NDC 70518-1913

Zoloft

Sertraline Hydrochloride

Zoloft is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Remedyrepack Inc.. The primary component is Sertraline Hydrochloride.

Product ID70518-1913_82eb23dd-a0e8-380e-e053-2a91aa0a7532
NDC70518-1913
Product TypeHuman Prescription Drug
Proprietary NameZoloft
Generic NameSertraline Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2019-02-27
Marketing CategoryNDA / NDA
Application NumberNDA019839
Labeler NameREMEDYREPACK INC.
Substance NameSERTRALINE HYDROCHLORIDE
Active Ingredient Strength50 mg/1
Pharm ClassesSerotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 70518-1913-0

30 TABLET, FILM COATED in 1 BLISTER PACK (70518-1913-0)
Marketing Start Date2019-02-27
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70518-1913-0 [70518191300]

Zoloft TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA019839
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-02-27

Drug Details

Active Ingredients

IngredientStrength
SERTRALINE HYDROCHLORIDE50 mg/1

OpenFDA Data

SPL SET ID:39e38986-fa4f-470a-9a68-74ba1db53f69
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 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
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