FDA.reportPublic FDA data

NDC 16729-395 - 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
16729-395
Package NDCs from labels
16729-395-10, 16729-395-15, 16729-395-16, 16729-395-17
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
16729-395-10amlodipine besylate and olmesartan medoxomil30 in 1 BOTTLETABLET, FILM COATED302
16729-395-15amlodipine besylate and olmesartan medoxomil90 in 1 BOTTLETABLET, FILM COATED902
16729-395-16amlodipine besylate and olmesartan medoxomil500 in 1 BOTTLETABLET, FILM COATED5002
16729-395-17amlodipine besylate and olmesartan medoxomil1000 in 1 BOTTLETABLET, FILM COATED10002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16729-395AMLODIPINE 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 92 of 121 · 2,408 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Equate Sunscreen SPF 50 KIDS Broad SpectrumTITANIUM DIOXIDE, ZINC OXIDEWAL-MART STORES INC81cb6b2e-1ca3-4a83-a8df-9bfee61e79af2024-10-16WarningsExact identifier
unii: 15FIX9V2JP
OLMESARTAN MEDOXOMILOLMESARTAN MEDOXOMILRising Pharma Holdings, Inc.b02ff20e-3f0e-43f4-a7b5-6ce56295d0232024-10-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6M97XTV3HD
MINERAL BASED SPF 50 SUNSCREENZINC OXIDE, TITANIUM DIOXIDETHE KROGER COMPANYa4e6936d-a76c-e8fd-e053-2995a90a965f2024-10-15WarningsExact identifier
unii: 15FIX9V2JP
TopCare Everyday Mineral Sunscreen Continuous Broad Spectrum SPF 50 Reef-Conscious FormulaTITANIUM DIOXIDE, ZINC OXIDETOPCO ASSOCIATES LLCf14f43e6-ee57-5495-e053-2a95a90a40112024-10-15WarningsExact identifier
unii: 15FIX9V2JP
MINERAL SUNSCREEN SPF 50ZINC OXIDE, TITANIUM DIOXIDETOPCO ASSOCIATES LLCbfe076fa-f21f-2c46-e053-2a95a90acee42024-10-15WarningsExact identifier
unii: 15FIX9V2JP
H.E.B. Mineral Sunscreen Broad Spectrum SPF 50TITANIUM DIOXIDE, ZINC OXIDEH.E.B.c5279caf-3af9-d163-e053-2995a90a943b2024-10-15WarningsExact identifier
unii: 15FIX9V2JP
Amlodipine BesylateAMLODIPINE BESYLATEA-S Medication Solutions91e11ca6-05fb-47be-bd40-f8649a35d47d2024-10-15Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Target Up and Up Mineral Sunscreen Broad Spectrum SPF 50 Reef-Conscious FormulaTITANIUM DIOXIDE, ZINC OXIDETARGET CORPORATIONcfd735d2-df3a-5ed0-e053-2995a90a9f262024-10-14WarningsExact identifier
unii: 15FIX9V2JP
Target Up and Up SPF 50 Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDETARGET CORPORATIONf99028fa-a17e-4a84-e053-6294a90a927f2024-10-14WarningsExact identifier
unii: 15FIX9V2JP
Amlodipine BesylateAMLODIPINE BESYLATEA-S Medication Solutions3bd019d3-b58c-44ab-9190-606a0af5e9b62024-10-14Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATEA-S Medication Solutions699d3ba2-a342-4e3d-b8ad-c14e0df64dfe2024-10-09Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATEA-S Medication Solutionsda4e36d3-1ddc-4350-9a00-86975e523f752024-10-09Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
AMOREPACIFIC COLOR CONTROL CUSHION COMPACT NO.102ZINC OXIDE, OCTINOXATE, AND TITANIUM DIOXIDEAMOREPACIFIC CORPORATION531f60c9-c89a-46bc-8460-d01b2e838e6f2024-10-08WarningsExact identifier
unii: 15FIX9V2JP
AMOREPACIFIC COLOR CONTROL CUSHION COMPACT NO.104OCTINOXATE, TITANIUM DIOXIDE, AND ZINC OXIDEAMOREPACIFIC CORPORATION60964d9f-d96c-4397-b273-6b63d18867222024-10-08WarningsExact identifier
unii: 15FIX9V2JP
IOPE AIR CUSHION Cover 21 VanillaZINC OXIDE, OCTINOXATE, AND TITANIUM DIOXIDEAMOREPACIFIC CORPORATION29d6cc8d-1469-479d-a15a-e78d4e22d4a22024-10-08WarningsExact identifier
unii: 15FIX9V2JP
Amlodipine BesylateAMLODIPINE BESYLATEBryant Ranch Prepack49d69d27-2a75-4a07-bfb9-24f8af8531382024-10-07Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
DermacinRx Skin Moisturizing Ultra SPF 50 SunscreenAVOBENZONE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDEPureTek Corporation86eb06cc-d63f-4500-a52e-14ef99a565322024-10-02WarningsExact identifier
unii: 15FIX9V2JP
TiZO2TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD43bec652-3f2c-4671-8a0c-c4c4a4bfcc7a2024-10-01WarningsExact identifier
unii: 15FIX9V2JP
Olmesartan MedoxomilOLMESARTAN MEDOXOMILDirect_Rx16754802-d5a4-0350-e063-6394a90aa9672024-09-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6M97XTV3HD
CalamineCALAMINE AND ZINC OXIDEStrategic Sourcing Services, LLC22173332-9d09-768c-e063-6394a90a94e12024-09-14WarningsExact identifier
unii: 1K09F3G675

Reported adverse events (FAERS/openFDA)#

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