buspirone hydrochloride

Generic: buspirone hydrochloride

Labeler: asclemed usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name buspirone hydrochloride
Generic Name buspirone hydrochloride
Labeler asclemed usa, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

buspirone hydrochloride 15 mg/1

Manufacturer
Asclemed USA, Inc.

Identifiers & Regulatory

Product NDC 76420-809
Product ID 76420-809_18136eaf-1bda-f421-e063-6394a90a2e20
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210907
Listing Expiration 2026-12-31
Marketing Start 2019-11-14

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 76420809
Hyphenated Format 76420-809

Supplemental Identifiers

RxCUI
866018 866083 866090 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 ANDA210907 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 15 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE, PLASTIC (76420-809-01)
  • 500 TABLET in 1 BOTTLE, PLASTIC (76420-809-05)
  • 180 TABLET in 1 BOTTLE, PLASTIC (76420-809-18)
  • 30 TABLET in 1 BOTTLE, PLASTIC (76420-809-30)
  • 60 TABLET in 1 BOTTLE, PLASTIC (76420-809-60)
  • 90 TABLET in 1 BOTTLE, PLASTIC (76420-809-90)
source: ndc

Packages (6)

76420-809-01 100 TABLET in 1 BOTTLE, PLASTIC (76420-809-01) 76420-809-05 500 TABLET in 1 BOTTLE, PLASTIC (76420-809-05) 76420-809-18 180 TABLET in 1 BOTTLE, PLASTIC (76420-809-18) 76420-809-30 30 TABLET in 1 BOTTLE, PLASTIC (76420-809-30) 76420-809-60 60 TABLET in 1 BOTTLE, PLASTIC (76420-809-60) 76420-809-90 90 TABLET in 1 BOTTLE, PLASTIC (76420-809-90)

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": "18136eaf-1bda-f421-e063-6394a90a2e20", "openfda": {"unii": ["207LT9J9OC"], "rxcui": ["866018", "866083", "866090", "866094"], "spl_set_id": ["97f2d082-0931-4e4f-a5be-7792e399e42b"], "manufacturer_name": ["Asclemed USA, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE, PLASTIC (76420-809-01)", "package_ndc": "76420-809-01", "marketing_start_date": "20240506"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE, PLASTIC (76420-809-05)", "package_ndc": "76420-809-05", "marketing_start_date": "20240506"}, {"sample": false, "description": "180 TABLET in 1 BOTTLE, PLASTIC (76420-809-18)", "package_ndc": "76420-809-18", "marketing_start_date": "20240506"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (76420-809-30)", "package_ndc": "76420-809-30", "marketing_start_date": "20240506"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE, PLASTIC (76420-809-60)", "package_ndc": "76420-809-60", "marketing_start_date": "20240506"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE, PLASTIC (76420-809-90)", "package_ndc": "76420-809-90", "marketing_start_date": "20240506"}], "brand_name": "Buspirone Hydrochloride", "product_id": "76420-809_18136eaf-1bda-f421-e063-6394a90a2e20", "dosage_form": "TABLET", "product_ndc": "76420-809", "generic_name": "Buspirone Hydrochloride", "labeler_name": "Asclemed USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Buspirone Hydrochloride", "active_ingredients": [{"name": "BUSPIRONE HYDROCHLORIDE", "strength": "15 mg/1"}], "application_number": "ANDA210907", "marketing_category": "ANDA", "marketing_start_date": "20191114", "listing_expiration_date": "20261231"}