FDA.reportPublic FDA data

NDC 16729-394 - 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
16729-394
Package NDCs from labels
16729-394-10, 16729-394-15, 16729-394-16, 16729-394-17
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
16729-394-10amlodipine besylate and olmesartan medoxomil30 in 1 BOTTLETABLET, FILM COATED302
16729-394-15amlodipine besylate and olmesartan medoxomil90 in 1 BOTTLETABLET, FILM COATED902
16729-394-16amlodipine besylate and olmesartan medoxomil500 in 1 BOTTLETABLET, FILM COATED5002
16729-394-17amlodipine besylate and olmesartan medoxomil1000 in 1 BOTTLETABLET, FILM COATED10002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16729-394AMLODIPINE 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 114 of 121 · 2,412 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
bareMinerals Original Foundation Broad Spectrum SPF 15 Golden Fair 04TITANIUM DIOXIDE AND ZINC OXIDEOrveon Global US LLCe486915b-8097-451a-a018-3279213239b32023-10-04WarningsExact identifier
unii: 15FIX9V2JP
bareMinerals Original Foundation Broad Spectrum SPF 15 Golden Deep 28TITANIUM DIOXIDE AND ZINC OXIDEOrveon Global US LLC5b51df09-40c3-4064-96d3-b7366fc838262023-10-04WarningsExact identifier
unii: 15FIX9V2JP
bareMinerals Original Foundation Broad Spectrum SPF 15 Fairly Medium 05TITANIUM DIOXIDE AND ZINC OXIDEOrveon Global US LLCf1714e23-030c-4bd9-b9e7-111c3813ed342023-10-04WarningsExact identifier
unii: 15FIX9V2JP
bareMinerals Original Foundation Broad Spectrum SPF 15 Medium Dark 23TITANIUM DIOXIDE AND ZINC OXIDEOrveon Global US LLC828fe263-f223-45c3-9710-fd8d59ad56b12023-10-04WarningsExact identifier
unii: 15FIX9V2JP
bareMinerals Multi-Tasking SPF 20 Concealer BisqueTITANIUM DIOXIDEOrveon Global US LLCd4c30bea-8c56-4ed8-8ec4-f1b1e0e456dd2023-10-04WarningsExact identifier
unii: 15FIX9V2JP
BareMinerals Mineral VeilTITANIUM DIOXIDE AND ZINC OXIDEOrveon Global US LLC64b163dd-8a86-483f-8dab-80fa8740b12f2023-10-04WarningsExact identifier
unii: 15FIX9V2JP
Amlodipine BesylateAMLODIPINE BESYLATEA-S Medication Solutions4512feee-a09d-4244-bc03-c43193e53a0e2023-09-20Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Olmesartan Medoxomil and HydrochlorothiazideOLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEA-S Medication Solutionsba452478-f40c-446e-b61d-388379a55efd2023-09-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6M97XTV3HD
OLMESARTAN MEDOXOMILOLMESARTAN MEDOXOMILInventia Healthcare Limited05a807bf-5175-43a2-a676-215bba2645a82023-09-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6M97XTV3HD
Olmesartan medoxomilOLMESARTAN MEDOXOMILA-S Medication Solutions9d9f1c08-4f65-484c-943e-7e664281910f2023-09-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6M97XTV3HD
DR ANDREW WEILS FOR ORIGINS MEGA-DEFENSE ADVANCED DAILY UV DEFENDER BROAD SPECTRUM SPF 45TITANIUM DIOXIDE AND ZINC OXIDEORIGINS NATURAL RESOURCES INC.11248cab-c3a5-4e16-8280-9f70bb863cf72023-09-11WarningsExact identifier
unii: 15FIX9V2JP
Olmesartan medoxomilOLMESARTAN MEDOXOMILA-S Medication Solutions5f410909-a68a-4ada-963a-32018d37572f2023-09-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6M97XTV3HD
Amlodipine and Benazepril HydrochlorideAMLODIPINE AND BENAZEPRIL HYDROCHLORIDEA-S Medication Solutionsf77db79c-c998-4b63-9984-4cf245f188a72023-09-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATEAphena Pharma Solutions - Tennessee, LLCd830173d-7676-4490-ab3d-d3515df9ad2e2023-09-07Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine besylateAMLODIPINE BESYLATEAphena Pharma Solutions - Tennessee, LLC5dfcba1f-91c4-4ca5-8a98-fc4fdb2f7ee12023-09-07Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
AnubisMedSPF 50 BROAD SPECTRUM PROTECTION FLUID EMULSIONANUBIS COSMETICS SLe99d92c4-8768-9c0a-e053-2a95a90a609e2023-09-05WarningsExact identifier
unii: 15FIX9V2JP
LipotoxSQUALENE, CHOLESTERINUM, ESTRADIOL, PROGESTERONE, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUM, ARSENICUM ALBUM, LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, ACETICUM ACIDUM, BENZOICUM ACIDUM, BENZYL ALCOHOL, BORICUM ACIDUM, CHLORINUM, CORTISONE ACETICUM, EUGENOL, FOLLICULINUM, ISOPROPYL PALMITATE, LACTICUM ACIDUM, PETROLEUM JELLY, PHENYL BUTAZONE, PLUMBUM METALLICUM,BioActive Nutritional, Inc.a1538692-ca00-4e52-9b7e-409767ee27e12023-09-05WarningsExact identifier
unii: 15FIX9V2JP
Anubis Barcelona Protective LineETHYLHEXYL METHOXYCINNAMATE, BUTYL METHOXYDIBENZOYLMETHANE, ETHYLHEXYL SALICYLATE, OCTOCRYLENEANUBIS COSMETICS SLec83846f-11c0-8f59-e053-2995a90ab9d22023-09-01WarningsExact identifier
unii: 15FIX9V2JP
Anubis Barcelona Spa LineORYZA SATIVA (RICE) STARCH, PERLITE, PALMITIC ACIDANUBIS COSMETICS SLeb01a962-ab38-18ec-e053-2995a90acdeb2023-09-01WarningsExact identifier
unii: 15FIX9V2JP
olmesartan medoxomilOLMESARTAN MEDOXOMILA-S Medication Solutions949e6bad-fcb2-42f2-b9c8-e5620ef5ccd52023-08-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6M97XTV3HD

Reported adverse events (FAERS/openFDA)#

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