FDA.reportPublic FDA data

Celexa

Product NDC
0456-4010
11-digit product format
004564010
Labeler code
0456
Product ID
0456-4010_0eee9751-8886-474c-a806-8003e90cb151
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
citalopram
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Allergan, Inc.
Application
NDA020822
Marketing category
NDA
Marketing start
1998-07-17
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
Celexa
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CITALOPRAM HYDROBROMIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiI1E9D14F36
Rxcui200371, 213344, 213345, 283672, 284591, 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
0456-4010-01Celexa100 in 1 BOTTLETABLET, FILM COATED10039

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0456-4010-01EA - Each0456-401017c5ec5b-787c-469b-8d72-d74e1d10e30812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
citalopram hydrobromideACTIVE INGREDIENTI1E9D14F36CELEXA (CITALOPRAM HYDROBROMIDE) TABLET, FILM COATED [FOREST LABORATORIES, INC.]18
citalopramACTIVE MOIETY0DHU5B8D6VCELEXA (CITALOPRAM HYDROBROMIDE) TABLET, FILM COATED [FOREST LABORATORIES, INC.]18
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UCELEXA (CITALOPRAM HYDROBROMIDE) TABLET, FILM COATED [FOREST LABORATORIES, INC.]18
copovidoneINACTIVE INGREDIENTD9C330MD8BCELEXA (CITALOPRAM HYDROBROMIDE) TABLET, FILM COATED [FOREST LABORATORIES, INC.]18
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48CELEXA (CITALOPRAM HYDROBROMIDE) TABLET, FILM COATED [FOREST LABORATORIES, INC.]18
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675CELEXA (CITALOPRAM HYDROBROMIDE) TABLET, FILM COATED [FOREST LABORATORIES, INC.]18
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTCELEXA (CITALOPRAM HYDROBROMIDE) TABLET, FILM COATED [FOREST LABORATORIES, INC.]18
glycerinINACTIVE INGREDIENTPDC6A3C0OXCELEXA (CITALOPRAM HYDROBROMIDE) TABLET, FILM COATED [FOREST LABORATORIES, INC.]18
hypromellosesINACTIVE INGREDIENT3NXW29V3WOCELEXA (CITALOPRAM HYDROBROMIDE) TABLET, FILM COATED [FOREST LABORATORIES, INC.]18
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XCELEXA (CITALOPRAM HYDROBROMIDE) TABLET, FILM COATED [FOREST LABORATORIES, INC.]18
magnesium stearateINACTIVE INGREDIENT70097M6I30CELEXA (CITALOPRAM HYDROBROMIDE) TABLET, FILM COATED [FOREST LABORATORIES, INC.]18
polyethylene glycolsINACTIVE INGREDIENT3WJQ0SDW1ACELEXA (CITALOPRAM HYDROBROMIDE) TABLET, FILM COATED [FOREST LABORATORIES, INC.]18
starch, cornINACTIVE INGREDIENTO8232NY3SJCELEXA (CITALOPRAM HYDROBROMIDE) TABLET, FILM COATED [FOREST LABORATORIES, INC.]18
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPCELEXA (CITALOPRAM HYDROBROMIDE) TABLET, FILM COATED [FOREST LABORATORIES, INC.]18
CITALOPRAM HYDROBROMIDEACTIVE INGREDIENTI1E9D14F36CELEXA (CITALOPRAM HYDROBROMIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]2
CITALOPRAMACTIVE MOIETY0DHU5B8D6VCELEXA (CITALOPRAM HYDROBROMIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCELEXA (CITALOPRAM HYDROBROMIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CELEXA (CITALOPRAM HYDROBROMIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCELEXA (CITALOPRAM HYDROBROMIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCELEXA (CITALOPRAM HYDROBROMIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCELEXA (CITALOPRAM HYDROBROMIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CELEXA (CITALOPRAM HYDROBROMIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]2
