NDC 52959-875

Sertraline Hydrochloride

Sertraline Hydrochloride

Sertraline Hydrochloride is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by H.j. Harkins Company Inc.. The primary component is Sertraline Hydrochloride.

Product ID52959-875_a62fcc0d-ac44-43dd-b293-8e0204d7f882
NDC52959-875
Product TypeHuman Prescription Drug
Proprietary NameSertraline Hydrochloride
Generic NameSertraline Hydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2007-12-18
Marketing CategoryANDA / ANDA
Application NumberANDA077397
Labeler NameH.J. Harkins Company Inc.
Substance NameSERTRALINE HYDROCHLORIDE
Active Ingredient Strength50 mg/1
Pharm ClassesSerotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 52959-875-30

30 TABLET in 1 BOTTLE (52959-875-30)
Marketing Start Date2007-12-18
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 52959-875-60 [52959087560]

Sertraline Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA077397
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2007-12-18
Inactivation Date2019-11-13

NDC 52959-875-90 [52959087590]

Sertraline Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA077397
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2007-12-18
Inactivation Date2019-11-13

NDC 52959-875-30 [52959087530]

Sertraline Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA077397
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2007-12-18
Inactivation Date2019-11-13

Drug Details

Active Ingredients

IngredientStrength
SERTRALINE HYDROCHLORIDE50 mg/1

OpenFDA Data

SPL SET ID:5365e9a7-ad09-4a85-95a1-a86f40c890a5
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 312941
  • 312938
  • 312940

    • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    0143-9580Sertraline Hydrochloridesertraline hydrochloride
    0143-9581Sertraline Hydrochloridesertraline hydrochloride
    0143-9582Sertraline Hydrochloridesertraline hydrochloride
    68071-1317Sertraline HydrochlorideSertraline Hydrochloride
    68071-1318Sertraline HydrochlorideSertraline Hydrochloride
    68071-1976Sertraline HydrochlorideSertraline Hydrochloride
    68071-3071Sertraline HydrochlorideSertraline Hydrochloride
    68071-2162Sertraline HydrochlorideSertraline Hydrochloride
    68071-3146Sertraline HydrochlorideSertraline Hydrochloride
    68071-3309SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDE
    68071-4029SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDE
    68071-4370Sertraline HydrochlorideSertraline Hydrochloride
    68071-3379SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDE
    68071-4658Sertraline HydrochlorideSertraline Hydrochloride
    68071-4750SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDE
    68071-4494Sertraline HydrochlorideSertraline Hydrochloride
    68071-4462Sertraline HydrochlorideSertraline Hydrochloride
    68084-181Sertraline HydrochlorideSertraline Hydrochloride
    68382-043Sertraline HydrochlorideSertraline Hydrochloride
    68382-045Sertraline HydrochlorideSertraline Hydrochloride
    68387-119Sertraline HydrochlorideSertraline Hydrochloride
    68382-044Sertraline HydrochlorideSertraline Hydrochloride
    68645-523Sertraline HydrochlorideSertraline Hydrochloride
    68645-522Sertraline HydrochlorideSertraline Hydrochloride
    68645-521Sertraline HydrochlorideSertraline Hydrochloride
    68788-6919Sertraline HydrochlorideSertraline Hydrochloride
    68788-6437Sertraline HydrochlorideSertraline Hydrochloride
    68788-6835Sertraline HydrochlorideSertraline Hydrochloride
    68788-6429Sertraline HydrochlorideSertraline Hydrochloride
    68788-7035SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDE
    68788-6923Sertraline HydrochlorideSertraline Hydrochloride
    68788-7001SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDE
    68788-9693Sertraline HydrochlorideSertraline Hydrochloride
    68788-9873Sertraline HydrochlorideSertraline Hydrochloride
    68788-9872Sertraline HydrochlorideSertraline Hydrochloride
    69097-157Sertraline HydrochlorideSertraline Hydrochloride
    69097-833Sertraline HydrochlorideSertraline Hydrochloride
    69097-155Sertraline HydrochlorideSertraline Hydrochloride
    69097-156Sertraline HydrochlorideSertraline Hydrochloride
    69097-835Sertraline HydrochlorideSertraline Hydrochloride
    69097-834Sertraline HydrochlorideSertraline Hydrochloride
    70518-0094Sertraline HydrochlorideSertraline Hydrochloride
    70518-0679Sertraline HydrochlorideSertraline Hydrochloride
    70518-1276Sertraline HydrochlorideSertraline Hydrochloride
    70518-1748Sertraline HydrochlorideSertraline Hydrochloride
    70518-1350Sertraline HydrochlorideSertraline Hydrochloride
    70518-1615SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDE
    70934-176Sertraline HydrochlorideSertraline Hydrochloride
    70934-169SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDE
    71205-047SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDE
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.