sertraline

Generic: sertraline

Labeler: remedyrepack inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sertraline
Generic Name sertraline
Labeler remedyrepack inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

sertraline hydrochloride 50 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-1617
Product ID 70518-1617_494f96d1-de22-da69-e063-6294a90aaa4f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077670
Listing Expiration 2027-12-31
Marketing Start 2018-10-30

Pharmacologic Class

Classes
cytochrome p450 2d6 inhibitors [moa] serotonin reuptake inhibitor [epc] serotonin uptake inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 705181617
Hyphenated Format 70518-1617

Supplemental Identifiers

RxCUI
312941
UNII
UTI8907Y6X

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name sertraline (source: ndc)
Generic Name sertraline (source: ndc)
Application Number ANDA077670 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-1617-0)
source: ndc

Packages (1)

70518-1617-0 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-1617-0)

Ingredients (1)

sertraline hydrochloride (50 mg/1)

Linked Drug Pages (1)

Sertraline ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "494f96d1-de22-da69-e063-6294a90aaa4f", "openfda": {"unii": ["UTI8907Y6X"], "rxcui": ["312941"], "spl_set_id": ["c614be38-cb45-44a1-b78e-0cdfc0691618"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BLISTER PACK (70518-1617-0)", "package_ndc": "70518-1617-0", "marketing_start_date": "20181030"}], "brand_name": "Sertraline", "product_id": "70518-1617_494f96d1-de22-da69-e063-6294a90aaa4f", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Cytochrome P450 2D6 Inhibitors [MoA]", "Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "70518-1617", "generic_name": "Sertraline", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sertraline", "active_ingredients": [{"name": "SERTRALINE HYDROCHLORIDE", "strength": "50 mg/1"}], "application_number": "ANDA077670", "marketing_category": "ANDA", "marketing_start_date": "20181030", "listing_expiration_date": "20271231"}