FDA.reportPublic FDA data

NDC 16729-393 - 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
16729-393
Package NDCs from labels
16729-393-10, 16729-393-15, 16729-393-16, 16729-393-17
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
16729-393-10amlodipine besylate and olmesartan medoxomil30 in 1 BOTTLETABLET, FILM COATED302
16729-393-15amlodipine besylate and olmesartan medoxomil90 in 1 BOTTLETABLET, FILM COATED902
16729-393-16amlodipine besylate and olmesartan medoxomil500 in 1 BOTTLETABLET, FILM COATED5002
16729-393-17amlodipine besylate and olmesartan medoxomil1000 in 1 BOTTLETABLET, FILM COATED10002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16729-393AMLODIPINE 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 107 of 123 · 2,441 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Likewise Facial Moisturizer - Sun Protectant SPF 50 Oily SkinTITANIUM DIOXIDE, ZINC OXIDELikewise Incorporated28b8c519-8417-427e-8d4f-94da44a69d9f2023-12-12WarningsExact identifier
unii: 15FIX9V2JP
Bass Pro Shops Bass P Sunscreen Broad Spectrum SPF 50TITANIUM DIOXIDE, ZINC OXIDEENGLEWOOD LAB, INC.c06ecc56-2044-4396-8acd-6d18af9b984c2023-12-12WarningsExact identifier
unii: 15FIX9V2JP
SUMMARY EVERYDAY MINERAL SUNSCREEN BROAD SPECTRUM SPF 30TITANIUM DIOXIDE, ZINC OXIDEENGLEWOOD LAB, INC.f5c7b7ce-b3ed-3e96-e053-2995a90a8ea92023-12-12WarningsExact identifier
unii: 15FIX9V2JP
Vichy Laboratoires Capital Soleil 60 Mineral Sunscreen Broad Spectrum SPF 60 Water Resistant 80 Minutes Sheer Tint Ultra LightweightTITANIUM DIOXIDELOreal USA Products Inc4692b146-1abe-48e8-b097-ea9c556962b62023-12-11WarningsExact identifier
unii: 15FIX9V2JP
Vichy Laboratoires Capital Soleil 60 Mineral Broad Spectrum SPF 60 Water Resistant 80 Minutes Sheer Tint Ultra Lightweight SunscreenTITANIUM DIOXIDECosmetique Active Productionacb887bc-7e46-4257-9fe3-a2cade6c4f382023-12-11WarningsExact identifier
unii: 15FIX9V2JP
Solar Defense TintedTITANIUM DIOXIDE, ZINC OXIDEHydroPeptide LLC45ec77c5-5ec4-0e51-e054-00144ff8d46c2023-12-09WarningsExact identifier
unii: 15FIX9V2JP
Solar Defense Non TintedTITANIUM DIOXIDE, ZINC OXIDEHydroPeptide LLC45ec77c5-5ea1-0e51-e054-00144ff8d46c2023-12-09WarningsExact identifier
unii: 15FIX9V2JP
Erborian BB creme au Ginseng chocolate SPF 20OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDELABORATOIRES M&Lddcd6ea4-e7b1-88df-e053-2a95a90a99232023-12-09WarningsExact identifier
unii: 15FIX9V2JP
ERBORIAN - BB CREME AU GINSENG CARAMEL SPF20OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDELABORATOIRES M&L43c81760-6bb6-25fe-e054-00144ff8d46c2023-12-09WarningsExact identifier
unii: 15FIX9V2JP
Erborian CC Dull Correct SPF25OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDELABORATOIRES M&Lcb23ba95-1e83-4523-a35c-3b70c0605dd12023-12-09WarningsExact identifier
unii: 15FIX9V2JP
Cetaphil Sheer Mineral Sunscreen SPF 30TITANIUM DIOXIDE, ZINC OXIDEGalderma Laboratories, L.P.ac2d5713-9955-477e-a10f-e8a1191b5fdd2023-12-07WarningsExact identifier
unii: 15FIX9V2JP
CCC Clean Corrective with Vitamin C Tinted Moisturizer Broad Spectrum SPF 30ZINC OXIDE, TITANIUM DIOXIDEThe Honest Company, Inc.c1720cff-a897-68cb-e053-2995a90a30b62023-12-05WarningsExact identifier
unii: 15FIX9V2JP
CCC Clean Corrective with Vitamin C Tinted Moisturizer Broad Spectrum SPF 30ZINC OXIDE, TITANIUM DIOXIDEThe Honest Company, Inc.c12272c3-d4ed-2212-e053-2995a90add372023-12-05WarningsExact identifier
unii: 15FIX9V2JP
CCC Clean Corrective with Vitamin C Tinted Moisturizer Broad Spectrum SPF 30ZINC OXIDE, TITANIUM DIOXIDEThe Honest Company, Inc.c12272c3-d4f0-2212-e053-2995a90add372023-12-05WarningsExact identifier
unii: 15FIX9V2JP
CCC Clean Corrective with Vitamin C Tinted Moisturizer Broad Spectrum SPF 30ZINC OXIDE, TITANIUM DIOXIDEThe Honest Company, Inc.c1228ca6-8fb4-5964-e053-2a95a90a30ca2023-12-05WarningsExact identifier
unii: 15FIX9V2JP
CCC Clean Corrective with Vitamin C Tinted Moisturizer Broad Spectrum SPF 30ZINC OXIDE, TITANIUM DIOXIDEThe Honest Company, Inc.c12292a8-c98f-eb27-e053-2a95a90a9bbc2023-12-05WarningsExact identifier
unii: 15FIX9V2JP
RECHARGE Regimen for Balancing, Boosting and Defending Healthy-Looking skinTITANIUM DIOXIDE, ZINC OXIDERodan & Fieldsb7401ff8-ca47-4c74-813c-99c5f28c0b6d2023-12-04WarningsExact identifier
unii: 15FIX9V2JP
olmesartan medoxomil / amlodipine besylate / hydrochlorothiazideOLMESARTAN MEDOXOMIL / AMLODIPINE BESYLATE / HYDROCHLOROTHIAZIDEBryant Ranch Prepack900024f4-23d6-4505-81db-4f643e12858c2023-12-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
unii: 6M97XTV3HD
Perbelle CC SPF43 UVA UVB Broad SpectrumTITANIUM DIOXIDEPerbelle Cosmetics Global Ltd.b5e2724e-9806-5bcc-e053-2a95a90a05082023-12-01WarningsExact identifier
unii: 15FIX9V2JP
Good Neighbor Pharmacy Artifical Tears Lubricant Eye DropsPOLYVINYL ALCOHOL, POVIDONEProficient Rx LP73e12596-6dd5-4cd2-83ed-992e1211b4b82023-12-01WarningsExact identifier
unii: 532B59J990

Reported adverse events (FAERS/openFDA)#

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