NDC 57297-352

Sertraline

Sertraline

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

Product ID57297-352_eb14d261-675a-418d-a62d-81453d423180
NDC57297-352
Product TypeHuman Prescription Drug
Proprietary NameSertraline
Generic NameSertraline
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2007-02-06
Marketing CategoryANDA / ANDA
Application NumberANDA077670
Labeler NameLUPIN LIMITED
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 57297-352-01

100 TABLET, FILM COATED in 1 BOTTLE (57297-352-01)
Marketing Start Date2007-02-06
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 57297-352-02 [57297035202]

Sertraline TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077670
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2007-02-06
Inactivation Date2020-01-31

NDC 57297-352-03 [57297035203]

Sertraline TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077670
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2007-02-06
Inactivation Date2020-01-31

NDC 57297-352-09 [57297035209]

Sertraline TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077670
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2007-02-06
Inactivation Date2020-01-31

NDC 57297-352-01 [57297035201]

Sertraline TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077670
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2007-02-06
Inactivation Date2020-01-31

NDC 57297-352-05 [57297035205]

Sertraline TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077670
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2007-02-06
Inactivation Date2020-01-31

NDC 57297-352-06 [57297035206]

Sertraline TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077670
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2007-02-06
Inactivation Date2020-01-31

NDC 57297-352-11 [57297035211]

Sertraline TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077670
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2007-02-06
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
SERTRALINE HYDROCHLORIDE50 mg/1

OpenFDA Data

SPL SET ID:9e914b27-baba-4eb0-8b1c-ac09828a14c2
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" or generic name "Sertraline"

    NDCBrand NameGeneric Name
    0143-9654Sertralinesertraline hydrochloride
    0143-9655Sertralinesertraline hydrochloride
    0143-9656Sertralinesertraline hydrochloride
    0615-6558SertralineSertraline Hydrochloride
    0615-6559SertralineSertraline Hydrochloride
    0615-6560SertralineSertraline Hydrochloride
    0615-7989SertralineSertraline
    0615-7990SertralineSertraline
    0615-7991SertralineSertraline
    0904-6924SertralineSertraline
    0904-6925SertralineSertraline
    0904-6926SertralineSertraline
    33261-346SertralineSertraline
    42708-068SertralineSertraline
    43353-809SERTRALINESertraline
    43353-812SERTRALINESertraline
    43353-817SERTRALINESertraline
    50090-0989SertralineSertraline
    50090-0991SertralineSertraline
    50090-3562SERTRALINESertraline
    50090-5848SertralineSertraline
    50436-3520SertralineSertraline
    50436-6304SERTRALINESertraline Hydrochloride
    51655-352SertralineSertraline
    51655-830SertralineSertraline
    51655-979SertralineSertraline
    53217-380SertralineSertraline
    55154-3569SertralineSertraline
    55154-3570SertralineSertraline
    68071-4400SertralineSertraline
    68180-351SertralineSertraline
    68180-352SertralineSertraline
    68180-353SertralineSertraline
    70518-0153SertralineSertraline
    70518-0240SertralineSertraline
    70518-0201SertralineSertraline
    70518-0378SertralineSertraline
    70518-0938SertralineSertraline
    70518-1040SertralineSertraline
    70518-1290SertralineSertraline
    70518-1461SertralineSertraline
    70518-1617SertralineSertraline
    71335-0404SertralineSertraline
    76282-212SERTRALINESERTRALINE
    76282-213SERTRALINESERTRALINE
    76282-214SERTRALINESERTRALINE
    55154-6627SertralineSertraline
    55700-225SertralineSertraline
    55700-222SertralineSertraline
    57297-352SertralineSertraline
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