FDA.reportPublic FDA data

Citalopram

Product NDC
65862-006
11-digit product format
658620006
Labeler code
65862
Product ID
65862-006_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
20 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 HYDROBROMIDE20 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
65862-006-01Citalopram100 in 1 BOTTLETABLET, FILM COATED10024
65862-006-05Citalopram500 in 1 BOTTLETABLET, FILM COATED50024
65862-006-10Citalopram10 in 1 BLISTER PACKTABLET, FILM COATED1024
65862-006-10Citalopram10 in 1 CARTONTABLET, FILM COATED1024
65862-006-30Citalopram30 in 1 BOTTLETABLET, FILM COATED3024
65862-006-32Citalopram30 in 1 BLISTER PACKTABLET, FILM COATED3024
65862-006-60Citalopram60 in 1 BOTTLETABLET, FILM COATED6024
65862-006-90Citalopram90 in 1 BOTTLETABLET, FILM COATED9024

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-006-01EA - Each65862-0067103ea19-e259-402d-bff8-55f2eed2d0fd12012-07-24
65862-006-05EA - Each65862-006a7dc19a6-8060-4d6d-8e55-78dae858fd4612012-07-24
65862-006-30EA - Each65862-00695faf50b-4ca9-4904-8aba-58f963fcbef712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CITALOPRAM HYDROBROMIDEACTIVE INGREDIENTI1E9D14F36CITALOPRAM (CITALOPRAM HYDROBROMIDE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]13
CITALOPRAMACTIVE MOIETY0DHU5B8D6VCITALOPRAM (CITALOPRAM HYDROBROMIDE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]13
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCITALOPRAM (CITALOPRAM HYDROBROMIDE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]13
COPOVIDONE K25-31INACTIVE INGREDIENTD9C330MD8BCITALOPRAM (CITALOPRAM HYDROBROMIDE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]13
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CITALOPRAM (CITALOPRAM HYDROBROMIDE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]13
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675CITALOPRAM (CITALOPRAM HYDROBROMIDE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]13
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTCITALOPRAM (CITALOPRAM HYDROBROMIDE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]13
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6CITALOPRAM (CITALOPRAM HYDROBROMIDE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]13
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCITALOPRAM (CITALOPRAM HYDROBROMIDE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]13
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CITALOPRAM (CITALOPRAM HYDROBROMIDE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]13
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQCITALOPRAM (CITALOPRAM HYDROBROMIDE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]13
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCITALOPRAM (CITALOPRAM HYDROBROMIDE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]13
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCITALOPRAM (CITALOPRAM HYDROBROMIDE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]13
CITALOPRAM HYDROBROMIDEACTIVE INGREDIENTI1E9D14F36CITALOPRAM (CITALOPRAM HYDROBROMIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
CITALOPRAMACTIVE MOIETY0DHU5B8D6VCITALOPRAM (CITALOPRAM HYDROBROMIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCITALOPRAM (CITALOPRAM HYDROBROMIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
COPOVIDONEINACTIVE INGREDIENTD9C330MD8BCITALOPRAM (CITALOPRAM HYDROBROMIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CITALOPRAM (CITALOPRAM HYDROBROMIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675CITALOPRAM (CITALOPRAM HYDROBROMIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTCITALOPRAM (CITALOPRAM HYDROBROMIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6CITALOPRAM (CITALOPRAM HYDROBROMIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCITALOPRAM (CITALOPRAM HYDROBROMIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CITALOPRAM (CITALOPRAM HYDROBROMIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQCITALOPRAM (CITALOPRAM HYDROBROMIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCITALOPRAM (CITALOPRAM HYDROBROMIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCITALOPRAM (CITALOPRAM HYDROBROMIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
CITALOPRAM HYDROBROMIDEACTIVE INGREDIENTI1E9D14F36CITALOPRAM (CITALOPRAM HYDROBROMIDE) TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
CITALOPRAMACTIVE MOIETY0DHU5B8D6VCITALOPRAM (CITALOPRAM HYDROBROMIDE) TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCITALOPRAM (CITALOPRAM HYDROBROMIDE) TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
