buspirone hydrochloride

Generic: buspirone hydrochloride

Labeler: epic pharma, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name buspirone hydrochloride
Generic Name buspirone hydrochloride
Labeler epic pharma, llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

buspirone 10 mg/1

Manufacturer
EPIC PHARMA, LLC

Identifiers & Regulatory

Product NDC 42806-832
Product ID 42806-832_160f52d2-2e08-4969-80c3-c653767652f0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218628
Listing Expiration 2026-12-31
Marketing Start 2025-03-13

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42806832
Hyphenated Format 42806-832

Supplemental Identifiers

RxCUI
2708991 2708993 2708994
UPC
0342806832011
UNII
TK65WKS8HL

Packaging Origin

Original Packager
true

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 ANDA218628 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (42806-832-01)
source: ndc

Packages (1)

Ingredients (1)

buspirone (10 mg/1)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "160f52d2-2e08-4969-80c3-c653767652f0", "openfda": {"upc": ["0342806832011"], "unii": ["TK65WKS8HL"], "rxcui": ["2708991", "2708993", "2708994"], "spl_set_id": ["160f52d2-2e08-4969-80c3-c653767652f0"], "manufacturer_name": ["EPIC PHARMA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (42806-832-01)", "package_ndc": "42806-832-01", "marketing_start_date": "20250313"}], "brand_name": "Buspirone Hydrochloride", "product_id": "42806-832_160f52d2-2e08-4969-80c3-c653767652f0", "dosage_form": "CAPSULE", "product_ndc": "42806-832", "generic_name": "Buspirone Hydrochloride", "labeler_name": "EPIC PHARMA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Buspirone Hydrochloride", "active_ingredients": [{"name": "BUSPIRONE", "strength": "10 mg/1"}], "application_number": "ANDA218628", "marketing_category": "ANDA", "marketing_start_date": "20250313", "listing_expiration_date": "20261231"}