NDC 43353-817

SERTRALINE

Sertraline

SERTRALINE is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Aphena Pharma Solutions - Tennessee, Llc. The primary component is Sertraline Hydrochloride.

Product ID43353-817_0693bc9f-ad99-415a-816e-5f3e0e33e682
NDC43353-817
Product TypeHuman Prescription Drug
Proprietary NameSERTRALINE
Generic NameSertraline
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2012-08-20
Marketing CategoryANDA / ANDA
Application NumberANDA077397
Labeler NameAphena Pharma Solutions - Tennessee, LLC
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 43353-817-15

15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-817-15)
Marketing Start Date2012-12-20
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 43353-817-15 [43353081715]

SERTRALINE TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077397
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-12-20

NDC 43353-817-45 [43353081745]

SERTRALINE TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077397
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-12-20

NDC 43353-817-30 [43353081730]

SERTRALINE TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077397
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-03-13

Drug Details

Active Ingredients

IngredientStrength
SERTRALINE HYDROCHLORIDE50 mg/1

OpenFDA Data

SPL SET ID:c01ed291-3c4f-4285-b54d-d15d39327b21
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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