NDC 80425-0320-01 - Escitalopram

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
80425-0320
Requested NDC
80425-0320-01
Package NDCs from labels
80425-0320-1, 80425-0320-2, 80425-0320-3, 80425-0320-01
Manufacturer
Advanced Rx Pharmacy of Tennessee, LLC
Effective date
2024-12-31
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Escitalopram - Advanced Rx Pharmacy of Tennessee, LLCAdvanced Rx Pharmacy of Tennessee, LLC2024-12-31HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0320-1Escitalopram30 in 1 BOTTLETABLET, FILM COATED302
80425-0320-2Escitalopram60 in 1 BOTTLETABLET, FILM COATED602
80425-0320-3Escitalopram60 in 1 BOTTLETABLET, FILM COATED602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0320ESCITALOPRAM TABLET, FILM COATED [ADVANCED RX PHARMACY OF TENNESSEE, LLC]2Current NDC, 3 package rows20250102_f914fec5-4ce7-794d-e053-6294a90a7cc5.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0320-1EA - Each80425-032046dcd70d-fdea-4981-8764-ddbaaccae7cc12023-06-06
80425-0320-2EA - Each80425-03207cff7ce0-3352-459a-b266-2a305e782f8f12023-06-06
80425-0320-3EA - Each80425-03200b8ccf87-87c4-429f-9b0d-52dba9ec86d612023-06-06

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 5 of 6 · 110 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EscitalopramESCITALOPRAMBryant Ranch Prepack102c3893-4fdc-40b3-bd83-775e292723d72024-08-23Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA078032
rxcui: 351250
unii: 5U85DBW7LO
EscitalopramESCITALOPRAMBryant Ranch Prepackc842ec12-8792-47a9-82ad-9edf99e549ba2024-08-23Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA078032
rxcui: 349332
unii: 5U85DBW7LO
Escitalopram OxalateESCITALOPRAM OXALATEA-S Medication Solutions76993020-6715-4090-847e-0fdcc5328f312024-07-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 351250
unii: 5U85DBW7LO
Escitalopram OxalateESCITALOPRAM OXALATEA-S Medication Solutionsc980262b-31f0-46df-902d-e593e1557fef2024-07-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 351250
unii: 5U85DBW7LO
EscitalopramESCITALOPRAMNuCare Pharmaceuticals, Inc.4a645652-ae1f-3811-e054-00144ff8d46c2024-07-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 351250
unii: 5U85DBW7LO
EscitalopramESCITALOPRAMNuCare Pharmaceuticals,Inc.a489600b-6ae0-edb7-e053-2a95a90a7d002024-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA078032
rxcui: 351250
unii: 5U85DBW7LO
Escitalopram OxalateESCITALOPRAM OXALATENorthStar RxLLC81840aec-96fd-4af2-bd10-3f38d068f39a2024-07-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 351249
rxcui: 351250
rxcui: 349332
unii: 5U85DBW7LO
Escitalopram oxalateESCITALOPRAMExelan Pharmaceuticals Inc.8a3f4bc9-cd6e-49b1-ab6c-982b70f51fd22024-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 351249
rxcui: 351250
rxcui: 349332
unii: 5U85DBW7LO
EscitalopramESCITALOPRAMNuCare Pharmaceuticals,Inc.8e88bc86-d5e2-50ca-e053-2995a90a0f0e2024-06-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 351250
unii: 5U85DBW7LO
escitalopramESCITALOPRAMMacleods Pharmaceuticals Limited4d5c3142-b850-49b9-9f5c-81fe15ea7bfb2024-05-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 5U85DBW7LO
Escitalopram OxalateESCITALOPRAM OXALATEMacleods Pharmaceuticals Limited24b43cb4-1a26-44a2-b1d8-a40239eb5c7c2024-05-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 351249
rxcui: 351250
rxcui: 349332
unii: 5U85DBW7LO
EscitalopramESCITALOPRAM OXALATEA-S Medication Solutionsb85ef018-0217-4ddf-885d-206acc0a5f842024-04-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 349332
unii: 5U85DBW7LO
EscitalopramESCITALOPRAMA-S Medication Solutions2ffc6ec3-830f-46bc-9b3f-7c42cefa39b22024-04-25Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA078032
rxcui: 351250
unii: 5U85DBW7LO
EscitalopramESCITALOPRAM OXALATEAdvanced Rx Pharmacy of Tennessee, LLC138f8703-2f13-6d07-e063-6394a90a44132024-03-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 349332
unii: 5U85DBW7LO
EscitalopramESCITSLOPRAMLupin Pharmaceuticals, Inc.41f7392a-1f5c-4542-9c5c-f9e1098513812023-12-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 351249
rxcui: 351250
rxcui: 349332
unii: 5U85DBW7LO
EscitalopramESCITALOPRAMA-S Medication Solutions575d7755-0518-4d48-bb1a-4ad01321fde72023-12-15Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA078032
rxcui: 351250
unii: 5U85DBW7LO
LexaproESCITALOPRAMAllergan, Inc.13bb8267-1cab-43e5-acae-55a4d957630a2023-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 351249
rxcui: 351250
rxcui: 349332
unii: 5U85DBW7LO
EscitalopramESCITALOPRAMA-S Medication Solutions9b0b3c54-5bbc-4db9-9c69-00dac1347f242023-07-24Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA078032
rxcui: 351249
unii: 5U85DBW7LO
EscitalopramESCITALOPRAM OXALATENCS HealthCare of KY, LLC dba Vangard Labsac9ede0c-7912-4e7d-83b3-964feee612152023-07-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 351250
unii: 5U85DBW7LO
EscitalopramESCITALOPRAM OXALATEA-S Medication Solutions10b25a10-c5e7-479b-a9f5-7eeafd8023232023-04-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 351250
unii: 5U85DBW7LO

Reported adverse events (FAERS/openFDA)#

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