NDC 67544-298

Zoloft

Sertraline Hydrochloride

Zoloft is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Aphena Pharma Solutions - Tennessee, Llc. The primary component is Sertraline Hydrochloride.

Product ID67544-298_bedd246d-d8fe-4d00-98bd-8042d81f964b
NDC67544-298
Product TypeHuman Prescription Drug
Proprietary NameZoloft
Generic NameSertraline Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date1992-02-11
Marketing CategoryNDA / NDA
Application NumberNDA019839
Labeler NameAphena Pharma Solutions - Tennessee, LLC
Substance NameSERTRALINE HYDROCHLORIDE
Active Ingredient Strength50 mg/1
Pharm ClassesSerotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 67544-298-45

45 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (67544-298-45)
Marketing Start Date1992-02-11
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 67544-298-45 [67544029845]

Zoloft TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA019839
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2005-03-14
Marketing End Date2019-05-17

NDC 67544-298-15 [67544029815]

Zoloft TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA019839
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2005-05-28
Marketing End Date2019-05-17

NDC 67544-298-30 [67544029830]

Zoloft TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA019839
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2005-03-15
Marketing End Date2019-05-17

Drug Details

Active Ingredients

IngredientStrength
SERTRALINE HYDROCHLORIDE50 mg/1

OpenFDA Data

SPL SET ID:92278f12-0f00-4c0b-bb44-c6dd2dbb5b6c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 312938
  • 208149
  • 312941
  • 208161

    • Pharmacological Class

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

    NDC Crossover Matching brand name "Zoloft" or generic name "Sertraline Hydrochloride"

    NDCBrand NameGeneric Name
    0049-0050Zoloftsertraline hydrochloride
    0049-4900Zoloftsertraline hydrochloride
    0049-4910Zoloftsertraline hydrochloride
    0049-4940Zoloftsertraline hydrochloride
    0049-4960Zoloftsertraline hydrochloride
    70518-1913ZoloftZoloft
    55289-409ZoloftZoloft
    67544-080ZoloftZoloft
    67544-298ZoloftZoloft
    0143-9654Sertralinesertraline hydrochloride
    0143-9655Sertralinesertraline hydrochloride
    0143-9656Sertralinesertraline hydrochloride
    0143-9580Sertraline Hydrochloridesertraline hydrochloride
    0143-9581Sertraline Hydrochloridesertraline hydrochloride
    0143-9582Sertraline Hydrochloridesertraline hydrochloride

    Trademark Results [Zoloft]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ZOLOFT
    ZOLOFT
    74054440 1704085 Live/Registered
    PFIZER INC
    1990-04-30
    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.