FDA.reportPublic FDA data

Enalapril Maleate

Product NDC
51672-4038
11-digit product format
516724038
Labeler code
51672
Product ID
51672-4038_e64450c0-8dde-4920-9bf9-c714e09e1566
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Enalapril Maleate
Dosage form
TABLET
Route
ORAL
Labeler
Taro Pharmaceuticals U.S.A., Inc.
Application
ANDA075657
Marketing category
ANDA
Marketing start
2001-01-23
Substance
ENALAPRIL MALEATE
Active strength
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 MALEATE5 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
51672-4038-1Enalapril Maleate100 in 1 BOTTLETABLET10013
51672-4038-3Enalapril Maleate1000 in 1 BOTTLETABLET100013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-4038-1EA - Each51672-4038a4d72af7-6ecd-4df1-b833-43669eab8d5c12013-02-13
51672-4038-3EA - Each51672-4038687d907e-5dba-4a27-b4b7-48dc5c9a16d912013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Enalapril MaleateACTIVE INGREDIENT9O25354EPJENALAPRIL MALEATE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]6
Enalaprilat AnhydrousACTIVE MOIETYQ508Q118JMENALAPRIL MALEATE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]6
Ferric Oxide RedINACTIVE INGREDIENT1K09F3G675ENALAPRIL MALEATE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]6
Ferric Oxide YellowINACTIVE INGREDIENTEX438O2MRTENALAPRIL MALEATE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]6
Lactose MonohydrateINACTIVE INGREDIENTEWQ57Q8I5XENALAPRIL MALEATE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]6
Magnesium StearateINACTIVE INGREDIENT70097M6I30ENALAPRIL MALEATE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]6
Sodium BicarbonateINACTIVE INGREDIENT8MDF5V39QOENALAPRIL MALEATE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]6
Enalapril MaleateACTIVE INGREDIENT9O25354EPJENALAPRIL MALEATE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]2
ENALAPRILAT ANHYDROUSACTIVE MOIETYQ508Q118JMENALAPRIL MALEATE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ENALAPRIL MALEATE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTENALAPRIL MALEATE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]2
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XENALAPRIL MALEATE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]2
magnesium stearateINACTIVE INGREDIENT70097M6I30ENALAPRIL MALEATE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]2
sodium bicarbonateINACTIVE INGREDIENT8MDF5V39QOENALAPRIL MALEATE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJENALAPRIL MALEATE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-4038ENALAPRIL MALEATE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]13Current NDC, Legacy NDC, 2 package rows20230728_f103b9f9-e081-419d-a2d8-b86acda834dd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
858813enalapril maleate 5 MG Oral TabletPSNbdb34c96-1532-4ce5-93a7-3cc90904c910102
858813enalapril maleate 5 MG Oral TabletSCDbdb34c96-1532-4ce5-93a7-3cc90904c910102
858817enalapril maleate 10 MG Oral TabletPSNf103b9f9-e081-419d-a2d8-b86acda834dd13
858804enalapril maleate 2.5 MG Oral TabletPSNf103b9f9-e081-419d-a2d8-b86acda834dd13
858810enalapril maleate 20 MG Oral TabletPSNf103b9f9-e081-419d-a2d8-b86acda834dd13
858813enalapril maleate 5 MG Oral TabletPSNf103b9f9-e081-419d-a2d8-b86acda834dd13
858817enalapril maleate 10 MG Oral TabletSCDf103b9f9-e081-419d-a2d8-b86acda834dd13
858804enalapril maleate 2.5 MG Oral TabletSCDf103b9f9-e081-419d-a2d8-b86acda834dd13
858810enalapril maleate 20 MG Oral TabletSCDf103b9f9-e081-419d-a2d8-b86acda834dd13
858813enalapril maleate 5 MG Oral TabletSCDf103b9f9-e081-419d-a2d8-b86acda834dd13
858817enalapril maleate 10 MG Oral TabletPSN0a12343f-5733-40cc-93b4-a02f5147fb9111
858804enalapril maleate 2.5 MG Oral TabletPSN0a12343f-5733-40cc-93b4-a02f5147fb9111
858810enalapril maleate 20 MG Oral TabletPSN0a12343f-5733-40cc-93b4-a02f5147fb9111
858813enalapril maleate 5 MG Oral TabletPSN0a12343f-5733-40cc-93b4-a02f5147fb9111
858817enalapril maleate 10 MG Oral TabletSCD0a12343f-5733-40cc-93b4-a02f5147fb9111
858804enalapril maleate 2.5 MG Oral TabletSCD0a12343f-5733-40cc-93b4-a02f5147fb9111
858810enalapril maleate 20 MG Oral TabletSCD0a12343f-5733-40cc-93b4-a02f5147fb9111
858813enalapril maleate 5 MG Oral TabletSCD0a12343f-5733-40cc-93b4-a02f5147fb9111
858813enalapril maleate 5 MG Oral TabletPSN0ad4bfb4-62db-4759-af60-88eb031d125a10
858813enalapril maleate 5 MG Oral TabletSCD0ad4bfb4-62db-4759-af60-88eb031d125a10
858813enalapril maleate 5 MG Oral TabletPSN97674aec-5e1a-40d4-b753-d38a829c550f1
858813enalapril maleate 5 MG Oral TabletSCD97674aec-5e1a-40d4-b753-d38a829c550f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51672-4038-151672403801100 TABLET in 1 BOTTLE (51672-4038-1) 100 tablet2001-01-230000-00-00NoNoCurrent
51672-4038-3516724038031000 TABLET in 1 BOTTLE (51672-4038-3) 1000 tablet2001-01-230000-00-00NoNoCurrent