ravicti

Generic: glycerol phenylbutyrate

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

Drug Facts

Product Profile

Brand Name ravicti
Generic Name glycerol phenylbutyrate
Labeler horizon therapeutics usa, inc.
Dosage Form LIQUID
Routes
ORAL
Active Ingredients

glycerol phenylbutyrate 1.1 g/mL

Manufacturer
Horizon Therapeutics USA, Inc.

Identifiers & Regulatory

Product NDC 75987-050
Product ID 75987-050_a58b617c-635a-4a67-9f27-f9c93f8cba22
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA203284
Listing Expiration 2026-12-31
Marketing Start 2013-02-28

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 75987050
Hyphenated Format 75987-050

Supplemental Identifiers

RxCUI
1368453 1368459
UNII
ZH6F1VCV7B

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 ravicti (source: ndc)
Generic Name glycerol phenylbutyrate (source: ndc)
Application Number NDA203284 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1.1 g/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (75987-050-06) / 25 mL in 1 BOTTLE
  • 4 BOTTLE in 1 CARTON (75987-050-07) / 25 mL in 1 BOTTLE
source: ndc

Packages (2)

75987-050-06 1 BOTTLE in 1 CARTON (75987-050-06) / 25 mL in 1 BOTTLE 75987-050-07 4 BOTTLE in 1 CARTON (75987-050-07) / 25 mL in 1 BOTTLE

Ingredients (1)

glycerol phenylbutyrate (1.1 g/mL)

Linked Drug Pages (1)

Ravicti ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "a58b617c-635a-4a67-9f27-f9c93f8cba22", "openfda": {"unii": ["ZH6F1VCV7B"], "rxcui": ["1368453", "1368459"], "spl_set_id": ["900e7dc0-9afe-4f50-80de-90567bb78519"], "manufacturer_name": ["Horizon Therapeutics USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (75987-050-06)  / 25 mL in 1 BOTTLE", "package_ndc": "75987-050-06", "marketing_start_date": "20130228"}, {"sample": false, "description": "4 BOTTLE in 1 CARTON (75987-050-07)  / 25 mL in 1 BOTTLE", "package_ndc": "75987-050-07", "marketing_start_date": "20130228"}], "brand_name": "Ravicti", "product_id": "75987-050_a58b617c-635a-4a67-9f27-f9c93f8cba22", "dosage_form": "LIQUID", "pharm_class": ["Ammonium Ion Binding Activity [MoA]", "Nitrogen Binding Agent [EPC]"], "product_ndc": "75987-050", "generic_name": "glycerol phenylbutyrate", "labeler_name": "Horizon Therapeutics USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ravicti", "active_ingredients": [{"name": "GLYCEROL PHENYLBUTYRATE", "strength": "1.1 g/mL"}], "application_number": "NDA203284", "marketing_category": "NDA", "marketing_start_date": "20130228", "listing_expiration_date": "20261231"}