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 3 of 6 · 111 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EscitalopramESCITALOPRAMA-S Medication Solutionsa0344290-6e12-46c4-a11c-5347a770adbe2026-02-12Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA078032
rxcui: 349332
unii: 5U85DBW7LO
escitalopramESCITALOPRAMTorrent Pharmaceuticals Limited068bb338-23f3-4278-958b-c34b404560242026-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 351249
rxcui: 351250
rxcui: 349332
unii: 5U85DBW7LO
Escitalopram Oral SolutionESCITALOPRAM ORALChartwell Governmental & Specialty RX, LLC.45ed4d16-6358-40a1-9352-319e58f55e5d2026-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 5U85DBW7LO
EscitalopramESCITALOPRAMNorthwind Health Company, LLCf2b3b385-658d-5918-e053-2a95a90afcba2026-01-19Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA078032
rxcui: 351249
unii: 5U85DBW7LO
EscitalopramESCITALOPRAM OXALATENorthwind Health Company, LLCf6ca64ec-68ff-e1ea-e053-6294a90ae0f82026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 351250
unii: 5U85DBW7LO
EscitalopramESCITALOPRAMNorthwind Health Company, LLCd9ba6c65-22bd-10c4-e053-2995a90ada2e2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 349332
unii: 5U85DBW7LO
EscitalopramESCITALOPRAMNorthwind Health Company, LLCdabf8bc0-5de6-edce-e053-2995a90a73c92026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 351250
unii: 5U85DBW7LO
EscitalopramESCITALOPRAMNorthwind Health Company, LLCf2b7b0a6-481b-1f6f-e053-2a95a90a2d042026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA078032
rxcui: 349332
unii: 5U85DBW7LO
EscitalopramESCITALOPRAMNorthwind Health Company, LLCaddccf96-cc60-6045-e053-2a95a90aaac02026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA078032
rxcui: 351250
unii: 5U85DBW7LO
EscitalopramESCITALOPRAMNorthwind Health Company, LLCc9f52332-8616-19d8-e053-2995a90ad7532026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 349332
unii: 5U85DBW7LO
EscitalopramESCITALOPRAMNorthwind Health Company, LLCda7feb56-5f5a-7487-e053-2995a90a119e2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 351249
unii: 5U85DBW7LO
EscitalopramESCITALOPRAMDirect_Rxf81e3858-f01e-1df6-e053-6394a90aef4f2025-12-16Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA078032
rxcui: 351250
unii: 5U85DBW7LO
EscitalopramESCITALOPRAM OXALATEQPharma, Inc.85fbcce8-a870-4f04-8a0e-a12e46eed3cf2025-12-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 349332
unii: 5U85DBW7LO
EscitalopramESCITALOPRAMQPharma, Inc.e56e8d41-188c-5a6f-e053-2a95a90a70e62025-12-01Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA078032
rxcui: 349332
unii: 5U85DBW7LO
EscitalopramESCITALOPRAMQPharma, Inc.f682f991-1807-176a-e053-2995a90a3dfa2025-12-01Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA078032
rxcui: 351250
unii: 5U85DBW7LO
escitalopram oxalateESCITALOPRAM OXALATEPD-Rx Pharmaceuticals, Inc.b7670e51-8f44-4f64-b110-3f2f431a40322025-10-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 349332
unii: 5U85DBW7LO
EscitalopramESCITALOPRAMAccord Healthcare Inc.84b2028d-eff4-434d-b71e-6a3c0812f6252025-10-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 351249
rxcui: 351250
rxcui: 349332
unii: 5U85DBW7LO
Escitalopram OxalateESCITALOPRAMCipla USA Inc.31ce0b82-58fe-44f3-8887-c55d8df1b7732025-10-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 351249
rxcui: 351250
rxcui: 349332
unii: 5U85DBW7LO
escitalopramESCITALOPRAMAlmatica Pharma LLCc0401570-a3b0-bef2-7365-c23dc952b8b62025-08-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 5U85DBW7LO
ESCITALOPRAM OXALATEESCITALOPRAMAscent Pharmaceuticals, Inc1285841d-d9f8-49c6-9456-bf51c8e372712025-08-08Boxed 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.