FDA.reportPublic FDA data

Citalopram

Product NDC
65862-005
11-digit product format
658620005
Labeler code
65862
Product ID
65862-005_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
10 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 HYDROBROMIDE10 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
65862-005-01Citalopram100 in 1 BOTTLETABLET, FILM COATED10024
65862-005-05Citalopram500 in 1 BOTTLETABLET, FILM COATED50024
65862-005-10Citalopram10 in 1 CARTONTABLET, FILM COATED1024
65862-005-10Citalopram10 in 1 BLISTER PACKTABLET, FILM COATED1024
65862-005-30Citalopram30 in 1 BOTTLETABLET, FILM COATED3024
65862-005-32Citalopram30 in 1 BLISTER PACKTABLET, FILM COATED3024
65862-005-60Citalopram60 in 1 BOTTLETABLET, FILM COATED6024
65862-005-90Citalopram90 in 1 BOTTLETABLET, FILM COATED9024

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-005-01EA - Each65862-00578753051-ab86-4f5c-96f9-4b44587f75c912012-07-24
65862-005-05EA - Each65862-005d480ed29-4796-4efd-8288-337c9a55f32912012-07-24
65862-005-30EA - Each65862-0050cccea25-7050-4fd7-860f-ec7f8d28b8ad12012-07-24

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
CHOLINEACTIVE INGREDIENTN91BDP6H0XSENTRALOPRAM AM-10 (CITALOPRAM HYDROBROMIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]9
CITALOPRAM HYDROBROMIDEACTIVE INGREDIENTI1E9D14F36SENTRALOPRAM AM-10 (CITALOPRAM HYDROBROMIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]9
CHOLINEACTIVE MOIETYN91BDP6H0XSENTRALOPRAM AM-10 (CITALOPRAM HYDROBROMIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]9
CITALOPRAMACTIVE MOIETY0DHU5B8D6VSENTRALOPRAM AM-10 (CITALOPRAM HYDROBROMIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]9
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USENTRALOPRAM AM-10 (CITALOPRAM HYDROBROMIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]9
COPOVIDONEINACTIVE INGREDIENTD9C330MD8BSENTRALOPRAM AM-10 (CITALOPRAM HYDROBROMIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]9
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48SENTRALOPRAM AM-10 (CITALOPRAM HYDROBROMIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]9
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675SENTRALOPRAM AM-10 (CITALOPRAM HYDROBROMIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]9
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTSENTRALOPRAM AM-10 (CITALOPRAM HYDROBROMIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]9
GELATININACTIVE INGREDIENT2G86QN327LSENTRALOPRAM AM-10 (CITALOPRAM HYDROBROMIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]9
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6SENTRALOPRAM AM-10 (CITALOPRAM HYDROBROMIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]9
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XSENTRALOPRAM AM-10 (CITALOPRAM HYDROBROMIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]9
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SENTRALOPRAM AM-10 (CITALOPRAM HYDROBROMIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]9
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DSENTRALOPRAM AM-10 (CITALOPRAM HYDROBROMIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]9
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQSENTRALOPRAM AM-10 (CITALOPRAM HYDROBROMIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]9
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSENTRALOPRAM AM-10 (CITALOPRAM HYDROBROMIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]9
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSENTRALOPRAM AM-10 (CITALOPRAM HYDROBROMIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]9
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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-005CITALOPRAM (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
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
283672citalopram 10 MG Oral TabletPSN2500cc9d-a67d-46c5-9a76-99bc63959d6711
283672citalopram 10 MG Oral TabletSCD2500cc9d-a67d-46c5-9a76-99bc63959d6711
283672citalopram 10 MG (as citalopram HBr 12.49 MG) Oral TabletSY2500cc9d-a67d-46c5-9a76-99bc63959d6711
283672citalopram 10 MG Oral TabletPSNfd761647-e16b-45b3-a4bc-364de0ed70159
283672citalopram 10 MG Oral TabletPSNb0e39608-a7ed-464a-91c9-867ad7cd293c9
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
283672citalopram 10 MG Oral TabletSCDb0e39608-a7ed-464a-91c9-867ad7cd293c9
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
283672citalopram 10 MG (as citalopram HBr 12.49 MG) Oral TabletSYb0e39608-a7ed-464a-91c9-867ad7cd293c9
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
283672citalopram 10 MG Oral TabletPSNd9cc1649-913d-832d-e053-2995a90a5f9a4
283672citalopram 10 MG Oral TabletSCDd9cc1649-913d-832d-e053-2995a90a5f9a4
283672citalopram 10 MG (as citalopram HBr 12.49 MG) Oral TabletSYd9cc1649-913d-832d-e053-2995a90a5f9a4
283672citalopram 10 MG Oral TabletPSN5caff592-a90f-420d-a6ec-9b2dc914529e2
283672citalopram 10 MG Oral TabletPSNf8b06b55-f6a2-2438-e053-6394a90a530a2
200371citalopram 20 MG Oral TabletPSN5caff592-a90f-420d-a6ec-9b2dc914529e2
309314citalopram 40 MG Oral TabletPSN5caff592-a90f-420d-a6ec-9b2dc914529e2
283672citalopram 10 MG Oral TabletSCDf8b06b55-f6a2-2438-e053-6394a90a530a2
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 TabletSYf8b06b55-f6a2-2438-e053-6394a90a530a2
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-005-0165862000501100 TABLET, FILM COATED in 1 BOTTLE (65862-005-01) 2004-10-280000-00-00NoNoCurrent
65862-005-0565862000505500 TABLET, FILM COATED in 1 BOTTLE (65862-005-05) 2004-10-280000-00-00NoNoCurrent
65862-005-106586200051010 BLISTER PACK in 1 CARTON (65862-005-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK10 blister pack2004-10-280000-00-00NoNoCurrent
65862-005-306586200053030 TABLET, FILM COATED in 1 BOTTLE (65862-005-30) 2004-10-280000-00-00NoNoCurrent
65862-005-326586200053230 TABLET, FILM COATED in 1 BLISTER PACK (65862-005-32) 2004-10-280000-00-00NoNoCurrent
65862-005-606586200056060 TABLET, FILM COATED in 1 BOTTLE (65862-005-60) 2004-10-280000-00-00NoNoCurrent
65862-005-906586200059090 TABLET, FILM COATED in 1 BOTTLE (65862-005-90) 2004-10-280000-00-00NoNoCurrent