🇺🇸
United States · US · US:0480-3777_b3a567c1-929b-4fd7-88ba-d66310188ab9
Glycerol phenylbutyrate
Orange BookUNIISPLATC A16AX09
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerTeva Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeA16AX09
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1104803777581 BOTTLE in 1 CARTON (0480-3777-58) / 25 mL in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
ZH6F1VCV7B
GLYCEROL PHENYLBUTYRATE
RxCUI 1368451
Orange Book
A218738
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": "0480-3777_b3a567c1-929b-4fd7-88ba-d66310188ab9",
"productndc": "0480-3777",
"dosage_form": "LIQUID",
"orange_book": {
"appl_no": "218738",
"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": "ANDA218738",
"marketing_category": "ANDA",
"nonproprietary_name": "Glycerol phenylbutyrate",
"start_marketing_date": "20260416",
"active_numerator_strength": "1.1"
}Related drugs
Other records sharing ATC code A16AX09.
- 🇺🇸glycerol phenylbutyrateLupin Pharmaceuticals, Inc.
- 🇺🇸Glycerol phenylbutyrateNovadoz Pharmaceuticals LLC
- 🇺🇸Glycerol PhenylbutyrateAurobindo Pharma Limited
- 🇺🇸Glycerol PhenylbutyrateZydus Pharmaceuticals USA Inc.
- 🇺🇸Glycerol PhenylbutyratePar Health USA, LLC
- NORavictiImmedica Pharma AB (1)
- DKRavictiImmedica Pharma AB
- PLRavictiImmedica Pharma AB
Access this data programmatically
Query Glycerol phenylbutyrate and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.