FDA.reportPublic FDA data

Enalapril Maleate

Product NDC
51672-4245
11-digit product format
516724245
Labeler code
51672
Product ID
51672-4245_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
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
51672-4245-1Enalapril Maleate100 in 1 BOTTLETABLET10013
51672-4245-3Enalapril Maleate1000 in 1 BOTTLETABLET100013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-4245-1EA - Each51672-42454783b04f-762e-466c-b4ab-652d8e12ddeb12023-10-16
51672-4245-3EA - Each51672-4245ed82a21e-f396-472f-886f-b1bbea41b04d12023-10-16

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-4245ENALAPRIL MALEATE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]13Current NDC, 2 package rows20230728_f103b9f9-e081-419d-a2d8-b86acda834dd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
858817enalapril maleate 10 MG Oral TabletPSN7fdc2d8a-9b5d-43c4-b32f-6f2505aee33c100
858817enalapril maleate 10 MG Oral TabletSCD7fdc2d8a-9b5d-43c4-b32f-6f2505aee33c100
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 TabletPSN3fbc6cce-7ad5-49d5-9705-5f66ef92d5442
858817enalapril maleate 10 MG Oral TabletPSNf3754f29-9b75-4e2c-9c28-b3479f5bf9062
858817enalapril maleate 10 MG Oral TabletSCD3fbc6cce-7ad5-49d5-9705-5f66ef92d5442
858817enalapril maleate 10 MG Oral TabletSCDf3754f29-9b75-4e2c-9c28-b3479f5bf9062
858817enalapril maleate 10 MG Oral TabletPSN074fe718-88d8-365c-e063-6394a90a299d1
858817enalapril maleate 10 MG Oral TabletSCD074fe718-88d8-365c-e063-6394a90a299d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51672-4245-151672424501100 TABLET in 1 BOTTLE (51672-4245-1) 100 tablet2023-07-17NoNoCurrent
51672-4245-3516724245031000 TABLET in 1 BOTTLE (51672-4245-3) 1000 tablet2023-07-17NoNoCurrent