FDA.reportPublic FDA data

Citalopram

Product NDC
71335-2232
11-digit product format
713352232
Labeler code
71335
Product ID
71335-2232_ff4ddb77-91cf-4e45-b855-55e4c264d085
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
citalopram
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA077042
Marketing category
ANDA
Marketing start
2008-07-28
Substance
CITALOPRAM HYDROBROMIDE
Active strength
40 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

Additional Listing Data#

Finished product
Yes
Brand name base
Citalopram
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CITALOPRAM HYDROBROMIDE40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiI1E9D14F36
Rxcui309314

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
71335-2232-1Citalopram30 in 1 BOTTLE, PLASTICTABLET, FILM COATED30102
71335-2232-2Citalopram40 in 1 BOTTLE, PLASTICTABLET, FILM COATED40102
71335-2232-3Citalopram60 in 1 BOTTLE, PLASTICTABLET, FILM COATED60102
71335-2232-4Citalopram90 in 1 BOTTLE, PLASTICTABLET, FILM COATED90102
71335-2232-5Citalopram100 in 1 BOTTLE, PLASTICTABLET, FILM COATED100102
71335-2232-6Citalopram180 in 1 BOTTLE, PLASTICTABLET, FILM COATED180102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-2232-1EA - Each71335-2232360fd497-8042-45f5-9d91-32eb02883d5512025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2232CITALOPRAM TABLET, FILM COATED [BRYANT RANCH PREPACK]102Current NDC, 6 package rows20241019_2a8acad8-0ba0-4631-9f6d-f587e7a8558c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309314citalopram 40 MG Oral TabletPSN2a8acad8-0ba0-4631-9f6d-f587e7a8558c102
309314citalopram 40 MG Oral TabletSCD2a8acad8-0ba0-4631-9f6d-f587e7a8558c102
309314citalopram 40 MG (as citalopram HBr 49.98 MG) Oral TabletSY2a8acad8-0ba0-4631-9f6d-f587e7a8558c102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-2232-17133522320130 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-2232-1) 2023-09-18NoNoHistorical
71335-2232-27133522320240 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-2232-2) 2024-10-04NoNoHistorical
71335-2232-37133522320360 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-2232-3) 2024-10-04NoNoHistorical
71335-2232-47133522320490 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-2232-4) 2023-09-18NoNoHistorical
71335-2232-571335223205100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-2232-5) 2024-10-04NoNoHistorical
71335-2232-671335223206180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-2232-6) 2024-10-04NoNoHistorical