FDA.reportPublic FDA data

NDC 16729-392 - 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
16729-392
Package NDCs from labels
16729-392-10, 16729-392-15, 16729-392-16, 16729-392-17
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
16729-392-10amlodipine besylate and olmesartan medoxomil30 in 1 BOTTLETABLET, FILM COATED302
16729-392-15amlodipine besylate and olmesartan medoxomil90 in 1 BOTTLETABLET, FILM COATED902
16729-392-16amlodipine besylate and olmesartan medoxomil500 in 1 BOTTLETABLET, FILM COATED5002
16729-392-17amlodipine besylate and olmesartan medoxomil1000 in 1 BOTTLETABLET, FILM COATED10002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16729-392AMLODIPINE 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 107 of 121 · 2,412 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Max MineralTITANIUM DIOXIDE, ZINC OXIDEPeter Thomas Roth Labs, LLC0980992c-6488-2fa1-e063-6294a90a41ea2023-11-14WarningsExact identifier
unii: 15FIX9V2JP
Amlodipine BesylateAMLODIPINE BESYLATEA-S Medication Solutions5c50c3fe-afe5-459e-95c0-c9af4cbb69092023-11-13Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Tropical Sands, SPF-50 Broad Spectrum SunscreenTITANIUM DIOXIDE, ZINC OXIDEElements Brands, Inc.493551d0-10a0-3d78-e054-00144ff8d46c2023-11-11WarningsExact identifier
unii: 15FIX9V2JP
Tropical Sands SPF-30 Broad Spectrum SunscreenTITANIUM DIOXIDE, ZINC OXIDEElements Brands, Inc.494a7886-d677-1648-e054-00144ff8d46c2023-11-11WarningsExact identifier
unii: 15FIX9V2JP
Tropical Sands SPF-30 Broad Spectrum SunscreenTITANIUM DIOXIDE, ZINC OXIDEElements Brands, Inc.ab691543-e37a-487a-912e-56d2e0e4d30a2023-11-11WarningsExact identifier
unii: 15FIX9V2JP
PURE HAVEN BODY SPF 30TITANIUM DIOXIDE, ZINC OXIDEPure haven, LLC6f298fcd-8a97-8f66-e053-2991aa0adb102023-11-11WarningsExact identifier
unii: 15FIX9V2JP
Sunstation All-Natural SPF 30 SunscreenTITANIUM DIOXIDE, ZINC OXIDESunstation USA, LLC499d366a-a7f1-6070-e054-00144ff88e882023-11-11WarningsExact identifier
unii: 15FIX9V2JP
Pure Haven EssentialsTITANIUM DIOXIDE, ZINC OXIDEPure Haven LLC4bccc017-266d-11ce-e054-00144ff8d46c2023-11-11WarningsExact identifier
unii: 15FIX9V2JP
koa protect our ocean life OXYBENZONE FREE Broad Spectrum SPF 30 UVA UVB Protection SunscreenTITANIUM DIOXIDE, ZINC OXIDEKapa'ihi, Inc66e5eb1b-4ef0-459d-8428-b3e2f221bc852023-11-11WarningsExact identifier
unii: 15FIX9V2JP
YOU-V SPF-30 Broad Spectrum SunscreenTITANIUM DIOXIDE, ZINC OXIDEYouV, LLC290cd617-aa90-4f10-8a1d-d8954b9270042023-11-11WarningsExact identifier
unii: 15FIX9V2JP
OUTER REEF Reef Safe (WR) Broad Spectrum SPF 30TITANIUM DIOXIDECoral Reef Park Co., Inc.743f3d23-0f5c-4724-9f69-411c109506e12023-11-11WarningsExact identifier
unii: 15FIX9V2JP
ONCODERM Rx Mineral Sunscreen SPF-30TITANIUM DIOXIDE, ZINC OXIDEOncoderm, LLC9f16e832-067c-4ae8-bd7d-6f0dc0ad6fae2023-11-11WarningsExact identifier
unii: 15FIX9V2JP
PROJECT REEF Mineral Sunscreen SPF-50ZINC OXIDE, TITANIUM DIOXIDEProject Reef LLC87b9170c-956e-4aa2-9416-da00cca81b582023-11-11WarningsExact identifier
unii: 15FIX9V2JP
DERMAKA Broad Spectrum SPF-42 SunscreenTITANIUM DIOXIDE, ZINC OXIDEDERMAKA SKIN PRODUCTS32b892fd-c68f-4670-bbaa-0b3de57128492023-11-11WarningsExact identifier
unii: 15FIX9V2JP
WILMA SCHUMANN Moisture Protektiv Day Cream SPF-20OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDESKINMETICS INC4a719986-d1d0-4156-b803-04004b7215042023-11-11WarningsExact identifier
unii: 15FIX9V2JP
DERMAKA Broad Spectrum SPF-42 Sunscreen UntintedTITANIUM DIOXIDE, ZINC OXIDEDERMAKA SKIN PRODUCTS9aa24e1f-e338-4947-a437-554fb6b227a22023-11-11WarningsExact identifier
unii: 15FIX9V2JP
TRENDY JOHN SPF-32 Sheer Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDETRENDY JOHN LLC80dccecb-fbb3-4af6-9cb4-6acea733e9962023-11-11WarningsExact identifier
unii: 15FIX9V2JP
KOVR All-Natural SPF-30 Moisturizing Sunscreen for WomenTITANIUM DIOXIDE, ZINC OXIDEACTIVE LIFE INC0ddc3bb9-595e-4ebd-ad3e-df4d94fd34ed2023-11-11WarningsExact identifier
unii: 15FIX9V2JP
Personalized Day Moisturizer with SPFTITANIUM DIOXIDE, ZINC OXIDEProven Skincare3b6546ed-22ee-48e6-83cc-5cbadf5674992023-11-10WarningsExact identifier
unii: 15FIX9V2JP
Tropical Sands SPF-30 Broad Spectrum Sunscreen (Coconut)TITANIUM DIOXIDE, ZINC OXIDEElements Brands, Inc.4935f888-cd92-61d1-e054-00144ff8d46c2023-11-10WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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