FDA.reportPublic FDA data

Citalopram Hydrobromide

Product NDC
68788-0802
11-digit product format
687880802
Labeler code
68788
Product ID
68788-0802_543a6dbf-f42d-4bc1-ad77-9ceac5e6bfe9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Citalopram Hydrobromide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA078216
Marketing category
ANDA
Marketing start
2013-03-26
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Citalopram Hydrobromide
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CITALOPRAM HYDROBROMIDE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiI1E9D14F36
Rxcui200371, 283672

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
68788-0802-1Citalopram Hydrobromide100 in 1 BOTTLETABLET, FILM COATED10014
68788-0802-3Citalopram Hydrobromide30 in 1 BOTTLETABLET, FILM COATED3014
68788-0802-6Citalopram Hydrobromide60 in 1 BOTTLETABLET, FILM COATED6014
68788-0802-8Citalopram Hydrobromide120 in 1 BOTTLETABLET, FILM COATED12014
68788-0802-9Citalopram Hydrobromide90 in 1 BOTTLETABLET, FILM COATED9014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-0802-3EA - Each68788-0802a3ab9ee1-378e-4b72-ab48-abe9f31e94cf12020-05-08
68788-0802-9EA - Each68788-08025c032b43-aad8-429b-960b-14b5bd75c46212020-05-08

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CITALOPRAM HYDROBROMIDEACTIVE INGREDIENTI1E9D14F36CITALOPRAM HYDROBROMIDE TABLET [PREFERRED PHARMACEUTICALS, INC.]4
CITALOPRAMACTIVE MOIETY0DHU5B8D6VCITALOPRAM HYDROBROMIDE TABLET [PREFERRED PHARMACEUTICALS, INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-0802CITALOPRAM HYDROBROMIDE TABLET [PREFERRED PHARMACEUTICALS, INC.]13Current NDC, Legacy NDC, 5 package rows20240329_b52acd68-fed1-4680-9eaf-b72e7dcba6fb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283672citalopram 10 MG Oral TabletPSNb52acd68-fed1-4680-9eaf-b72e7dcba6fb14
200371citalopram 20 MG Oral TabletPSNb52acd68-fed1-4680-9eaf-b72e7dcba6fb14
283672citalopram 10 MG Oral TabletSCDb52acd68-fed1-4680-9eaf-b72e7dcba6fb14
200371citalopram 20 MG Oral TabletSCDb52acd68-fed1-4680-9eaf-b72e7dcba6fb14
283672citalopram 10 MG (as citalopram HBr 12.49 MG) Oral TabletSYb52acd68-fed1-4680-9eaf-b72e7dcba6fb14
200371citalopram 20 MG (as citalopram HBr 24.99 MG) Oral TabletSYb52acd68-fed1-4680-9eaf-b72e7dcba6fb14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-0802-168788080201100 TABLET, FILM COATED in 1 BOTTLE (68788-0802-1) 2013-03-260000-00-00NoNoCurrent
68788-0802-36878808020330 TABLET, FILM COATED in 1 BOTTLE (68788-0802-3) 2013-03-260000-00-00NoNoCurrent
68788-0802-66878808020660 TABLET, FILM COATED in 1 BOTTLE (68788-0802-6) 2013-03-260000-00-00NoNoCurrent
68788-0802-868788080208120 TABLET, FILM COATED in 1 BOTTLE (68788-0802-8) 2013-03-260000-00-00NoNoCurrent
68788-0802-96878808020990 TABLET, FILM COATED in 1 BOTTLE (68788-0802-9) 2013-03-260000-00-00NoNoCurrent