FDA.reportPublic FDA data

ENALAPRIL MALEATE

Product NDC
64980-685
11-digit product format
649800685
Labeler code
64980
Product ID
64980-685_6f4c73c0-8b68-485d-87f6-cd77746aada8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ENALAPRIL MALEATE
Dosage form
TABLET
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA218531
Marketing category
ANDA
Marketing start
2025-02-24
Substance
ENALAPRIL MALEATE
Active strength
2.5 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 MALEATE2.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9O25354EPJ
Rxcui858804, 858810, 858813, 858817

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
64980-685-01ENALAPRIL MALEATE100 in 1 BOTTLETABLET1003
64980-685-10ENALAPRIL MALEATE1000 in 1 BOTTLETABLET10003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64980-685-01EA - Each64980-6858002f52c-643d-46d0-a7d9-6d9e3ef24e2712025-05-14
64980-685-10EA - Each64980-6858884f467-5441-4ca6-8934-42bf896443e112025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64980-685ENALAPRIL MALEATE (ENALAPRIL MALEATE) TABLET [RISING PHARMA HOLDINGS, INC.]1Current NDC, 2 package rows20250227_71e9fff3-7283-437e-b107-72fc16f09989.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
858817enalapril maleate 10 MG Oral TabletPSN71e9fff3-7283-437e-b107-72fc16f099893
858804enalapril maleate 2.5 MG Oral TabletPSN71e9fff3-7283-437e-b107-72fc16f099893
858810enalapril maleate 20 MG Oral TabletPSN71e9fff3-7283-437e-b107-72fc16f099893
858813enalapril maleate 5 MG Oral TabletPSN71e9fff3-7283-437e-b107-72fc16f099893
858817enalapril maleate 10 MG Oral TabletSCD71e9fff3-7283-437e-b107-72fc16f099893
858804enalapril maleate 2.5 MG Oral TabletSCD71e9fff3-7283-437e-b107-72fc16f099893
858810enalapril maleate 20 MG Oral TabletSCD71e9fff3-7283-437e-b107-72fc16f099893
858813enalapril maleate 5 MG Oral TabletSCD71e9fff3-7283-437e-b107-72fc16f099893

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
64980-685-0164980068501100 TABLET in 1 BOTTLE (64980-685-01) 100 tablet2025-02-24NoNoHistorical
64980-685-10649800685101000 TABLET in 1 BOTTLE (64980-685-10) 1000 tablet2025-02-24NoNoHistorical