NDC 64205-965

Sertraline

Sertraline Hydrochloride

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

Product ID64205-965_52b33a33-da21-4d86-aa55-393db4046b28
NDC64205-965
Product TypeHuman Prescription Drug
Proprietary NameSertraline
Generic NameSertraline Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2012-11-06
Marketing CategoryANDA / ANDA
Application NumberANDA077864
Labeler NameReadyMeds
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 64205-965-30

30 TABLET, FILM COATED in 1 BOTTLE (64205-965-30)
Marketing Start Date2012-11-06
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 64205-965-90 [64205096590]

Sertraline TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077864
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-11-06
Inactivation Date2019-11-27

NDC 64205-965-30 [64205096530]

Sertraline TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077864
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-11-06
Inactivation Date2019-11-27

Drug Details

Active Ingredients

IngredientStrength
SERTRALINE HYDROCHLORIDE50 mg/1

OpenFDA Data

SPL SET ID:97f320c5-aa0b-43a8-85e8-c277a5929d97
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 312941

    • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    0143-9654Sertralinesertraline hydrochloride
    0143-9655Sertralinesertraline hydrochloride
    0143-9656Sertralinesertraline hydrochloride
    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
    0615-6560SertralineSertraline
    0615-6558SertralineSertraline
    0615-6559SertralineSertraline
    76282-212SERTRALINESERTRALINE
    76282-213SERTRALINESERTRALINE
    0615-7990SertralineSertraline
    76282-214SERTRALINESERTRALINE
    0615-7991SertralineSertraline
    0615-7989SertralineSertraline
    33261-346SertralineSertraline
    42708-068SertralineSertraline
    43353-812SERTRALINESERTRALINE
    43353-817SERTRALINESERTRALINE
    43353-809SERTRALINESERTRALINE
    50090-0991SertralineSertraline
    50090-0989SertralineSertraline
    50090-3562SERTRALINESERTRALINE
    50436-3520SertralineSertraline
    50436-6304SERTRALINESERTRALINE
    51655-830SertralineSertraline
    51655-979SertralineSertraline
    51655-352SertralineSertraline
    53217-380SertralineSertraline
    55154-6627SertralineSertraline
    55700-225SertralineSertraline
    55700-222SertralineSertraline
    57297-352SertralineSertraline
    57297-353SertralineSertraline
    57297-351SertralineSertraline
    61919-416SERTRALINESERTRALINE
    61919-457SERTRALINESERTRALINE
    63187-212SertralineSertraline
    63187-478SertralineSertraline
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