FDA.reportPublic FDA data

Enalapril maleate oral solution

Product NDC
72603-247
11-digit product format
726030247
Labeler code
72603
Product ID
72603-247_16595fbf-a903-56fc-e063-6294a90a4710
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Enalapril maleate
Dosage form
SOLUTION
Route
ORAL
Labeler
NorthStar RxLLC
Application
ANDA214467
Marketing category
ANDA
Marketing start
2024-05-01
Substance
ENALAPRIL MALEATE
Active strength
1 mg/mL
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 oral solution
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ENALAPRIL MALEATE1 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9O25354EPJ
Rxcui1435624

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5ffbd585-373a-fcf5-c6c8-1f04bf28013eProduct name320250331
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
2c0b09af-323c-477d-9a19-d8165aefa3b0Product name420250107
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
628e4aea-ca7c-e8c4-6fcc-d791c4deb0aeProduct name120140508
78637fb0-95c8-441f-e4b4-db1274b6f956Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72603-247-01Enalapril maleate oral solution1 in 1 CARTONSOLUTION11
72603-247-01Enalapril maleate oral solution150 mL in 1 BOTTLESOLUTION1501

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72603-247-01ML - Milliliter72603-2474826ea3f-4faf-49a5-9ab0-e1289ab1b2df12024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72603-247ENALAPRIL MALEATE ORAL SOLUTION (ENALAPRIL MALEATE) SOLUTION [NORTHSTAR RXLLC]1Current NDC, 2 package rows20240501_19606da3-c6b0-40a5-9690-77fc37072b51.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1435624enalapril maleate 1 MG in 1 mL Oral SolutionPSN19606da3-c6b0-40a5-9690-77fc37072b511
1435624enalapril maleate 1 MG/ML Oral SolutionSCD19606da3-c6b0-40a5-9690-77fc37072b511
1435624enalapril maleate 1 MG per 1 ML Oral SolutionSY19606da3-c6b0-40a5-9690-77fc37072b511

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72603-247-01726030247011 BOTTLE in 1 CARTON (72603-247-01) / 150 mL in 1 BOTTLE1 bottle2024-05-01NoNoCurrent