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 103 of 133 · 2,648 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Olmesartan Medoxomil and HydrochlorothiazideOLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEBryant Ranch Prepacke8a9dcaa-04e3-4f4e-a53d-42903e3da2d42024-06-26Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 403855
unii: 0J48LPH2TH
unii: 6M97XTV3HD
Lancome Paris Teint Idole Ultra Wear Breathable Coverage Foundation Reno Broad Spectrum SPF 25 SunscreenOCTINOXATE AND TITANIUM DIOXIDEL'Oreal USA Products Incbe2a83fb-e4f8-4313-b5bd-150f351fb3452024-06-26WarningsExact identifier
unii: 15FIX9V2JP
HydrochlorothiazideHYDROCHLOROTHIAZIDEAurobindo Pharma Limitede31bd548-29ae-419a-831a-80ebb26e042f2024-06-26Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Lancome Paris Teint Idole Ultra Wear Breathable Coverage Foundation Reno Broad Spectrum SPF 25 SunscreenOCTINOXATE AND TITANIUM DIOXIDESICOS ET CIE066a0951-2e7e-40c0-8035-4d708a32f16c2024-06-26WarningsExact identifier
unii: 15FIX9V2JP
HydrochlorothiazideHYDROCHLOROTHIAZIDEAurobindo Pharma Limited01f1f478-5493-439f-9b99-f4f82023781c2024-06-26Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Yves Saint Laurent All Hours Foundation Broad Spectrum SPF 30 Sunscreen Luminous Matte FoundationOCTINOXATE AND TITANIUM DIOXIDESICOS ET CIE66a91768-6012-485a-b569-a293ea6d48802024-06-24WarningsExact identifier
unii: 15FIX9V2JP
Yves Saint Laurent All Hours Foundation Broad Spectrum SPF 30 Sunscreen Luminous Matte FoundationOCTINOXATE AND TITANIUM DIOXIDEL'Oreal USA Products Inc43539766-2e70-4b42-b64b-1d30367b2eb92024-06-24WarningsExact identifier
unii: 15FIX9V2JP
Exel Clarifying Line SPF 50OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TATANIUM DIOXIDEBiocosmetica Exel Argentina SRLe65a68f6-d1b7-4cbf-a3f8-5cc04036221a2024-06-23WarningsExact identifier
unii: 15FIX9V2JP
Telmisartan and HydrochlorothiazideTELMISARTAN AND HYDROCHLOROTHIAZIDEAurobindo Pharma Limited681dfb5c-fc5c-427e-81f6-4b4e934978a22024-06-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
HydrochlorothiazideHYDROCHLOROTHIAZIDENuCare Pharmaceuticals,Inc.a111cb8f-a100-a05d-e053-2995a90a020c2024-06-20Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Protectif Fair TintZINC OXIDE AND TITANIUM DIOXIDEDerma Research Group Inc.1a8c8804-1d6b-b5a5-e063-6394a90a12602024-06-18WarningsExact identifier
unii: 15FIX9V2JP
benazepril hydrochloride and hydrochlorothiazideBENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDEBryant Ranch Prepackf4120568-dd9b-47a5-bd44-4de6ed343bbe2024-06-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Valsartan and HydrochlorothiazideVALSARTAN AND HYDROCHLOROTHIAZIDEAurobindo Pharma Limitedc5bc7c55-b50c-4e61-ad1f-5ebb607c262f2024-06-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Protectif UntintedZINC OXIDE AND TITANIUM DIOXIDEDerma Research Group Inc.1acd3f09-87f2-75e4-e063-6394a90a0cd92024-06-13WarningsExact identifier
unii: 15FIX9V2JP
OLMESARTAN MEDOXOMILOLMESARTAN MEDOXOMILBryant Ranch Prepack879630ff-662a-40bd-b74f-a864661dea952024-06-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6M97XTV3HD
Triamterene and HydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDENuCare Pharmaceuticals,Inc.7e7cb50d-c984-5c01-e053-2a91aa0a68a52024-06-12Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDENuCare Pharmaceuticals,Inc.6c57bf12-9ad5-3a25-e053-2a91aa0aaf262024-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDENuCare Pharmaceuticals,Inc.72c97b7f-d945-5106-e053-2a91aa0a9b3b2024-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Valsartan and HydrochlorothiazideVALSARTAN AND HYDROCHLOROTHIAZIDEAlembic Pharmaceuticals Inc.973973a3-9fec-4afc-910f-187f099dfe2d2024-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Youth 3 Activating BB Cream SPF 30 MediumZINC OXIDE, TITANIUM DIOXIDEShaklee Corporationccc80ea4-f270-4fd4-970c-eaa63df936e42024-06-06WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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