NDC 50436-6304

SERTRALINE

Sertraline Hydrochloride

SERTRALINE is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Unit Dose Services. The primary component is Sertraline Hydrochloride.

Product ID50436-6304_0f5f2a54-442a-4653-bdf5-8b351956d0f4
NDC50436-6304
Product TypeHuman Prescription Drug
Proprietary NameSERTRALINE
Generic NameSertraline Hydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2007-10-18
Marketing CategoryANDA / ANDA
Application NumberANDA077397
Labeler NameUnit Dose Services
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 50436-6304-1

30 TABLET in 1 BOTTLE (50436-6304-1)
Marketing Start Date2007-10-18
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50436-6304-1 [50436630401]

SERTRALINE TABLET
Marketing CategoryANDA
Application NumberANDA077397
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2007-10-18
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
SERTRALINE HYDROCHLORIDE50 mg/1

OpenFDA Data

SPL SET ID:31fd504e-5955-49f9-a77e-2720a126fbc7
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

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.