FDA.reportPublic FDA data

NDC 16729-321-46 - 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
16729-321
Requested NDC
16729-321-46
Package NDCs from labels
16729-321-10, 16729-321-15, 16729-321-16, 16729-321-17, 16729-321-45, 16729-321-46
Manufacturer
Accord Healthcare Inc. | Intas Pharmaceuticals Limited
Effective date
2025-10-29
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
olmesartan medoxomil - Accord Healthcare Inc. | Intas Pharmaceuticals LimitedAccord Healthcare Inc. | Intas Pharmaceuticals Limited2025-10-29HUMAN PRESCRIPTION DRUG LABEL
olmesartan medoxomil - REMEDYREPACK INC.REMEDYREPACK INC.2025-03-10HUMAN PRESCRIPTION DRUG LABEL
OLMESARTAN MEDOXOMIL - direct rxdirect rx2025-01-17HUMAN PRESCRIPTION DRUG LABEL
olmesartan medoxomil - Bryant Ranch PrepackBryant Ranch Prepack2024-08-27HUMAN PRESCRIPTION DRUG LABEL
olmesartan medoxomil - A-S Medication SolutionsA-S Medication Solutions2023-11-07HUMAN PRESCRIPTION DRUG LABEL
olmesartan medoxomil - A-S Medication SolutionsA-S Medication Solutions2023-08-28HUMAN PRESCRIPTION DRUG LABEL
olmesartan medoxomil - REMEDYREPACK INC.REMEDYREPACK INC.2019-11-13HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16729-321-10olmesartan medoxomil30 in 1 BOTTLE, PLASTICTABLET, FILM COATED309
16729-321-15olmesartan medoxomil90 in 1 BOTTLE, PLASTICTABLET, FILM COATED909
16729-321-16olmesartan medoxomil500 in 1 BOTTLE, PLASTICTABLET, FILM COATED5009
16729-321-17olmesartan medoxomil1000 in 1 BOTTLE, PLASTICTABLET, FILM COATED10009
16729-321-45olmesartan medoxomil10 in 1 BLISTER PACKTABLET, FILM COATED109
16729-321-46olmesartan medoxomil100 in 1 BOX, UNIT-DOSETABLET, FILM COATED1009

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16729-321OLMESARTAN MEDOXOMIL TABLET, FILM COATED [ACCORD HEALTHCARE INC.]8Current NDC, Legacy NDC, 6 package rows20240718_e5dbca00-4e1b-4479-b829-021b11bc021e.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16729-321-10EA - Each16729-321d1b3d3ec-be0d-4bdd-8ae2-484645b8f76612017-05-03
16729-321-15EA - Each16729-321e0daec77-c6b6-40ce-b831-b404d11ea4c812017-05-03
16729-321-17EA - Each16729-321a1cb3908-cd4c-4a7f-83dd-f217a6ddd4f012017-05-03

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 45 of 107 · 2,121 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 29WOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.17073264-ec02-4801-841d-86778debd8c42025-12-09WarningsExact identifier
unii: 15FIX9V2JP
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 41NOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.caee5c88-1907-41c1-987e-5bc544267dca2025-12-09WarningsExact identifier
unii: 15FIX9V2JP
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 33WOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.973b70f1-ee59-4dd9-aca3-432d721204ab2025-12-09WarningsExact identifier
unii: 15FIX9V2JP
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 27WOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.208fe03e-384b-4599-a4d0-a553fba306da2025-12-09WarningsExact identifier
unii: 15FIX9V2JP
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 35NOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.279258dd-b3fa-47be-8540-66bd9c879fc52025-12-09WarningsExact identifier
unii: 15FIX9V2JP
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 47NOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.c2ad2a5e-f8fe-41b3-8b0f-9981c337ec5c2025-12-09WarningsExact identifier
unii: 15FIX9V2JP
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 31NOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.4206b607-5c26-4c9d-ade7-58c9740cdbe82025-12-09WarningsExact identifier
unii: 15FIX9V2JP
Olmesartan Medoxomil and HydrochlorothiazideOLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDELifestar Pharma LLC9771066e-c05d-6a93-e053-2995a90a7e872025-12-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6M97XTV3HD
OLMESARTAN MEDOXOMILOLMESARTAN MEDOXOMILLifestar Pharma LLCa337a621-bf57-4aa4-8224-4356fa2cdbc42025-12-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 349373
rxcui: 349401
rxcui: 349405
unii: 6M97XTV3HD
Non-tinted Physical Block SunscreenTITANIUM DIOXIDE, ZINC OXIDETucson Acne Clinic30dd2f6b-5dcc-b081-e063-6394a90ae5f12025-12-09WarningsExact identifier
unii: 15FIX9V2JP
Tinted Physical Block SunscreenTITANIUM DIOXIDE, ZINC OXIDETucson Acne Clinic30dc6e23-ecca-ed0b-e063-6294a90a79512025-12-09WarningsExact identifier
unii: 15FIX9V2JP
Tinted Physical Block SunscreenTITANIUM DIOXIDE, ZINC OXIDETucson Acne Clinic30ddc3d7-76df-3344-e063-6294a90a65ae2025-12-09WarningsExact identifier
unii: 15FIX9V2JP
Tinted Physical Block SunscreenTITANIUM DIOXIDE, ZINC OXIDETucson Acne Clinic30ddf80c-8496-0f47-e063-6394a90afc182025-12-09WarningsExact identifier
unii: 15FIX9V2JP
Advanced Lip GuardTITANIUM DIOXIDE, ZINC OXIDEADVANCED DERMATOLOGY32e66ff3-ae1a-4a2a-e063-6294a90a79632025-12-09Exact identifier
unii: 15FIX9V2JP
Original TintTITANIUM DIOXIDE, ZINC OXIDEL.S. MOORE LLC37f1e019-32c4-b733-e063-6394a90aca282025-12-09Exact identifier
unii: 15FIX9V2JP
Original TintTITANIUM DIOXIDE, ZINC OXIDEL.S. MOORE LLC37f2e363-e85f-f601-e063-6294a90ab1202025-12-09Exact identifier
unii: 15FIX9V2JP
Original TintTITANIUM DIOXIDE, ZINC OXIDEL MOORE AESTHETICS37f1ac8c-3bfb-10da-e063-6294a90a8ca82025-12-09Exact identifier
unii: 15FIX9V2JP
Mineral Sunscreen Dry Touch NTTITANIUM DIOXIDE, ZINC OXIDECutis Wellness Dermatology And Dermatopathology PLLC334ffc49-3196-0995-e063-6394a90ad5592025-12-09Exact identifier
unii: 15FIX9V2JP
Foam Weightless Sunscreen Non-Tinted Drytouch NTTITANIUM DIOXIDE, ZINC OXIDECutis Wellness Dermatology And Dermatopathology PLLC335ec22c-6a9a-c4d1-e063-6394a90ac0b02025-12-09Exact identifier
unii: 15FIX9V2JP
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDELily Lee, MD323356ea-31a0-6ff0-e063-6294a90a135c2025-12-09Exact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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