FDA.reportPublic FDA data

NDC 50090-5357-00 - Amlodipine Besylate and Benazepril Hydrochloride

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
50090-5357
Requested NDC
50090-5357-00
Package NDCs from labels
50090-5357-0, 50090-5357-00
Manufacturer
A-S Medication Solutions
Effective date
2026-05-11
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Amlodipine Besylate and Benazepril Hydrochloride - A-S Medication SolutionsA-S Medication Solutions2026-05-11HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-5357-02023-02-07C16284748780-1f386c64a-41f7-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE CAPSULES safely and effectively. See full prescribing information for AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE CAPSULES. AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE capsules, for oral use. Initial U.S. Approval: 1995
50090-5357-02023-01-30C16284748780-1f386c64a-41f7-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE CAPSULES safely and effectively. See full prescribing information for AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE CAPSULES. AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE capsules, for oral use. Initial U.S. Approval: 1995

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5357-0Amlodipine Besylate and Benazepril Hydrochloride90 in 1 BOTTLECAPSULE906

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5357AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS]4Current NDC, Legacy NDC, 1 package rows20230919_c695f95d-6064-4a22-84ba-c8e62477b3a7.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5357-0EA - Each50090-535724ec4890-63b3-4008-9883-1dba8503c4c512023-10-16

