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 54 of 107 · 2,121 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
e l f Camo Semi Matte CC SPF 30 Light 250 WZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.0b1c20e6-9d98-4b69-8fe0-ac5e9f2b9b2c2025-10-31WarningsExact identifier
unii: 15FIX9V2JP
e l f Camo Semi Matte CC SPF 30 Medium 370 NZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.b8d4862e-2671-4b85-8338-f935e0d0194f2025-10-31WarningsExact identifier
unii: 15FIX9V2JP
e l f Camo Semi Matte CC SPF 30 Medium 310 CZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.8d53abee-73bc-4268-b08d-0c196ff4d8522025-10-31WarningsExact identifier
unii: 15FIX9V2JP
e l f Camo Semi Matte CC SPF 30 Medium 375 NZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.1de296f5-276b-4e8f-8db2-78ea01965c4a2025-10-31WarningsExact identifier
unii: 15FIX9V2JP
e l f Camo Semi Matte CC SPF 30 Rich 610 NZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.75543b93-8ed9-4c7b-9fcf-99745df5a1942025-10-31WarningsExact identifier
unii: 15FIX9V2JP
e l f Camo Semi Matte CC SPF 30 Rich 620 WZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.798eecb3-ff6e-46d1-9053-b40e9cd02e5c2025-10-31WarningsExact identifier
unii: 15FIX9V2JP
e l f Camo Semi Matte CC SPF 30 Rich 640 WZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.cbf949b3-e640-48eb-acf6-fccd6f2588652025-10-31WarningsExact identifier
unii: 15FIX9V2JP
e l f Camo Semi Matte CC SPF 30 Rich 650 CZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.b8bfad36-54b7-42f3-bb5b-5eda1a10f0212025-10-31WarningsExact identifier
unii: 15FIX9V2JP
e l f Camo Semi Matte CC SPF 30 Rich 660 NZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.853100ea-a9dc-43eb-9715-125b543d2be02025-10-31WarningsExact identifier
unii: 15FIX9V2JP
e l f Camo Semi Matte CC SPF 30 Tan 400 WZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.e4f2b579-4886-4e20-a527-c033e9d60bf52025-10-31WarningsExact identifier
unii: 15FIX9V2JP
e l f Camo Semi Matte CC SPF 30 Tan 460 WZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.49255019-fa24-4667-b527-ef7189a51f122025-10-31WarningsExact identifier
unii: 15FIX9V2JP
Clove Hill Tinted Mineral Sunscreen SPF 40TITANIUM DIOXIDE, ZINC OXIDEClove Hill LLCeb2ff5a7-384f-4379-b149-47c1c8c2291d2025-10-30WarningsExact identifier
unii: 15FIX9V2JP
Tinted Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEClove Hill LLCa37db64d-8b79-40f4-843f-f38949c5b9d22025-10-30WarningsExact identifier
unii: 15FIX9V2JP
MOOYAM Dark Skin SunscreenSUNSCREENGuangdong Bisutang Biotechnology Co., LTD4246e9f1-1c51-d888-e063-6394a90abda02025-10-29WarningsExact identifier
unii: 15FIX9V2JP
olmesartan medoxomilOLMESARTAN MEDOXOMILAccord Healthcare Inc.e5dbca00-4e1b-4479-b829-021b11bc021e2025-10-29Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA207662
ndc (package): 16729-322-46
ndc (package): 16729-320-45
ndc (package): 16729-321-10
ndc (package): 16729-322-10
ndc (package): 16729-322-15
ndc (package): 16729-321-46
ndc (package): 16729-320-16
ndc (package): 16729-320-46
ndc (package): 16729-320-10
ndc (package): 16729-321-17
ndc (package): 16729-322-16
ndc (package): 16729-321-16
ndc (package): 16729-320-15
ndc (package): 16729-322-45
ndc (package): 16729-321-15
ndc (package): 16729-322-17
ndc (package): 16729-321-45
ndc (package): 16729-320-17
ndc (product): 16729-322
ndc (product): 16729-320
ndc (product): 16729-321
ndc11 (package): 16729032146
rxcui: 349373
rxcui: 349401
rxcui: 349405
spl id: 424dbf67-5be3-2810-e063-6294a90a3558
spl set id: e5dbca00-4e1b-4479-b829-021b11bc021e
unii: 6M97XTV3HD
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEOLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEAccord Healthcare Inc.d858a6de-dda5-4bcd-a255-5723d01d896f2025-10-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6M97XTV3HD
non-tinted mineral sunscreenTITANIUM DIOXIDE, ZINC OXIDEClove Hill LLC311b270f-b9e2-2374-e063-6294a90af5812025-10-29WarningsExact identifier
unii: 15FIX9V2JP
Perricone MD Neuropeptide Restorative Neck and Chest Therapy Broad Spectrum SPF 25TITANIUM DIOXIDETHG Beauty USA LLC23f4cf41-0eed-2df3-e063-6294a90ad4022025-10-28WarningsExact identifier
unii: 15FIX9V2JP
TIBENA EVERYTHING MULTI CUSHION SPF50HOMOSALATE, TITANIUM DIOXIDEKONAD CO LTD421eda8f-62b2-30fb-e063-6394a90a49472025-10-27WarningsExact identifier
unii: 15FIX9V2JP
Olmesartan MedoxomilOLMESARTAN MEDOXOMILBryant Ranch Prepackeff499eb-a0e4-4240-870c-83bb53434cc22025-10-24Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 349373
unii: 6M97XTV3HD

Reported adverse events (FAERS/openFDA)#

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