FDA.reportPublic FDA data

Citalopram Hydrobromide

Product NDC
63187-203
11-digit product format
631870203
Labeler code
63187
Product ID
63187-203_70196c8d-c1c0-457c-b9b2-dd1182416714
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Citalopram Hydrobromide
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA078216
Marketing category
ANDA
Marketing start
2007-10-18
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 Hydrobromide
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CITALOPRAM HYDROBROMIDE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiI1E9D14F36
Rxcui200371, 283672

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
63187-203-00Citalopram Hydrobromide100 in 1 BOTTLETABLET1008
63187-203-30Citalopram Hydrobromide30 in 1 BOTTLETABLET308
63187-203-60Citalopram Hydrobromide60 in 1 BOTTLETABLET608
63187-203-72Citalopram Hydrobromide120 in 1 BOTTLETABLET1208
63187-203-90Citalopram Hydrobromide90 in 1 BOTTLETABLET908

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-203-60EA - Each63187-203a395fd6d-2359-4943-bad0-e43655a3a5b412022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CITALOPRAM HYDROBROMIDEACTIVE INGREDIENTI1E9D14F36CITALOPRAM HYDROBROMIDE TABLET [PROFICIENT RX LP]2
CITALOPRAMACTIVE MOIETY0DHU5B8D6VCITALOPRAM HYDROBROMIDE TABLET [PROFICIENT RX LP]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-203CITALOPRAM HYDROBROMIDE TABLET [PROFICIENT RX LP]8Current NDC, Legacy NDC, 5 package rows20241129_1a136cc3-d655-4f3c-8710-2603dc008492.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283672citalopram 10 MG Oral TabletPSN1a136cc3-d655-4f3c-8710-2603dc0084928
200371citalopram 20 MG Oral TabletPSN1a136cc3-d655-4f3c-8710-2603dc0084928
283672citalopram 10 MG Oral TabletSCD1a136cc3-d655-4f3c-8710-2603dc0084928
200371citalopram 20 MG Oral TabletSCD1a136cc3-d655-4f3c-8710-2603dc0084928
283672citalopram 10 MG (as citalopram HBr 12.49 MG) Oral TabletSY1a136cc3-d655-4f3c-8710-2603dc0084928
200371citalopram 20 MG (as citalopram HBr 24.99 MG) Oral TabletSY1a136cc3-d655-4f3c-8710-2603dc0084928

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-203-0063187020300100 TABLET in 1 BOTTLE (63187-203-00) 100 tablet2015-11-020000-00-00NoNoCurrent
63187-203-306318702033030 TABLET in 1 BOTTLE (63187-203-30) 30 tablet2015-11-020000-00-00NoNoCurrent
63187-203-606318702036060 TABLET in 1 BOTTLE (63187-203-60) 60 tablet2015-11-020000-00-00NoNoCurrent
63187-203-7263187020372120 TABLET in 1 BOTTLE (63187-203-72) 120 tablet2015-11-020000-00-00NoNoCurrent
63187-203-906318702039090 TABLET in 1 BOTTLE (63187-203-90) 90 tablet2015-11-020000-00-00NoNoCurrent