sertraline

Generic: sertraline

Labeler: avpak
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sertraline
Generic Name sertraline
Labeler avpak
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

sertraline hydrochloride 50 mg/1

Manufacturer
AvPAK

Identifiers & Regulatory

Product NDC 50268-769
Product ID 50268-769_48364c4d-880c-1d77-e063-6294a90a9011
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077670
Listing Expiration 2027-12-31
Marketing Start 2024-02-06

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 50268769
Hyphenated Format 50268-769

Supplemental Identifiers

RxCUI
312938 312940 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
  • 50 BLISTER PACK in 1 BOX (50268-769-15) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-769-11)
source: ndc

Packages (1)

50268-769-15 50 BLISTER PACK in 1 BOX (50268-769-15) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-769-11)

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": "48364c4d-880c-1d77-e063-6294a90a9011", "openfda": {"unii": ["UTI8907Y6X"], "rxcui": ["312938", "312940", "312941"], "spl_set_id": ["10baaffd-061e-d665-e063-6294a90a1594"], "manufacturer_name": ["AvPAK"]}, "finished": true, "packaging": [{"sample": false, "description": "50 BLISTER PACK in 1 BOX (50268-769-15)  / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-769-11)", "package_ndc": "50268-769-15", "marketing_start_date": "20240206"}], "brand_name": "Sertraline", "product_id": "50268-769_48364c4d-880c-1d77-e063-6294a90a9011", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Cytochrome P450 2D6 Inhibitors [MoA]", "Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "50268-769", "generic_name": "Sertraline", "labeler_name": "AvPAK", "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": "20240206", "listing_expiration_date": "20271231"}