FDA.reportPublic FDA data

NDC 51672-4038-01 - 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
51672-4038
Requested NDC
51672-4038-01
Package NDCs from labels
51672-4038-1, 51672-4038-3, 51672-4038-01
Manufacturer
Bryant Ranch Prepack
Effective date
2026-08-20
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Enalapril Maleate - Bryant Ranch PrepackBryant Ranch Prepack2026-08-20HUMAN PRESCRIPTION DRUG LABEL
Enalapril Maleate Tablets, USPGolden State Medical Supply, Inc.2026-08-05HUMAN PRESCRIPTION DRUG LABEL
Enalapril Maleate Tablets, USPSun Pharmaceutical Industries, Inc. | Taro Pharmaceuticals Industries Ltd.2026-07-14HUMAN PRESCRIPTION DRUG LABEL
Enalapril Maleate Tablets, USPPreferred Pharmaceuticals Inc.2024-04-15HUMAN PRESCRIPTION DRUG LABEL
Enalapril Maleate Tablets, USPREMEDYREPACK INC.2024-02-21HUMAN PRESCRIPTION DRUG LABEL
Enalapril Maleate - A-S Medication SolutionsA-S Medication Solutions2023-12-12HUMAN PRESCRIPTION DRUG LABEL
Enalapril Maleate - St. Mary's Medical Park PharmacySt. Mary's Medical Park Pharmacy2021-10-06HUMAN PRESCRIPTION DRUG LABEL
Enalapril Maleate - Denton Pharma, Inc. dba Northwind PharmaceuticalsDenton Pharma, Inc. dba Northwind Pharmaceuticals2020-07-07HUMAN PRESCRIPTION DRUG LABEL
Enalapril Maleate - Denton Pharma, Inc. dba Northwind PharmaceuticalsDenton Pharma, Inc. dba Northwind Pharmaceuticals2020-03-26HUMAN PRESCRIPTION DRUG LABEL
Enalapril Maleate Tablets, USPREMEDYREPACK INC.2019-09-15HUMAN PRESCRIPTION DRUG LABEL
Enalapril Maleate - DOH CENTRAL PHARMACYDOH CENTRAL PHARMACY2019-01-17HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-4038-1Enalapril Maleate100 in 1 BOTTLETABLET10013
51672-4038-3Enalapril Maleate1000 in 1 BOTTLETABLET100013

