FDA.reportPublic FDA data

NDC 68071-3453-03 - AMLODIPINE BESYLATE 10 mg

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
68071-3453
Requested NDC
68071-3453-03
Package NDCs from labels
68071-3453-2, 68071-3453-9, 68071-3453-3, 68071-3453-03
Manufacturer
NuCare Pharmaceuticals,Inc.
Effective date
2024-03-26
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
AMLODIPINE BESYLATE 10 mg - NuCare Pharmaceuticals,Inc.NuCare Pharmaceuticals,Inc.2024-03-26HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-3453-2AMLODIPINE BESYLATE10 mg120 in 1 BOTTLETABLET1203
68071-3453-3AMLODIPINE BESYLATE10 mg30 in 1 BOTTLETABLET303
68071-3453-9AMLODIPINE BESYLATE10 mg90 in 1 BOTTLETABLET903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3453AMLODIPINE BESYLATE 10 MG (AMLODIPINE BESYLATE) TABLET [NUCARE PHARMACEUTICALS,INC.]3Current NDC, 3 package rows20240328_ffe96aa1-db66-33e4-e053-6394a90a7e4e.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 2 of 13 · 249 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AMLODIPINE BESYLATEAMLODIPINE BESYLATEREMEDYREPACK INC.a6fa364c-3ad6-4bf9-b9ee-5ec3b1a7eb552026-06-24Warnings, Adverse reactionsExact identifier
rxcui: 308135
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATEUnit Dose Solutions, Inc.5467eee5-1519-7859-e063-6294a90afed12026-06-16Warnings, Adverse reactionsExact identifier
rxcui: 197361
rxcui: 308135
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATESafecor Health LLC572bc798-c3d9-4fe2-98be-8e1913bda8f32026-06-12Warnings, Adverse reactionsExact identifier
rxcui: 197361
rxcui: 308136
rxcui: 308135
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATEChina Resources Saike Pharmaceutical Co., Ltd.3518853a-4c5b-4161-a178-8da7f656f0092026-06-08Warnings, Adverse reactionsExact identifier
rxcui: 197361
rxcui: 308136
rxcui: 308135
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATEProficient Rx LP61cb7f91-d1f6-40bd-98a3-c461098a20d92026-06-01Warnings, Adverse reactionsExact identifier
rxcui: 308136
unii: 864V2Q084H
AMLODIPINE BESYLATEAMLODIPINE BESYLATEBryant Ranch Prepackf546047f-1cc6-4bbe-a67b-b5c9815b89af2026-05-22Warnings, Adverse reactionsExact identifier
rxcui: 197361
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATEST. MARY'S MEDICAL PARK PHARMACYb2d5cccd-e5ff-2909-e053-2a95a90a97732026-05-22Warnings, Adverse reactionsExact identifier
rxcui: 308135
unii: 864V2Q084H
Amlodipine and AtorvastatinAMLODIPINE AND ATORVASTATINPrasco Laboratories14124e56-77ba-426d-8f5a-dbe42eda1a202026-05-21Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
AMLODIPINE BESYLATEAMLODIPINE BESYLATEBryant Ranch Prepack215e0890-0484-45e8-a731-aea53821ad8e2026-05-19Warnings, Adverse reactionsExact identifier
rxcui: 308135
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATECoupler LLC2904c6e1-2c51-8035-e063-6294a90aa04b2026-05-13Warnings, Adverse reactionsExact identifier
rxcui: 308136
unii: 864V2Q084H
Amlodipine Besylate and Benazepril HydrochlorideAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEA-S Medication Solutionsc695f95d-6064-4a22-84ba-c8e62477b3a72026-05-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATEPD-Rx Pharmaceuticals, Inc.5a0b3dd4-91f5-4173-a992-e91b1cac6a182026-05-05Warnings, Adverse reactionsExact identifier
rxcui: 197361
rxcui: 308136
rxcui: 308135
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATEBryant Ranch Prepack72dafc2f-5266-442b-914a-61d1ef1f7ab82026-04-29Warnings, Adverse reactionsExact identifier
rxcui: 308136
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATEREMEDYREPACK INC.d2f66b58-78ec-456b-8397-2120a223827c2026-04-28Warnings, Adverse reactionsExact identifier
rxcui: 308136
unii: 864V2Q084H
amlodipine besylate and olmesartan medoxomilAMLODIPINE BESYLATE AND OLMESARTAN MEDOXOMILGolden State Medical Supply, Inc.132cca8f-48a2-2516-e063-6394a90a5f322026-04-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATEA-S Medication Solutionscd305e6e-9107-4d25-9918-8d0d9b9ba1ca2026-04-24Warnings, Adverse reactionsExact identifier
rxcui: 308136
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATEA-S Medication Solutions50204e86-a345-4d2f-b62f-a548787e197f2026-04-24Warnings, Adverse reactionsExact identifier
rxcui: 308136
unii: 864V2Q084H
Amlodipine Besylate and Benazepril HydrochlorideAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEBryant Ranch Prepack318b3273-e8f7-416c-b371-10c56fa8e0fd2026-04-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATELupin Pharmaceuticals, Inc.003dd1ec-16f8-4f96-b6a8-c4689d35892a2026-04-20Warnings, Adverse reactionsExact identifier
rxcui: 197361
rxcui: 308136
rxcui: 308135
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATEREMEDYREPACK INC.988e5acb-356e-4116-b6db-ab8468ed72342026-04-13Warnings, Adverse reactionsExact identifier
rxcui: 197361
unii: 864V2Q084H

Reported adverse events (FAERS/openFDA)#

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