🇺🇸
United States · US · US:59651-988_11981aec-dbf1-4906-acfd-3c10708fe0a6
Glycerol Phenylbutyrate
Orange BookUNIISPLATC A16AX09
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAurobindo Pharma Limited
CountryUS (United States)
ATC codeA16AX09
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1159651988251 BOTTLE, GLASS in 1 CARTON (59651-988-25) / 25 mL in 1 BOTTLE, GLASS
Annotations
UNII (FDA Substance ID)
ZH6F1VCV7B
GLYCEROL PHENYLBUTYRATE
RxCUI 1368451
Orange Book
A220313
AA
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "ZH6F1VCV7B",
"rxcui": "1368451",
"inchikey": "ZSDBFLMJVAGKOU-UHFFFAOYSA-N",
"display_name": "GLYCEROL PHENYLBUTYRATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"c094cb63-3aa0-4564-9c53-7e78f2a56367": {
"match": "brand_token",
"title": "GLYCEROL PHENYLBUTYRATE LIQUID [ZYDUS PHARMACEUTICALS USA INC.]",
"spl_version": "1",
"published_date": "2026-05-06"
}
},
"productid": "59651-988_11981aec-dbf1-4906-acfd-3c10708fe0a6",
"productndc": "59651-988",
"dosage_form": "LIQUID",
"orange_book": {
"appl_no": "220313",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "1.1GM/ML",
"product_no": "001",
"approval_date": "Apr 15, 2026"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "GLYCEROL PHENYLBUTYRATE",
"proprietary_name": "Glycerol Phenylbutyrate",
"active_ingred_unit": "g/mL",
"application_number": "ANDA220313",
"marketing_category": "ANDA",
"nonproprietary_name": "Glycerol Phenylbutyrate",
"start_marketing_date": "20260415",
"active_numerator_strength": "1.1"
}Related drugs
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