FDA.reportPublic FDA data

Citalopram

Product NDC
60760-009
11-digit product format
607600009
Labeler code
60760
Product ID
60760-009_526a9e07-4349-dc47-e063-6294a90add49
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Citalopram
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
St. Mary's Medical Park Pharmacy
Application
ANDA078216
Marketing category
ANDA
Marketing start
2011-04-06
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
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 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
60760-009-30Citalopram30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3016
60760-009-90Citalopram90 in 1 BOTTLE, PLASTICTABLET, FILM COATED9016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60760-009-30EA - Each60760-0091ef9e04a-b9e6-4eb0-a5f5-f49eef1b288812012-07-24
60760-009-90EA - Each60760-0090fffc9e7-7f22-48dd-b730-8a50d5dc0f8712015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CITALOPRAM HYDROBROMIDEACTIVE INGREDIENTI1E9D14F36CITALOPRAM HYDROBROMIDE TABLET [ST MARYS MEDICAL PARK PHARMACY]5
CITALOPRAMACTIVE MOIETY0DHU5B8D6VCITALOPRAM HYDROBROMIDE TABLET [ST MARYS MEDICAL PARK PHARMACY]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60760-009CITALOPRAM HYDROBROMIDE TABLET [ST MARYS MEDICAL PARK PHARMACY]14Current NDC, Legacy NDC, 2 package rows20220513_351ca54b-0eb6-4e93-8ab4-82fb18dcc9e1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283672citalopram 10 MG Oral TabletPSN351ca54b-0eb6-4e93-8ab4-82fb18dcc9e116
283672citalopram 10 MG Oral TabletSCD351ca54b-0eb6-4e93-8ab4-82fb18dcc9e116
283672citalopram 10 MG (as citalopram HBr 12.49 MG) Oral TabletSY351ca54b-0eb6-4e93-8ab4-82fb18dcc9e116

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60760-009-306076000093030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-009-30) 2011-04-060000-00-00NoNoCurrent
60760-009-906076000099090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-009-90) 2013-09-120000-00-00NoNoCurrent