NDC 70518-2512

Sertraline

Sertraline

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

Product ID70518-2512_9afa9c7e-d86c-26a4-e053-2a95a90ac4e4
NDC70518-2512
Product TypeHuman Prescription Drug
Proprietary NameSertraline
Generic NameSertraline
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2019-12-30
Marketing CategoryANDA / ANDA
Application NumberANDA077670
Labeler NameREMEDYREPACK INC.
Substance NameSERTRALINE HYDROCHLORIDE
Active Ingredient Strength25 mg/1
Pharm ClassesSerotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 70518-2512-0

30 TABLET, FILM COATED in 1 BLISTER PACK (70518-2512-0)
Marketing Start Date2019-12-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70518-2512-0 [70518251200]

Sertraline TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077670
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-12-30

NDC 70518-2512-1 [70518251201]

Sertraline TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077670
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-01-22

Drug Details

Active Ingredients

IngredientStrength
SERTRALINE HYDROCHLORIDE25 mg/1

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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