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 112 of 123 · 2,441 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Youth 4 Activating BB Cream SPF 30 DarkZINC OXIDE, TITANIUM DIOXIDEShaklee Corporation63f7f8bd-02f0-4a13-bb1e-298754b24fce2023-11-03WarningsExact identifier
unii: 15FIX9V2JP
Youth 1 Activating BB Cream SPF 30 LightZINC OXIDE, TITANIUM DIOXIDEShaklee Corporationc9e05055-48ea-405d-b1d4-50b263d0dbf92023-11-03WarningsExact identifier
unii: 15FIX9V2JP
CAPTURE DREAMSKIN FRESH and PERFECT CUSHION WITH SUNSCREEN BROAD SPECTRUM SPF 50 020OCTINOXATE,TITANIUM DIOXIDE,ZINC OXIDEParfums Christian Diorfe03fc14-4132-4dab-b013-d490764be0d42023-11-03WarningsExact identifier
unii: 15FIX9V2JP
CAPTURE DREAMSKIN FRESH and PERFECT CUSHION WITH SUNSCREEN BROAD SPECTRUM SPF 50 000OCTINOXATE,TITANIUM DIOXIDE,ZINC OXIDEParfums Christian Dior968cfae7-89b6-4ef3-ab60-1c675b90c1512023-11-03WarningsExact identifier
unii: 15FIX9V2JP
CAPTURE DREAMSKIN FRESH and PERFECT CUSHION WITH SUNSCREEN BROAD SPECTRUM SPF 50 010OCTINOXATE,TITANIUM DIOXIDE,ZINC OXIDEParfums Christian Dior775f4009-9fc2-475b-a141-b4b5e55421802023-11-03WarningsExact identifier
unii: 15FIX9V2JP
CAPTURE DREAMSKIN FRESH and PERFECT CUSHION WITH SUNSCREEN BROAD SPECTRUM SPF 50 030OCTINOXATE,TITANIUM DIOXIDE,ZINC OXIDEParfums Christian Dior189f8767-f463-4c83-8a38-975ce8672b2a2023-11-03WarningsExact identifier
unii: 15FIX9V2JP
FOREVER SKIN VEIL Extreme Wear and Moisturizing Primer Correction, Protection, Illumination With Sunscreen Floral Extract-Enriched Broad Spectrum SPF20OCTISALATE, TITANIUM DIOXIDEParfums Christian Diorc59b4ece-0534-4072-afe8-2142a43c6bb22023-11-03WarningsExact identifier
unii: 15FIX9V2JP
CAPTURE DREAMSKIN FRESH AND PERFECT CUSHION WITH SUNSCREEN BROAD SPECTRUM SPF 50 030OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEParfums Christian Diorcdc2a156-5ccd-4d40-98af-c529f0911a9e2023-11-03WarningsExact identifier
unii: 15FIX9V2JP
FOREVER SKIN GLOW 24h Wear Radiant Perfection Skin Caring Foundation With Sunscreen BROAD SPECTRUM SPF 35 Lasting Hydration 2WPOCTINOXATE, TITANIUM DIOXIDEPARFUMS CHRISTIAN DIOR6ee0284e-739d-4aad-9352-9ea9c106efa42023-11-03WarningsExact identifier
unii: 15FIX9V2JP
THE SOF FLUID LONG WEAR FOUNDATION BROAD SPECTRUM SPF 20OCTINOXATE AND TITANIUM DIOXIDEMAX HUBER RESEARCH LAB INC97787725-9175-46a7-8e3a-af5d06e21d7f2023-10-30WarningsExact identifier
unii: 15FIX9V2JP
LA MER THE RADIANT SKINTINT BROAD SPECTRUM SPF 30OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDEMAX HUBER RESEARCH LAB INCecc942c7-5495-43b1-9ffa-d38be78911522023-10-30WarningsExact identifier
unii: 15FIX9V2JP
Vivier Sheer SPF 30 MineralTITANIUM DIOXIDE, ZINC OXIDEVivier Pharma, Inc.1be5ee36-3566-495c-aae2-4d0d7fc210ed2023-10-27WarningsExact identifier
unii: 15FIX9V2JP
SIMPLE TRUTH MINERAL BASED SPF 50 SUNSCREENTITANIUM DIOXIDE, ZINC OXIDETHE KROGER COMPANYa52872bf-cd0f-06da-e053-2995a90af28d2023-10-26WarningsExact identifier
unii: 15FIX9V2JP
PERFECTIONIST PRO MULTI-DEFENSE UV FLUID BROAD SPRECTRUM SPF 45TITANIUM DIOXIDE AND ZINC OXIDEESTEE LAUDER INCe87c4a76-5f21-4989-a1e0-0b7c6902f2012023-10-26WarningsExact identifier
unii: 15FIX9V2JP
Diamond Luminous UV Defense Light Tinted Fluid Sunscreen Broad Spectrum SPF 40TITANIUM DIOXIDE, ZINC OXIDENATURA BISSE INTERNATIONAL SAbf8b71c7-257b-0eb6-e053-2a95a90a3a4c2023-10-26WarningsExact identifier
unii: 15FIX9V2JP
Amlodipine and Benazepril HydrochlorideAMLODIPINE AND BENAZEPRIL HYDROCHLORIDEA-S Medication Solutions89d8d490-3a9c-40f2-86b7-94b5101dd09a2023-10-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Artistry Skin Nutrition Multi-Defense UV ProtectZINC OXIDE, TITANIUM DIOXIDEAccess Business Group LLC82623c46-9ec3-4331-a2db-9b8d07fa18172023-10-23WarningsExact identifier
unii: 15FIX9V2JP
Farmasi CC Cream LIGHT to MEDIUM 02TITANIUM DIOXIDETAN ALIZE KOZMETIK VE TEMIZLIK URUNLERI SANAYI VE TICARET ANONIM SIRKETI28b3fdff-1986-4048-9ed5-a3d784a4014e2023-10-23WarningsExact identifier
unii: 15FIX9V2JP
Farmasi CC Cream- MEDIUM 03TITANIUM DIOXIDETAN ALIZE KOZMETIK VE TEMIZLIK URUNLERI SANAYI VE TICARET ANONIM SIRKETI65de3c45-8ec2-4d73-8a29-6203d3b47bd72023-10-23WarningsExact identifier
unii: 15FIX9V2JP
Farmasi BB Cream- MEDIUM 03TITANIUM DIOXIDETAN ALIZE KOZMETIK VE TEMIZLIK URUNLERI SANAYI VE TICARET ANONIM SIRKETI9102aa2f-0308-4985-b8a8-8e105047b61f2023-10-23WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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