buphenyl

Generic: sodium phenylbutyrate

Labeler: horizon therapeutics usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name buphenyl
Generic Name sodium phenylbutyrate
Labeler horizon therapeutics usa, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

sodium phenylbutyrate 500 mg/1

Manufacturer
Horizon Therapeutics USA, Inc.

Identifiers & Regulatory

Product NDC 75987-060
Product ID 75987-060_3178e0bc-ebb7-4ddd-be43-630ff87eeb02
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA020572
Listing Expiration 2026-12-31
Marketing Start 1996-05-13

Pharmacologic Class

Classes
ammonium ion binding activity [moa] nitrogen binding agent [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 75987060
Hyphenated Format 75987-060

Supplemental Identifiers

RxCUI
199369 213196 984105 984107
UNII
NT6K61736T

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 buphenyl (source: ndc)
Generic Name sodium phenylbutyrate (source: ndc)
Application Number NDA020572 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (75987-060-08) / 250 TABLET in 1 BOTTLE
source: ndc

Packages (1)

75987-060-08 1 BOTTLE in 1 CARTON (75987-060-08) / 250 TABLET in 1 BOTTLE

Ingredients (1)

sodium phenylbutyrate (500 mg/1)

Linked Drug Pages (1)

BUPHENYL, Buphenyl ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3178e0bc-ebb7-4ddd-be43-630ff87eeb02", "openfda": {"unii": ["NT6K61736T"], "rxcui": ["199369", "213196", "984105", "984107"], "spl_set_id": ["463a36fa-3eb2-4326-8bd0-c8c7a11bca3a"], "manufacturer_name": ["Horizon Therapeutics USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (75987-060-08)  / 250 TABLET in 1 BOTTLE", "package_ndc": "75987-060-08", "marketing_start_date": "19960513"}], "brand_name": "BUPHENYL", "product_id": "75987-060_3178e0bc-ebb7-4ddd-be43-630ff87eeb02", "dosage_form": "TABLET", "pharm_class": ["Ammonium Ion Binding Activity [MoA]", "Nitrogen Binding Agent [EPC]"], "product_ndc": "75987-060", "generic_name": "sodium phenylbutyrate", "labeler_name": "Horizon Therapeutics USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "BUPHENYL", "active_ingredients": [{"name": "SODIUM PHENYLBUTYRATE", "strength": "500 mg/1"}], "application_number": "NDA020572", "marketing_category": "NDA", "marketing_start_date": "19960513", "listing_expiration_date": "20261231"}