NDC 0615-7989

Sertraline

Sertraline

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

Product ID0615-7989_2622f272-25ec-440d-b04b-649b3720175c
NDC0615-7989
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 NameNCS HealthCare of KY, LLC dba Vangard Labs
Substance NameSERTRALINE HYDROCHLORIDE
Active Ingredient Strength25 mg/1
Pharm ClassesCytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 0615-7989-05

15 TABLET, FILM COATED in 1 BLISTER PACK (0615-7989-05)
Marketing Start Date2016-05-12
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0615-7989-30 [00615798930]

Sertraline TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077670
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-05-18

NDC 0615-7989-39 [00615798939]

Sertraline TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077670
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-05-12

NDC 0615-7989-05 [00615798905]

Sertraline TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077670
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-05-12

Drug Details

Active Ingredients

IngredientStrength
SERTRALINE HYDROCHLORIDE25 mg/1

OpenFDA Data

SPL SET ID:0e7fd69c-1273-4836-a7a3-beb9cc31e44e
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
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.