NDC 65841-043

Sertraline Hydrochloride

Sertraline Hydrochloride

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

Product ID65841-043_7a75de5d-e255-4be3-92bf-e8f55eee07ef
NDC65841-043
Product TypeHuman Prescription Drug
Proprietary NameSertraline Hydrochloride
Generic NameSertraline Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2017-12-02
Marketing CategoryANDA / ANDA
Application NumberANDA077106
Labeler NameCadila Healthcare Limited
Substance NameSERTRALINE HYDROCHLORIDE
Active Ingredient Strength25 mg/1
Pharm ClassesSerotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 65841-043-01

100 TABLET, FILM COATED in 1 BOTTLE (65841-043-01)
Marketing Start Date2017-12-02
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 65841-043-06 [65841004306]

Sertraline Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077106
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-12-02

NDC 65841-043-10 [65841004310]

Sertraline Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077106
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-12-02

NDC 65841-043-14 [65841004314]

Sertraline Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077106
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-12-02

NDC 65841-043-16 [65841004316]

Sertraline Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077106
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-12-02

NDC 65841-043-18 [65841004318]

Sertraline Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077106
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-12-02

NDC 65841-043-01 [65841004301]

Sertraline Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077106
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-12-02

NDC 65841-043-05 [65841004305]

Sertraline Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077106
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-12-02

Drug Details

Active Ingredients

IngredientStrength
SERTRALINE HYDROCHLORIDE25 mg/1

OpenFDA Data

SPL SET ID:34c3d223-99bb-407d-abd4-7634f104e1f2
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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