buspirone hydrochloride

Generic: buspirone hydrochloride

Labeler: mylan pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

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 15 mg/1

Manufacturer
Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0378-1165
Product ID 0378-1165_bf3ebca4-75bb-4f84-a906-06a1337e190f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076008
Listing Expiration 2027-12-31
Marketing Start 2001-03-28

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03781165
Hyphenated Format 0378-1165

Supplemental Identifiers

RxCUI
866018 866083 866090 866094 866111
UPC
0303781150019 0303781165914 0303781145015 0303781175913 0303781140010
UNII
207LT9J9OC

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 ANDA076008 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 15 mg/1
source: ndc
Packaging
  • 500 TABLET in 1 BOTTLE, PLASTIC (0378-1165-05)
  • 180 TABLET in 1 BOTTLE, PLASTIC (0378-1165-80)
  • 60 TABLET in 1 BOTTLE, PLASTIC (0378-1165-91)
source: ndc

Packages (3)

0378-1165-05 500 TABLET in 1 BOTTLE, PLASTIC (0378-1165-05) 0378-1165-80 180 TABLET in 1 BOTTLE, PLASTIC (0378-1165-80) 0378-1165-91 60 TABLET in 1 BOTTLE, PLASTIC (0378-1165-91)

Ingredients (1)

buspirone hydrochloride (15 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": "bf3ebca4-75bb-4f84-a906-06a1337e190f", "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": "500 TABLET in 1 BOTTLE, PLASTIC (0378-1165-05)", "package_ndc": "0378-1165-05", "marketing_start_date": "20010329"}, {"sample": false, "description": "180 TABLET in 1 BOTTLE, PLASTIC (0378-1165-80)", "package_ndc": "0378-1165-80", "marketing_end_date": "20260930", "marketing_start_date": "20010329"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE, PLASTIC (0378-1165-91)", "package_ndc": "0378-1165-91", "marketing_end_date": "20260930", "marketing_start_date": "20010328"}], "brand_name": "Buspirone Hydrochloride", "product_id": "0378-1165_bf3ebca4-75bb-4f84-a906-06a1337e190f", "dosage_form": "TABLET", "product_ndc": "0378-1165", "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": "15 mg/1"}], "application_number": "ANDA076008", "marketing_category": "ANDA", "marketing_start_date": "20010328", "listing_expiration_date": "20271231"}