Citalopram

Product NDC
80425-0557
11-digit product format
804250557
Labeler code
80425
Product ID
80425-0557_43408cc0-4400-3827-e063-6394a90adcfe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Citalopram
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Advanced Rx of Tennessee, LLC
Application
ANDA078216
Marketing category
ANDA
Marketing start
2025-11-07
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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CITALOPRAM HYDROBROMIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiI1E9D14F36
Rxcui283672

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
80425-0557-1Citalopram30 in 1 BOTTLETABLET, FILM COATED301
80425-0557-2Citalopram60 in 1 BOTTLETABLET, FILM COATED601
80425-0557-3Citalopram90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0557-1EA - Each80425-055776650329-c6a2-4271-832c-c000176eedf712025-12-16
80425-0557-2EA - Each80425-0557480a3215-4366-4d78-ac5c-60b62131d27912025-12-16
80425-0557-3EA - Each80425-055784caa3c3-474f-4729-bfe1-ce72215ff89f12025-12-16

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283672citalopram 10 MG Oral TabletPSN434094b4-fa3b-385a-e063-6394a90ac6381
283672citalopram 10 MG Oral TabletSCD434094b4-fa3b-385a-e063-6394a90ac6381
283672citalopram 10 MG (as citalopram HBr 12.49 MG) Oral TabletSY434094b4-fa3b-385a-e063-6394a90ac6381

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
80425-0557-18042505570130 TABLET, FILM COATED in 1 BOTTLE (80425-0557-1) 2025-11-07NoNoCurrent
80425-0557-28042505570260 TABLET, FILM COATED in 1 BOTTLE (80425-0557-2) 2025-11-07NoNoCurrent
80425-0557-38042505570390 TABLET, FILM COATED in 1 BOTTLE (80425-0557-3) 2025-11-07NoNoCurrent