Citalopram

Product NDC
80425-0557
11-digit product format
804250557
Labeler code
80425
Product ID
80425-0557_43408cc0-4400-3827-e063-6394a90adcfe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Citalopram
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Advanced Rx of Tennessee, LLC
Application
ANDA078216
Marketing category
ANDA
Marketing start
2025-11-07
Substance
CITALOPRAM HYDROBROMIDE
Active strength
10 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
I1E9D14F36CITALOPRAM HYDROBROMIDE59729-32-7CITALOPRAM HYDROBROMIDE
0DHU5B8D6VCITALOPRAM59729-33-8Citalopram

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
80425-0557-18042505570130 TABLET, FILM COATED in 1 BOTTLE (80425-0557-1) 2025-11-07NoNoHistorical
80425-0557-28042505570260 TABLET, FILM COATED in 1 BOTTLE (80425-0557-2) 2025-11-07NoNoHistorical
80425-0557-38042505570390 TABLET, FILM COATED in 1 BOTTLE (80425-0557-3) 2025-11-07NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
CitalopramAdvanced Rx of Tennessee, LLC2025-11-07HUMAN PRESCRIPTION DRUG LABEL1