Citalopram

Product NDC
70518-4416
11-digit product format
705184416
Labeler code
70518
Product ID
70518-4416_3b8bf64b-77c4-de20-e063-6394a90a4c21
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Citalopram
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA078216
Marketing category
ANDA
Marketing start
2025-07-31
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
70518-4416-07051844160030 TABLET, FILM COATED in 1 BLISTER PACK (70518-4416-0) 2025-07-31NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
CitalopramREMEDYREPACK INC.2025-08-04HUMAN PRESCRIPTION DRUG LABEL1