FDA.reportPublic FDA data

NDC 16729-395 - amlodipine besylate and olmesartan medoxomil

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
16729-395
Package NDCs from labels
16729-395-10, 16729-395-15, 16729-395-16, 16729-395-17
Manufacturer
Accord Healthcare Inc. | Intas Pharmaceuticals Limited
Effective date
2019-08-14
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
POVIDONE K30 - Accord Healthcare Inc. | Intas Pharmaceuticals LimitedAccord Healthcare Inc. | Intas Pharmaceuticals Limited2019-08-14HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16729-395-10amlodipine besylate and olmesartan medoxomil30 in 1 BOTTLETABLET, FILM COATED302
16729-395-15amlodipine besylate and olmesartan medoxomil90 in 1 BOTTLETABLET, FILM COATED902
16729-395-16amlodipine besylate and olmesartan medoxomil500 in 1 BOTTLETABLET, FILM COATED5002
16729-395-17amlodipine besylate and olmesartan medoxomil1000 in 1 BOTTLETABLET, FILM COATED10002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16729-395AMLODIPINE BESYLATE AND OLMESARTAN MEDOXOMIL TABLET, FILM COATED [ACCORD HEALTHCARE INC.]24 package rows20220901_a855ce60-6918-490a-9158-3be5a0ef76b5.zip

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 64 of 121 · 2,412 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Amlodipine BesylateAMLODIPINE BESYLATEPD-Rx Pharmaceuticals, Inc.47114f60-4151-43d4-ac2d-adc49492a6792025-10-15Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Defend and Balance TInted Mineral Sunscreen SPF 50SUNSCREENEpicuren Discovery41367f05-59d8-6736-e063-6394a90a5f172025-10-15WarningsExact identifier
unii: 15FIX9V2JP
Amlodipine BesylateAMLODIPINE BESYLATEPD-Rx Pharmaceuticals, Inc.ac0dd8fb-ebe1-4d02-bd0d-4f979c6e36082025-10-15Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine and Benazepril HydrochlorideAMLODIPINE AND BENAZEPRIL HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.02e233c4-48d1-456d-8fc8-f99a06ef854a2025-10-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
olmesartan medoxomilOLMESARTAN MEDOXOMILBryant Ranch Prepack640936ee-55a6-47ae-a1ad-cffae316b9252025-10-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6M97XTV3HD
Skinlycious Multi Protection Mineral Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE , ZINC OXIDESkinlycious Pte Ltde0ad02c3-f5ed-4b72-ba96-07d9c489a4ea2025-10-13WarningsExact identifier
unii: 15FIX9V2JP
AMLODIPINE BESYLATEAMLODIPINE BESYLATEQuallent Pharmaceuticals Health LLCc262dedb-1d13-4447-9355-f11e1dbbfb4d2025-10-13Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Vertra S Dorian Kona Gold Signature Face Stick SPF 38TITANIUM DIOXIDEEai-jr 286, Incb6c316c3-661b-6428-e053-2a95a90a1a6b2025-10-10WarningsExact identifier
unii: 15FIX9V2JP
OLMESARTAN MEDOXOMILOLMESARTAN MEDOXOMILA-S Medication Solutions3c001b8d-f6c1-4316-b8c0-590b2fa7f2e52025-10-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6M97XTV3HD
Amlodipine and Benazepril HydrochlorideAMLODIPINE AND BENAZEPRIL HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.7b5eb6bd-e953-429e-9280-07da4f7d7f472025-10-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Dr Lift Mineral SPF 50TITANIUM DIOXIDE, ZINC OXIDESpa de Soleil40c03d65-8d09-371a-e063-6294a90a7ac62025-10-09WarningsExact identifier
unii: 15FIX9V2JP
Dr Lift Mineral SPF 30TITANIUM DIOXIDESpa de Soleil40c0e0d2-2c1d-e629-e063-6394a90a5aaf2025-10-09WarningsExact identifier
unii: 15FIX9V2JP
OLMESARTAN MEDOXOMILOLMESARTAN MEDOXOMILA-S Medication Solutions38f7f201-3a3a-4922-bde7-d34187b4c81d2025-10-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6M97XTV3HD
Essential Defense Mineral Shield Broad Spectrum SPF 35 SunscreenTITANIUM DIOXIDE AND ZINC OXIDEAllergan, Inc.29817fdc-f14c-4013-a8ed-4367f3b2867c2025-10-09WarningsExact identifier
unii: 15FIX9V2JP
Vertra Pearl White Face Stick SPF 50PADIMATE O, TITANIUM DIOXIDEEai-jr 286, Incb69a75e0-8724-35ae-e053-2a95a90a5f342025-10-07WarningsExact identifier
unii: 15FIX9V2JP
Vertra Mick Fanning Signature Foundation Sunscreen Face Stick SPF 35 Coolangatta BeigeTITANIUM DIOXIDEEAI-JR 286, Inc.b9ea12e8-6ed9-d805-e053-2a95a90aa1072025-10-07WarningsExact identifier
unii: 15FIX9V2JP
SPF50 SunscreenSUNSCREENKINGKEY MBC LIFE TECHNOLOGY GROUP CO., LTDb3cde609-7d62-2ac7-e053-2a95a90a26b32025-10-07Exact identifier
unii: 15FIX9V2JP
Vertra Mick Fanning Signature Foundation Sunscreen Face Stick SPF 35 Coolangatta BeigeTITANIUM DIOXIDEToshiki Pigment Co., Ltd.b9eba15f-493a-43c9-e053-2995a90a04512025-10-06WarningsExact identifier
unii: 15FIX9V2JP
PURE SOL SPF 37 Tinted MoisturizerZINC OXIDE TITANIUM DIOXIDEBrand 2022b LLC4052c4e4-2105-80c0-e063-6294a90af41d2025-10-04WarningsExact identifier
unii: 15FIX9V2JP
Olmesartan MedoxomilOLMESARTAN MEDOXOMILBryant Ranch Prepacke43e5643-b258-469d-812a-887f913cfe712025-10-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6M97XTV3HD

Reported adverse events (FAERS/openFDA)#

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