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 10 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-962
Product ID 71610-962_47e30f25-1be3-1cd2-e063-6294a90ae97f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202087
Listing Expiration 2027-12-31
Marketing Start 2025-09-18

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71610962
Hyphenated Format 71610-962

Supplemental Identifiers

RxCUI
866083
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
  • 10 mg/1
source: ndc
Packaging
  • 60 TABLET in 1 BOTTLE (71610-962-53)
  • 90 TABLET in 1 BOTTLE (71610-962-60)
  • 120 TABLET in 1 BOTTLE (71610-962-70)
  • 180 TABLET in 1 BOTTLE (71610-962-80)
  • 270 TABLET in 1 BOTTLE (71610-962-92)
source: ndc

Packages (5)

71610-962-53 60 TABLET in 1 BOTTLE (71610-962-53) 71610-962-60 90 TABLET in 1 BOTTLE (71610-962-60) 71610-962-70 120 TABLET in 1 BOTTLE (71610-962-70) 71610-962-80 180 TABLET in 1 BOTTLE (71610-962-80) 71610-962-92 270 TABLET in 1 BOTTLE (71610-962-92)

Ingredients (1)

buspirone hydrochloride (10 mg/1)

Linked Drug Pages (1)

Buspirone hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "47e30f25-1be3-1cd2-e063-6294a90ae97f", "openfda": {"unii": ["207LT9J9OC"], "rxcui": ["866083"], "spl_set_id": ["427ad27e-6664-afee-e063-6394a90a1890"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET in 1 BOTTLE (71610-962-53)", "package_ndc": "71610-962-53", "marketing_start_date": "20251105"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (71610-962-60)", "package_ndc": "71610-962-60", "marketing_start_date": "20251031"}, {"sample": false, "description": "120 TABLET in 1 BOTTLE (71610-962-70)", "package_ndc": "71610-962-70", "marketing_start_date": "20260108"}, {"sample": false, "description": "180 TABLET in 1 BOTTLE (71610-962-80)", "package_ndc": "71610-962-80", "marketing_start_date": "20251105"}, {"sample": false, "description": "270 TABLET in 1 BOTTLE (71610-962-92)", "package_ndc": "71610-962-92", "marketing_start_date": "20260108"}], "brand_name": "Buspirone hydrochloride", "product_id": "71610-962_47e30f25-1be3-1cd2-e063-6294a90ae97f", "dosage_form": "TABLET", "product_ndc": "71610-962", "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": "10 mg/1"}], "application_number": "ANDA202087", "marketing_category": "ANDA", "marketing_start_date": "20250918", "listing_expiration_date": "20271231"}