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1ACELEXA (CITALOPRAM HYDROBROMIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCELEXA (CITALOPRAM HYDROBROMIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCELEXA (CITALOPRAM HYDROBROMIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0456-4010CELEXA (CITALOPRAM) TABLET, FILM COATED [ALLERGAN, INC.]39Current NDC, Legacy NDC, 1 package rows20240628_4259d9b1-de34-43a4-85a8-41dd214e9177.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
284591CeleXA 10 MG Oral TabletPSN4259d9b1-de34-43a4-85a8-41dd214e917739
213344CeleXA 20 MG Oral TabletPSN4259d9b1-de34-43a4-85a8-41dd214e917739
213345CeleXA 40 MG Oral TabletPSN4259d9b1-de34-43a4-85a8-41dd214e917739
283672citalopram 10 MG Oral TabletPSN4259d9b1-de34-43a4-85a8-41dd214e917739
200371citalopram 20 MG Oral TabletPSN4259d9b1-de34-43a4-85a8-41dd214e917739
309314citalopram 40 MG Oral TabletPSN4259d9b1-de34-43a4-85a8-41dd214e917739
284591citalopram 10 MG Oral Tablet [Celexa]SBD4259d9b1-de34-43a4-85a8-41dd214e917739
213344citalopram 20 MG Oral Tablet [Celexa]SBD4259d9b1-de34-43a4-85a8-41dd214e917739
213345citalopram 40 MG Oral Tablet [Celexa]SBD4259d9b1-de34-43a4-85a8-41dd214e917739
283672citalopram 10 MG Oral TabletSCD4259d9b1-de34-43a4-85a8-41dd214e917739
200371citalopram 20 MG Oral TabletSCD4259d9b1-de34-43a4-85a8-41dd214e917739
309314citalopram 40 MG Oral TabletSCD4259d9b1-de34-43a4-85a8-41dd214e917739
284591Celexa 10 MG Oral TabletSY4259d9b1-de34-43a4-85a8-41dd214e917739
213344Celexa 20 MG Oral TabletSY4259d9b1-de34-43a4-85a8-41dd214e917739
213345Celexa 40 MG Oral TabletSY4259d9b1-de34-43a4-85a8-41dd214e917739
283672citalopram 10 MG (as citalopram HBr 12.49 MG) Oral TabletSY4259d9b1-de34-43a4-85a8-41dd214e917739
200371citalopram 20 MG (as citalopram HBr 24.99 MG) Oral TabletSY4259d9b1-de34-43a4-85a8-41dd214e917739
309314citalopram 40 MG (as citalopram HBr 49.98 MG) Oral TabletSY4259d9b1-de34-43a4-85a8-41dd214e917739
284591CeleXA 10 MG Oral TabletPSN6c96373f-6744-49d4-aec5-3720bc993fab2
213344CeleXA 20 MG Oral TabletPSN6c96373f-6744-49d4-aec5-3720bc993fab2
213345CeleXA 40 MG Oral TabletPSN6c96373f-6744-49d4-aec5-3720bc993fab2
283672citalopram 10 MG Oral TabletPSN6c96373f-6744-49d4-aec5-3720bc993fab2
200371citalopram 20 MG Oral TabletPSN6c96373f-6744-49d4-aec5-3720bc993fab2
309314citalopram 40 MG Oral TabletPSN6c96373f-6744-49d4-aec5-3720bc993fab2
284591citalopram 10 MG Oral Tablet [Celexa]SBD6c96373f-6744-49d4-aec5-3720bc993fab2
213344citalopram 20 MG Oral Tablet [Celexa]SBD6c96373f-6744-49d4-aec5-3720bc993fab2
213345citalopram 40 MG Oral Tablet [Celexa]SBD6c96373f-6744-49d4-aec5-3720bc993fab2
283672citalopram 10 MG Oral TabletSCD6c96373f-6744-49d4-aec5-3720bc993fab2
200371citalopram 20 MG Oral TabletSCD6c96373f-6744-49d4-aec5-3720bc993fab2
309314citalopram 40 MG Oral TabletSCD6c96373f-6744-49d4-aec5-3720bc993fab2
284591Celexa 10 MG Oral TabletSY6c96373f-6744-49d4-aec5-3720bc993fab2
213344Celexa 20 MG Oral TabletSY6c96373f-6744-49d4-aec5-3720bc993fab2
213345Celexa 40 MG Oral TabletSY6c96373f-6744-49d4-aec5-3720bc993fab2
283672citalopram 10 MG (as citalopram HBr 12.49 MG) Oral TabletSY6c96373f-6744-49d4-aec5-3720bc993fab2
200371citalopram 20 MG (as citalopram HBr 24.99 MG) Oral TabletSY6c96373f-6744-49d4-aec5-3720bc993fab2
309314citalopram 40 MG (as citalopram HBr 49.98 MG) Oral TabletSY6c96373f-6744-49d4-aec5-3720bc993fab2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0456-4010-0100456401001100 TABLET, FILM COATED in 1 BOTTLE (0456-4010-01) 1998-07-170000-00-00NoNoCurrent