FDA.reportPublic FDA data

Citalopram Hydrobromide

Product NDC
72657-111
11-digit product format
726570111
Labeler code
72657
Product ID
72657-111_c5c89eef-6b45-4dc7-8c88-89d972a3e4b5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Citalopram Hydrobromide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Glenmark Therapeutics Inc., USA
Application
ANDA077654
Marketing category
ANDA
Marketing start
2022-01-13
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Citalopram Hydrobromide
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CITALOPRAM HYDROBROMIDE40 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
72657-111-01Citalopram Hydrobromide100 in 1 BOTTLETABLET, FILM COATED1004
72657-111-05Citalopram Hydrobromide500 in 1 BOTTLETABLET, FILM COATED5004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72657-111CITALOPRAM HYDROBROMIDE TABLET, FILM COATED [GLENMARK THERAPEUTICS INC., USA]4Current NDC, Legacy NDC, 2 package rows20240605_18330b41-27ad-461b-a0a9-aac94e8ee87f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283672citalopram 10 MG Oral TabletPSN18330b41-27ad-461b-a0a9-aac94e8ee87f4
200371citalopram 20 MG Oral TabletPSN18330b41-27ad-461b-a0a9-aac94e8ee87f4
309314citalopram 40 MG Oral TabletPSN18330b41-27ad-461b-a0a9-aac94e8ee87f4
283672citalopram 10 MG Oral TabletSCD18330b41-27ad-461b-a0a9-aac94e8ee87f4
200371citalopram 20 MG Oral TabletSCD18330b41-27ad-461b-a0a9-aac94e8ee87f4
309314citalopram 40 MG Oral TabletSCD18330b41-27ad-461b-a0a9-aac94e8ee87f4
283672citalopram 10 MG (as citalopram HBr 12.49 MG) Oral TabletSY18330b41-27ad-461b-a0a9-aac94e8ee87f4
200371citalopram 20 MG (as citalopram HBr 24.99 MG) Oral TabletSY18330b41-27ad-461b-a0a9-aac94e8ee87f4
309314citalopram 40 MG (as citalopram HBr 49.98 MG) Oral TabletSY18330b41-27ad-461b-a0a9-aac94e8ee87f4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72657-111-0172657011101100 TABLET, FILM COATED in 1 BOTTLE (72657-111-01) 2022-01-130000-00-00NoNoCurrent
72657-111-0572657011105500 TABLET, FILM COATED in 1 BOTTLE (72657-111-05) 2022-01-130000-00-00NoNoCurrent