NDC 0615-6558

Sertraline

Sertraline Hydrochloride

Sertraline is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Ncs Healthcare Of Ky, Inc Dba Vangard Labs. The primary component is Sertraline Hydrochloride.

Product ID0615-6558_6cbf0268-58a8-48d6-8f3b-6089a0922ed4
NDC0615-6558
Product TypeHuman Prescription Drug
Proprietary NameSertraline
Generic NameSertraline Hydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2007-12-18
Marketing CategoryANDA / ANDA
Application NumberANDA077397
Labeler NameNCS HealthCare of KY, Inc dba Vangard Labs
Substance NameSERTRALINE HYDROCHLORIDE
Active Ingredient Strength25 mg/1
Pharm ClassesSerotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 0615-6558-30

6 BLISTER PACK in 1 BOX, UNIT-DOSE (0615-6558-30) > 5 TABLET in 1 BLISTER PACK
Marketing Start Date2007-12-18
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0615-6558-30 [00615655830]

Sertraline TABLET
Marketing CategoryANDA
Application NumberANDA077397
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-12-02
Inactivation Date2020-01-31

NDC 0615-6558-05 [00615655805]

Sertraline TABLET
Marketing CategoryANDA
Application NumberANDA077397
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2007-12-18
Inactivation Date2020-01-31

NDC 0615-6558-39 [00615655839]

Sertraline TABLET
Marketing CategoryANDA
Application NumberANDA077397
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2007-12-18
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
SERTRALINE HYDROCHLORIDE25 mg/1

OpenFDA Data

SPL SET ID:ecc38d95-880f-43ea-aa8b-41472803c780
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 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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