glycerol phenylbutyrate

Generic: glycerol phenylbutyrate

Labeler: lupin pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name glycerol phenylbutyrate
Generic Name glycerol phenylbutyrate
Labeler lupin pharmaceuticals, inc.
Dosage Form LIQUID
Routes
ORAL
Active Ingredients

glycerol phenylbutyrate 1.1 g/mL

Manufacturer
Lupin Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 70748-425
Product ID 70748-425_fd8b7042-85e8-4193-8ce3-2d4ca69d6371
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA203284
Listing Expiration 2026-12-31
Marketing Start 2025-10-20

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70748425
Hyphenated Format 70748-425

Supplemental Identifiers

RxCUI
1368453
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 (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 (70748-425-01) / 25 mL in 1 BOTTLE
source: ndc

Packages (1)

70748-425-01 1 BOTTLE in 1 CARTON (70748-425-01) / 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": "fd8b7042-85e8-4193-8ce3-2d4ca69d6371", "openfda": {"unii": ["ZH6F1VCV7B"], "rxcui": ["1368453"], "spl_set_id": ["9bfa912f-c86c-4702-ac99-464c4356d80c"], "manufacturer_name": ["Lupin Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (70748-425-01)  / 25 mL in 1 BOTTLE", "package_ndc": "70748-425-01", "marketing_start_date": "20251020"}], "brand_name": "glycerol phenylbutyrate", "product_id": "70748-425_fd8b7042-85e8-4193-8ce3-2d4ca69d6371", "dosage_form": "LIQUID", "pharm_class": ["Ammonium Ion Binding Activity [MoA]", "Nitrogen Binding Agent [EPC]"], "product_ndc": "70748-425", "generic_name": "glycerol phenylbutyrate", "labeler_name": "Lupin Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "glycerol phenylbutyrate", "active_ingredients": [{"name": "GLYCEROL PHENYLBUTYRATE", "strength": "1.1 g/mL"}], "application_number": "NDA203284", "marketing_category": "NDA", "marketing_start_date": "20251020", "listing_expiration_date": "20261231"}