FDA.reportPublic FDA data

Enalaprilat

Product NDC
0143-9786
11-digit product format
001439786
Labeler code
0143
Product ID
0143-9786_bde8c35d-1cf2-42ea-a2a7-c4eb165e6d0d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
enalaprilat
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA078687
Marketing category
ANDA
Marketing start
2008-12-23
Substance
ENALAPRILAT DIHYDRATE
Active strength
2.5 mg/2mL
Pharmacologic classes
Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], Decreased Blood Pressure [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Enalaprilat
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ENALAPRILAT DIHYDRATE2.5 mg/2mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiGV0O7ES0R3
Rxcui1729200, 1729205

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5ffbd585-373a-fcf5-c6c8-1f04bf28013eProduct name320250331
2c0b09af-323c-477d-9a19-d8165aefa3b0Product name420250107
628e4aea-ca7c-e8c4-6fcc-d791c4deb0aeProduct name120140508
78637fb0-95c8-441f-e4b4-db1274b6f956Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0143-9786-01Enalaprilat2 mL in 1 VIALINJECTION212
0143-9786-10Enalaprilat10 in 1 CARTONINJECTION1012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9786-01ML - Milliliter0143-9786ef218fb7-dda9-4146-a30d-ad3e3fbebf5312018-05-09
0143-9786-10ML - Milliliter0143-9786b31617bf-d716-47e7-848c-de9aed85e70112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ENALAPRILATACTIVE INGREDIENTGV0O7ES0R3ENALAPRILAT INJECTION [WEST-WARD PHARMACEUTICAL CORP]3
ENALAPRILATACTIVE MOIETYGV0O7ES0R3ENALAPRILAT INJECTION [WEST-WARD PHARMACEUTICAL CORP]3
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHENALAPRILAT INJECTION [WEST-WARD PHARMACEUTICAL CORP]3
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XENALAPRILAT INJECTION [WEST-WARD PHARMACEUTICAL CORP]3
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IENALAPRILAT INJECTION [WEST-WARD PHARMACEUTICAL CORP]3
WATERINACTIVE INGREDIENT059QF0KO0RENALAPRILAT INJECTION [WEST-WARD PHARMACEUTICAL CORP]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9786ENALAPRILAT INJECTION [HIKMA PHARMACEUTICALS USA INC.]12Current NDC, Legacy NDC, 2 package rows20240105_eabae489-e254-4987-ab90-7cda20a6f856.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1729200enalaprilat 1.25 MG in 1 ML InjectionPSNeabae489-e254-4987-ab90-7cda20a6f85612
1729205enalaprilat 2.5 MG in 2 ML InjectionPSNeabae489-e254-4987-ab90-7cda20a6f85612
17292001 ML enalaprilat 1.25 MG/ML InjectionSCDeabae489-e254-4987-ab90-7cda20a6f85612
17292052 ML enalaprilat 1.25 MG/ML InjectionSCDeabae489-e254-4987-ab90-7cda20a6f85612
1729200enalaprilat 1.25 MG per 1 ML InjectionSYeabae489-e254-4987-ab90-7cda20a6f85612
1729205enalaprilat 2.5 MG per 2 ML InjectionSYeabae489-e254-4987-ab90-7cda20a6f85612

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0143-9786-01001439786012 mL in 1 VIAL2 mlHistorical
0143-9786-100014397861010 VIAL in 1 CARTON (0143-9786-10) / 2 mL in 1 VIAL (0143-9786-01) 10 vial2008-12-230000-00-00NoNoCurrent