Home NDC 24689-933 Buspirone Hydrochloride
Product NDC 24689-933
11-digit product format 246890933
Labeler code 24689
Product ID 24689-933_19f3df29-51b2-7f8b-e063-6294a90a542f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Buspirone Hydrochloride
Dosage form TABLET
Route ORAL
Labeler APNAR PHARMA LP
Application ANDA209696
Marketing category ANDA
Marketing start 2024-06-17
Substance BUSPIRONE HYDROCHLORIDE
Active strength 30 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 · 5 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A209696-001 BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2018-05-03 A209696-002 BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2018-05-03 A209696-003 BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2018-05-03 A209696-004 BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2018-05-03 A209696-005 BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 30MG TABLET / ORAL AB 2018-05-03
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 · 215 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 A209696-001 BUSPIRONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2018-05-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 A209696-002 BUSPIRONE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2018-05-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 A209696-003 BUSPIRONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2018-05-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 A209696-004 BUSPIRONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2018-05-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 A209696-005 BUSPIRONE HYDROCHLORIDE 30MG TABLET / ORAL AB 2018-05-03 84e616aacf4f…2026-08-18 06:07:40 2026-07 A209696-001 BUSPIRONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2018-05-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A209696-002 BUSPIRONE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2018-05-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A209696-003 BUSPIRONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2018-05-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A209696-004 BUSPIRONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2018-05-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A209696-005 BUSPIRONE HYDROCHLORIDE 30MG TABLET / ORAL AB 2018-05-03 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A209696-001 BUSPIRONE HYDROCHLORIDE 5MG TABLET / ORAL BX 2018-05-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A209696-002 BUSPIRONE HYDROCHLORIDE 7.5MG TABLET / ORAL BX 2018-05-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A209696-003 BUSPIRONE HYDROCHLORIDE 10MG TABLET / ORAL BX 2018-05-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A209696-004 BUSPIRONE HYDROCHLORIDE 15MG TABLET / ORAL BX 2018-05-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A209696-005 BUSPIRONE HYDROCHLORIDE 30MG TABLET / ORAL BX 2018-05-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209696-001 BUSPIRONE HYDROCHLORIDE 5MG TABLET / ORAL BX 2018-05-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209696-002 BUSPIRONE HYDROCHLORIDE 7.5MG TABLET / ORAL BX 2018-05-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209696-003 BUSPIRONE HYDROCHLORIDE 10MG TABLET / ORAL BX 2018-05-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209696-004 BUSPIRONE HYDROCHLORIDE 15MG TABLET / ORAL BX 2018-05-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209696-005 BUSPIRONE HYDROCHLORIDE 30MG TABLET / ORAL BX 2018-05-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209696-001 BUSPIRONE HYDROCHLORIDE 5MG TABLET / ORAL BX 2018-05-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A209696-002 BUSPIRONE HYDROCHLORIDE 7.5MG TABLET / ORAL BX 2018-05-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A209696-003 BUSPIRONE HYDROCHLORIDE 10MG TABLET / ORAL BX 2018-05-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A209696-004 BUSPIRONE HYDROCHLORIDE 15MG TABLET / ORAL BX 2018-05-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A209696-005 BUSPIRONE HYDROCHLORIDE 30MG TABLET / ORAL BX 2018-05-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209696-001 BUSPIRONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2018-05-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209696-002 BUSPIRONE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2018-05-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209696-003 BUSPIRONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2018-05-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209696-004 BUSPIRONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2018-05-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209696-005 BUSPIRONE HYDROCHLORIDE 30MG TABLET / ORAL AB 2018-05-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209696-001 BUSPIRONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2018-05-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209696-002 BUSPIRONE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2018-05-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209696-003 BUSPIRONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2018-05-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209696-004 BUSPIRONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2018-05-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209696-005 BUSPIRONE HYDROCHLORIDE 30MG TABLET / ORAL AB 2018-05-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209696-001 BUSPIRONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2018-05-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209696-002 BUSPIRONE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2018-05-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209696-003 BUSPIRONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2018-05-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209696-004 BUSPIRONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2018-05-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209696-005 BUSPIRONE HYDROCHLORIDE 30MG TABLET / ORAL AB 2018-05-03 03ed91905a0d…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 6 · 215 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 30 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 · 5 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 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 24689-933-06 Buspirone Hydrochloride 60 in 1 BOTTLE TABLET 60 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 24689-933 BUSPIRONE HYDROCHLORIDE TABLET [APNAR PHARMA LP] 8 Current NDC, Legacy NDC, 1 package rows 20240618_3c115eea-9dbc-4e2c-9d79-42e3388fde5a.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 24689-933-06 24689093306 60 TABLET in 1 BOTTLE (24689-933-06) 60 tablet 2024-06-17 0000-00-00 No No Current