FDA.reportPublic FDA data

NDC 70518-4197-01 - 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
70518-4197
Requested NDC
70518-4197-01
Package NDCs from labels
70518-4197-0, 70518-4197-1, 70518-4197-2, 70518-4197-01
Manufacturer
REMEDYREPACK INC.
Effective date
2026-08-31
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
ENALAPRIL MALEATE TABLETS Rx onlyREMEDYREPACK INC.2026-08-31HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-4197-0Enalapril Maleate90 in 1 BOTTLE, PLASTICTABLET904
70518-4197-1Enalapril Maleate30 in 1 BLISTER PACKTABLET304
70518-4197-2Enalapril Maleate90 in 1 BOTTLE, PLASTICTABLET904

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-4197ENALAPRIL MALEATE TABLET [REMEDYREPACK INC.]1Current NDC, 3 package rows20241004_5118eb9f-1466-4318-b17e-cf5898edbeef.zip

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 9 of 17 · 336 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Omeprazole and sodium bicarbonateOMEPRAZOLE, SODIUM BICARBONATEWalgreen Company8753a131-f8b1-48e1-993b-73c1ee635fef2025-11-04WarningsExact identifier
unii: 8MDF5V39QO
Omeprazole and Sodium BicarbonateOMEPRAZOLE, SODIUM BICARBONATECVS Pharmacy186732a3-13b9-4ea2-ba54-424f63298a2e2025-11-04WarningsExact identifier
unii: 8MDF5V39QO
basic care omeprazole and sodium bicarbonateOMEPRAZOLE, SODIUM BICARBONATEAmazon.com Services LLC4587f491-04ef-4c31-b7b6-bfafd31776fb2025-11-04WarningsExact identifier
unii: 8MDF5V39QO
Calamine Plus Pramoxine HClCALAMINE PLUS NO TOUCH SPRAYPremier Brands of America Inc.36481d67-2346-470b-e063-6294a90aae992025-11-03WarningsExact identifier
unii: 1K09F3G675
Omeprazole and sodium bicarbonateOMEPRAZOLE, SODIUM BICARBONATEH E Bddc8d73f-f4a1-42a7-89ee-420346820f612025-11-03WarningsExact identifier
unii: 8MDF5V39QO
Calamine PlusCALAMINE PLUS PRAMOXINE HCLAmerisourceBergen Drug Corporationf161e151-4fab-2fbc-e053-2a95a90a54372025-10-30WarningsExact identifier
unii: 1K09F3G675
REMEDY Calazime Skin ProtectantCALAMINE, MENTHOL, WHITE PETROLATUM, ZINC OXIDEMedline Industries, LP1295cfcc-5b61-481b-964b-f53ffd0cb58e2025-10-30WarningsExact identifier
unii: 1K09F3G675
Calamine PlusCALAMINE PLUS PRAMOXINE HCLMeijer Distribution Inc.03c46823-0b1f-4101-e063-6294a90aaf942025-10-30WarningsExact identifier
unii: 1K09F3G675
Aveeno Anti-Itch ConcentratedZINC OXIDE, FERRIC OXIDE RED, AND PRAMOXINE HYDROCHLORIDEKenvue Brands LLC07f4d4d0-9cee-46c3-bc71-2024abd31c9e2025-10-29WarningsExact identifier
unii: 1K09F3G675
Calamine Plus Pramoxine HClCALAMINE PLUS SPRAYPremier Brands of America, Inc.d3452573-f91f-f157-e053-2a95a90a1ad82025-10-27WarningsExact identifier
unii: 1K09F3G675
Walgreens Antacid Pain Relief Extra StrengthASPIRIN, CITRIC ACID, SODIUM BICARBONATEWalgreensb60df498-07db-500b-e053-2a95a90aff6a2025-10-17WarningsExact identifier
unii: 8MDF5V39QO
Equate Effervescent Antacid and Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATEWalmart6271b34b-55a0-40a8-e053-2a91aa0acb222025-10-17Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
ENALAPRIL MALEATEENALAPRIL MALEATEA-S Medication Solutionsaafdb635-fa17-4bfb-bcd3-86c7e7b147e22025-10-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 858817
unii: 9O25354EPJ
ENALAPRIL MALEATEENALAPRIL MALEATEA-S Medication Solutionsfd0a7ecc-d6a2-4e04-a14f-1ed4dacb7df32025-10-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 858810
unii: 9O25354EPJ
EQUATE SALINE PACKETSNASAL CLEANING SALTWALMART INC9e905ecb-d4d5-514a-e053-2a95a90adfbb2025-10-08WarningsExact identifier
unii: 8MDF5V39QO
EQUATE NETI POT SINUS WASHNASAL WASHWALMART INC9e90c1c1-4dcd-106e-e053-2995a90afd152025-10-08WarningsExact identifier
unii: 8MDF5V39QO
GURUNANDA NASAL SALINENASAL WASHGURUNANDA LLC2b4d78ae-b587-6dfe-e063-6394a90a88762025-10-08WarningsExact identifier
unii: 8MDF5V39QO
Omeprazole and Sodium BicarbonateOMEPRAZOLE AND SODIUM BICARBONATEAjanta Pharma USA Inc.cb657607-b038-47ee-b4e7-a5f419a14c332025-10-06Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
ENALAPRIL MALEATEENALAPRIL MALEATERising Pharma Holdings, Inc.71e9fff3-7283-437e-b107-72fc16f099892025-10-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 858804
rxcui: 858810
rxcui: 858817
rxcui: 858813
unii: 9O25354EPJ
Sodium BicarbonateSODIUM BICARBONATEFresenius Kabi USA, LLC0ab55004-bb63-436d-ad77-cd37969053702025-09-23Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO

Reported adverse events (FAERS/openFDA)#

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