FDA.reportPublic FDA data

Citalopram

Product NDC
69097-822
11-digit product format
690970822
Labeler code
69097
Product ID
69097-822_6f82cb3c-dec1-4200-9cfa-9b41438a71b8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Citalopram
Dosage form
TABLET
Route
ORAL
Labeler
Cipla USA Inc.
Application
ANDA077534
Marketing category
ANDA
Marketing start
2016-07-22
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
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
69097-822-02Citalopram30 in 1 BOTTLETABLET3010
69097-822-07Citalopram100 in 1 BOTTLETABLET10010
69097-822-12Citalopram500 in 1 BOTTLETABLET50010
69097-822-15Citalopram1000 in 1 BOTTLETABLET100010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69097-822CITALOPRAM TABLET [CIPLA USA INC.]10Current NDC, Legacy NDC, 4 package rows20240911_0580559a-783a-4a0a-8d81-ee30a29077c5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283672citalopram 10 MG Oral TabletPSN0580559a-783a-4a0a-8d81-ee30a29077c510
200371citalopram 20 MG Oral TabletPSN0580559a-783a-4a0a-8d81-ee30a29077c510
309314citalopram 40 MG Oral TabletPSN0580559a-783a-4a0a-8d81-ee30a29077c510
283672citalopram 10 MG Oral TabletSCD0580559a-783a-4a0a-8d81-ee30a29077c510
200371citalopram 20 MG Oral TabletSCD0580559a-783a-4a0a-8d81-ee30a29077c510
309314citalopram 40 MG Oral TabletSCD0580559a-783a-4a0a-8d81-ee30a29077c510
283672citalopram 10 MG (as citalopram HBr 12.49 MG) Oral TabletSY0580559a-783a-4a0a-8d81-ee30a29077c510
200371citalopram 20 MG (as citalopram HBr 24.99 MG) Oral TabletSY0580559a-783a-4a0a-8d81-ee30a29077c510
309314citalopram 40 MG (as citalopram HBr 49.98 MG) Oral TabletSY0580559a-783a-4a0a-8d81-ee30a29077c510
283672citalopram 10 MG Oral TabletPSN04ac5286-fc2e-4990-a574-ea21131ef7317
283672citalopram 10 MG Oral TabletSCD04ac5286-fc2e-4990-a574-ea21131ef7317
283672citalopram 10 MG (as citalopram HBr 12.49 MG) Oral TabletSY04ac5286-fc2e-4990-a574-ea21131ef7317
283672citalopram 10 MG Oral TabletPSNf77ef23b-3015-d074-e053-6394a90a11e14
283672citalopram 10 MG Oral TabletSCDf77ef23b-3015-d074-e053-6394a90a11e14
283672citalopram 10 MG (as citalopram HBr 12.49 MG) Oral TabletSYf77ef23b-3015-d074-e053-6394a90a11e14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69097-822-026909708220230 TABLET in 1 BOTTLE (69097-822-02) 30 tablet2016-07-220000-00-00NoNoCurrent
69097-822-0769097082207100 TABLET in 1 BOTTLE (69097-822-07) 100 tablet2016-07-220000-00-00NoNoCurrent
69097-822-1269097082212500 TABLET in 1 BOTTLE (69097-822-12) 500 tablet2016-07-220000-00-00NoNoCurrent
69097-822-15690970822151000 TABLET in 1 BOTTLE (69097-822-15) 1000 tablet2016-07-220000-00-00NoNoCurrent