Home NDC 82868-082 busPIRone HCl
Product NDC 82868-082
11-digit product format 828680082
Labeler code 82868
Product ID 82868-082_549f29bc-fc35-3e7f-e063-6294a90ad602
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name buspirone hydrochloride
Dosage form TABLET
Route ORAL
Labeler Northwind Health Company, LLC
Application ANDA075521
Marketing category ANDA
Marketing start 2025-06-19
Substance BUSPIRONE HYDROCHLORIDE
Active strength 7.5 mg/1
NDC exclude flag No
Listing certified through 2027-12-31
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 A075521-001 BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2002-04-05 A075521-002 BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2002-04-05 A075521-003 BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2002-04-05 A075521-004 BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2021-03-16 A075521-005 BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 30MG TABLET / ORAL AB 2021-03-16
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 · 201 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 A075521-001 BUSPIRONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2002-04-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 A075521-002 BUSPIRONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2002-04-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 A075521-003 BUSPIRONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2002-04-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 A075521-004 BUSPIRONE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2021-03-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 A075521-005 BUSPIRONE HYDROCHLORIDE 30MG TABLET / ORAL AB 2021-03-16 84e616aacf4f…2026-08-18 06:07:40 2026-07 A075521-001 BUSPIRONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2002-04-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A075521-002 BUSPIRONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2002-04-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A075521-003 BUSPIRONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2002-04-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A075521-004 BUSPIRONE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2021-03-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A075521-005 BUSPIRONE HYDROCHLORIDE 30MG TABLET / ORAL AB 2021-03-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A075521-001 BUSPIRONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2002-04-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075521-002 BUSPIRONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2002-04-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075521-003 BUSPIRONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2002-04-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075521-004 BUSPIRONE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2021-03-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075521-005 BUSPIRONE HYDROCHLORIDE 30MG TABLET / ORAL AB 2021-03-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075521-001 BUSPIRONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2002-04-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075521-002 BUSPIRONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2002-04-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075521-003 BUSPIRONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2002-04-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075521-004 BUSPIRONE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2021-03-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075521-005 BUSPIRONE HYDROCHLORIDE 30MG TABLET / ORAL AB 2021-03-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075521-001 BUSPIRONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2002-04-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075521-002 BUSPIRONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2002-04-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075521-003 BUSPIRONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2002-04-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075521-004 BUSPIRONE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2021-03-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075521-005 BUSPIRONE HYDROCHLORIDE 30MG TABLET / ORAL AB 2021-03-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075521-001 BUSPIRONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2002-04-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075521-002 BUSPIRONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2002-04-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075521-003 BUSPIRONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2002-04-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075521-004 BUSPIRONE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2021-03-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075521-005 BUSPIRONE HYDROCHLORIDE 30MG TABLET / ORAL AB 2021-03-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075521-001 BUSPIRONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2002-04-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075521-002 BUSPIRONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2002-04-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075521-003 BUSPIRONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2002-04-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075521-004 BUSPIRONE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2021-03-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075521-005 BUSPIRONE HYDROCHLORIDE 30MG TABLET / ORAL AB 2021-03-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075521-001 BUSPIRONE HYDROCHLORIDE 5MG TABLET / ORAL AB 2002-04-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075521-002 BUSPIRONE HYDROCHLORIDE 10MG TABLET / ORAL AB 2002-04-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075521-003 BUSPIRONE HYDROCHLORIDE 15MG TABLET / ORAL AB 2002-04-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075521-004 BUSPIRONE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2021-03-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075521-005 BUSPIRONE HYDROCHLORIDE 30MG TABLET / ORAL AB 2021-03-16 03ed91905a0d…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 180 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 HCl
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BUSPIRONE HYDROCHLORIDE 7.5 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 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 82868-082-30 busPIRone HCl 30 in 1 BOTTLE, PLASTIC TABLET 30 2
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 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 82868-082-30 82868008230 30 TABLET in 1 BOTTLE, PLASTIC (82868-082-30) 30 tablet 2025-06-19 No No Current