FDA.reportPublic FDA data

Enalapril maleate

Product NDC
50090-7222
11-digit product format
500907222
Labeler code
50090
Product ID
50090-7222_84a4d2a1-8eaf-4c1b-af62-6387c89ff302
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Enalapril maleate
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA075479
Marketing category
ANDA
Marketing start
2020-04-28
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Enalapril maleate
Listing expiration
2027-12-31

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
50090-7222-0Enalapril maleate30 in 1 BOTTLETABLET308
50090-7222-1Enalapril maleate100 in 1 BOTTLETABLET1008
50090-7222-3Enalapril maleate90 in 1 BOTTLETABLET908

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7222-0EA - Each50090-7222451f7efd-6042-496a-be27-739da77cd1b312024-09-09
50090-7222-1EA - Each50090-7222652625e0-860d-4e39-85d4-66a17033371712024-09-09
50090-7222-3EA - Each50090-72222a4f6fc8-02fa-4b13-a4e6-dcd8126416d112024-09-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-7222ENALAPRIL MALEATE TABLET [A-S MEDICATION SOLUTIONS]4Current NDC, 3 package rows20240816_9f913e79-fe6d-4ff2-9f8e-eef9df689fa8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
858813enalapril maleate 5 MG Oral TabletPSN9f913e79-fe6d-4ff2-9f8e-eef9df689fa88
858813enalapril maleate 5 MG Oral TabletSCD9f913e79-fe6d-4ff2-9f8e-eef9df689fa88

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-7222-05009072220030 TABLET in 1 BOTTLE (50090-7222-0) 30 tablet2024-08-13NoNoHistorical
50090-7222-150090722201100 TABLET in 1 BOTTLE (50090-7222-1) 100 tablet2024-08-13NoNoHistorical
50090-7222-35009072220390 TABLET in 1 BOTTLE (50090-7222-3) 90 tablet2024-08-13NoNoHistorical