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 2 of 7 · 138 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CalamineCALAMINE AND ZINC OXIDEMarie's Original Formulas LLC571083ce-cd35-a638-e063-6394a90ae4c72026-07-20WarningsExact identifier
unii: 1K09F3G675
CalamineFERRIC OXIDE REDBetter Living Brands, LLCc7ef0ef3-6861-4b94-af4b-371fee8c1f3d2026-07-16Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
Enalapril MaleateENALAPRIL MALEATESun Pharmaceutical Industries, Inc.f103b9f9-e081-419d-a2d8-b86acda834dd2026-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9O25354EPJ
Enalapril Maleate and HydrochlorothiazideENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDESun Pharmaceutical Industries, Inc.7cb92cf2-46f2-4379-937c-168d230e43a42026-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9O25354EPJ
ENALAPRIL MALEATEENALAPRIL MALEATEPreferred Pharmaceuticals Inc.eee8633b-9d9e-453d-8c6b-8b13c94d2f582026-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9O25354EPJ
Calamine Plus Pramoxine HClCALAMINE PLUS SPRAYTarget Corporation36602b7a-99c0-f6a4-e063-6294a90a87582026-06-29WarningsExact identifier
unii: 1K09F3G675
ENALAPRIL MALEATEENALAPRIL MALEATEScieGen Pharmaceuticals, Inc.63187a94-9ac7-4320-ac70-0631e08c2b8d2026-06-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9O25354EPJ
CalaSootheCALAMINE, MENTHOL, AND ZINC OXIDEDynarex Corporation54f12005-acfe-4821-e063-6394a90ac3042026-06-24WarningsExact identifier
unii: 1K09F3G675
Enalapril MaleateENALAPRIL MALEATESt. Mary's Medical Park Pharmacyed266486-e4a5-9dd1-e053-2a95a90a80d32026-06-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9O25354EPJ
Enalapril Maleate Oral SolutionENALAPRIL MALEATE ORAL SOLUTIONAscend Laboratories, LLC964d561a-2e04-4ad9-9762-932419ee19ae2026-06-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9O25354EPJ
Calamine, Pramoxind HClCALAMINE, PRAMOXIND HCLH E B4a7a0b09-d9bc-e752-e063-6394a90a9f2c2026-06-15Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
Calamine, Zinc OxideCALAMINE, ZINC OXIDEH E B4a79259e-64ac-d187-e063-6294a90a78db2026-06-15Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
ENALAPRIL MALEATEENALAPRIL MALEATEBryant Ranch Prepackc1e4cd79-ece5-432c-bd3a-ed4633ccec702026-05-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9O25354EPJ
CalamineCALAMINE AND ZINC OXIDEPharma Nobis, LLCfbcfa541-beda-06de-e053-6294a90a92982026-05-26WarningsExact identifier
unii: 1K09F3G675
Calamine Plus Pramoxine HClCALAMINE PLUS SPRAYCVS Pharmacydb6f518d-3a0e-43f8-8d19-7382d9b7ff1c2026-05-11WarningsExact identifier
unii: 1K09F3G675
CalamineFERRIC OXIDE REDRetail Business Services, LLC7291e175-a9b6-4c47-93ce-227ce11e45992026-04-30Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
Enalapril MaleateENALAPRIL MALEATECoupler LLC508a58fa-9f66-e984-e063-6394a90a296a2026-04-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9O25354EPJ
Caldesene BabySTARCH, CORN AND ZINC OXIDEInsight Pharmaceuticals LLC9f12dee2-7afa-45e9-a729-0fd42bb777152026-04-22WarningsExact identifier
unii: O8232NY3SJ
Caldesene Medicated ProtectingCORNSTARCH AND ZINC OXIDEInsight Pharmaceuticals LLCffc92a0f-a7cf-4a46-b2f1-089df2bbb96b2026-04-22WarningsExact identifier
unii: O8232NY3SJ
Enalapril MaleateENALAPRIL MALEATEPreferred Pharmaceuticals Inc.5596ba00-4a1c-4503-99db-3a9617ed17c02026-04-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9O25354EPJ

Reported adverse events (FAERS/openFDA)#

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