FDA.reportPublic FDA data

Enalapril Maleate

Product NDC
50090-5976
11-digit product format
500905976
Labeler code
50090
Product ID
50090-5976_185ec7cb-acb2-4418-bfc8-8a2aed96ff38
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
enalapril maleate
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA075459
Marketing category
ANDA
Marketing start
2015-08-06
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
No
Listing certified through
2023-12-31
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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-5976-02024-01-30C16284748780-11030e365-09f1-111a-e063-dadaa90a10e2ENALAPRIL MALEATE TABLETS, USP Rx only
50090-5976-12024-01-30C16284748780-11030e365-09f1-111a-e063-dadaa90a10e2ENALAPRIL MALEATE TABLETS, USP Rx only
50090-5976-42024-01-30C16284748780-11030e365-09f1-111a-e063-dadaa90a10e2ENALAPRIL MALEATE TABLETS, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5976-0Enalapril Maleate30 in 1 BOTTLETABLET301
50090-5976-1Enalapril Maleate100 in 1 BOTTLETABLET1001
50090-5976-4Enalapril Maleate90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5976-0EA - Each50090-5976f8a1b6b0-737b-4324-8cc8-301f6aaa886912022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5976ENALAPRIL MALEATE TABLET [A-S MEDICATION SOLUTIONS]1Legacy NDC, 3 package rows20220511_3177b98e-e408-4cbe-b470-5087993e767a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
858817enalapril maleate 10 MG Oral TabletPSN3177b98e-e408-4cbe-b470-5087993e767a1
858817enalapril maleate 10 MG Oral TabletSCD3177b98e-e408-4cbe-b470-5087993e767a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5976-05009059760030 TABLET in 1 BOTTLE (50090-5976-0) 30 tablet2022-05-020000-00-00NoNoCurrent
50090-5976-150090597601100 TABLET in 1 BOTTLE (50090-5976-1) 100 tablet2022-05-020000-00-00NoNoCurrent
50090-5976-45009059760490 TABLET in 1 BOTTLE (50090-5976-4) 90 tablet2022-05-020000-00-00NoNoCurrent