FDA.reportPublic FDA data

Enalapril Maleate

Product NDC
16714-444
11-digit product format
167140444
Labeler code
16714
Product ID
16714-444_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
10 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 MALEATE10 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
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
628e4aea-ca7c-e8c4-6fcc-d791c4deb0aeProduct name120140508
78637fb0-95c8-441f-e4b4-db1274b6f956Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16714-444-01Enalapril Maleate100 in 1 BOTTLETABLET1009
16714-444-02Enalapril Maleate1000 in 1 BOTTLETABLET10009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-444-01EA - Each16714-44437ba982a-1672-474b-9d78-bd459f6ac69d12015-08-04
16714-444-02EA - Each16714-44459c93dbb-505e-499c-a227-9ff49125e66c12015-08-04

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
16714-444ENALAPRIL 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
858817enalapril maleate 10 MG Oral TabletPSN3177b98e-e408-4cbe-b470-5087993e767a1
858817enalapril maleate 10 MG Oral TabletSCD3177b98e-e408-4cbe-b470-5087993e767a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16714-444-0116714044401100 TABLET in 1 BOTTLE (16714-444-01) 100 tablet2015-08-060000-00-00NoNoCurrent
16714-444-02167140444021000 TABLET in 1 BOTTLE (16714-444-02) 1000 tablet2015-08-060000-00-00NoNoCurrent