FDA.reportPublic FDA data

NDC 63629-2240-01 - olmesartan medoxomil / amlodipine besylate / 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
63629-2240
Requested NDC
63629-2240-01
Package NDCs from labels
63629-2240-1, 63629-2240-01
Manufacturer
Bryant Ranch Prepack
Effective date
2023-12-04
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
OLMESARTAN MEDOXOMIL - Bryant Ranch PrepackBryant Ranch Prepack2023-12-04HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-2240-1olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide90 in 1 BOTTLETABLET, FILM COATED90103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-2240OLMESARTAN MEDOXOMIL / AMLODIPINE BESYLATE / HYDROCHLOROTHIAZIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 1 package rows20231205_900024f4-23d6-4505-81db-4f643e12858c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-2240-1EA - Each63629-2240f2813e38-a5f7-4c89-ab85-ef0f5a46af2412021-05-05

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 1 of 142 · 2,827 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30W Aesthetics5b0f2c8f-d6fa-5e25-e063-6394a90a084d2026-09-09WarningsExact identifier
unii: 15FIX9V2JP
Amlodipine Besylate and Benazepril HydrochlorideAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEREMEDYREPACK INC.0f253cac-67ac-4b03-b1a8-f2c345938dda2026-09-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine Besylate and Benazepril HydrochlorideAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEREMEDYREPACK INC.dc206611-5188-40a6-b025-61db41f68a5a2026-09-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine Besylate and Benazepril HydrochlorideAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEREMEDYREPACK INC.2542895b-c8f8-4f21-9e12-f5a7fe17f9052026-09-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATECoupler LLC5af8493b-2b73-859c-e063-6394a90a46202026-09-08Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Triamterene and HydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDEREMEDYREPACK INC.5ee165a3-39a4-4d12-aff2-a6fb3309ce392026-09-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Telmisartan and HydrochlorothiazideTELMISARTAN AND HYDROCHLOROTHIAZIDEAvKARE1b303136-dccd-178b-e063-6394a90a35f82026-09-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Triamterene and HydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDEREMEDYREPACK INC.7dc3414b-dcb5-4b11-bca7-c0fa3f474aea2026-09-03Boxed warning, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Amlodipine and AtorvastatinAMLODIPINE AND ATORVASTATINApotex Corp.4c7b1b11-90a3-bc1c-0e45-9e2a14ef0b032026-09-03Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATEGSMS, Incorporated9c0f83f4-06ad-4bb1-a8e3-dcac43b840cf2026-09-01Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATENCS HealthCare of KY, LLC dba Vangard Labs6efc0ef6-0424-44fc-a9ea-eb30c3b832392026-09-01Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Bisoprolol Fumarate and HydrochlorothiazideBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEEdenbridge Pharmaceuticals LLC.295532b5-65c8-40c3-8d27-cfd334d128022026-08-28Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
olmesartan medoxomil / amlodipine besylate / hydrochlorothiazideOLMESARTAN MEDOXOMIL / AMLODIPINE BESYLATE / HYDROCHLOROTHIAZIDEREMEDYREPACK INC.57ffeef7-bfa8-4f92-aadc-23cd000226072026-08-28Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA206137
unii: 0J48LPH2TH
unii: 864V2Q084H
unii: 6M97XTV3HD
olmesartan medoxomilOLMESARTAN MEDOXOMILREMEDYREPACK INC.1be698df-30a0-4117-8c24-7253af94c8ad2026-08-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6M97XTV3HD
HydrochlorothiazideHYDROCHLOROTHIAZIDEREMEDYREPACK INC.f20fd735-30c7-4f89-8ceb-b6186646eea62026-08-27Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
MZANK SUNSCREEN DAILY ULTIMATE PROTECTION SPF50SUNSCREEN SPF50Guangzhou Meixi Biotechnology Co., Ltd.5a0b4bd2-f6ad-35dc-e063-6294a90a8a662026-08-27WarningsExact identifier
unii: 15FIX9V2JP
MELAO Hydrating Lightweight SunscreenAVOBENZONE,ENSULIZOLE,HOMOSALATE,OCTISALATE,OCTOCRYLENE,TITANIUM DIOXIDEGuangdong Aimu Biological Technology Co., Ltd59eeaea1-d726-99f3-e063-6394a90aeea32026-08-26WarningsExact identifier
unii: 15FIX9V2JP
HydrochlorothiazideHYDROCHLOROTHIAZIDEREMEDYREPACK INC.8e0683e2-5473-4246-97ae-b71c21c39ac72026-08-26Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Q Skin ScienceSUNSCREENInternational Cosmeceuticals, Inc59e4c3d0-ee4c-2350-e063-6394a90ac9d22026-08-25WarningsExact identifier
unii: 15FIX9V2JP
MELAO zinc stick(GREEN)TITANIUM DIOXIDE,ZINC OXIDE,OCTOCRYLENEGuangzhou Haishi Biological Technology Co., Ltd.59c70c82-f7ff-9a04-e063-6294a90a7b3d2026-08-24WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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