CITALOPRAM HYDROBROMIDE

Product NDC
76282-628
11-digit product format
762820628
Labeler code
76282
Product ID
76282-628_fd69f24e-8108-4b9e-92ca-13ebbdf86e45
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CITALOPRAM
Dosage form
TABLET
Route
ORAL
Labeler
Exelan Pharmaceuticals Inc.
Application
ANDA077534
Marketing category
ANDA
Marketing start
2017-11-10
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 HYDROBROMIDE
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
76282-628-05CITALOPRAM HYDROBROMIDE500 in 1 BOTTLETABLET50015
76282-628-10CITALOPRAM HYDROBROMIDE1000 in 1 BOTTLETABLET100015
76282-628-30CITALOPRAM HYDROBROMIDE30 in 1 BOTTLETABLET3015
76282-628-90CITALOPRAM HYDROBROMIDE90 in 1 BOTTLETABLET9015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76282-628-10EA - Each76282-628944ea364-4687-4ea3-ad6f-a7acb71ec32c12018-06-11
76282-628-90EA - Each76282-628aab4c72b-6dc4-499c-9f20-85811853f8d612022-09-12

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76282-628CITALOPRAM HYDROBROMIDE (CITALOPRAM ) TABLET [EXELAN PHARMACEUTICALS INC.]15Current NDC, Legacy NDC, 4 package rows20240912_a8e8fde2-8392-4d5b-902b-e2b9dd55a02d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283672citalopram 10 MG Oral TabletPSNa8e8fde2-8392-4d5b-902b-e2b9dd55a02d15
200371citalopram 20 MG Oral TabletPSNa8e8fde2-8392-4d5b-902b-e2b9dd55a02d15
309314citalopram 40 MG Oral TabletPSNa8e8fde2-8392-4d5b-902b-e2b9dd55a02d15
283672citalopram 10 MG Oral TabletSCDa8e8fde2-8392-4d5b-902b-e2b9dd55a02d15
200371citalopram 20 MG Oral TabletSCDa8e8fde2-8392-4d5b-902b-e2b9dd55a02d15
309314citalopram 40 MG Oral TabletSCDa8e8fde2-8392-4d5b-902b-e2b9dd55a02d15
283672citalopram 10 MG (as citalopram HBr 12.49 MG) Oral TabletSYa8e8fde2-8392-4d5b-902b-e2b9dd55a02d15
200371citalopram 20 MG (as citalopram HBr 24.99 MG) Oral TabletSYa8e8fde2-8392-4d5b-902b-e2b9dd55a02d15
309314citalopram 40 MG (as citalopram HBr 49.98 MG) Oral TabletSYa8e8fde2-8392-4d5b-902b-e2b9dd55a02d15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76282-628-0576282062805500 TABLET in 1 BOTTLE (76282-628-05) 500 tablet2017-11-100000-00-00NoNoCurrent
76282-628-10762820628101000 TABLET in 1 BOTTLE (76282-628-10) 1000 tablet2017-11-100000-00-00NoNoCurrent
76282-628-307628206283030 TABLET in 1 BOTTLE (76282-628-30) 30 tablet2017-11-100000-00-00NoNoCurrent
76282-628-907628206289090 TABLET in 1 BOTTLE (76282-628-90) 90 tablet2017-11-100000-00-00NoNoCurrent