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 71610-943
Product ID 71610-943_3e4b22e7-e800-e5b1-e063-6294a90a6d49
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075388
Listing Expiration 2026-12-31
Marketing Start 2020-07-27

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71610943
Hyphenated Format 71610-943

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 ANDA075388 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 60 TABLET in 1 BOTTLE (71610-943-53)
  • 90 TABLET in 1 BOTTLE (71610-943-60)
  • 180 TABLET in 1 BOTTLE (71610-943-80)
  • 270 TABLET in 1 BOTTLE (71610-943-92)
source: ndc

Packages (4)

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": "3e4b22e7-e800-e5b1-e063-6294a90a6d49", "openfda": {"unii": ["207LT9J9OC"], "rxcui": ["866094"], "spl_set_id": ["3dd7f213-afd8-67d6-e063-6294a90ac108"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET in 1 BOTTLE (71610-943-53)", "package_ndc": "71610-943-53", "marketing_start_date": "20250902"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (71610-943-60)", "package_ndc": "71610-943-60", "marketing_start_date": "20250902"}, {"sample": false, "description": "180 TABLET in 1 BOTTLE (71610-943-80)", "package_ndc": "71610-943-80", "marketing_start_date": "20250902"}, {"sample": false, "description": "270 TABLET in 1 BOTTLE (71610-943-92)", "package_ndc": "71610-943-92", "marketing_start_date": "20250903"}], "brand_name": "Buspirone Hydrochloride", "product_id": "71610-943_3e4b22e7-e800-e5b1-e063-6294a90a6d49", "dosage_form": "TABLET", "product_ndc": "71610-943", "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": "ANDA075388", "marketing_category": "ANDA", "marketing_start_date": "20200727", "listing_expiration_date": "20261231"}