07:40 2026-07 A074253-001 BUSPIRONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2001-03-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A074253-002 BUSPIRONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2001-03-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A074253-003 BUSPIRONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2002-03-13 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Normalized TE history page 4 of 4 · 132 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 10544-176-30 Buspirone HCl 30 in 1 BOTTLE, PLASTIC TABLET 30 1 10544-176-90 Buspirone HCl 90 in 1 BOTTLE, PLASTIC TABLET 90 1
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 [BLENHEIM PHARMACAL, INC.] 1 BUSPIRONE ACTIVE MOIETY TK65WKS8HL BUSPIRONE HCL (BUSPIRONE HYDROCHLORIDE) TABLET [BLENHEIM PHARMACAL, INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U BUSPIRONE HCL (BUSPIRONE HYDROCHLORIDE) TABLET [BLENHEIM PHARMACAL, 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 [BLENHEIM PHARMACAL, INC.] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 BUSPIRONE HCL (BUSPIRONE HYDROCHLORIDE) TABLET [BLENHEIM PHARMACAL, INC.] 1 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 BUSPIRONE HCL (BUSPIRONE HYDROCHLORIDE) TABLET [BLENHEIM PHARMACAL, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 10544-176 BUSPIRONE HCL (BUSPIRONE HYDROCHLORIDE) TABLET [BLENHEIM PHARMACAL, INC.] 1 Legacy NDC, 2 package rows 20150219_0f67e593-2c33-54d5-e054-00144ff88e88.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 10544-176-30 10544017630 30 in 1 BOTTLE, PLASTIC Historical 10544-176-90 10544017690 90 in 1 BOTTLE, PLASTIC Historical