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 22 of 153 · 3,047 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Allergy Maximum StrengthURTICA DIOICA, ALTHAEA OFFICINALIS ROOT, INULA HELENIUM ROOT, ANGELICA ARCHANGELICA ROOT, PINE NEEDLE OIL (PINUS SYLVESTRIS), SODIUM CHLORIDE, AND SILICON DIOXIDEForces of Nature122ca23e-43f1-4e5c-afc2-1418b17176792026-02-20WarningsExact identifier
unii: ETJ7Z6XBU4
Perfect Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDESKIN PERFECT MEDICAL4b47e7cb-17d6-6a7c-e063-6294a90abbea2026-02-20WarningsExact identifier
unii: 15FIX9V2JP
Allay Skin Solutions Protect Nourish Mineral Sunscreen SPF 42TITANIUM DIOXIDE, ZINC OXIDEALLAY SKIN SOLUTIONS LLC425bf1d7-f2cf-4237-9047-dd53054acd1c2026-02-18WarningsExact identifier
unii: 15FIX9V2JP
Hermes Plein Air-Baume de Teint Perfecteur Naturel-Enhancing Complexion Balm 85 TAMARINTITANIUM DIOXIDES.A. COMPTOIR NOUVEAU DE LA PARFUMERIEdacff3dc-49d7-6416-e053-2a95a90a85c62026-02-18WarningsExact identifier
unii: 15FIX9V2JP
Mitochondria ProARALIA QUINQUEFOLIA, ARNICA MONTANA, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALPHA-KETOGLUTARICUM ACIDUM, ASCORBICUM ACIDUM, ALPHA-LIPOICUM ACIDUM, CALCAREA CARBONICA, CITRICUM ACIDUM, CUPRUM METALLICUM, CYSTEINUM, FERRUM METALLICUM, IODIUM, LEVOTHYROXINUM, MAGNESIUM GLUCONICUM DIHYDRICUM, MALICUM ACIDUM, MANGANUM ACETICUM, NADIDUM, NATRUM PYRUVICUM, NICOTINAMIDUM, PYRIDOXINUM HYDROCHLORICUM, RIBOFLAVINUM, SELENIUM METALLICUM, SULPHUR, THIAMINUM HYDROCHLORICUM, UBIDECARENONUM, ZINCUM METALLICUM,Energique, Inc.2f365207-b730-428d-9465-8853e86e79ff2026-02-18WarningsExact identifier
unii: ETJ7Z6XBU4
BIO COM 25 ACIDITYNAT PHOS, NAT SULPH, SILICEABM Private Limited3b3c3455-b321-071d-e063-6394a90a01602026-02-17WarningsExact identifier
unii: ETJ7Z6XBU4
ExforgeAMLODIPINE BESYLATE AND VALSARTANNovartis Pharmaceuticals Corporationd0caec89-96ec-411d-a933-63eda74a6da72026-02-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
CINAAMBROSIA, CINA, CUCURBITA CIT, CUCURBITA PEP, INDIGO, SANTONINE, SILICEABM PRIVATE LIMITED3b3c0874-90b5-deda-e063-6394a90a78022026-02-15WarningsExact identifier
unii: ETJ7Z6XBU4
Acne/Pimple ControlCALENDULA OFFICINALIS FLOWERING TOP AND SILICON DIOXIDEForces of Naturee871e46e-463e-49ec-a2af-5aa98548ee122026-02-13WarningsExact identifier
unii: ETJ7Z6XBU4
Amlodipine and AtorvastatinAMLODIPINE AND ATORVASTATINBryant Ranch Prepack043c4742-081d-4bc4-bf27-dad92bb2dfbc2026-02-12Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
FuligoCIMICIFUGA, DROSERA, FORMICA RUFA, FULIGO, INULA HEL., KALI MUR, LAPIS ALBUS, SILICEABM Private Limited3b27225f-4587-d915-e063-6294a90a72252026-02-12WarningsExact identifier
unii: ETJ7Z6XBU4
Amlodipine Besylate and Benazepril HydrochlorideAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEREMEDYREPACK INC.ea774c36-e970-4d9c-9487-6cc57741fec52026-02-09Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA078466
rxcui: 898342
unii: N1SN99T69T
unii: 864V2Q084H
Alumier MD Clear Shield Broad Spectrum SPF 42 SunscreenTITANIUM DIOXIDE, ZINC OXIDEAlumier Labsa9c970c8-b6e3-b0a1-e053-2a95a90a89c72026-02-09WarningsExact identifier
unii: 15FIX9V2JP
Droptics Performance Eye DropsNAPHAZOLINE HYDROCHLORIDE, PROPYLENE GLYCOLDroptics LLC20fd6822-a7fd-4593-92bb-0a07260893e22026-02-09WarningsExact identifier
unii: 6DC9Q167V3
Mold, Yeast and DustADRENALINUM, ARSENICUM IODATUM, ASPERGILLUS FLAVUS, ASPERGILLUS FUMIGATUS, ASPERGILLUS GLAUCUS, ASPERGILLUS NIDULANS, ASPERGILLUS NIGER, CANDIDA ALBICANS, DERMATOPHAGOIDES FARINAE, HISTAMINUM HYDROCHLORICUM, LYCOPODIUM CLAVATUM, MUCOR PLUMBEUS, NATRUM SULPHURICUM, PENICILLIUM DIGITATUM, PENICILLIUM ROQUEFORTII, SACCHAROMYCES CEREVISIAE, SILICEANaturalCare32afa0f0-bca5-4246-bc2e-decd757fcf9d2026-02-09WarningsExact identifier
unii: ETJ7Z6XBU4
Hampton Sun SPF 50 MineralZINC OXIDE 19.5% TITANIUM DIOXIDE 4.00%S&C Hampton Sun LLCd6c33436-042e-44e8-8b55-98be6e2468792026-02-06WarningsExact identifier
unii: 15FIX9V2JP
SHISEIDO WASO COLOR-SMART DAY MOISTURIZEROCTINOXATE, TITANIUM DIOXIDEShiseido Americas Corporationf291f077-1c72-48fc-bb19-c20bdeaaa5962026-02-06WarningsExact identifier
unii: 15FIX9V2JP
Amlodipine BesylateAMLODIPINE BESYLATEAphena Pharma Solutions - Tennessee, LLC4a2bba2d-9b7a-f43a-e063-6294a90af80e2026-02-06Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
SHISEIDO WASO COLOR-SMART DAY MOISTURIZEROCTINOXATE, TITANIUM DIOXIDEShiseido Americas Corporation54f63dd8-e77f-42e4-a6d3-61ab7beecf502026-02-06WarningsExact identifier
unii: 15FIX9V2JP
GoodSense Eye Drops Advanced Relief MoisturizerDEXTRAN, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLSportpharm LLC8d58dcbb-72a0-41f0-9eeb-613072a6d7ae2026-02-06WarningsExact identifier
unii: FZ989GH94E

Reported adverse events (FAERS/openFDA)#

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