buspirone hydrochloride

Generic: buspirone hydrochloride

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

Drug Facts

Product Profile

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

buspirone hydrochloride 10 mg/1

Manufacturer
Nivagen Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 75834-268
Product ID 75834-268_5bad7053-8f63-45fc-adb0-88c628fa039b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209696
Listing Expiration 2026-12-31
Marketing Start 2021-02-15

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 75834268
Hyphenated Format 75834-268

Supplemental Identifiers

RxCUI
866018 866083 866090 866094 866111
UPC
0375834270609 0375834269016
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 ANDA209696 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (75834-268-01)
  • 500 TABLET in 1 BOTTLE (75834-268-05)
source: ndc

Packages (2)

75834-268-01 100 TABLET in 1 BOTTLE (75834-268-01) 75834-268-05 500 TABLET in 1 BOTTLE (75834-268-05)

Ingredients (1)

buspirone hydrochloride (10 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": "5bad7053-8f63-45fc-adb0-88c628fa039b", "openfda": {"upc": ["0375834270609", "0375834269016"], "unii": ["207LT9J9OC"], "rxcui": ["866018", "866083", "866090", "866094", "866111"], "spl_set_id": ["b08dd2e7-e808-4b51-b404-5009076b82eb"], "manufacturer_name": ["Nivagen Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (75834-268-01)", "package_ndc": "75834-268-01", "marketing_start_date": "20210215"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (75834-268-05)", "package_ndc": "75834-268-05", "marketing_start_date": "20210215"}], "brand_name": "Buspirone Hydrochloride", "product_id": "75834-268_5bad7053-8f63-45fc-adb0-88c628fa039b", "dosage_form": "TABLET", "product_ndc": "75834-268", "generic_name": "Buspirone Hydrochloride", "labeler_name": "Nivagen Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Buspirone Hydrochloride", "active_ingredients": [{"name": "BUSPIRONE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA209696", "marketing_category": "ANDA", "marketing_start_date": "20210215", "listing_expiration_date": "20261231"}