FDA.reportPublic FDA data

Citalopram

Product NDC
65862-007
11-digit product format
658620007
Labeler code
65862
Product ID
65862-007_5642ea11-17b4-431a-a896-2cb336929100
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Citalopram Hydrobromide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aurobindo Pharma Limited
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
Rxcui200371, 283672, 309314

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
65862-007-01Citalopram100 in 1 BOTTLETABLET, FILM COATED10024
65862-007-05Citalopram500 in 1 BOTTLETABLET, FILM COATED50024
65862-007-10Citalopram10 in 1 BLISTER PACKTABLET, FILM COATED1024
65862-007-10Citalopram10 in 1 CARTONTABLET, FILM COATED1024
65862-007-30Citalopram30 in 1 BOTTLETABLET, FILM COATED3024
65862-007-32Citalopram30 in 1 BLISTER PACKTABLET, FILM COATED3024
65862-007-60Citalopram60 in 1 BOTTLETABLET, FILM COATED6024
65862-007-90Citalopram90 in 1 BOTTLETABLET, FILM COATED9024

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-007CITALOPRAM (CITALOPRAM HYDROBROMIDE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]24Current NDC, Legacy NDC, 8 package rows20240630_2632b547-2e13-447f-ac85-c774e437d6a8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309314citalopram 40 MG Oral TabletPSN31a18cdf-b0aa-18f5-e054-00144ff8d46c30
309314citalopram 40 MG Oral TabletSCD31a18cdf-b0aa-18f5-e054-00144ff8d46c30
309314citalopram 40 MG (as citalopram HBr 49.98 MG) Oral TabletSY31a18cdf-b0aa-18f5-e054-00144ff8d46c30
283672citalopram 10 MG Oral TabletPSN2632b547-2e13-447f-ac85-c774e437d6a824
200371citalopram 20 MG Oral TabletPSN2632b547-2e13-447f-ac85-c774e437d6a824
309314citalopram 40 MG Oral TabletPSN2632b547-2e13-447f-ac85-c774e437d6a824
283672citalopram 10 MG Oral TabletSCD2632b547-2e13-447f-ac85-c774e437d6a824
200371citalopram 20 MG Oral TabletSCD2632b547-2e13-447f-ac85-c774e437d6a824
309314citalopram 40 MG Oral TabletSCD2632b547-2e13-447f-ac85-c774e437d6a824
283672citalopram 10 MG (as citalopram HBr 12.49 MG) Oral TabletSY2632b547-2e13-447f-ac85-c774e437d6a824
200371citalopram 20 MG (as citalopram HBr 24.99 MG) Oral TabletSY2632b547-2e13-447f-ac85-c774e437d6a824
309314citalopram 40 MG (as citalopram HBr 49.98 MG) Oral TabletSY2632b547-2e13-447f-ac85-c774e437d6a824
309314citalopram 40 MG Oral TabletPSNb244d4eb-8311-4663-8bca-dc08e88e5f5d12
309314citalopram 40 MG Oral TabletSCDb244d4eb-8311-4663-8bca-dc08e88e5f5d12
309314citalopram 40 MG (as citalopram HBr 49.98 MG) Oral TabletSYb244d4eb-8311-4663-8bca-dc08e88e5f5d12
309314citalopram 40 MG Oral TabletPSNc6730edc-7226-4521-a04a-1bf296b01b8d10
309314citalopram 40 MG Oral TabletSCDc6730edc-7226-4521-a04a-1bf296b01b8d10
309314citalopram 40 MG (as citalopram HBr 49.98 MG) Oral TabletSYc6730edc-7226-4521-a04a-1bf296b01b8d10
283672citalopram 10 MG Oral TabletPSNfd761647-e16b-45b3-a4bc-364de0ed70159
200371citalopram 20 MG Oral TabletPSNfd761647-e16b-45b3-a4bc-364de0ed70159
309314citalopram 40 MG Oral TabletPSNfd761647-e16b-45b3-a4bc-364de0ed70159
283672citalopram 10 MG Oral TabletSCDfd761647-e16b-45b3-a4bc-364de0ed70159
200371citalopram 20 MG Oral TabletSCDfd761647-e16b-45b3-a4bc-364de0ed70159
309314citalopram 40 MG Oral TabletSCDfd761647-e16b-45b3-a4bc-364de0ed70159
283672citalopram 10 MG (as citalopram HBr 12.49 MG) Oral TabletSYfd761647-e16b-45b3-a4bc-364de0ed70159
200371citalopram 20 MG (as citalopram HBr 24.99 MG) Oral TabletSYfd761647-e16b-45b3-a4bc-364de0ed70159
