FDA.reportPublic FDA data

Enalapril Maleate

Product NDC
68788-8385
11-digit product format
687888385
Labeler code
68788
Product ID
68788-8385_4a146d3a-f11f-4e18-91b6-96ff1646f632
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Enalapril Maleate
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuicals Inc.
Application
ANDA213273
Marketing category
ANDA
Marketing start
2023-03-01
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
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 MALEATE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9O25354EPJ
Rxcui858817

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
68788-8385-1Enalapril Maleate100 in 1 BOTTLETABLET1004
68788-8385-3Enalapril Maleate30 in 1 BOTTLETABLET304
68788-8385-6Enalapril Maleate60 in 1 BOTTLETABLET604
68788-8385-9Enalapril Maleate90 in 1 BOTTLETABLET904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8385-1EA - Each68788-838572dbd8de-713b-48c5-a53f-3ead3a82aeb212023-06-06
68788-8385-3EA - Each68788-83858f5bf359-ab27-4f99-af50-aaa9ee38b1e512023-06-06
68788-8385-6EA - Each68788-838537fd6a1e-6a4c-4e45-9514-99339a5bac9012023-06-06
68788-8385-9EA - Each68788-83851c8c6bda-7d9f-4ff3-aa87-873b60cdea7312023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8385ENALAPRIL MALEATE TABLET [PREFERRED PHARMACEUICALS INC.]3Current NDC, 4 package rows20250409_898b36d6-320f-4d6c-9734-0be8363dc3d7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
858817enalapril maleate 10 MG Oral TabletPSN898b36d6-320f-4d6c-9734-0be8363dc3d74
858817enalapril maleate 10 MG Oral TabletSCD898b36d6-320f-4d6c-9734-0be8363dc3d74

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8385-168788838501100 TABLET in 1 BOTTLE (68788-8385-1) 100 tablet2023-03-01NoNoHistorical
68788-8385-36878883850330 TABLET in 1 BOTTLE (68788-8385-3) 30 tablet2023-03-01NoNoHistorical
68788-8385-66878883850660 TABLET in 1 BOTTLE (68788-8385-6) 60 tablet2023-03-01NoNoHistorical
68788-8385-96878883850990 TABLET in 1 BOTTLE (68788-8385-9) 90 tablet2023-03-01NoNoHistorical