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-4038ENALAPRIL MALEATE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]13Current NDC, Legacy NDC, 2 package rows20230728_f103b9f9-e081-419d-a2d8-b86acda834dd.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-4038-1EA - Each51672-4038a4d72af7-6ecd-4df1-b833-43669eab8d5c12013-02-13
51672-4038-3EA - Each51672-4038687d907e-5dba-4a27-b4b7-48dc5c9a16d912013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Enalapril MaleateACTIVE INGREDIENT9O25354EPJENALAPRIL MALEATE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]6
Enalaprilat AnhydrousACTIVE MOIETYQ508Q118JMENALAPRIL MALEATE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]6
Ferric Oxide RedINACTIVE INGREDIENT1K09F3G675ENALAPRIL MALEATE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]6
Ferric Oxide YellowINACTIVE INGREDIENTEX438O2MRTENALAPRIL MALEATE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]6
Lactose MonohydrateINACTIVE INGREDIENTEWQ57Q8I5XENALAPRIL MALEATE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]6
Magnesium StearateINACTIVE INGREDIENT70097M6I30ENALAPRIL MALEATE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]6
Sodium BicarbonateINACTIVE INGREDIENT8MDF5V39QOENALAPRIL MALEATE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]6
Enalapril MaleateACTIVE INGREDIENT9O25354EPJENALAPRIL MALEATE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]2
ENALAPRILAT ANHYDROUSACTIVE MOIETYQ508Q118JMENALAPRIL MALEATE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ENALAPRIL MALEATE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTENALAPRIL MALEATE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]2
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XENALAPRIL MALEATE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]2
magnesium stearateINACTIVE INGREDIENT70097M6I30ENALAPRIL MALEATE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]2
sodium bicarbonateINACTIVE INGREDIENT8MDF5V39QOENALAPRIL MALEATE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJENALAPRIL MALEATE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]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 15 of 18 · 343 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SODIUM BICARBONATESODIUM BICARBONATE INJECTION,Long Grove Pharmaceuticals, LLCa26d709b-b294-4b02-9a88-7e840f099a332024-09-25Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
CalamineCALAMINE AND ZINC OXIDEStrategic Sourcing Services, LLC22173332-9d09-768c-e063-6394a90a94e12024-09-14WarningsExact identifier
unii: 1K09F3G675
2150f2cd-743f-b51a-e063-6394a90adee1b5beccb6-f64b-4b88-b1c4-9a5ab738de192024-09-04Boxed warning, Warnings, Adverse reactionsExact identifier
spl set id: b5beccb6-f64b-4b88-b1c4-9a5ab738de19
Insect sting relief latex 01SODIUM BICARBONATECosmuses Cosmetics (Ningbo) Co., Ltd.1b9e2d4c-bc0c-6ed0-e063-6294a90a91032024-08-19WarningsExact identifier
unii: 8MDF5V39QO
Quality Choice Effervescent Antacid and Pain Relief - Extra StrengthASPIRIN, ANHYDROUS CITRIC ACID, SODIUM BICARBONATEChain Drug Marketing Association1f926637-a61c-8eb7-e063-6394a90a65022024-08-13WarningsExact identifier
unii: 8MDF5V39QO
Omeprazole/Sodiium BicarbonateOMEPRAZOLE/SODIIUM BICARBONATEDirect_rx1f7f63c1-17c2-9a05-e063-6394a90abc6f2024-08-12Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Omeprazole and Sodium BicarbonateOMEPRAZOLE AND SODIUM BICARBONATEDr. Reddy's Laboratories Inc.,ddee28fb-c871-a6d4-984f-515522b284122024-07-15WarningsExact identifier
unii: 8MDF5V39QO
Enalapril maleate oral solutionENALAPRIL MALEATEBionpharma Inc.9391b8d8-2217-4838-8976-1a5ad90ef4ca2024-07-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9O25354EPJ
Insect sting relief pad 01SODIUM BICARBONATECosmuses Cosmetics (Ningbo) Co., Ltd.1b0f0088-6482-6de7-e063-6294a90aeeb72024-06-17WarningsExact identifier
unii: 8MDF5V39QO
CalamineFERRIC OXIDE REDNuCare Pharmaceuticals,Inc.66e98554-e158-a519-e053-2a91aa0a67832024-06-06Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
Omeprazole and Sodium BicarbonateOMEPRAZOLE AND SODIUM BICARBONATEANI Pharmaceuticals, Inc.63c3bd6c-a586-4ec0-8f45-ed936936dfeb2024-06-06Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Enalapril maleate oral solutionENALAPRIL MALEATENorthStar RxLLC19606da3-c6b0-40a5-9690-77fc37072b512024-04-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9O25354EPJ
Enalapril MaleateENALAPRIL MALEATEBryant Ranch Prepack2061543d-67e7-46b6-aa56-cafa11ae4b932024-04-03Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA075657
rxcui: 858810
unii: 9O25354EPJ
Pure Cornstarch BabyCORN STARCHWalgreen Companyd0e9bd13-b568-4f7e-b036-8d23e71ad8bf2024-03-25WarningsExact identifier
unii: O8232NY3SJ
SODIUM BICARBONATESODIUM BICARBONATESun Pharmaceutical Industries Limited5ae65432-04a1-4b6b-8536-2535064fc7822024-03-06Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Sodium BicarbonateSODIUM BICARBONATESteriscience Specialties Private Limitedeb2996b4-c04c-4678-b8a9-5cbbe509bb702024-03-04Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Sodium BicarbonateSODIUM BICARBONATEBryant Ranch Prepack4493d7c5-f2c3-416e-a5c1-35398fc7f61d2024-02-29Boxed warning, WarningsExact identifier
unii: 8MDF5V39QO
SODIUM BICARBONATESODIUM BICARBONATEHF Acquisition Co LLC, DBA HealthFirsta5eedf57-2783-b3d0-e053-2a95a90a9ff52024-02-22Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
SODIUM BICARBONATESODIUM BICARBONATEHF Acquisition Co LLC, DBA HealthFirst76131655-3a87-feac-e053-2991aa0a82a12024-01-28Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
ENALAPRIL MALEATEENALAPRIL MALEATEAurobindo Pharma Limited337707cc-4ed9-4121-bfff-c5015e5eca9d2024-01-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9O25354EPJ

Reported adverse events (FAERS/openFDA)#

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