ENALAPRIL MALEATE

Product NDC
10544-170
11-digit product format
105440170
Labeler code
10544
Product ID
10544-170_dd2b32b3-a1c6-49ea-8d7c-3407966584a1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ENALAPRIL MALEATE
Dosage form
TABLET
Route
ORAL
Labeler
Blenheim Pharmacal, Inc.
Application
ANDA075483
Marketing category
ANDA
Marketing start
2011-04-18
Marketing end
0000-00-00
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
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
10544-170-302020-01-31C16284748780-19d75b9d0-d0f9-f424-e053-dadaa90a57ceENALAPRIL MALEATE TABLETS, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10544-170-30ENALAPRIL MALEATE30 in 1 BOTTLETABLET304

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10544-170-30EA - Each10544-170d7fe19ab-4189-40d2-b21b-08052be1932312015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ENALAPRIL MALEATEACTIVE INGREDIENT9O25354EPJENALAPRIL MALEATE TABLET [BLENHEIM PHARMACAL, INC.]4
ENALAPRILAT ANHYDROUSACTIVE MOIETYQ508Q118JMENALAPRIL MALEATE TABLET [BLENHEIM PHARMACAL, INC.]4
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKENALAPRIL MALEATE TABLET [BLENHEIM PHARMACAL, INC.]4
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6ENALAPRIL MALEATE TABLET [BLENHEIM PHARMACAL, INC.]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJENALAPRIL MALEATE TABLET [BLENHEIM PHARMACAL, INC.]4
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APENALAPRIL MALEATE TABLET [BLENHEIM PHARMACAL, INC.]4
TALCINACTIVE INGREDIENT7SEV7J4R1UENALAPRIL MALEATE TABLET [BLENHEIM PHARMACAL, INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10544-170ENALAPRIL MALEATE TABLET [BLENHEIM PHARMACAL, INC.]4Legacy NDC, 1 package rows20150903_4eb78a73-bec0-41bb-b284-22353f5fb5a1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
858817enalapril maleate 10 MG Oral TabletPSN4eb78a73-bec0-41bb-b284-22353f5fb5a14
858817enalapril maleate 10 MG Oral TabletSCD4eb78a73-bec0-41bb-b284-22353f5fb5a14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
10544-170-301054401703030 in 1 BOTTLEHistorical