Buspirone Hydrochloride

Generic: buspirone hydrochloride

Labeler: Mylan Pharmaceuticals Inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Active

Drug Facts

Product Profile

Brand Name Buspirone Hydrochloride
Generic Name buspirone hydrochloride
Labeler Mylan Pharmaceuticals Inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

BUSPIRONE HYDROCHLORIDE 7.5 mg/1

Identifiers & Regulatory

Product NDC 0378-1145
Product ID 0378-1145_e57f1e9c-369a-4176-8864-6f6b5fdd3cb3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076008
Listing Expiration 2026-12-31
Marketing Start 2013-07-31

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03781145
Hyphenated Format 0378-1145

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 ANDA076008 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 7.5 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE, PLASTIC (0378-1145-01)
source: ndc

Packages (1)

0378-1145-01 100 TABLET in 1 BOTTLE, PLASTIC (0378-1145-01)

Ingredients (1)

BUSPIRONE HYDROCHLORIDE (7.5 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": "e57f1e9c-369a-4176-8864-6f6b5fdd3cb3", "openfda": {"upc": ["0303781150019", "0303781165914", "0303781145015", "0303781175913", "0303781140010"], "unii": ["207LT9J9OC"], "rxcui": ["866018", "866083", "866090", "866094", "866111"], "spl_set_id": ["7c9eafb9-9ce1-4b28-900c-8fcb4b23424e"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE, PLASTIC (0378-1145-01)", "package_ndc": "0378-1145-01", "marketing_start_date": "20130731"}], "brand_name": "Buspirone Hydrochloride", "product_id": "0378-1145_e57f1e9c-369a-4176-8864-6f6b5fdd3cb3", "dosage_form": "TABLET", "product_ndc": "0378-1145", "generic_name": "buspirone hydrochloride", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Buspirone Hydrochloride", "active_ingredients": [{"name": "BUSPIRONE HYDROCHLORIDE", "strength": "7.5 mg/1"}], "application_number": "ANDA076008", "marketing_category": "ANDA", "marketing_start_date": "20130731", "listing_expiration_date": "20261231"}