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 43 of 135 · 2,684 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
True Tone TintedTITANIUM DIOXIDE, ZINC OXIDEThat Face PLLC36c2bb0e-479d-89cd-e063-6294a90aa3d42025-12-16Exact identifier
unii: 15FIX9V2JP
Eucerin Daily Protection FaceENSULIZOLE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDEBeiersdorf Inc76403f03-aee9-4c0b-b331-f79b6953118c2025-12-16WarningsExact identifier
unii: 15FIX9V2JP
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEJEFFREY J. ROTH, M.D., A PROFESSIONAL CORPORATION36c0400b-8ad9-654b-e063-6294a90ad0402025-12-16Exact identifier
unii: 15FIX9V2JP
Non Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEJEFFREY J. ROTH, M.D., A PROFESSIONAL CORPORATION36c00301-ee41-333c-e063-6294a90a61d52025-12-16Exact identifier
unii: 15FIX9V2JP
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEJEFFREY J. ROTH, M.D., A PROFESSIONAL CORPORATION36c078fa-05f9-ad80-e063-6394a90af3bb2025-12-16Exact identifier
unii: 15FIX9V2JP
Non Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEJEFFREY J. ROTH, M.D., A PROFESSIONAL CORPORATION36c0a55d-16d3-086a-e063-6394a90a30cf2025-12-16Exact identifier
unii: 15FIX9V2JP
Really Great Lip ShieldTITANIUM DIOXIDE, ZINC OXIDEJEFFREY J. ROTH, M.D., A PROFESSIONAL CORPORATION36c1341d-fbf5-56a5-e063-6294a90aa0452025-12-16Exact identifier
unii: 15FIX9V2JP
Tinted Mineral Sun DefenseTITANIUM DIOXIDE, ZINC OXIDEHelen's Haven36c465ea-979b-9474-e063-6394a90ab3f82025-12-16Exact identifier
unii: 15FIX9V2JP
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEHelen's Haven36c4a27b-96e9-4f30-e063-6294a90a56552025-12-16Exact identifier
unii: 15FIX9V2JP
Mineral Sunscreen Non TintedTITANIUM DIOXIDE, ZINC OXIDESAN JOSE MEDICAL SPA37ef19e5-1775-a8d5-e063-6394a90acaef2025-12-16Exact identifier
unii: 15FIX9V2JP
Tinted Mineral SunscreenZINC OXIDE, TITANIUM DIOXIDEBABYFACE LLC36d69eb5-59b4-14a0-e063-6394a90a0a492025-12-16Exact identifier
unii: 15FIX9V2JP
Non Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEBABYFACE LLC36d6141c-6967-d779-e063-6294a90af0a72025-12-16Exact identifier
unii: 15FIX9V2JP
Non-Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEESTHETIC ACADEMY LLC36c043e0-fd6c-5f7a-e063-6294a90a88992025-12-16Exact identifier
unii: 15FIX9V2JP
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEESTHETIC ACADEMY LLC36c0c1ca-80a8-9d37-e063-6294a90a824f2025-12-16Exact identifier
unii: 15FIX9V2JP
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEESTHETIC ACADEMY LLC36c0f5df-6bfb-3c0d-e063-6294a90a2e5f2025-12-16Exact identifier
unii: 15FIX9V2JP
HydrochlorothiazideHYDROCHLOROTHIAZIDEQPharma, Inc.c9c44c37-bb49-4364-9293-3c8fd51b759e2025-12-16Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Total Eye 3-In-1 Renewal Therapy SPF 35TITANIUM DIOXIDE AND ZINC OXIDEColorescience4b116cc4-94d2-4bfc-b7f9-5f486a194c6c2025-12-16WarningsExact identifier
unii: 15FIX9V2JP
INZIRQOHYDROCHLOROTHIAZIDEANI Pharmaceuticals, Inc.41aaea48-6c1b-42c8-a96f-5923d49dc9342025-12-16Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEThe Essential Brazilian Spa LLC3543a22c-34d5-e572-e063-6394a90ad5792025-12-15Exact identifier
unii: 15FIX9V2JP
Stellar Tinted Mineral Sunscreen StickTITANIUM DIOXIDE, ZINC OXIDEThe Essential Brazilian Spa LLC3bb6488c-d216-8742-e063-6394a90a16e22025-12-15WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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