FDA.reportPublic FDA data

Citalopram

Product NDC
68071-3357
11-digit product format
680713357
Labeler code
68071
Product ID
68071-3357_3880e5dd-0433-2990-e063-6394a90a0ef8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Citalopram Hydrobromide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA077031
Marketing category
ANDA
Marketing start
2004-10-28
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-3357-12020-05-13C16284748780-19d75b9d0-3310-f424-e053-dadaa90a57ceCitalopram Tablets, USP
68071-3357-32020-05-13C16284748780-19d75b9d0-3310-f424-e053-dadaa90a57ceCitalopram Tablets, USP
68071-3357-42020-05-13C16284748780-19d75b9d0-3310-f424-e053-dadaa90a57ceCitalopram Tablets, USP
68071-3357-52020-05-13C16284748780-19d75b9d0-3310-f424-e053-dadaa90a57ceCitalopram Tablets, USP
68071-3357-62020-05-13C16284748780-19d75b9d0-3310-f424-e053-dadaa90a57ceCitalopram Tablets, USP
68071-3357-92020-05-13C16284748780-19d75b9d0-3310-f424-e053-dadaa90a57ceCitalopram Tablets, USP
68071-3357-12020-01-31C16284748780-19d75b9d0-3310-f424-e053-dadaa90a57ceCitalopram Tablets, USP
68071-3357-32020-01-31C16284748780-19d75b9d0-3310-f424-e053-dadaa90a57ceCitalopram Tablets, USP
68071-3357-42020-01-31C16284748780-19d75b9d0-3310-f424-e053-dadaa90a57ceCitalopram Tablets, USP
68071-3357-52020-01-31C16284748780-19d75b9d0-3310-f424-e053-dadaa90a57ceCitalopram Tablets, USP
68071-3357-62020-01-31C16284748780-19d75b9d0-3310-f424-e053-dadaa90a57ceCitalopram Tablets, USP
68071-3357-92020-01-31C16284748780-19d75b9d0-3310-f424-e053-dadaa90a57ceCitalopram Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-3357-1Citalopram15 in 1 BOTTLETABLET, FILM COATED154
68071-3357-3Citalopram30 in 1 BOTTLETABLET, FILM COATED304
68071-3357-4Citalopram40 in 1 BOTTLETABLET, FILM COATED404
68071-3357-5Citalopram45 in 1 BOTTLETABLET, FILM COATED454
68071-3357-6Citalopram60 in 1 BOTTLETABLET, FILM COATED604
68071-3357-9Citalopram90 in 1 BOTTLETABLET, FILM COATED904

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309314citalopram 40 MG Oral TabletPSN544ba802-a536-579a-e054-00144ff88e884
309314citalopram 40 MG Oral TabletSCD544ba802-a536-579a-e054-00144ff88e884
309314citalopram 40 MG (as citalopram HBr 49.98 MG) Oral TabletSY544ba802-a536-579a-e054-00144ff88e884

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68071-3357-16807133570115 TABLET, FILM COATED in 1 BOTTLE (68071-3357-1) 2017-07-14NoNoHistorical
68071-3357-36807133570330 TABLET, FILM COATED in 1 BOTTLE (68071-3357-3) 2017-07-14NoNoHistorical
68071-3357-46807133570440 TABLET, FILM COATED in 1 BOTTLE (68071-3357-4) 2017-07-14NoNoHistorical
68071-3357-56807133570545 TABLET, FILM COATED in 1 BOTTLE (68071-3357-5) 2017-07-14NoNoHistorical
68071-3357-66807133570660 TABLET, FILM COATED in 1 BOTTLE (68071-3357-6) 2017-07-14NoNoHistorical
68071-3357-96807133570990 TABLET, FILM COATED in 1 BOTTLE (68071-3357-9) 2017-07-14NoNoHistorical