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 120 of 121 · 2,412 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NorvascAMLODIPINE BESYLATEPFIZER LABORATORIES DIV PFIZER INCabd6a2ca-40c2-485c-bc53-db1c652505ed2019-01-15Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
CLE CCC Golden Medium DeepTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEKW ABSC, INC.b7a4847f-b84d-4f36-8787-104eccd838a02018-12-03WarningsExact identifier
unii: 15FIX9V2JP
CLE CCC Warm Medium DeepTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEKW ABSC, INC.229c20a3-6288-4ac3-9098-6d1622e906ab2018-11-29WarningsExact identifier
unii: 15FIX9V2JP
CLE CCC Warm Medium LightTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEKW ABSC, INC.fc90fb8a-44b3-47cd-882e-94ed324ed3892018-11-27WarningsExact identifier
unii: 15FIX9V2JP
CLE CCC Warm MediumTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEKW ABSC, INC.b585f216-4234-47c5-9a6b-8b133ef48aae2018-11-27WarningsExact identifier
unii: 15FIX9V2JP
CLE CCC Warm LightTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEKW ABSC, INC.14891e26-b3b6-4545-99b1-da914b7f56292018-11-24WarningsExact identifier
unii: 15FIX9V2JP
Telmisartan and AmlodipineTELMISARTAN AND AMLODIPINEMylan Pharmaceuticals Inc.ca60a4d5-ace7-4889-94ee-e2265fd638112018-11-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
AdditoxTRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, BELLADONNA, CHELIDONIUM MAJUS, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUMBioActive Nutritional, Inc.319ee2fe-58e3-495e-bf0d-df201f6fbb1c2018-07-18WarningsExact identifier
unii: 15FIX9V2JP
Your Name Cosmetics Mineral Sheet Tint Broad Spectrum SPF 20YOUR NAME COSMETICS MINERAL SHEET TINT BROAD SPECTRUM SPF 20Mana Products657d5090-30a8-46d0-879d-469178aa234d2018-01-25WarningsExact identifier
unii: 15FIX9V2JP
Mineral Sunscreen Moisturizer Broad Spectrum SPF 20ZINC OXIDE AND TITANIUM DIOXIDEAllure Labs, Inc316c2132-ab81-47f6-8e80-71e9252a26632017-12-12WarningsExact identifier
unii: 15FIX9V2JP
Mineral Sunscreen Broad Spectrum SPF 45ZINC OXIDE AND TITANIUM DIOXIDEAllure Labs, Inc96d2d0f1-dbde-4b66-9b2c-9d07f75470662017-12-11WarningsExact identifier
unii: 15FIX9V2JP
Cover Recover SPF 30 IvoryZINC OXIDE AND TITANIUM DIOXIDEAllure Labs, Incfe207b88-8eb8-424d-89b4-8d5b188dd2c32017-12-05WarningsExact identifier
unii: 15FIX9V2JP
Cover Recover SPF 30 TawnyZINC OXIDE AND TITANIUM DIOXIDEAllure Labs, Inc94d604d4-b0bf-4f3e-888c-b6104241925b2017-12-05WarningsExact identifier
unii: 15FIX9V2JP
Cover Recover SPF 30 CocoaZINC OXIDE AND TITANIUM DIOXIDEAllure Labs, Inc9f6a5740-174c-4244-b291-6ab6367ce5122017-12-05WarningsExact identifier
unii: 15FIX9V2JP
SkinPerfect Primer SPF 30TITANIUM DIOXIDE AND ZINC OXIDEDermalogica, Inc.5fc75cef-5b76-44ab-891a-7b90c04a06812017-12-05WarningsExact identifier
unii: 15FIX9V2JP
Cover Recover SPF 30 TaupeZINC OXIDE AND TITANIUM DIOXIDEAllure Labs, Inc46e1dc9c-acb8-4a61-8503-065d18c9eb302017-12-05WarningsExact identifier
unii: 15FIX9V2JP
Cover Recover SPF 30 CreamZINC OXIDE AND TITANIUM DIOXIDEAllure Labs, Inc5096ab46-879c-49ec-b0f0-18462814adec2017-12-05WarningsExact identifier
unii: 15FIX9V2JP
Cover Recover SPF 30 Warm BeigeZINC OXIDE AND TITANIUM DIOXIDEAllure Labs, Incd8cab2e9-02fd-451c-b0e0-70ba0fc274d52017-12-05WarningsExact identifier
unii: 15FIX9V2JP
Cover Recover SPF 30 SandZINC OXIDE AND TITANIUM DIOXIDEAllure Labs, Ince5e8d83e-b3e6-470f-b521-4d7e96ecd1b62017-12-05WarningsExact identifier
unii: 15FIX9V2JP
Cover Recover SPF 30 BeigeZINC OXIDE AND TITANIUM DIOXIDEAllure Labs, Incec6749b7-377b-4ac5-8992-ac709bd0204e2017-12-05WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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