NDC 80425-0320-02 - 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
80425-0320-02
Package NDCs from labels
80425-0320-1, 80425-0320-2, 80425-0320-3, 80425-0320-02
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 1 of 6 · 114 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
escitalopramESCITALOPRAMREMEDYREPACK INC.d75e3b97-1ead-4e7b-9ae3-3626aede1efd2026-09-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 351249
unii: 5U85DBW7LO
escitalopramESCITALOPRAMREMEDYREPACK INC.53a7e974-9945-4e42-8395-b567bf9f1c4e2026-09-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 351250
unii: 5U85DBW7LO
escitalopramESCITALOPRAMPreferred Pharmaceuticals Inc.9ddd1f24-3ebd-4307-bb23-6acd742cd1402026-07-24Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 351250
unii: 5U85DBW7LO
Escitalopram OxalateESCITALOPRAMREMEDYREPACK INC.4508226c-5623-41d3-8916-5f94ffdb88392026-07-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 349332
unii: 5U85DBW7LO
EscitalopramESCITALOPRAM OXALATEPD-Rx Pharmaceuticals, Inc.517a551a-6f60-4b8d-9341-63a41baff12d2026-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 351250
unii: 5U85DBW7LO
EscitalopramESCITALOPRAM OXALATEJubilant Cadista Pharmaceuticals Inc.2db02476-325f-ee47-a7e5-b5aed56c364c2026-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 351249
rxcui: 351250
rxcui: 349332
unii: 5U85DBW7LO
escitalopramESCITALOPRAMSt. Mary's Medical Park Pharmacy1b2ec266-be5b-9265-e063-6294a90a10e32026-06-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 349332
unii: 5U85DBW7LO
EscitalopramESCITALOPRAMBryant Ranch Prepack20281fe6-7db9-4b33-8418-b25e6a5404ca2026-06-30Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA078032
rxcui: 351249
unii: 5U85DBW7LO
EscitalopramESCITALOPRAM OXALATEBryant Ranch Prepackee5963ad-3b53-48e5-b7a9-b13af5740ef12026-06-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 351249
unii: 5U85DBW7LO
EscitalopramESCITALOPRAMBluePoint Laboratoriesd31c02d0-81d9-4aa4-bde9-52135aa5a66d2026-06-15Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA078032
rxcui: 351249
rxcui: 351250
rxcui: 349332
unii: 5U85DBW7LO
escitalopramESCITALOPRAMBryant Ranch Prepack1d2f83c1-8ffe-48f3-a084-1502890017432026-06-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 351250
unii: 5U85DBW7LO
escitalopramESCITALOPRAMBryant Ranch Prepack5c00c4d3-8248-4321-adec-03886c0d0f7b2026-06-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 349332
unii: 5U85DBW7LO
escitalopramESCITALOPRAMREMEDYREPACK INC.76a8aedd-7853-4d3f-9a00-f8222f55bea82026-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 349332
unii: 5U85DBW7LO
EscitalopramESCITALOPRAM OXALATESt. Mary's Medical Park Pharmacy09945404-e4cf-6269-e063-6294a90a5b8d2026-06-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 351250
unii: 5U85DBW7LO
EscitalopramESCITALOPRAMREMEDYREPACK INC.83fb7392-087d-4284-b27b-fa192e49dc212026-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA078032
rxcui: 351250
unii: 5U85DBW7LO
EscitalopramESCITALOPRAMBryant Ranch Prepack43eb9e4f-1a46-46f7-9e9d-43e866963b372026-05-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 351249
unii: 5U85DBW7LO
Escitalopram OxalateESCITALOPRAM OXALATECamber Pharmaceuticals, Inc.82d793ee-4039-45fc-ac83-4bd5235f00aa2026-05-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 5U85DBW7LO
Escitalopram OxalateESCITALOPRAM OXALATERising Pharma Holdings, Inc.79fddc2d-2dc2-444f-8fd3-0337090ee7442026-05-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 5U85DBW7LO
EscitalopramESCITALOPRAMREMEDYREPACK INC.b6fbd554-9da7-40fd-87a5-2c4af2aa3e6c2026-05-21Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA078032
rxcui: 349332
unii: 5U85DBW7LO
EscitalopramESCITALOPRAMREMEDYREPACK INC.83a642b9-acee-45d3-95a1-52a491b770fd2026-05-21Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA078032
rxcui: 351249
unii: 5U85DBW7LO

Reported adverse events (FAERS/openFDA)#

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