FDA.reportPublic FDA data

Citalopram

Product NDC
70518-2228
11-digit product format
705182228
Labeler code
70518
Product ID
70518-2228_4ba688dd-17ac-975f-e063-6394a90aef14
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Citalopram
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA077534
Marketing category
ANDA
Marketing start
2019-07-13
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
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
70518-2228-0Citalopram30 in 1 BLISTER PACKTABLET3018
70518-2228-1Citalopram90 in 1 BOTTLE, PLASTICTABLET9018
70518-2228-2Citalopram30 in 1 BOTTLE, PLASTICTABLET3018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70518-2228-1EA - Each70518-22286bc3bb30-b1d5-4041-8925-b7fd5c5d3f7312026-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2228CITALOPRAM TABLET [REMEDYREPACK INC.]11Current NDC, Legacy NDC, 3 package rows20250309_c9809dfe-939e-4f9d-b6dd-f9808fd9f2b1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309314citalopram 40 MG Oral TabletPSNc9809dfe-939e-4f9d-b6dd-f9808fd9f2b118
309314citalopram 40 MG Oral TabletSCDc9809dfe-939e-4f9d-b6dd-f9808fd9f2b118
309314citalopram 40 MG (as citalopram HBr 49.98 MG) Oral TabletSYc9809dfe-939e-4f9d-b6dd-f9808fd9f2b118

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-2228-07051822280030 TABLET in 1 BLISTER PACK (70518-2228-0) 30 tablet2019-07-130000-00-00NoNoCurrent
70518-2228-17051822280190 TABLET in 1 BOTTLE, PLASTIC (70518-2228-1) 90 tablet2019-10-050000-00-00NoNoCurrent
70518-2228-27051822280230 in 1 BOTTLE, PLASTICHistorical