FDA.reportPublic FDA data

Citalopram Hydrobromide

Product NDC
71205-764
11-digit product format
712050764
Labeler code
71205
Product ID
71205-764_4eb71151-241a-476e-a495-4a021bc55bda
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
40 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 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
71205-764-30Citalopram Hydrobromide30 in 1 BOTTLETABLET301
71205-764-60Citalopram Hydrobromide60 in 1 BOTTLETABLET601
71205-764-90Citalopram Hydrobromide90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-764-30EA - Each71205-764b35ae3d3-ede7-4125-acdc-3d917769608912023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-764CITALOPRAM HYDROBROMIDE TABLET [PROFICIENT RX LP]1Current NDC, 3 package rows20230222_4eb71151-241a-476e-a495-4a021bc55bda.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309314citalopram 40 MG Oral TabletPSN4eb71151-241a-476e-a495-4a021bc55bda1
309314citalopram 40 MG Oral TabletSCD4eb71151-241a-476e-a495-4a021bc55bda1
309314citalopram 40 MG (as citalopram HBr 49.98 MG) Oral TabletSY4eb71151-241a-476e-a495-4a021bc55bda1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71205-764-307120507643030 TABLET in 1 BOTTLE (71205-764-30) 30 tablet2023-02-14NoNoCurrent
71205-764-607120507646060 TABLET in 1 BOTTLE (71205-764-60) 60 tablet2023-02-14NoNoCurrent
71205-764-907120507649090 TABLET in 1 BOTTLE (71205-764-90) 90 tablet2023-02-14NoNoCurrent