buspirone hydrochloride

Generic: buspirone hydrochloride

Labeler: aphena pharma solutions - tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name buspirone hydrochloride
Generic Name buspirone hydrochloride
Labeler aphena pharma solutions - tennessee, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

buspirone hydrochloride 5 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-959
Product ID 71610-959_45a02819-f5c1-f623-e063-6294a90a1284
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202087
Listing Expiration 2026-12-31
Marketing Start 2025-09-18

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71610959
Hyphenated Format 71610-959

Supplemental Identifiers

RxCUI
866094
UNII
207LT9J9OC

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name buspirone hydrochloride (source: ndc)
Generic Name buspirone hydrochloride (source: ndc)
Application Number ANDA202087 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (71610-959-30)
  • 60 TABLET in 1 BOTTLE (71610-959-53)
  • 90 TABLET in 1 BOTTLE (71610-959-60)
  • 180 TABLET in 1 BOTTLE (71610-959-80)
  • 270 TABLET in 1 BOTTLE (71610-959-92)
source: ndc

Packages (5)

Ingredients (1)

buspirone hydrochloride (5 mg/1)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "45a02819-f5c1-f623-e063-6294a90a1284", "openfda": {"unii": ["207LT9J9OC"], "rxcui": ["866094"], "spl_set_id": ["424d81f0-b195-5bc2-e063-6394a90a2104"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (71610-959-30)", "package_ndc": "71610-959-30", "marketing_start_date": "20251028"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (71610-959-53)", "package_ndc": "71610-959-53", "marketing_start_date": "20251028"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (71610-959-60)", "package_ndc": "71610-959-60", "marketing_start_date": "20251028"}, {"sample": false, "description": "180 TABLET in 1 BOTTLE (71610-959-80)", "package_ndc": "71610-959-80", "marketing_start_date": "20251028"}, {"sample": false, "description": "270 TABLET in 1 BOTTLE (71610-959-92)", "package_ndc": "71610-959-92", "marketing_start_date": "20251209"}], "brand_name": "Buspirone hydrochloride", "product_id": "71610-959_45a02819-f5c1-f623-e063-6294a90a1284", "dosage_form": "TABLET", "product_ndc": "71610-959", "generic_name": "Buspirone hydrochloride", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Buspirone hydrochloride", "active_ingredients": [{"name": "BUSPIRONE HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "ANDA202087", "marketing_category": "ANDA", "marketing_start_date": "20250918", "listing_expiration_date": "20261231"}