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United States · US · US:0143-9786_bde8c35d-1cf2-42ea-a2a7-c4eb165e6d0d
Enalaprilat
Orange BookUNIISPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerHikma Pharmaceuticals USA Inc.
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11014397861010 VIAL in 1 CARTON (0143-9786-10) / 2 mL in 1 VIAL (0143-9786-01)
Annotations
UNII (FDA Substance ID)
GV0O7ES0R3
ENALAPRILAT DIHYDRATE
RxCUI 3829
Orange Book
A078687
AP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "GV0O7ES0R3",
"rxcui": "3829",
"inchikey": "MZYVOFLIPYDBGD-MLZQUWKJSA-N",
"display_name": "ENALAPRILAT DIHYDRATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAVENOUS",
"spl_meta": {
"5d398da1-020c-ccb1-a775-ce8e0b29d621": {
"match": "brand_token",
"title": "ENALAPRILAT INJECTION [DR. REDDYS LABORATORIES INC]",
"spl_version": "6",
"published_date": "2024-06-10"
}
},
"productid": "0143-9786_bde8c35d-1cf2-42ea-a2a7-c4eb165e6d0d",
"productndc": "0143-9786",
"dosage_form": "INJECTION",
"orange_book": {
"appl_no": "078687",
"products": [
{
"rs": true,
"rld": false,
"te_code": "AP",
"strength": "1.25MG/ML",
"product_no": "001",
"approval_date": "Dec 23, 2008"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ENALAPRILAT DIHYDRATE",
"proprietary_name": "Enalaprilat",
"active_ingred_unit": "mg/2mL",
"application_number": "ANDA078687",
"marketing_category": "ANDA",
"nonproprietary_name": "enalaprilat",
"start_marketing_date": "20081223",
"active_numerator_strength": "2.5"
}Access this data programmatically
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