FDA.reportPublic FDA data

Enalapril Maleate

Product NDC
16714-445
11-digit product format
167140445
Labeler code
16714
Product ID
16714-445_4bc84994-0116-425c-8dab-ba08b0880b24
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
enalapril maleate
Dosage form
TABLET
Route
ORAL
Labeler
Northstar RxLLC
Application
ANDA075459
Marketing category
ANDA
Marketing start
2015-08-06
Substance
ENALAPRIL MALEATE
Active strength
20 mg/1
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
Enalapril Maleate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ENALAPRIL MALEATE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9O25354EPJ
Rxcui858804, 858810, 858813, 858817

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
16714-445-01Enalapril Maleate100 in 1 BOTTLETABLET1009
16714-445-02Enalapril Maleate1000 in 1 BOTTLETABLET10009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-445-01EA - Each16714-445130c6ccf-ad0f-4ab6-ae48-bc81d0cbcba612015-08-04
16714-445-02EA - Each16714-44503f15d4d-6c73-4bec-ba8d-0a52abd19ec012015-08-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ENALAPRIL MALEATEACTIVE INGREDIENT9O25354EPJENALAPRIL MALEATE TABLET [NORTHSTAR RXLLC]6
ENALAPRILAT ANHYDROUSACTIVE MOIETYQ508Q118JMENALAPRIL MALEATE TABLET [NORTHSTAR RXLLC]6
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ENALAPRIL MALEATE TABLET [NORTHSTAR RXLLC]6
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ENALAPRIL MALEATE TABLET [NORTHSTAR RXLLC]6
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTENALAPRIL MALEATE TABLET [NORTHSTAR RXLLC]6
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357ENALAPRIL MALEATE TABLET [NORTHSTAR RXLLC]6
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XENALAPRIL MALEATE TABLET [NORTHSTAR RXLLC]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ENALAPRIL MALEATE TABLET [NORTHSTAR RXLLC]6
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QOENALAPRIL MALEATE TABLET [NORTHSTAR RXLLC]6
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJENALAPRIL MALEATE TABLET [NORTHSTAR RXLLC]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16714-445ENALAPRIL MALEATE TABLET [NORTHSTAR RXLLC]8Current NDC, Legacy NDC, 2 package rows20181212_e109e7b1-4650-4416-9d89-7c1185d5cf48.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
858817enalapril maleate 10 MG Oral TabletPSNe109e7b1-4650-4416-9d89-7c1185d5cf489
858804enalapril maleate 2.5 MG Oral TabletPSNe109e7b1-4650-4416-9d89-7c1185d5cf489
858810enalapril maleate 20 MG Oral TabletPSNe109e7b1-4650-4416-9d89-7c1185d5cf489
858813enalapril maleate 5 MG Oral TabletPSNe109e7b1-4650-4416-9d89-7c1185d5cf489
858817enalapril maleate 10 MG Oral TabletSCDe109e7b1-4650-4416-9d89-7c1185d5cf489
858804enalapril maleate 2.5 MG Oral TabletSCDe109e7b1-4650-4416-9d89-7c1185d5cf489
858810enalapril maleate 20 MG Oral TabletSCDe109e7b1-4650-4416-9d89-7c1185d5cf489
858813enalapril maleate 5 MG Oral TabletSCDe109e7b1-4650-4416-9d89-7c1185d5cf489

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16714-445-0116714044501100 TABLET in 1 BOTTLE (16714-445-01) 100 tablet2015-08-060000-00-00NoNoCurrent
16714-445-02167140445021000 TABLET in 1 BOTTLE (16714-445-02) 1000 tablet2015-08-060000-00-00NoNoCurrent