FDA.reportPublic FDA data

Citalopram

Product NDC
71335-0377
11-digit product format
713350377
Labeler code
71335
Product ID
71335-0377_c637e8e7-2e86-44d2-ae06-98f6c96a24e5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Citalopram
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA078216
Marketing category
ANDA
Marketing start
2007-10-18
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Citalopram
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CITALOPRAM HYDROBROMIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiI1E9D14F36
Rxcui283672

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
475812f9-1b2c-4cb0-9e72-1e52f935ae6fProduct name120221114
0b05d650-9b7b-4b36-a6f4-1a850d5a2e64Product name120151228
e61ea6cb-0b08-40a9-a984-7b23201c7aa2Product name120151222

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-0377-1Citalopram30 in 1 BOTTLETABLET, FILM COATED30106
71335-0377-2Citalopram60 in 1 BOTTLETABLET, FILM COATED60106
71335-0377-3Citalopram90 in 1 BOTTLETABLET, FILM COATED90106
71335-0377-4Citalopram21 in 1 BOTTLETABLET, FILM COATED21106
71335-0377-5Citalopram100 in 1 BOTTLETABLET, FILM COATED100106

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0377CITALOPRAM HYDROBROMIDE TABLET [BRYANT RANCH PREPACK]105Current NDC, Legacy NDC, 5 package rows20241109_9b53c14c-224c-49ed-8a00-96f871593ab0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283672citalopram 10 MG Oral TabletPSN9b53c14c-224c-49ed-8a00-96f871593ab0106
283672citalopram 10 MG Oral TabletSCD9b53c14c-224c-49ed-8a00-96f871593ab0106
283672citalopram 10 MG (as citalopram HBr 12.49 MG) Oral TabletSY9b53c14c-224c-49ed-8a00-96f871593ab0106

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-0377-17133503770130 TABLET, FILM COATED in 1 BOTTLE (71335-0377-1) 2018-02-120000-00-00NoNoCurrent
71335-0377-27133503770260 TABLET, FILM COATED in 1 BOTTLE (71335-0377-2) 2018-04-270000-00-00NoNoCurrent
71335-0377-37133503770390 TABLET, FILM COATED in 1 BOTTLE (71335-0377-3) 2018-03-220000-00-00NoNoCurrent
71335-0377-47133503770421 TABLET, FILM COATED in 1 BOTTLE (71335-0377-4) 2026-03-310000-00-00NoNoCurrent
71335-0377-571335037705100 TABLET, FILM COATED in 1 BOTTLE (71335-0377-5) 2025-01-10NoNoHistorical