FDA.reportPublic FDA data

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 4 of 6 · 111 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
escitalopramESCITALOPRAMST. MARY'S MEDICAL PARK PHARMACY362327ce-2dde-f657-e063-6394a90a0b632025-05-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 351249
unii: 5U85DBW7LO
Escitalopram OxalateESCITALOPRAMAmneal Pharmaceuticals LLC09894a38-4e3a-475d-96cd-c6c8ed87869a2025-04-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 5U85DBW7LO
escitalopramESCITALOPRAMA-S Medication Solutions3965ca55-a5ff-4ed0-940c-363d74683fab2025-04-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 351249
unii: 5U85DBW7LO
EscitalopramESCITALOPRAM OXALATEAmerican Health Packaging3019a647-9bcf-48cf-928c-0467f9b921a82025-03-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 351250
rxcui: 349332
unii: 5U85DBW7LO
EscitalopramESCITALOPRAMAmerican Health Packagingde803217-6d32-4ef8-afe7-02462f37bf0c2025-03-20Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA078032
rxcui: 351249
unii: 5U85DBW7LO
Escitalopram Oral SolutionESCITALOPRAM ORALChartwell RX, LLC0458445b-e431-4c82-86b8-90373813c10a2025-03-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 5U85DBW7LO
escitalopramESCITALOPRAMCoupler LLC2d54a1cf-29cd-c485-e063-6394a90aeba32025-02-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 351249
unii: 5U85DBW7LO
escitalopramESCITALOPRAMCoupler LLC2d58c448-4a6c-1b7d-e063-6294a90a7d032025-02-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 351250
unii: 5U85DBW7LO
EscitalopramESCITALOPRAMBryant Ranch Prepackd143ec01-9445-42d5-a259-b0b5a7f9445f2025-01-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 351250
unii: 5U85DBW7LO
EscitalopramESCITALOPRAMBryant Ranch Prepack4966fd83-ee96-4f87-beb1-dd40d70de4452025-01-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 349332
unii: 5U85DBW7LO
EscitalopramESCITALOPRAM OXALATENCS HealthCare of KY, LLC dba Vangard Labsb29ae169-d60b-464a-9763-f1d8d9e0598d2025-01-24Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 351249
rxcui: 349332
unii: 5U85DBW7LO
EscitalopramESCITALOPRAMRedPharm Drug, Inc.fc61822a-4058-343c-e053-6294a90af72c2025-01-23Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA078032
rxcui: 351250
unii: 5U85DBW7LO
EscitalopramESCITALOPRAMDirect_Rxf6cacd68-0f55-deb9-e053-6294a90aa2662025-01-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 351250
unii: 5U85DBW7LO
EscitalopramESCITALOPRAMDirect_Rxf75aabf8-f4a1-acd1-e053-6294a90ab9a62025-01-22Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA078032
rxcui: 351249
unii: 5U85DBW7LO
EscitalopramESCITALOPRAMAdvanced Rx Pharmacy of Tennessee, LLCf914fec5-4ce7-794d-e053-6294a90a7cc52024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA078032
ndc (package): 80425-0320-3
ndc (package): 80425-0320-2
ndc (package): 80425-0320-1
ndc (product): 80425-0320
ndc11 (package): 80425032001
rxcui: 349332
spl id: 2a9bf7d3-46db-0dfa-e063-6394a90a76a4
spl set id: f914fec5-4ce7-794d-e053-6294a90a7cc5
unii: 5U85DBW7LO
escitalopramESCITALOPRAMBryant Ranch Prepack3ca5da44-403b-4c9f-9dde-f5a87866836d2024-12-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 351249
unii: 5U85DBW7LO
escitalopramESCITALOPRAMBryant Ranch Prepack735a138b-fff3-4ed0-8a51-9090cf88ba302024-12-11Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 351250
unii: 5U85DBW7LO
escitalopram oxalateESCITALOPRAM OXALATEBryant Ranch Prepack86cfcd96-6397-42ef-8a79-f62706f0aca62024-10-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 351250
unii: 5U85DBW7LO
escitalopram oxalateESCITALOPRAM OXALATEQuallent Pharmaceuticals Health LLCd8e22060-4d06-42bf-a881-caaf65ecc3e32024-10-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 351249
rxcui: 351250
rxcui: 349332
unii: 5U85DBW7LO
Escitalopram OxalateESCITALOPRAM OXALATEAmneal Pharmaceuticals of New York LLC4f941d7a-5abb-4907-a7a1-480245deef872024-10-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 351249
rxcui: 351250
rxcui: 349332
unii: 5U85DBW7LO

Reported adverse events (FAERS/openFDA)#

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