FDA.reportPublic FDA data

NDC 68788-0802-01 - Citalopram Hydrobromide

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
68788-0802
Requested NDC
68788-0802-01
Package NDCs from labels
68788-0802-3, 68788-0802-6, 68788-0802-9, 68788-0802-1, 68788-0802-8, 68788-0802-01
Manufacturer
Preferred Pharmaceuticals, Inc.
Effective date
2026-01-26
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Citalopram Hydrobromide - Preferred Pharmaceuticals, Inc.Preferred Pharmaceuticals, Inc.2026-01-26HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-0802-1Citalopram Hydrobromide100 in 1 BOTTLETABLET, FILM COATED10014
68788-0802-3Citalopram Hydrobromide30 in 1 BOTTLETABLET, FILM COATED3014
68788-0802-6Citalopram Hydrobromide60 in 1 BOTTLETABLET, FILM COATED6014
68788-0802-8Citalopram Hydrobromide120 in 1 BOTTLETABLET, FILM COATED12014
68788-0802-9Citalopram Hydrobromide90 in 1 BOTTLETABLET, FILM COATED9014

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-0802CITALOPRAM HYDROBROMIDE TABLET [PREFERRED PHARMACEUTICALS, INC.]13Current NDC, Legacy NDC, 5 package rows20240329_b52acd68-fed1-4680-9eaf-b72e7dcba6fb.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-0802-3EA - Each68788-0802a3ab9ee1-378e-4b72-ab48-abe9f31e94cf12020-05-08
68788-0802-9EA - Each68788-08025c032b43-aad8-429b-960b-14b5bd75c46212020-05-08

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CITALOPRAM HYDROBROMIDEACTIVE INGREDIENTI1E9D14F36CITALOPRAM HYDROBROMIDE TABLET [PREFERRED PHARMACEUTICALS, INC.]4
CITALOPRAMACTIVE MOIETY0DHU5B8D6VCITALOPRAM HYDROBROMIDE TABLET [PREFERRED PHARMACEUTICALS, INC.]4

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
ndc (product): 13668-010
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
ndc (package): 68788-0802-6
ndc (package): 68788-0802-9
ndc (package): 68788-9692-8
ndc (package): 68788-9692-9
ndc (package): 68788-9692-6
ndc (package): 68788-0802-3
ndc (package): 68788-0802-1
ndc (package): 68788-0802-8
ndc (package): 68788-9692-1
ndc (package): 68788-9692-3
ndc (product): 68788-9692
ndc (product): 68788-0802
ndc11 (package): 68788080201
rxcui: 283672
rxcui: 200371
spl id: 543a6dbf-f42d-4bc1-ad77-9ceac5e6bfe9
spl set id: b52acd68-fed1-4680-9eaf-b72e7dcba6fb
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
rxcui: 283672
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.