COPOVIDONEINACTIVE INGREDIENTD9C330MD8BCITALOPRAM (CITALOPRAM HYDROBROMIDE) TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CITALOPRAM (CITALOPRAM HYDROBROMIDE) TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675CITALOPRAM (CITALOPRAM HYDROBROMIDE) TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTCITALOPRAM (CITALOPRAM HYDROBROMIDE) TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
HYPROMELLOSE 2910 (6 CPS)INACTIVE INGREDIENT0WZ8WG20P6CITALOPRAM (CITALOPRAM HYDROBROMIDE) TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCITALOPRAM (CITALOPRAM HYDROBROMIDE) TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CITALOPRAM (CITALOPRAM HYDROBROMIDE) TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQCITALOPRAM (CITALOPRAM HYDROBROMIDE) TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCITALOPRAM (CITALOPRAM HYDROBROMIDE) TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCITALOPRAM (CITALOPRAM HYDROBROMIDE) TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-006CITALOPRAM (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
200371citalopram 20 MG Oral TabletPSN0bc0e09e-0f1d-4d52-b8fe-3ef8a2e5ea52100
200371citalopram 20 MG Oral TabletSCD0bc0e09e-0f1d-4d52-b8fe-3ef8a2e5ea52100
200371citalopram 20 MG (as citalopram HBr 24.99 MG) Oral TabletSY0bc0e09e-0f1d-4d52-b8fe-3ef8a2e5ea52100
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
200371citalopram 20 MG Oral TabletPSNfc766b76-18c1-42cd-b276-f720f5821c1111
200371citalopram 20 MG Oral TabletSCDfc766b76-18c1-42cd-b276-f720f5821c1111
200371citalopram 20 MG (as citalopram HBr 24.99 MG) Oral TabletSYfc766b76-18c1-42cd-b276-f720f5821c1111
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 TabletPSN0a967468-3869-4c8c-849f-9fc3a8dcc4898
200371citalopram 20 MG Oral TabletSCD0a967468-3869-4c8c-849f-9fc3a8dcc4898
200371citalopram 20 MG (as citalopram HBr 24.99 MG) Oral TabletSY0a967468-3869-4c8c-849f-9fc3a8dcc4898
200371citalopram 20 MG Oral TabletPSNc0175164-03a6-41bb-91d6-e1ee78b2d0706
309314citalopram 40 MG Oral TabletPSNc0175164-03a6-41bb-91d6-e1ee78b2d0706
200371citalopram 20 MG Oral TabletSCDc0175164-03a6-41bb-91d6-e1ee78b2d0706
309314citalopram 40 MG Oral TabletSCDc0175164-03a6-41bb-91d6-e1ee78b2d0706
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 TabletSYc0175164-03a6-41bb-91d6-e1ee78b2d0706
200371citalopram 20 MG Oral TabletPSN625a78b2-4751-4ca5-91b6-7c85fd9f8c2e4
200371citalopram 20 MG Oral TabletSCD625a78b2-4751-4ca5-91b6-7c85fd9f8c2e4
200371citalopram 20 MG (as citalopram HBr 24.99 MG) Oral TabletSY625a78b2-4751-4ca5-91b6-7c85fd9f8c2e4
200371citalopram 20 MG Oral TabletPSNd9ccb3fb-b607-9491-e053-2995a90a39c93
200371citalopram 20 MG Oral TabletPSN289c1d5e-902f-47db-85b8-5e1a55ec86843
200371citalopram 20 MG Oral TabletSCD289c1d5e-902f-47db-85b8-5e1a55ec86843
200371citalopram 20 MG Oral TabletSCDd9ccb3fb-b607-9491-e053-2995a90a39c93
200371citalopram 20 MG (as citalopram HBr 24.99 MG) Oral TabletSY289c1d5e-902f-47db-85b8-5e1a55ec86843
200371citalopram 20 MG (as citalopram HBr 24.99 MG) Oral TabletSYd9ccb3fb-b607-9491-e053-2995a90a39c93
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
200371citalopram 20 MG Oral TabletPSN653233ce-04c3-4059-9d45-a7075ddbf9201
309314citalopram 40 MG Oral TabletPSN653233ce-04c3-4059-9d45-a7075ddbf9201
200371citalopram 20 MG Oral TabletSCD653233ce-04c3-4059-9d45-a7075ddbf9201
309314citalopram 40 MG Oral TabletSCD653233ce-04c3-4059-9d45-a7075ddbf9201
200371citalopram 20 MG (as citalopram HBr 24.99 MG) Oral TabletSY653233ce-04c3-4059-9d45-a7075ddbf9201
309314citalopram 40 MG (as citalopram HBr 49.98 MG) Oral TabletSY653233ce-04c3-4059-9d45-a7075ddbf9201

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-006-0165862000601100 TABLET, FILM COATED in 1 BOTTLE (65862-006-01) 2004-10-280000-00-00NoNoCurrent
65862-006-0565862000605500 TABLET, FILM COATED in 1 BOTTLE (65862-006-05) 2004-10-280000-00-00NoNoCurrent
65862-006-106586200061010 BLISTER PACK in 1 CARTON (65862-006-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK10 blister pack2004-10-280000-00-00NoNoCurrent
65862-006-306586200063030 TABLET, FILM COATED in 1 BOTTLE (65862-006-30) 2004-10-280000-00-00NoNoCurrent
65862-006-326586200063230 TABLET, FILM COATED in 1 BLISTER PACK (65862-006-32) 2004-10-280000-00-00NoNoCurrent
65862-006-606586200066060 TABLET, FILM COATED in 1 BOTTLE (65862-006-60) 2004-10-280000-00-00NoNoCurrent
65862-006-906586200069090 TABLET, FILM COATED in 1 BOTTLE (65862-006-90) 2004-10-280000-00-00NoNoCurrent