🇺🇸
United States · US · US:70748-425_fd8b7042-85e8-4193-8ce3-2d4ca69d6371
glycerol phenylbutyrate
Orange BookUNIISPLATC A16AX09
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerLupin Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeA16AX09
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1170748425011 BOTTLE in 1 CARTON (70748-425-01) / 25 mL in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
ZH6F1VCV7B
GLYCEROL PHENYLBUTYRATE
RxCUI 1368451
Orange Book
N203284
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": "70748-425_fd8b7042-85e8-4193-8ce3-2d4ca69d6371",
"productndc": "70748-425",
"dosage_form": "LIQUID",
"orange_book": {
"appl_no": "203284",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AA",
"strength": "1.1GM/ML",
"product_no": "001",
"approval_date": "Feb 1, 2013"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "GLYCEROL PHENYLBUTYRATE",
"proprietary_name": "glycerol phenylbutyrate",
"active_ingred_unit": "g/mL",
"application_number": "NDA203284",
"marketing_category": "NDA",
"nonproprietary_name": "glycerol phenylbutyrate",
"start_marketing_date": "20251020",
"active_numerator_strength": "1.1"
}Related drugs
Other records sharing ATC code A16AX09.
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- NORavictiImmedica Pharma AB (1)
- DKRavictiImmedica Pharma AB
- 🇺🇸RavictiHorizon Therapeutics USA, Inc.
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