NDC 13107-013

Sertraline Hydrochloride

Sertraline Hydrochloride

Sertraline Hydrochloride is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Aurolife Pharma Llc. The primary component is Sertraline Hydrochloride.

Product ID13107-013_966d728e-87ca-4491-9411-2ec253eca632
NDC13107-013
Product TypeHuman Prescription Drug
Proprietary NameSertraline Hydrochloride
Generic NameSertraline Hydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2011-03-15
Marketing CategoryANDA / ANDA
Application NumberANDA077206
Labeler NameAurolife Pharma LLC
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 13107-013-01

100 TABLET in 1 BOTTLE (13107-013-01)
Marketing Start Date2011-03-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 13107-013-01 [13107001301]

Sertraline Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA077206
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-03-15
Inactivation Date2019-10-29

NDC 13107-013-90 [13107001390]

Sertraline Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA077206
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-03-15
Inactivation Date2019-10-29

NDC 13107-013-50 [13107001350]

Sertraline Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA077206
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-03-15
Inactivation Date2019-10-29

NDC 13107-013-25 [13107001325]

Sertraline Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA077206
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-03-15
Inactivation Date2019-10-29

NDC 13107-013-60 [13107001360]

Sertraline Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA077206
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-03-15
Inactivation Date2019-10-29

NDC 13107-013-05 [13107001305]

Sertraline Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA077206
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-03-15
Inactivation Date2019-10-29

NDC 13107-013-30 [13107001330]

Sertraline Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA077206
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-03-15
Inactivation Date2019-10-29

Drug Details

Active Ingredients

IngredientStrength
SERTRALINE HYDROCHLORIDE100 mg/1

OpenFDA Data

SPL SET ID:966d728e-87ca-4491-9411-2ec253eca632
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
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