Home NDC 72789-181 Buspirone Hydrochloride
Product NDC 72789-181
11-digit product format 727890181
Labeler code 72789
Product ID 72789-181_4019e519-dc9e-1fc4-e063-6294a90a8865
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name buspirone hydrochloride
Dosage form TABLET
Route ORAL
Labeler PD-Rx Pharmaceuticals, Inc.
Application ANDA075388
Marketing category ANDA
Marketing start 2020-07-27
Substance BUSPIRONE HYDROCHLORIDE
Active strength 10 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 43 .
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 A075388-001 BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2002-05-09 A075388-002 BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2002-05-09 A075388-003 BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2002-05-09
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 · 129 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 2026-09-14 22:38:34 2026-08 A075388-001 BUSPIRONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2002-05-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 A075388-002 BUSPIRONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2002-05-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 A075388-003 BUSPIRONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2002-05-09 84e616aacf4f…2026-08-18 06:07:40 2026-07 A075388-001 BUSPIRONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2002-05-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A075388-002 BUSPIRONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2002-05-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A075388-003 BUSPIRONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2002-05-09 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A075388-001 BUSPIRONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2002-05-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075388-002 BUSPIRONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2002-05-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075388-003 BUSPIRONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2002-05-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075388-001 BUSPIRONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2002-05-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075388-002 BUSPIRONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2002-05-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075388-003 BUSPIRONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2002-05-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075388-001 BUSPIRONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2002-05-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075388-002 BUSPIRONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2002-05-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075388-003 BUSPIRONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2002-05-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075388-001 BUSPIRONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2002-05-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075388-002 BUSPIRONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2002-05-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075388-003 BUSPIRONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2002-05-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075388-001 BUSPIRONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2002-05-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075388-002 BUSPIRONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2002-05-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075388-003 BUSPIRONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2002-05-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075388-001 BUSPIRONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2002-05-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075388-002 BUSPIRONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2002-05-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075388-003 BUSPIRONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2002-05-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075388-001 BUSPIRONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2002-05-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075388-002 BUSPIRONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2002-05-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075388-003 BUSPIRONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2002-05-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075388-001 BUSPIRONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2002-05-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075388-002 BUSPIRONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2002-05-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075388-003 BUSPIRONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2002-05-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075388-001 BUSPIRONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2002-05-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075388-002 BUSPIRONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2002-05-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075388-003 BUSPIRONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2002-05-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075388-001 BUSPIRONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2002-05-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075388-002 BUSPIRONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2002-05-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075388-003 BUSPIRONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2002-05-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075388-001 BUSPIRONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2002-05-09 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075388-002 BUSPIRONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2002-05-09 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075388-003 BUSPIRONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2002-05-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075388-001 BUSPIRONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2002-05-09 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 117 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 10 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 866083 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 72789-181-90 Buspirone Hydrochloride 90 in 1 BOTTLE, PLASTIC TABLET 90 11
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72789-181 BUSPIRONE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.] 10 Current NDC, Legacy NDC, 1 package rows 20240412_b217f341-7d51-475d-887f-f16786164c7b.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 2 of 2 · 25 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 72789-181-90 72789018190 90 TABLET in 1 BOTTLE, PLASTIC (72789-181-90) 90 tablet 2021-04-13 0000-00-00 No No Current