309314citalopram 40 MG (as citalopram HBr 49.98 MG) Oral TabletSYfd761647-e16b-45b3-a4bc-364de0ed70159
200371citalopram 20 MG Oral TabletPSNc0175164-03a6-41bb-91d6-e1ee78b2d0706
309314citalopram 40 MG Oral TabletPSNc0175164-03a6-41bb-91d6-e1ee78b2d0706
309314citalopram 40 MG Oral TabletPSNf37cc307-8b7d-4e5c-8beb-cd8779bc86a76
200371citalopram 20 MG Oral TabletSCDc0175164-03a6-41bb-91d6-e1ee78b2d0706
309314citalopram 40 MG Oral TabletSCDc0175164-03a6-41bb-91d6-e1ee78b2d0706
309314citalopram 40 MG Oral TabletSCDf37cc307-8b7d-4e5c-8beb-cd8779bc86a76
200371citalopram 20 MG (as citalopram HBr 24.99 MG) Oral TabletSYc0175164-03a6-41bb-91d6-e1ee78b2d0706
309314citalopram 40 MG (as citalopram HBr 49.98 MG) Oral TabletSYf37cc307-8b7d-4e5c-8beb-cd8779bc86a76
309314citalopram 40 MG (as citalopram HBr 49.98 MG) Oral TabletSYc0175164-03a6-41bb-91d6-e1ee78b2d0706
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
283672citalopram 10 MG Oral TabletPSN5caff592-a90f-420d-a6ec-9b2dc914529e2
200371citalopram 20 MG Oral TabletPSN5caff592-a90f-420d-a6ec-9b2dc914529e2
309314citalopram 40 MG Oral TabletPSN5caff592-a90f-420d-a6ec-9b2dc914529e2
283672citalopram 10 MG Oral TabletSCD5caff592-a90f-420d-a6ec-9b2dc914529e2
200371citalopram 20 MG Oral TabletSCD5caff592-a90f-420d-a6ec-9b2dc914529e2
309314citalopram 40 MG Oral TabletSCD5caff592-a90f-420d-a6ec-9b2dc914529e2
283672citalopram 10 MG (as citalopram HBr 12.49 MG) Oral TabletSY5caff592-a90f-420d-a6ec-9b2dc914529e2
200371citalopram 20 MG (as citalopram HBr 24.99 MG) Oral TabletSY5caff592-a90f-420d-a6ec-9b2dc914529e2
309314citalopram 40 MG (as citalopram HBr 49.98 MG) Oral TabletSY5caff592-a90f-420d-a6ec-9b2dc914529e2
309314citalopram 40 MG Oral TabletPSN613768da-6140-4c11-affc-85ba8fe920181
309314citalopram 40 MG Oral TabletPSN31ddd184-7560-473c-b674-5fa3187c55981
309314citalopram 40 MG Oral TabletPSN0109f365-bebd-4810-a56f-4451e10245db1
309314citalopram 40 MG Oral TabletSCD613768da-6140-4c11-affc-85ba8fe920181
309314citalopram 40 MG Oral TabletSCD0109f365-bebd-4810-a56f-4451e10245db1
309314citalopram 40 MG Oral TabletSCD31ddd184-7560-473c-b674-5fa3187c55981
309314citalopram 40 MG (as citalopram HBr 49.98 MG) Oral TabletSY613768da-6140-4c11-affc-85ba8fe920181
309314citalopram 40 MG (as citalopram HBr 49.98 MG) Oral TabletSY31ddd184-7560-473c-b674-5fa3187c55981
309314citalopram 40 MG (as citalopram HBr 49.98 MG) Oral TabletSY0109f365-bebd-4810-a56f-4451e10245db1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-007-0165862000701100 TABLET, FILM COATED in 1 BOTTLE (65862-007-01) 2004-10-280000-00-00NoNoCurrent
65862-007-0565862000705500 TABLET, FILM COATED in 1 BOTTLE (65862-007-05) 2004-10-280000-00-00NoNoCurrent
65862-007-106586200071010 BLISTER PACK in 1 CARTON (65862-007-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK10 blister pack2004-10-280000-00-00NoNoCurrent
65862-007-306586200073030 TABLET, FILM COATED in 1 BOTTLE (65862-007-30) 2004-10-280000-00-00NoNoCurrent
65862-007-326586200073230 TABLET, FILM COATED in 1 BLISTER PACK (65862-007-32) 2004-10-280000-00-00NoNoCurrent
65862-007-59658620007595000 TABLET, FILM COATED in 1 BAG (65862-007-59)28-OCT-04Current
65862-007-606586200076060 TABLET, FILM COATED in 1 BOTTLE (65862-007-60) 2004-10-280000-00-00NoNoCurrent
65862-007-61658620007616000 TABLET, FILM COATED in 1 BAG (65862-007-61)28-OCT-04Current
65862-007-906586200079090 TABLET, FILM COATED in 1 BOTTLE (65862-007-90) 2004-10-280000-00-00NoNoCurrent