FDA.reportPublic FDA data

NDC 16729-367-45 - OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE

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
16729-367
Requested NDC
16729-367-45
Package NDCs from labels
16729-367-10, 16729-367-15, 16729-367-16, 16729-367-17, 16729-367-45, 16729-367-46
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
LACTOSE MONOHYDRATE - Accord Healthcare Inc. | Intas Pharmaceuticals LimitedAccord Healthcare Inc. | Intas Pharmaceuticals Limited2025-10-29HUMAN PRESCRIPTION DRUG LABEL
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE - A-S Medication SolutionsA-S Medication Solutions2024-11-13HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16729-367-10OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE30 in 1 BOTTLETABLET, FILM COATED307
16729-367-15OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE90 in 1 BOTTLETABLET, FILM COATED907
16729-367-16OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE500 in 1 BOTTLETABLET, FILM COATED5007
16729-367-17OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE1000 in 1 BOTTLETABLET, FILM COATED10007
16729-367-45OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE10 in 1 BLISTER PACKTABLET, FILM COATED107
16729-367-46OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE100 in 1 CARTONTABLET, FILM COATED1007

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16729-367OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [ACCORD HEALTHCARE INC.]6Current NDC, Legacy NDC, 6 package rows20241006_d858a6de-dda5-4bcd-a255-5723d01d896f.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16729-367-10EA - Each16729-367aea7451f-249f-4002-a7df-f367e3bb051312020-09-14
16729-367-15EA - Each16729-3670eff996a-5135-4a4b-a09e-70ccc66334d412020-09-14

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 16 of 135 · 2,684 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDEBryant Ranch Prepack019ac336-0dc3-ec89-3e0a-09110e0fc30b2026-04-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
EltaMD UV RestoreTITANIUM DIOXIDE, ZINC OXIDE SUNSCREENCP Skin Health Group, Inc17b47994-82d6-4f9d-8249-bdb55106c9b32026-04-02WarningsExact identifier
unii: 15FIX9V2JP
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDEBryant Ranch Prepackeac8c44f-cf77-6a30-cfd7-7cffffc79bd62026-04-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEA-S Medication Solutionsbe99cc03-ea65-4b17-bd9e-df7ae43077782026-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Clinical Skin Filter Tinted SunscreenCLINICAL SKIN FILTER TINTED SUNSCREENBY KIN AESTHETICS LLC4e69a8a3-8dbb-577a-e063-6294a90a6a232026-04-01WarningsExact identifier
unii: 15FIX9V2JP
Krx Aesthetics All Day Glow SunblockerKRX AESTHETICS ALL DAY GLOW SUNBLOCKERBY KIN AESTHETICS LLC4e69df43-393b-bc09-e063-6394a90a275a2026-04-01WarningsExact identifier
unii: 15FIX9V2JP
HydrochlorothiazideHYDROCHLOROTHIAZIDEAccord Healthcare Inc.babb1b20-fe82-40ba-8e7a-0c56fe433b4a2026-04-01Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
spf 50 mineral powder sunscreenTITANIUM DIOXIDE, ZINC OXIDESmalls Brand LLC DBA Roe Wellnessf8762dd1-0484-74ea-e053-6294a90ac1122026-03-31WarningsExact identifier
unii: 15FIX9V2JP
SeranovaTM ULTRALIGHT SPF50 SERUMSERANOVATM ULTRALIGHT SPF50 SERUMGuangzhou Ariel Biotech Co., Ltd.4e5d716d-2b2d-d42f-e063-6294a90a1e522026-03-31WarningsExact identifier
unii: 15FIX9V2JP
Irbesartan and HydrochlorothiazideIRBESARTAN AND HYDROCHLOROTHIAZIDESolco Healthcare US, LLC72fa8cd4-bc2a-4a7d-8feb-2d60e077d8012026-03-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
HydrochlorothiazideHYDROCHLOROTHIAZIDEBryant Ranch Prepack45316037-52ec-438f-8780-b2e983fef3f52026-03-31Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Spironolactone and HydrochlorothiazideSPIRONOLACTONE AND HYDROCHLOROTHIAZIDEBryant Ranch Prepackb3228678-7992-4148-b4ab-aa0d8b1b85702026-03-27Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
HydrochlorothiazideHYDROCHLOROTHIAZIDENuCare Pharmaceuticals,Inc.c2db7e27-952f-c3f6-e053-2995a90af7c12026-03-27Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
UV SOLUTIONS BRIGHTENING TINTED BROAD SPECTRUM SPF 50 SUNSCREEN NIACINAMIDE ANTIOXIDANTS DARK SHADETITANIUM DIOXIDE AND ZINC OXIDECLINIQUE LABORATORIES LLC4e0bd355-99c6-8cf4-e063-6294a90ab4b32026-03-27WarningsExact identifier
unii: 15FIX9V2JP
Olmesartan medoxomilOLMESARTAN MEDOXOMILREMEDYREPACK INC.85a24657-583b-4776-98c9-b30285cb30582026-03-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6M97XTV3HD
SUNNYSIDEKICK UVA/UVB Broad Spectrum SPF 30 Brush-On MineralZINC OXIDE, TITANIUM DIOXIDEClassic Cosmetics LLC4df3b8c0-71bc-acdd-e063-6394a90a35c02026-03-26WarningsExact identifier
unii: 15FIX9V2JP
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEBryant Ranch Prepack59801c48-2af7-4967-ae70-99f865551a7a2026-03-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
HydrochlorothiazideHYDROCHLOROTHIAZIDENuCare Pharmaceuticals,Inc.c2d993ff-b11b-7a62-e053-2995a90a0b002026-03-25Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Silkscreen Sheer Tint Mineral Light-MediumTITANIUM DIOXIDE, ZINC OXIDECurology4ddbe349-6880-a5fc-e063-6294a90a275c2026-03-25WarningsExact identifier
unii: 15FIX9V2JP
BANANA BOATTITANIUM DIOXIDE,ZINC OXIDEEdgewell Personal Care Brands LLC4e0450ca-147a-91d7-e063-6394a90ae73b2026-03-25WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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