🇺🇸
United States · US · US:75987-050_a58b617c-635a-4a67-9f27-f9c93f8cba22
Ravicti
Orange BookUNIISPLATC A16AX09
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerHorizon Therapeutics USA, Inc.
CountryUS (United States)
ATC codeA16AX09
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1175987050061 BOTTLE in 1 CARTON (75987-050-06) / 25 mL in 1 BOTTLE
- ndc1175987050074 BOTTLE in 1 CARTON (75987-050-07) / 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": {
"900e7dc0-9afe-4f50-80de-90567bb78519": {
"match": "brand_token",
"title": "RAVICTI (GLYCEROL PHENYLBUTYRATE) LIQUID [HORIZON THERAPEUTICS USA, INC.]",
"spl_version": "13",
"published_date": "2025-11-20"
}
},
"productid": "75987-050_a58b617c-635a-4a67-9f27-f9c93f8cba22",
"productndc": "75987-050",
"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": "Ravicti",
"active_ingred_unit": "g/mL",
"application_number": "NDA203284",
"marketing_category": "NDA",
"nonproprietary_name": "glycerol phenylbutyrate",
"start_marketing_date": "20130228",
"active_numerator_strength": "1.1"
}Related drugs
Other records sharing ATC code A16AX09.
- 🇺🇸glycerol phenylbutyrateLupin Pharmaceuticals, Inc.
- 🇺🇸Glycerol phenylbutyrateNovadoz Pharmaceuticals LLC
- 🇺🇸Glycerol phenylbutyrateTeva Pharmaceuticals, Inc.
- 🇺🇸Glycerol PhenylbutyrateAurobindo Pharma Limited
- 🇺🇸Glycerol PhenylbutyrateZydus Pharmaceuticals USA Inc.
- 🇺🇸Glycerol PhenylbutyratePar Health USA, LLC
- NORavictiImmedica Pharma AB (1)
- DKRavictiImmedica Pharma AB
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