FDA.reportPublic FDA data

NDC 16729-393 - amlodipine besylate and olmesartan medoxomil

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
16729-393
Package NDCs from labels
16729-393-10, 16729-393-15, 16729-393-16, 16729-393-17
Manufacturer
Accord Healthcare Inc. | Intas Pharmaceuticals Limited
Effective date
2019-08-14
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
POVIDONE K30 - Accord Healthcare Inc. | Intas Pharmaceuticals LimitedAccord Healthcare Inc. | Intas Pharmaceuticals Limited2019-08-14HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16729-393-10amlodipine besylate and olmesartan medoxomil30 in 1 BOTTLETABLET, FILM COATED302
16729-393-15amlodipine besylate and olmesartan medoxomil90 in 1 BOTTLETABLET, FILM COATED902
16729-393-16amlodipine besylate and olmesartan medoxomil500 in 1 BOTTLETABLET, FILM COATED5002
16729-393-17amlodipine besylate and olmesartan medoxomil1000 in 1 BOTTLETABLET, FILM COATED10002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16729-393AMLODIPINE BESYLATE AND OLMESARTAN MEDOXOMIL TABLET, FILM COATED [ACCORD HEALTHCARE INC.]24 package rows20220901_a855ce60-6918-490a-9158-3be5a0ef76b5.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 18 of 123 · 2,441 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Amlodipine BesylateAMLODIPINE BESYLATEPreferred Pharmaceuticals Inc.1ff04bd2-9926-48a4-9afc-eab0789dba012026-02-23Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Perfect Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDESKIN PERFECT MEDICAL4b47e7cb-17d6-6a7c-e063-6294a90abbea2026-02-20WarningsExact identifier
unii: 15FIX9V2JP
CalamineFERRIC OXIDE REDPerrigo Direct, Inc256bd1d4-fd50-408f-9aee-84f218bb49712026-02-19Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
CalamineCALAMINE, PRAMOXIND HCLPerrigo Direct, Inc54a20ec9-ab86-4410-af94-e04393e9d4b32026-02-19Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
CalamineCALAMINE, PRAMOXINE HCLMeijer, Inc.6b369ef2-fd54-4931-a9eb-0fb42834c2ef2026-02-19Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
Allay Skin Solutions Protect Nourish Mineral Sunscreen SPF 42TITANIUM DIOXIDE, ZINC OXIDEALLAY SKIN SOLUTIONS LLC425bf1d7-f2cf-4237-9047-dd53054acd1c2026-02-18WarningsExact identifier
unii: 15FIX9V2JP
CalamineFERRIC OXIDE REDTarget Corporationd4ee05c8-ae62-45df-8783-1ed57fa030ec2026-02-18Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
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
ExforgeAMLODIPINE BESYLATE AND VALSARTANNovartis Pharmaceuticals Corporationd0caec89-96ec-411d-a933-63eda74a6da72026-02-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
CalamineFERRIC OXIDE REDTopco Associates LLC2b32e720-ac71-4d60-bc06-e28a00f8a4502026-02-13Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
CalamineCALAMINE, PRAMOXINE HCLTopco Associates LLC15d1ae3f-509c-4e6b-8f0c-cf92656803582026-02-13Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
Amlodipine and AtorvastatinAMLODIPINE AND ATORVASTATINBryant Ranch Prepack043c4742-081d-4bc4-bf27-dad92bb2dfbc2026-02-12Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine Besylate and Benazepril HydrochlorideAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEREMEDYREPACK INC.ea774c36-e970-4d9c-9487-6cc57741fec52026-02-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Alumier MD Clear Shield Broad Spectrum SPF 42 SunscreenTITANIUM DIOXIDE, ZINC OXIDEAlumier Labsa9c970c8-b6e3-b0a1-e053-2a95a90a89c72026-02-09WarningsExact identifier
unii: 15FIX9V2JP
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
Amlodipine Besylate and Benazepril HydrochlorideAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEBryant Ranch Prepack5813e6b6-f524-4fba-99ba-9f4e365bf5232026-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Olmesartan MedoxomilOLMESARTAN MEDOXOMILA-S Medication Solutionseeb16efc-4413-4464-9eb8-effa1e5684aa2026-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6M97XTV3HD

Reported adverse events (FAERS/openFDA)#

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