buspirone hydrochloride

Generic: buspirone hydrochloride

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

Drug Facts

Product Profile

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

buspirone hydrochloride 7.5 mg/1

Manufacturer
Zydus Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 68382-623
Product ID 68382-623_8692aee8-7eb4-4cbb-8a31-3ecc49660195
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078888
Listing Expiration 2026-12-31
Marketing Start 2023-03-21

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68382623
Hyphenated Format 68382-623

Supplemental Identifiers

RxCUI
866018 866083 866090 866094 866111
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 ANDA078888 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 7.5 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (68382-623-01)
  • 500 TABLET in 1 BOTTLE (68382-623-05)
  • 1000 TABLET in 1 BOTTLE (68382-623-10)
  • 100 BLISTER PACK in 1 CARTON (68382-623-30) / 10 TABLET in 1 BLISTER PACK
source: ndc

Packages (4)

68382-623-01 100 TABLET in 1 BOTTLE (68382-623-01) 68382-623-05 500 TABLET in 1 BOTTLE (68382-623-05) 68382-623-10 1000 TABLET in 1 BOTTLE (68382-623-10) 68382-623-30 100 BLISTER PACK in 1 CARTON (68382-623-30) / 10 TABLET in 1 BLISTER PACK

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": "8692aee8-7eb4-4cbb-8a31-3ecc49660195", "openfda": {"unii": ["207LT9J9OC"], "rxcui": ["866018", "866083", "866090", "866094", "866111"], "spl_set_id": ["14fd7c1c-778e-46d4-9024-89b319f15f39"], "manufacturer_name": ["Zydus Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (68382-623-01)", "package_ndc": "68382-623-01", "marketing_start_date": "20230321"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (68382-623-05)", "package_ndc": "68382-623-05", "marketing_start_date": "20230321"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (68382-623-10)", "package_ndc": "68382-623-10", "marketing_start_date": "20230321"}, {"sample": false, "description": "100 BLISTER PACK in 1 CARTON (68382-623-30)  / 10 TABLET in 1 BLISTER PACK", "package_ndc": "68382-623-30", "marketing_start_date": "20230321"}], "brand_name": "Buspirone hydrochloride", "product_id": "68382-623_8692aee8-7eb4-4cbb-8a31-3ecc49660195", "dosage_form": "TABLET", "product_ndc": "68382-623", "generic_name": "Buspirone hydrochloride", "labeler_name": "Zydus Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Buspirone hydrochloride", "active_ingredients": [{"name": "BUSPIRONE HYDROCHLORIDE", "strength": "7.5 mg/1"}], "application_number": "ANDA078888", "marketing_category": "ANDA", "marketing_start_date": "20230321", "listing_expiration_date": "20261231"}