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United States · US · US:70710-2193_97c20e1a-7e17-4311-9315-f492ff1b0261
Glycerol Phenylbutyrate
Orange BookUNIISPLATC A16AX09
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerZydus Pharmaceuticals USA Inc.
CountryUS (United States)
ATC codeA16AX09
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1170710219351 BOTTLE in 1 CARTON (70710-2193-5) / 25 mL in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
ZH6F1VCV7B
GLYCEROL PHENYLBUTYRATE
RxCUI 1368451
Orange Book
A220568
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": "70710-2193_97c20e1a-7e17-4311-9315-f492ff1b0261",
"productndc": "70710-2193",
"dosage_form": "LIQUID",
"orange_book": {
"appl_no": "220568",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "1.1GM/ML",
"product_no": "001",
"approval_date": "Apr 23, 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": "ANDA220568",
"marketing_category": "ANDA",
"nonproprietary_name": "Glycerol Phenylbutyrate",
"start_marketing_date": "20260504",
"active_numerator_strength": "1.1"
}Related drugs
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