FDA.reportPublic FDA data

NDC 68084-392-11 - ENALAPRIL MALEATE

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
68084-392
Requested NDC
68084-392-11
Package NDCs from labels
68084-392-11, 68084-392-01
Manufacturer
American Health Packaging
Effective date
2018-12-26
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
ENALAPRIL MALEATE - American Health PackagingAmerican Health Packaging2018-12-26HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68084-392-01EA - Each68084-392fbbcfe34-de27-44ce-84cb-6779d329f33912012-07-24
68084-392-11EA - Each68084-3920ecfd8ed-5628-4355-acad-234c062e893b12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ENALAPRIL MALEATEACTIVE INGREDIENT9O25354EPJENALAPRIL MALEATE TABLET [AMERICAN HEALTH PACKAGING]2
ENALAPRILAT ANHYDROUSACTIVE MOIETYQ508Q118JMENALAPRIL MALEATE TABLET [AMERICAN HEALTH PACKAGING]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKENALAPRIL MALEATE TABLET [AMERICAN HEALTH PACKAGING]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOENALAPRIL MALEATE TABLET [AMERICAN HEALTH PACKAGING]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJENALAPRIL MALEATE TABLET [AMERICAN HEALTH PACKAGING]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APENALAPRIL MALEATE TABLET [AMERICAN HEALTH PACKAGING]2
TALCINACTIVE INGREDIENT7SEV7J4R1UENALAPRIL MALEATE TABLET [AMERICAN HEALTH PACKAGING]2

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 8 · 141 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CalamineCALAMINE, PRAMOXINE HCLUnited Natural Foods, Inc. dba UNFI0bc1a9b4-1210-4d9a-bbd2-40e9225e86ea2026-09-04Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
Enalapril MaleateENALAPRIL MALEATEREMEDYREPACK INC.3fbc6cce-7ad5-49d5-9705-5f66ef92d5442026-09-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9O25354EPJ
Enalapril MaleateENALAPRIL MALEATEREMEDYREPACK INC.5118eb9f-1466-4318-b17e-cf5898edbeef2026-08-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9O25354EPJ
Enalapril MaleateENALAPRIL MALEATEREMEDYREPACK INC.a5c6e64c-a3ed-44f2-83e7-f4b62b6cd6222026-08-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9O25354EPJ
Enalapril maleateENALAPRIL MALEATEREMEDYREPACK INC.7077d32e-4b06-4d48-ba0c-6db2f8ebe08c2026-08-28Warnings, Adverse reactionsExact identifier
unii: 9O25354EPJ
CalamineFERRIC OXIDE REDYour Military Exchangesaf95a66c-f063-4019-80c6-6f7dc4fee4d82026-08-28Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
Enalapril MaleateENALAPRIL MALEATECoupler LLC59f44ba0-a323-493f-e063-6394a90a1c3c2026-08-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9O25354EPJ
Calamine PlusCALAMINE, PRAMOXINE HYDROCHLORIDEKroger Company44fdd5a4-3cac-15e5-e063-6294a90adb522026-08-26WarningsExact identifier
unii: 1K09F3G675
Enalapril MaleateENALAPRIL MALEATEREMEDYREPACK INC.e47afc0d-afc4-4972-a28a-5d3c640390ab2026-08-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9O25354EPJ
Enalapril MaleateENALAPRIL MALEATEBryant Ranch Prepack7fdc2d8a-9b5d-43c4-b32f-6f2505aee33c2026-08-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9O25354EPJ
Enalapril MaleateENALAPRIL MALEATEBryant Ranch Prepackb4b7b936-4a62-4991-8d3c-03bb37f044c12026-08-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9O25354EPJ
Enalapril MaleateENALAPRIL MALEATEBryant Ranch Prepackbdb34c96-1532-4ce5-93a7-3cc90904c9102026-08-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9O25354EPJ
Enalapril MaleateENALAPRIL MALEATEREMEDYREPACK INC.1b464099-491d-473b-836e-9d86b2b1eeec2026-08-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9O25354EPJ
Enalapril MaleateENALAPRIL MALEATEBryant Ranch Prepackfb3c7066-76cb-4e8e-b98b-bcb41a3631df2026-08-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9O25354EPJ
CalamineFERRIC OXIDE REDThe Kroger Co.9ddcd6ba-1aed-48f8-a91a-54bd6f0d93082026-08-06Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
Enalapril MaleateENALAPRIL MALEATEGolden State Medical Supply, Inc.0a12343f-5733-40cc-93b4-a02f5147fb912026-08-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9O25354EPJ
ENALAPRIL MALEATEENALAPRIL MALEATEBryant Ranch Prepackfa93d8e6-2ed2-4a3c-bf6d-33bd0a374efa2026-08-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9O25354EPJ
Enalapril MaleateENALAPRIL MALEATEGolden State Medical Supply, Inc.074fe718-88d8-365c-e063-6394a90a299d2026-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9O25354EPJ
ENALAPRIL MALEATEENALAPRIL MALEATEPreferred Pharmaceuticals Inc.b31372f7-cda3-4ead-a481-4cde62e843fd2026-07-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9O25354EPJ
CalamineCALAMINE AND ZINC OXIDEMarie's Original Formulas LLC57110309-9a3d-025f-e063-6394a90a015a2026-07-22WarningsExact identifier
unii: 1K09F3G675

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.