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 117 of 123 · 2,441 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AMLODIPINE BESYLATEAMLODIPINE BESYLATEAphena Pharma Solutions - Tennessee, LLC186b6149-9610-4380-9bf2-9416460692762023-05-04Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine Besylate and Benazepril HydrochlorideAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEBluePoint Laboratoriesdf8e23c8-6c8f-4293-8a37-5ad3d48dba942023-05-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
AMLODIPINE BESYLATE 5 mgAMLODIPINE BESYLATEAphena Pharma Solutions - Tennessee, LLCb597d1e1-aba1-4272-bed7-4c95e8150d582023-04-19Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Ferrum OxydatumFERRUM OXYDATUMHahnemann Laboratories, INC.f8b52d3f-3fe2-a850-e053-6394a90a5d9f2023-04-06Exact identifier
unii: 1K09F3G675
Amlodipine besylateAMLODIPINE BESYLATEExelan Pharmaceuticals, Inc.efd9eda5-f497-45a3-ae13-dee729add9992023-03-23Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
NorvascAMLODIPINE BESYLATEViatris Specialty LLC7367289c-b0b0-466a-83e2-558e2985c29f2023-02-15Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Mineral Sunscreen SPF 50ZINC OXIDE TITANIUM DIOXIDETopiderm, Inc.3a637542-0f79-47ae-815d-84d0036c737a2023-02-13WarningsExact identifier
unii: 15FIX9V2JP
Telmisartan and AmlodipineTELMISARTAN AND AMLODIPINEAlembic Pharmaceuticals Limited15b438b4-4874-43f4-a50a-4e6f3e5530ac2023-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine and ValsartanAMLODIPINE AND VALSARTANAlembic Pharmaceuticals Limiteda9c442dc-749e-4de0-bca3-1044eb78da722023-01-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine besylate and Olmesartran medoxomilAMLODIPINE BESYLATE AND OLMESARTRAN MEDOXOMILAlembic Pharmaceuticals Limitedcb2df7f7-fee8-42ba-8936-0788c4fcc0cb2023-01-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 730872
rxcui: 730866
rxcui: 730861
rxcui: 730869
unii: 864V2Q084H
unii: 6M97XTV3HD
Olmesartan Medoxomil and HydrochlorothiazideOLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEAlembic Pharmaceuticals Limited8c65d555-8db8-40d9-be30-309ef09f19be2023-01-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6M97XTV3HD
Olmesartan MedoxomilOLMESARTAN MEDOXOMILAlembic Pharmaceuticals Limitedac08ea7d-f529-42ca-850a-a0ecce7dc8302023-01-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6M97XTV3HD
Josie Maran Argan Daily Moisturizer SPF47ZINC OXIDE, TITANIUM DIOXIDEAutumn Harp, Inc.027821e6-db7d-4c03-956a-00313488ebc72023-01-14Boxed warning, WarningsExact identifier
unii: 15FIX9V2JP
Amlodipine Besylate and Benazepril HydrochlorideAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEDr.Reddy's Laboratories Limitedf12f18bb-7ddb-e7dc-4edd-32f4ac212bca2022-12-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine Besylate and Benazepril HydrochlorideAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEDr.Reddy's Laboratories Limitedca014f06-982c-6fe1-9948-a3701dd35d342022-12-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATEUnichem Pharmaceuticals (USA), Inc.a516b336-8f60-4b86-8921-c7d6c07629f22022-12-05Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine and Benazepril HydrochlorideAMLODIPINE AND BENAZEPRIL HYDROCHLORIDEProficient Rx LP29a0d87e-6afb-4766-9045-1963c5b0d1832022-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
amlodipine besylateAMLODIPINE BESYLATEAphena Pharma Solutions - Tennessee, LLCf3482709-c5c3-4bd0-8067-ad57f31bb5252022-10-18Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
AMLODIPINE AND VALSARTANAMLODIPINE AND VALSARTANLupin Pharmaceuticals,Inc.e05dd72c-7475-422e-bf8e-73148929450e2022-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATEProficient Rx LP445d1274-7249-476b-ad90-ff93aee56f6d2022-06-01Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H

Reported adverse events (FAERS/openFDA)#

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