NDC 61919-389

Citalopram

Citalopram

Citalopram is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Direct Rx. The primary component is Citalopram Hydrobromide.

Product ID61919-389_35e38d4b-d0eb-43f9-e054-00144ff8d46c
NDC61919-389
Product TypeHuman Prescription Drug
Proprietary NameCitalopram
Generic NameCitalopram
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2015-01-01
Marketing CategoryANDA / ANDA
Application NumberANDA078216
Labeler NameDirect Rx
Substance NameCITALOPRAM HYDROBROMIDE
Active Ingredient Strength20 mg/1
Pharm ClassesSerotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 61919-389-60

60 TABLET in 1 BOTTLE (61919-389-60)
Marketing Start Date2019-08-13
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 61919-389-90 [61919038990]

Citalopram TABLET
Marketing CategoryANDA
Application NumberANDA078216
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-01-01
Inactivation Date2020-01-31

NDC 61919-389-60 [61919038960]

Citalopram TABLET
Marketing CategoryANDA
Application NumberANDA078216
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-08-13

NDC 61919-389-30 [61919038930]

Citalopram TABLET
Marketing CategoryANDA
Application NumberANDA078216
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-01-01
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
CITALOPRAM HYDROBROMIDE20 mg/1

OpenFDA Data

SPL SET ID:1d629704-0f18-420a-a548-b7489ecf1d3b
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 200371
  • Pharmacological Class

    • Serotonin Reuptake Inhibitor [EPC]
    • Serotonin Uptake Inhibitors [MoA]

    NDC Crossover Matching brand name "Citalopram" or generic name "Citalopram"

    NDCBrand NameGeneric Name
    0054-0062CitalopramCitalopram
    0121-0848CitalopramCitalopram Hydrobromide
    0121-1696CitalopramCitalopram Hydrobromide
    0185-0371CitalopramCitalopram Hydrobromide
    0185-0372CitalopramCitalopram Hydrobromide
    0185-0373CitalopramCitalopram Hydrobromide
    0378-6231Citalopramcitalopram
    0378-6232Citalopramcitalopram
    0378-6233Citalopramcitalopram
    0615-6510CitalopramCitalopram
    0615-6511CitalopramCitalopram
    0615-6512CitalopramCitalopram
    0615-8022CitalopramCitalopram Hydrobromide
    0615-8023CitalopramCitalopram Hydrobromide
    0615-8141CitalopramCitalopram Hydrobromide
    0713-4740CitalopramCitalopram Tablets
    0713-4741CitalopramCitalopram Tablet
    68071-1970CitalopramCitalopram
    68071-3042CitalopramCitalopram
    68071-3034CitalopramCitalopram
    68071-3357CitalopramCitalopram
    68071-4291CitalopramCitalopram
    68071-4604CitalopramCitalopram
    68071-4477CitalopramCitalopram
    68071-4324CitalopramCitalopram
    68084-737CitalopramCitalopram
    68084-744CitalopramCitalopram
    68788-6810CitalopramCitalopram
    68788-0005CitalopramCitalopram
    68788-0007CitalopramCitalopram
    69097-822CitalopramCitalopram
    69097-824CitalopramCitalopram
    69097-823CitalopramCitalopram
    70518-0449CitalopramCitalopram
    70518-0561CitalopramCitalopram
    71335-0541CitalopramCitalopram
    71335-0573CitalopramCitalopram
    71335-0712CitalopramCitalopram
    71335-0656CitalopramCitalopram
    0713-4742CitalopramCitalopram
    10544-149CitalopramCitalopram
    10544-179CitalopramCitalopram
    10544-006CitalopramCitalopram
    10544-150CitalopramCitalopram
    10544-182CitalopramCitalopram
    13107-005CitalopramCitalopram
    13107-007CitalopramCitalopram
    13107-006CitalopramCitalopram
    21695-031CitalopramCitalopram
    21695-032CitalopramCitalopram

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.