NDC 63629-3309

Sertraline Hydrochloride

Sertraline Hydrochloride

Sertraline Hydrochloride is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Bryant Ranch Prepack. The primary component is Sertraline Hydrochloride.

Product ID63629-3309_cb99e18b-0d04-43a2-b13c-8ab71ea10d35
NDC63629-3309
Product TypeHuman Prescription Drug
Proprietary NameSertraline Hydrochloride
Generic NameSertraline Hydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2007-10-18
Marketing CategoryANDA / ANDA
Application NumberANDA077397
Labeler NameBryant Ranch Prepack
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 63629-3309-7

28 TABLET in 1 BOTTLE (63629-3309-7)
Marketing Start Date2007-10-18
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63629-3309-9 [63629330909]

Sertraline Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA077397
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2007-10-18
Inactivation Date2020-01-31

NDC 63629-3309-3 [63629330903]

Sertraline Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA077397
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2007-10-18
Inactivation Date2020-01-31

NDC 63629-3309-1 [63629330901]

Sertraline Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA077397
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2007-10-18
Inactivation Date2020-01-31

NDC 63629-3309-4 [63629330904]

Sertraline Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA077397
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2007-10-18
Inactivation Date2020-01-31

NDC 63629-3309-8 [63629330908]

Sertraline Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA077397
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2007-10-18
Inactivation Date2020-01-31

NDC 63629-3309-5 [63629330905]

Sertraline Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA077397
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2007-10-18
Inactivation Date2020-01-31

NDC 63629-3309-2 [63629330902]

Sertraline Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA077397
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2007-10-18
Inactivation Date2020-01-31

NDC 63629-3309-7 [63629330907]

Sertraline Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA077397
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2007-10-18
Inactivation Date2020-01-31

NDC 63629-3309-6 [63629330906]

Sertraline Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA077397
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2007-10-18
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
SERTRALINE HYDROCHLORIDE50 mg/1

OpenFDA Data

SPL SET ID:fc9b20f5-44f1-048f-14d1-7e7d08949490
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 312941
  • 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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