glycerol phenylbutyrate

Generic: glycerol phenylbutyrate oral

Labeler: par health usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name glycerol phenylbutyrate
Generic Name glycerol phenylbutyrate oral
Labeler par health usa, llc
Dosage Form LIQUID
Routes
ORAL
Active Ingredients

glycerol phenylbutyrate 1.1 g/mL

Manufacturer
Par Health USA, LLC

Identifiers & Regulatory

Product NDC 49884-264
Product ID 49884-264_88787621-3d7b-4665-9535-9e14d67aba66
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205742
Listing Expiration 2026-12-31
Marketing Start 2025-10-17

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 49884264
Hyphenated Format 49884-264

Supplemental Identifiers

RxCUI
1368453
UPC
0349884264956
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 glycerol phenylbutyrate (source: ndc)
Generic Name glycerol phenylbutyrate oral (source: ndc)
Application Number ANDA205742 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1.1 g/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (49884-264-95) / 25 mL in 1 BOTTLE
source: ndc

Packages (1)

49884-264-95 1 BOTTLE in 1 CARTON (49884-264-95) / 25 mL in 1 BOTTLE

Ingredients (1)

glycerol phenylbutyrate (1.1 g/mL)

Linked Drug Pages (1)

Glycerol Phenylbutyrate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "88787621-3d7b-4665-9535-9e14d67aba66", "openfda": {"upc": ["0349884264956"], "unii": ["ZH6F1VCV7B"], "rxcui": ["1368453"], "spl_set_id": ["e78f2dfd-fb39-4e4b-a639-64591d282ca6"], "manufacturer_name": ["Par Health USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (49884-264-95)  / 25 mL in 1 BOTTLE", "package_ndc": "49884-264-95", "marketing_start_date": "20251017"}], "brand_name": "Glycerol Phenylbutyrate", "product_id": "49884-264_88787621-3d7b-4665-9535-9e14d67aba66", "dosage_form": "LIQUID", "pharm_class": ["Ammonium Ion Binding Activity [MoA]", "Nitrogen Binding Agent [EPC]"], "product_ndc": "49884-264", "generic_name": "Glycerol Phenylbutyrate oral", "labeler_name": "Par Health USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Glycerol Phenylbutyrate", "active_ingredients": [{"name": "GLYCEROL PHENYLBUTYRATE", "strength": "1.1 g/mL"}], "application_number": "ANDA205742", "marketing_category": "ANDA", "marketing_start_date": "20251017", "listing_expiration_date": "20261231"}