NDC 43353-787

Sertraline Hydrochloride

Sertraline

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

Product ID43353-787_01211049-3b2e-4d9c-a26b-ff2b30bcb118
NDC43353-787
Product TypeHuman Prescription Drug
Proprietary NameSertraline Hydrochloride
Generic NameSertraline
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2012-02-03
Marketing CategoryANDA / ANDA
Application NumberANDA078626
Labeler NameAphena Pharma Solutions - Tennessee, Inc.
Substance NameSERTRALINE HYDROCHLORIDE
Active Ingredient Strength100 mg/1
Pharm ClassesSerotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 43353-787-73

135 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-787-73)
Marketing Start Date2012-02-03
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 43353-787-80 [43353078780]

Sertraline Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078626
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-02-03
Marketing End Date2018-10-31

NDC 43353-787-30 [43353078730]

Sertraline Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078626
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-02-03
Marketing End Date2018-10-31

NDC 43353-787-73 [43353078773]

Sertraline Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078626
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-02-03
Marketing End Date2018-10-31

NDC 43353-787-15 [43353078715]

Sertraline Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078626
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-02-03
Marketing End Date2018-10-31

NDC 43353-787-53 [43353078753]

Sertraline Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078626
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-02-03
Marketing End Date2018-10-31

NDC 43353-787-45 [43353078745]

Sertraline Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078626
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-02-03
Marketing End Date2018-10-31

NDC 43353-787-60 [43353078760]

Sertraline Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078626
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-02-03
Marketing End Date2018-10-31

Drug Details

Active Ingredients

IngredientStrength
SERTRALINE HYDROCHLORIDE100 mg/1

OpenFDA Data

SPL SET ID:ad1f3be2-b145-440a-b9a1-ccc668384ea5
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 312938

    • Pharmacological Class

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

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

    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
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