ENALAPRIL MALEATE

Product NDC
21695-487
11-digit product format
216950487
Labeler code
21695
Product ID
21695-487_53ac99fe-8ff3-4a6f-b90e-d602e1019acb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ENALAPRIL MALEATE
Dosage form
TABLET
Route
ORAL
Labeler
Rebel Distributors Corp
Application
ANDA075483
Marketing category
ANDA
Marketing start
2009-12-11
Marketing end
0000-00-00
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
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21695-487-302019-09-24C16284748780-1934fe258-4d16-48b1-e053-8cdaa90a720aEnalapril Maleate

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-487-30ENALAPRIL MALEATE30 in 1 BOTTLETABLET301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-487-30EA - Each21695-487451e5276-f120-4eb1-952d-35a57fe734bf12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ENALAPRIL MALEATEACTIVE INGREDIENT9O25354EPJENALAPRIL MALEATE TABLET [REBEL DISTRIBUTORS CORP]1
ENALAPRILACTIVE MOIETY69PN84IO1AENALAPRIL MALEATE TABLET [REBEL DISTRIBUTORS CORP]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APENALAPRIL MALEATE TABLET [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-487ENALAPRIL MALEATE TABLET [REBEL DISTRIBUTORS CORP]1Legacy NDC, 1 package rows20101126_53ac99fe-8ff3-4a6f-b90e-d602e1019acb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
858817enalapril maleate 10 MG Oral TabletPSN53ac99fe-8ff3-4a6f-b90e-d602e1019acb1
858810enalapril maleate 20 MG Oral TabletPSN53ac99fe-8ff3-4a6f-b90e-d602e1019acb1
858813enalapril maleate 5 MG Oral TabletPSN53ac99fe-8ff3-4a6f-b90e-d602e1019acb1
858817enalapril maleate 10 MG Oral TabletSCD53ac99fe-8ff3-4a6f-b90e-d602e1019acb1
858810enalapril maleate 20 MG Oral TabletSCD53ac99fe-8ff3-4a6f-b90e-d602e1019acb1
858813enalapril maleate 5 MG Oral TabletSCD53ac99fe-8ff3-4a6f-b90e-d602e1019acb1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-487-302169504873030 in 1 BOTTLEHistorical