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 2 of 6 · 111 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EscitalopramESCITALOPRAMSOLCO HEALTHCARE US, LLC155e973a-f4ff-4e5a-b937-09f1e106fe392026-05-20Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA078032
ndc (product): 43547-281
rxcui: 351249
rxcui: 351250
rxcui: 349332
spl id: 9eb8b7e7-53d7-461e-86e5-670262dad840
spl set id: 155e973a-f4ff-4e5a-b937-09f1e106fe39
unii: 5U85DBW7LO
EscitalopramESCITALOPRAM OXALATEAurobindo Pharma Limitedd5fbc8ce-bd41-4bd0-b413-0dea97e596c32026-05-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 351249
rxcui: 351250
rxcui: 349332
unii: 5U85DBW7LO
EscitalopramESCITALOPRAMPD-Rx Pharmaceuticals, Inc.2d125ea4-5430-5b4e-e054-00144ff88e882026-05-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 351250
unii: 5U85DBW7LO
Escitalopram OxalateESCITALOPRAM OXALATEAurobindo Pharma Limitedba60c357-8e61-4a3d-b1dc-25602dbbfc2a2026-05-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 5U85DBW7LO
EscitalopramESCITALOPRAMCoupler LLC5088d6cd-ec13-384d-e063-6394a90aee052026-04-28Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA078032
rxcui: 349332
unii: 5U85DBW7LO
escitalopramESCITALOPRAMCardinal Health 107, LLCcb3f9af4-5bb4-48a8-b972-ff92cff1ea012026-04-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 351250
rxcui: 349332
unii: 5U85DBW7LO
escitalopramESCITALOPRAMPreferred Pharmaceuticals Inc.eef1c681-1972-4c3f-b4ba-cbb3388f397a2026-04-13Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 351250
unii: 5U85DBW7LO
EscitalopramESCITALOPRAMPreferred Pharmaceuticals, Inc.3e3a3e36-fb2f-4d9b-bbcf-423bd97c9f882026-04-13Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA078032
rxcui: 351250
unii: 5U85DBW7LO
escitalopram oxalateESCITALOPRAM OXALATEPreferred Pharmaceuticals Inc.7d924d16-8a10-411d-be57-97c450f56de72026-04-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 349332
unii: 5U85DBW7LO
escitalopramESCITALOPRAMPreferred Pharmaceuticals Inc.d16a7510-c787-4c9b-818b-1ffbcc62b3c32026-04-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 349332
unii: 5U85DBW7LO
escitalopramESCITALOPRAMBryant Ranch Prepacka0ff752d-cb30-4131-a7d6-cd66d8a47b1a2026-03-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 351249
unii: 5U85DBW7LO
escitalopramESCITALOPRAMBryant Ranch Prepackcb30d1c5-2280-465f-84f4-4367ad5f1a312026-03-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 351250
unii: 5U85DBW7LO
escitalopramESCITALOPRAMBryant Ranch Prepack0de88dad-d54c-4773-a5d6-a705e012973a2026-03-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 349332
unii: 5U85DBW7LO
Escitalopram OxalateESCITALOPRAMLegacy Pharmaceutical Packaging, LLC9c68f89b-1d34-4735-9631-817f012935d72026-03-11Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 351250
rxcui: 349332
unii: 5U85DBW7LO
EscitalopramESCITALOPRAMDirect_Rxf435d670-87ff-f226-e053-2a95a90ac0ee2026-03-05Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA078032
rxcui: 349332
unii: 5U85DBW7LO
escitalopramESCITALOPRAMMajor Pharmaceuticalsf4a12048-181e-45ed-a382-f53096d1b6892026-02-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 351250
rxcui: 349332
unii: 5U85DBW7LO
EscitalopramESCITALOPRAMPD-Rx Pharmaceuticals, Inc.83510549-bd47-4969-aba0-c149a0fbb7f32026-02-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 349332
unii: 5U85DBW7LO
escitalopramESCITALOPRAMBryant Ranch Prepack64de12e0-c35f-4082-b902-ddbaee8158a62026-02-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 349332
unii: 5U85DBW7LO
EscitalopramESCITALOPRAM OXALATEAsclemed USA, Inc.2957a003-7714-4e16-aeca-623fd6c5d7022026-02-13Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 351249
rxcui: 351250
rxcui: 349332
unii: 5U85DBW7LO
EscitalopramESCITALOPRAMA-S Medication Solutionsba6a0c20-4915-4164-a39e-ca67d652cbfd2026-02-12Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA078032
rxcui: 349332
unii: 5U85DBW7LO

Reported adverse events (FAERS/openFDA)#

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