FDA.reportPublic FDA data

NDC 0591-0670 - 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
0591-0670
Package NDCs from labels
0591-0670-01, 0591-0670-05
Manufacturer
Watson Laboratories Inc.
Effective date
2008-03-10
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Enalapril Maleate Tablets USP Revised: November 2007 Rx onlyWatson Laboratories Inc.2008-03-10HUMAN PRESCRIPTION DRUG LABELING

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0591-0670-01Enalapril Maleate100 in 1 BOTTLETABLET1002
0591-0670-05Enalapril Maleate500 in 1 BOTTLETABLET5002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0591-0670ENALAPRIL MALEATE (ENALAPRIL MALEATE) TABLET [WATSON LABORATORIES INC.]22 package rows20080325_AC0289A6-9533-4F8C-B46C-506DCE1B90B5.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ENALAPRIL MALEATEACTIVE INGREDIENT9O25354EPJENALAPRIL MALEATE (ENALAPRIL MALEATE) TABLET [WATSON LABORATORIES INC.]2
ENALAPRILACTIVE MOIETY69PN84IO1AENALAPRIL MALEATE (ENALAPRIL MALEATE) TABLET [WATSON LABORATORIES INC.]2
anhydrous lactoseINACTIVE INGREDIENT3SY5LH9PMKENALAPRIL MALEATE (ENALAPRIL MALEATE) TABLET [WATSON LABORATORIES INC.]2
crospovidoneINACTIVE INGREDIENTENALAPRIL MALEATE (ENALAPRIL MALEATE) TABLET [WATSON LABORATORIES INC.]2
iron oxide red 30INACTIVE INGREDIENTENALAPRIL MALEATE (ENALAPRIL MALEATE) TABLET [WATSON LABORATORIES INC.]2
iron oxide yellow 10INACTIVE INGREDIENTENALAPRIL MALEATE (ENALAPRIL MALEATE) TABLET [WATSON LABORATORIES INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ENALAPRIL MALEATE (ENALAPRIL MALEATE) TABLET [WATSON LABORATORIES INC.]2
microcrystalline celulloseINACTIVE INGREDIENTENALAPRIL MALEATE (ENALAPRIL MALEATE) TABLET [WATSON LABORATORIES INC.]2
potassium bicarbonateINACTIVE INGREDIENTHM5Z15LEBNENALAPRIL MALEATE (ENALAPRIL MALEATE) TABLET [WATSON LABORATORIES 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 3 of 3 · 59 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Enalapril MaleateENALAPRIL MALEATEBryant Ranch Prepackec6c8c65-b438-40e3-9eb3-665d939abbdb2025-03-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 858810
Enalapril MaleateENALAPRIL MALEATEBryant Ranch Prepack2e4ecc3a-ec6d-418b-99a8-95ad3e1c59d62025-03-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 858817
Enalapril MaleateENALAPRIL MALEATEBryant Ranch Prepack4f56955c-fc61-49ad-b42f-ff9d3386af6a2025-03-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 858813
Enalapril MaleateENALAPRIL MALEATENuCare Pharmaceuticals,Inc.fd013f06-3456-c178-e053-6294a90a6bd92025-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 858817
Enalapril MaleateENALAPRIL MALEATENuCare Pharmaceuticals,Inc.0b3dbe11-ff75-cb98-e063-6294a90ad2e92025-02-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 858817
Enalapril MaleateENALAPRIL MALEATENorthstar RxLLCe109e7b1-4650-4416-9d89-7c1185d5cf482025-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 858804
rxcui: 858810
rxcui: 858817
rxcui: 858813
Enalapril MaleateENALAPRIL MALEATECoupler LLC2cc892e2-1d91-e52a-e063-6394a90a66492025-01-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 858813
Enalapril MaleateENALAPRIL MALEATENuCare Pharmaceuticals,Inc.fe2dfa84-0276-6603-e053-6394a90af8ee2025-01-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 858810
Enalapril MaleateENALAPRIL MALEATEA-S Medication Solutionsdfc439f7-83f5-4b9e-bbf2-f3d002860be32024-10-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 858813
Enalapril maleateENALAPRIL MALEATEChartwell RX, LLCb1df1832-dce4-443f-87fc-e4177d0690352024-10-09Warnings, Adverse reactionsExact identifier
rxcui: 858804
rxcui: 858810
rxcui: 858817
rxcui: 858813
Enalapril MaleateENALAPRIL MALEATEBryant Ranch Prepack2061543d-67e7-46b6-aa56-cafa11ae4b932024-04-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 858810
Enalapril MaleateENALAPRIL MALEATEA-S Medication Solutions0ad4bfb4-62db-4759-af60-88eb031d125a2023-12-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 858813
Enalapril MaleateENALAPRIL MALEATEA-S Medication Solutionsf3754f29-9b75-4e2c-9c28-b3479f5bf9062023-10-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 858817
Enalapril MaleateENALAPRIL MALEATEA-S Medication Solutions7b80abb4-fa75-48a4-a2e9-b0e31205234c2023-05-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 858813
Enalapril maleateENALAPRIL MALEATEA-S Medication Solutionsccdd0f67-e9d5-41e3-93d5-94b9792a6f8f2023-04-27Warnings, Adverse reactionsExact identifier
rxcui: 858810
Enalapril MaleateENALAPRIL MALEATEOCEANSIDE PHARMACEUTICALSebd2a62d-a704-4f8a-a104-749a5296502f2020-12-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 858804
rxcui: 858810
rxcui: 858817
rxcui: 858813
Enalapril MaleateENALAPRIL MALEATEProficient Rx LPca1d0143-bbd3-4041-9981-eadbb8893a2b2020-03-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 858810
Enalapril MaleateENALAPRIL MALEATEProficient Rx LPcc921315-8da1-487c-ba19-433470f5c8d82019-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 858817
B11DE2CB-8782-DDF2-2101-BAFFA641C8A0AC0289A6-9533-4F8C-B46C-506DCE1B90B52008-03-10Boxed warning, Warnings, Adverse reactionsExact identifier
spl id: B11DE2CB-8782-DDF2-2101-BAFFA641C8A0
spl set id: AC0289A6-9533-4F8C-B46C-506DCE1B90B5

Reported adverse events (FAERS/openFDA)#

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