FDA.reportPublic FDA data

Enalapril Maleate

Product NDC
50090-6490
11-digit product format
500906490
Labeler code
50090
Product ID
50090-6490_cdd905f1-e3c6-46b0-9ef0-38d431c4610d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
enalapril maleate
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA075496
Marketing category
ANDA
Marketing start
2015-08-06
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
Rxcui858813

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
50090-6490-0Enalapril Maleate30 in 1 BOTTLETABLET301
50090-6490-1Enalapril Maleate100 in 1 BOTTLETABLET1001
50090-6490-3Enalapril Maleate90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6490-0EA - Each50090-6490219b9ca0-a10b-4502-aa76-04edb6aea2f412023-07-06
50090-6490-3EA - Each50090-64907efb6d7e-25ad-44f4-a0b1-d2ca7ea4fcd612023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6490ENALAPRIL MALEATE TABLET [A-S MEDICATION SOLUTIONS]1Current NDC, 3 package rows20230525_7b80abb4-fa75-48a4-a2e9-b0e31205234c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
858813enalapril maleate 5 MG Oral TabletPSN7b80abb4-fa75-48a4-a2e9-b0e31205234c1
858813enalapril maleate 5 MG Oral TabletSCD7b80abb4-fa75-48a4-a2e9-b0e31205234c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-6490-05009064900030 TABLET in 1 BOTTLE (50090-6490-0) 30 tablet2023-05-18NoNoCurrent
50090-6490-150090649001100 TABLET in 1 BOTTLE (50090-6490-1) 100 tablet2023-05-18NoNoCurrent
50090-6490-35009064900390 TABLET in 1 BOTTLE (50090-6490-3) 90 tablet2023-05-18NoNoCurrent