FDA.reportPublic FDA data

Enalapril Maleate

Product NDC
68682-710
11-digit product format
686820710
Labeler code
68682
Product ID
68682-710_6771388d-89b3-43ec-b69e-9cebeaa2a00a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Enalapril Maleate
Dosage form
TABLET
Route
ORAL
Labeler
OCEANSIDE PHARMACEUTICALS
Application
NDA018998
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
1988-07-26
Substance
ENALAPRIL MALEATE
Active strength
2.5 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 MALEATE2.5 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
68682-710-01Enalapril Maleate100 in 1 BOTTLETABLET1007
68682-710-10Enalapril Maleate1000 in 1 BOTTLETABLET10007
68682-710-30Enalapril Maleate30 in 1 BOTTLETABLET307
68682-710-90Enalapril Maleate90 in 1 BOTTLETABLET907

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68682-710-01EA - Each68682-710542e6bec-1872-4536-a9af-b746e4e6ea6e12015-09-10
68682-710-10EA - Each68682-71041a3cc54-d025-45b8-a6c2-a14b0be0113312016-01-13
68682-710-30EA - Each68682-710740d6301-150e-4703-a2a8-5e988ad72efd12015-09-10
68682-710-90EA - Each68682-71060f28205-1af6-4834-aeb7-22eb5493dc9e12015-09-10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Enalapril MaleateACTIVE INGREDIENT9O25354EPJENALAPRIL MALEATE TABLET [OCEANSIDE PHARMACEUTICALS]2
Enalaprilat AnhydrousACTIVE MOIETYQ508Q118JMENALAPRIL MALEATE TABLET [OCEANSIDE PHARMACEUTICALS]2
ferric oxide redINACTIVE INGREDIENT1K09F3G675ENALAPRIL MALEATE TABLET [OCEANSIDE PHARMACEUTICALS]2
ferric oxide yellowINACTIVE INGREDIENTEX438O2MRTENALAPRIL MALEATE TABLET [OCEANSIDE PHARMACEUTICALS]2
lactoseINACTIVE INGREDIENTJ2B2A4N98GENALAPRIL MALEATE TABLET [OCEANSIDE PHARMACEUTICALS]2
magnesium stearateINACTIVE INGREDIENT70097M6I30ENALAPRIL MALEATE TABLET [OCEANSIDE PHARMACEUTICALS]2
sodium bicarbonateINACTIVE INGREDIENT8MDF5V39QOENALAPRIL MALEATE TABLET [OCEANSIDE PHARMACEUTICALS]2
sodium stearateINACTIVE INGREDIENTQU7E2XA9TGENALAPRIL MALEATE TABLET [OCEANSIDE PHARMACEUTICALS]2
starch, cornINACTIVE INGREDIENTO8232NY3SJENALAPRIL MALEATE TABLET [OCEANSIDE PHARMACEUTICALS]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68682-710ENALAPRIL MALEATE TABLET [OCEANSIDE PHARMACEUTICALS]7Current NDC, Legacy NDC, 4 package rows20210305_ebd2a62d-a704-4f8a-a104-749a5296502f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
858804enalapril maleate 2.5 MG Oral TabletPSN4984b255-e03b-0f7b-e054-00144ff88e888
858810enalapril maleate 20 MG Oral TabletPSN4984b255-e03b-0f7b-e054-00144ff88e888
858813enalapril maleate 5 MG Oral TabletPSN4984b255-e03b-0f7b-e054-00144ff88e888
858804enalapril maleate 2.5 MG Oral TabletSCD4984b255-e03b-0f7b-e054-00144ff88e888
858810enalapril maleate 20 MG Oral TabletSCD4984b255-e03b-0f7b-e054-00144ff88e888
858813enalapril maleate 5 MG Oral TabletSCD4984b255-e03b-0f7b-e054-00144ff88e888
858817enalapril maleate 10 MG Oral TabletPSNebd2a62d-a704-4f8a-a104-749a5296502f7
858804enalapril maleate 2.5 MG Oral TabletPSNebd2a62d-a704-4f8a-a104-749a5296502f7
858810enalapril maleate 20 MG Oral TabletPSNebd2a62d-a704-4f8a-a104-749a5296502f7
858813enalapril maleate 5 MG Oral TabletPSNebd2a62d-a704-4f8a-a104-749a5296502f7
858817enalapril maleate 10 MG Oral TabletSCDebd2a62d-a704-4f8a-a104-749a5296502f7
858804enalapril maleate 2.5 MG Oral TabletSCDebd2a62d-a704-4f8a-a104-749a5296502f7
858810enalapril maleate 20 MG Oral TabletSCDebd2a62d-a704-4f8a-a104-749a5296502f7
858813enalapril maleate 5 MG Oral TabletSCDebd2a62d-a704-4f8a-a104-749a5296502f7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68682-710-0168682071001100 TABLET in 1 BOTTLE (68682-710-01) 100 tablet1988-07-260000-00-00NoNoCurrent
68682-710-10686820710101000 TABLET in 1 BOTTLE (68682-710-10) 1000 tablet1988-07-260000-00-00NoNoCurrent
68682-710-306868207103030 in 1 BOTTLEHistorical
68682-710-906868207109090 in 1 BOTTLEHistorical