Citalopram Hydrobromide

Product NDC
68788-8962
11-digit product format
687888962
Labeler code
68788
Product ID
68788-8962_69cb4519-6c41-4519-bebb-66b263e76ea6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Citalopram Hydrobromide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA078216
Marketing category
ANDA
Marketing start
2016-01-04
Substance
CITALOPRAM HYDROBROMIDE
Active strength
40 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Citalopram Hydrobromide
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CITALOPRAM HYDROBROMIDE40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiI1E9D14F36
Rxcui309314

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
68788-8962-1Citalopram Hydrobromide100 in 1 BOTTLETABLET, FILM COATED10011
68788-8962-3Citalopram Hydrobromide30 in 1 BOTTLETABLET, FILM COATED3011
68788-8962-6Citalopram Hydrobromide60 in 1 BOTTLETABLET, FILM COATED6011
68788-8962-8Citalopram Hydrobromide120 in 1 CARTONTABLET, FILM COATED12011
68788-8962-9Citalopram Hydrobromide90 in 1 BOTTLETABLET, FILM COATED9011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8962CITALOPRAM HYDROBROMIDE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.]10Current NDC, Legacy NDC, 5 package rows20250306_27ddea53-f03d-4760-99bb-ec8efa44ff62.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309314citalopram 40 MG Oral TabletPSN27ddea53-f03d-4760-99bb-ec8efa44ff6211
309314citalopram 40 MG Oral TabletSCD27ddea53-f03d-4760-99bb-ec8efa44ff6211
309314citalopram 40 MG (as citalopram HBr 49.98 MG) Oral TabletSY27ddea53-f03d-4760-99bb-ec8efa44ff6211

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-8962-168788896201100 TABLET, FILM COATED in 1 BOTTLE (68788-8962-1) 2016-01-040000-00-00NoNoCurrent
68788-8962-36878889620330 TABLET, FILM COATED in 1 BOTTLE (68788-8962-3) 2016-01-040000-00-00NoNoCurrent
68788-8962-66878889620660 TABLET, FILM COATED in 1 BOTTLE (68788-8962-6) 2016-01-040000-00-00NoNoCurrent
68788-8962-868788896208120 TABLET, FILM COATED in 1 CARTON (68788-8962-8) 2016-01-040000-00-00NoNoCurrent
68788-8962-96878889620990 TABLET, FILM COATED in 1 BOTTLE (68788-8962-9) 2016-01-040000-00-00NoNoCurrent