FDA.reportPublic FDA data

Citalopram Hydrobromide

Product NDC
60760-495
11-digit product format
607600495
Labeler code
60760
Product ID
60760-495_364689f2-275d-3160-e063-6394a90a0ce0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Citalopram Hydrobromide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
St Marys Medical Park Pharmacy
Application
ANDA078216
Marketing category
ANDA
Marketing start
2014-01-23
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

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
60760-495-30Citalopram Hydrobromide30 in 1 BOTTLE, PLASTICTABLET, FILM COATED308
60760-495-60Citalopram Hydrobromide60 in 1 BOTTLE, PLASTICTABLET, FILM COATED608
60760-495-90Citalopram Hydrobromide90 in 1 BOTTLE, PLASTICTABLET, FILM COATED908

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60760-495-30EA - Each60760-49527bc49e3-ba5a-4340-8336-c69a7437651912016-07-19
60760-495-90EA - Each60760-495653c19a1-c079-422a-b82f-2fe240c9849012015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CITALOPRAM HYDROBROMIDEACTIVE INGREDIENTI1E9D14F36CITALOPRAM HYDROBROMIDE TABLET [ST MARYS MEDICAL PARK PHARMACY]1
CITALOPRAMACTIVE MOIETY0DHU5B8D6VCITALOPRAM HYDROBROMIDE TABLET [ST MARYS MEDICAL PARK PHARMACY]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200371citalopram 20 MG Oral TabletPSNdb900453-4777-4142-a236-5d3a6152d0a58
200371citalopram 20 MG Oral TabletSCDdb900453-4777-4142-a236-5d3a6152d0a58
200371citalopram 20 MG (as citalopram HBr 24.99 MG) Oral TabletSYdb900453-4777-4142-a236-5d3a6152d0a58

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60760-495-306076004953030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-495-30) 2025-05-290000-00-00NoNoCurrent
60760-495-606076004956060 in 1 BOTTLE, PLASTICHistorical
60760-495-906076004959090 in 1 BOTTLE, PLASTICHistorical