FDA.reportPublic FDA data

NDC 16729-366-10 - 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
16729-366
Requested NDC
16729-366-10
Package NDCs from labels
16729-366-10, 16729-366-15, 16729-366-16, 16729-366-17, 16729-366-45, 16729-366-46
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 Solutions2023-07-03HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16729-366-10OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE30 in 1 BOTTLETABLET, FILM COATED307
16729-366-15OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE90 in 1 BOTTLETABLET, FILM COATED907
16729-366-16OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE500 in 1 BOTTLETABLET, FILM COATED5007
16729-366-17OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE1000 in 1 BOTTLETABLET, FILM COATED10007
16729-366-45OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE10 in 1 BLISTER PACKTABLET, FILM COATED107
16729-366-46OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE100 in 1 CARTONTABLET, FILM COATED1007

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16729-366OLMESARTAN 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
16729-366-10EA - Each16729-36639fc2de8-f862-4a2d-a12c-bfab23d6c60e12020-09-14
16729-366-15EA - Each16729-3663400d9ab-caf6-4425-9c27-24a6d36b5abb12020-09-14

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 20 of 133 · 2,653 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Triamterene and HydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDEGolden State Medical Supply, Inc.9fe534cd-cf5f-64b4-e053-2995a90a926e2026-02-12Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEA-S Medication Solutions5ec290f4-bf21-4c5b-a576-8eb2bd6bd3792026-02-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
HydrochlorothiazideHYDROCHLOROTHIAZIDEScieGen Pharmaceuticals Inc911a18c1-120a-46b3-b7a8-25eb378434732026-02-10Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Spironolactone and HydrochlorothiazideSPIRONOLACTONE AND HYDROCHLOROTHIAZIDEPrasco Laboratories9d350fa2-d568-4970-a7a5-d128ff5d0a2f2026-02-10Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Alumier MD Clear Shield Broad Spectrum SPF 42 SunscreenTITANIUM DIOXIDE, ZINC OXIDEAlumier Labsa9c970c8-b6e3-b0a1-e053-2a95a90a89c72026-02-09WarningsExact identifier
unii: 15FIX9V2JP
HydrochlorothiazideHYDROCHLOROTHIAZIDEA-S Medication Solutions96838fd0-ad87-4b45-b2c0-efdd1d2f3d1e2026-02-06Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Hampton Sun SPF 50 MineralZINC OXIDE 19.5% TITANIUM DIOXIDE 4.00%S&C Hampton Sun LLCd6c33436-042e-44e8-8b55-98be6e2468792026-02-06WarningsExact identifier
unii: 15FIX9V2JP
SHISEIDO WASO COLOR-SMART DAY MOISTURIZEROCTINOXATE, TITANIUM DIOXIDEShiseido Americas Corporationf291f077-1c72-48fc-bb19-c20bdeaaa5962026-02-06WarningsExact identifier
unii: 15FIX9V2JP
SHISEIDO WASO COLOR-SMART DAY MOISTURIZEROCTINOXATE, TITANIUM DIOXIDEShiseido Americas Corporation54f63dd8-e77f-42e4-a6d3-61ab7beecf502026-02-06WarningsExact identifier
unii: 15FIX9V2JP
HydrochlorothiazideHYDROCHLOROTHIAZIDEA-S Medication Solutions088cb67f-3eaa-4e78-9fbe-ad2d6b7c57072026-02-06Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
HydrochlorothiazideHYDROCHLOROTHIAZIDEA-S Medication Solutionsf1f99065-04d2-48ac-b25d-9595237c869c2026-02-06Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
VALSARTAN AND HYDROCHLOROTHIAZIDEVALSARTAN AND HYDROCHLOROTHIAZIDEBryant Ranch Prepackaf46984c-cb58-4886-baa2-0ee075242c272026-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Olmesartan MedoxomilOLMESARTAN MEDOXOMILA-S Medication Solutionseeb16efc-4413-4464-9eb8-effa1e5684aa2026-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6M97XTV3HD
Olmesartan MedoxomilOLMESARTAN MEDOXOMILA-S Medication Solutions26065167-37c9-4e95-aa2c-3005b6805a522026-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6M97XTV3HD
SEYTU Body SunscreenTITANIUM DIOXIDE AND ZINC OXIDEOmnilife USA, Inc.c411e9a6-b2ea-446b-a886-b92c61736e6c2026-02-05WarningsExact identifier
unii: 15FIX9V2JP
OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDEOLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEBryant Ranch Prepackbb362b67-4a14-4491-9e12-0f7d5c7a65bc2026-02-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 403855
unii: 0J48LPH2TH
unii: 6M97XTV3HD
SEYTU Facial SunscreenTITANIUM DIOXIDE AND ZINC OXIDEOmnilife USA, Inc.96fd37fb-c3ff-413f-b2c8-50754f320ecc2026-02-05WarningsExact identifier
unii: 15FIX9V2JP
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 BambooOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SASebfe03e7-614f-44b1-b1f1-78edc7e274cc2026-02-05WarningsExact identifier
unii: 15FIX9V2JP
OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDEOLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEBryant Ranch Prepackde2d4628-08b3-4e31-aacc-ed85897f52e32026-02-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 403853
unii: 0J48LPH2TH
unii: 6M97XTV3HD
OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDEOLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEBryant Ranch Prepack89f525cb-fa15-4407-8cbf-14e7f6bf90552026-02-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 403854
unii: 0J48LPH2TH
unii: 6M97XTV3HD

Reported adverse events (FAERS/openFDA)#

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