CITALOPRAM HYDROBROMIDE

Product NDC
71610-092
11-digit product format
716100092
Labeler code
71610
Product ID
71610-092_d05f4e71-95f3-4f22-8b01-b21e5c19e0f2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CITALOPRAM
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA077534
Marketing category
ANDA
Marketing start
2017-11-10
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
71610-092-15CITALOPRAM HYDROBROMIDE15 in 1 BOTTLETABLET151
71610-092-30CITALOPRAM HYDROBROMIDE30 in 1 BOTTLETABLET301
71610-092-45CITALOPRAM HYDROBROMIDE45 in 1 BOTTLETABLET451
71610-092-60CITALOPRAM HYDROBROMIDE90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-092-15EA - Each71610-092d06ff6ef-f2a6-458a-8331-583e5af90c7412018-10-11
71610-092-30EA - Each71610-092e4aaf6b8-8498-4e2b-9498-a7287edeb88512018-10-11
71610-092-45EA - Each71610-0922c3a3d34-6961-4139-b88f-a95d1b66ece612018-10-11
71610-092-60EA - Each71610-09220caf520-a68e-4b91-aa4b-87755e8f460d12018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-092CITALOPRAM HYDROBROMIDE (CITALOPRAM ) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Current NDC, Legacy NDC, 4 package rows20180717_d05f4e71-95f3-4f22-8b01-b21e5c19e0f2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200371citalopram 20 MG Oral TabletPSNd05f4e71-95f3-4f22-8b01-b21e5c19e0f21
200371citalopram 20 MG Oral TabletSCDd05f4e71-95f3-4f22-8b01-b21e5c19e0f21
200371citalopram 20 MG (as citalopram HBr 24.99 MG) Oral TabletSYd05f4e71-95f3-4f22-8b01-b21e5c19e0f21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71610-092-157161000921515 TABLET in 1 BOTTLE (71610-092-15) 15 tablet2018-06-260000-00-00NoNoCurrent
71610-092-307161000923030 TABLET in 1 BOTTLE (71610-092-30) 30 tablet2018-06-260000-00-00NoNoCurrent
71610-092-457161000924545 TABLET in 1 BOTTLE (71610-092-45) 45 tablet2018-06-260000-00-00NoNoCurrent
71610-092-607161000926090 TABLET in 1 BOTTLE (71610-092-60) 90 tablet2018-06-260000-00-00NoNoCurrent