Package 70748-425-01
Brand: glycerol phenylbutyrate
Generic: glycerol phenylbutyratePackage Facts
Identity
Package NDC
70748-425-01
Digits Only
7074842501
Product NDC
70748-425
Description
1 BOTTLE in 1 CARTON (70748-425-01) / 25 mL in 1 BOTTLE
Marketing
Marketing Status
Brand
glycerol phenylbutyrate
Generic
glycerol phenylbutyrate
Sample Package
No
Linked Drug Pages (1)
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"}