FDA.reportPublic FDA data

NDC 80425-0557-01 - Citalopram

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
80425-0557
Requested NDC
80425-0557-01
Package NDCs from labels
80425-0557-1, 80425-0557-2, 80425-0557-3, 80425-0557-01
Manufacturer
Advanced Rx of Tennessee, LLC
Effective date
2025-11-07
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Citalopram - Advanced Rx of Tennessee, LLCAdvanced Rx of Tennessee, LLC2025-11-07HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0557-1Citalopram30 in 1 BOTTLETABLET, FILM COATED301
80425-0557-2Citalopram60 in 1 BOTTLETABLET, FILM COATED601
80425-0557-3Citalopram90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0557-1EA - Each80425-055776650329-c6a2-4271-832c-c000176eedf712025-12-16
80425-0557-2EA - Each80425-0557480a3215-4366-4d78-ac5c-60b62131d27912025-12-16
80425-0557-3EA - Each80425-055784caa3c3-474f-4729-bfe1-ce72215ff89f12025-12-16

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 5 · 88 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Citalopram HydrobromideCITALOPRAM HYDROBROMIDEPreferred Pharmaceuticals Inc.27ddea53-f03d-4760-99bb-ec8efa44ff622026-03-30Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA078216
rxcui: 309314
unii: I1E9D14F36
CITALOPRAMCITALOPRAMAurobindo Pharma Limited80af8ae8-c106-4895-bab3-0579b41f1e752026-03-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I1E9D14F36
CitalopramCITALOPRAMBryant Ranch Prepackbef27fa1-7876-4ce3-834c-a4855aec66c92026-03-13Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA078216
rxcui: 200371
unii: I1E9D14F36
CITALOPRAM HYDROBROMIDECITALOPRAMAphena Pharma Solutions - Tennessee, LLC7307df53-d570-4e26-971d-e97522ccce7f2026-03-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 200371
rxcui: 309314
unii: I1E9D14F36
CitalopramCITALOPRAMMajor Pharmaceuticalsa6949652-b15b-435b-9097-2219f398ac052026-02-18Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA078216
rxcui: 283672
rxcui: 200371
unii: I1E9D14F36
CitalopramCITALOPRAMChartwell RX, LLCb1f0c6e8-85eb-4368-8709-9cace32415cb2026-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I1E9D14F36
CitalopramCITALOPRAMTorrent Pharmaceuticals Limited04766f1d-7a69-49ed-8fd3-1a6305505d472026-02-04Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA078216
ndc (product): 13668-009
rxcui: 283672
rxcui: 200371
rxcui: 309314
spl id: 48423caf-4df2-4653-a8ed-b28462757ed3
spl set id: 04766f1d-7a69-49ed-8fd3-1a6305505d47
unii: I1E9D14F36
Citalopram HydrobromideCITALOPRAM HYDROBROMIDEPreferred Pharmaceuticals, Inc.b52acd68-fed1-4680-9eaf-b72e7dcba6fb2026-01-26Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA078216
rxcui: 283672
rxcui: 200371
unii: I1E9D14F36
CitalopramCITALOPRAMNorthwind Health Company, LLCf2b42bdc-47e0-19c5-e053-2a95a90a18282026-01-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 200371
unii: I1E9D14F36
CitalopramCITALOPRAMChartwell Governmental & Specialty RX, LLC.3114274f-d81f-4b1f-8f17-35db9eee2ffe2026-01-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I1E9D14F36
CitalopramCITALOPRAMNorthwind Health Company, LLCf2b54f10-221f-5eed-e053-2995a90ab47f2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 309314
unii: I1E9D14F36
CitalopramCITALOPRAM HYDROBROMIDENorthwind Health Company, LLCd9cc1649-913d-832d-e053-2995a90a5f9a2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 283672
unii: I1E9D14F36
CitalopramCITALOPRAM HYDROBROMIDENorthwind Health Company, LLCd9ccb3fb-b607-9491-e053-2995a90a39c92026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 200371
unii: I1E9D14F36
CitalopramCITALOPRAMNorthwind Health Company, LLCa7ef6ad2-5f22-4ac7-b57a-f498bcb53be12026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA078216
rxcui: 200371
rxcui: 309314
unii: I1E9D14F36
CitalopramCITALOPRAMNorthwind Health Company, LLCf77ef23b-3015-d074-e053-6394a90a11e12026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 283672
unii: I1E9D14F36
Citalopram HydrobromideCITALOPRAM HYDROBROMIDENorthwind Health Company, LLCc133fc77-6c8a-d2b1-e053-2995a90ab5f72025-12-26Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA078216
rxcui: 283672
unii: I1E9D14F36
CitalopramCITALOPRAM HYDROBROMIDEQPharma, Inc.0a967468-3869-4c8c-849f-9fc3a8dcc4892025-12-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 200371
unii: I1E9D14F36
CitalopramCITALOPRAMAdvanced Rx of Tennessee, LLC434094b4-fa3b-385a-e063-6394a90ac6382025-11-07Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA078216
ndc (package): 80425-0557-2
ndc (package): 80425-0557-1
ndc (package): 80425-0557-3
ndc (product): 80425-0557
ndc11 (package): 80425055701
rxcui: 283672
spl id: 43408cc0-4400-3827-e063-6394a90adcfe
spl set id: 434094b4-fa3b-385a-e063-6394a90ac638
unii: I1E9D14F36
CitalopramCITALOPRAM HYDROBROMIDEPD-Rx Pharmaceuticals, Inc.31a18cdf-b0aa-18f5-e054-00144ff8d46c2025-10-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 309314
unii: I1E9D14F36
CitalopramCITALOPRAM HYDROBROMIDENuCare Pharmaceuticals,Inc.544ba802-a536-579a-e054-00144ff88e882025-06-26Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 309314
unii: I1E9D14F36

Reported adverse events (FAERS/openFDA)#

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