sertraline

Generic: sertraline

Labeler: proficient rx lp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sertraline
Generic Name sertraline
Labeler proficient rx lp
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

sertraline hydrochloride 25 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 63187-478
Product ID 63187-478_820641b5-c569-4a24-b0a4-5d17d3cff8ee
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077670
Listing Expiration 2026-12-31
Marketing Start 2007-02-06

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 63187478
Hyphenated Format 63187-478

Supplemental Identifiers

RxCUI
312938 312940 312941
UPC
0363187212308 0363187055301 0363187478902
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
  • 25 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (63187-478-30)
  • 60 TABLET, FILM COATED in 1 BOTTLE (63187-478-60)
  • 90 TABLET, FILM COATED in 1 BOTTLE (63187-478-90)
source: ndc

Packages (3)

63187-478-30 30 TABLET, FILM COATED in 1 BOTTLE (63187-478-30) 63187-478-60 60 TABLET, FILM COATED in 1 BOTTLE (63187-478-60) 63187-478-90 90 TABLET, FILM COATED in 1 BOTTLE (63187-478-90)

Ingredients (1)

sertraline hydrochloride (25 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": "820641b5-c569-4a24-b0a4-5d17d3cff8ee", "openfda": {"upc": ["0363187212308", "0363187055301", "0363187478902"], "unii": ["UTI8907Y6X"], "rxcui": ["312938", "312940", "312941"], "spl_set_id": ["35dea1a2-ec26-4e52-8f09-ee4678e77946"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (63187-478-30)", "package_ndc": "63187-478-30", "marketing_start_date": "20150501"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (63187-478-60)", "package_ndc": "63187-478-60", "marketing_start_date": "20150501"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (63187-478-90)", "package_ndc": "63187-478-90", "marketing_start_date": "20150501"}], "brand_name": "Sertraline", "product_id": "63187-478_820641b5-c569-4a24-b0a4-5d17d3cff8ee", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Cytochrome P450 2D6 Inhibitors [MoA]", "Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "63187-478", "generic_name": "Sertraline", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sertraline", "active_ingredients": [{"name": "SERTRALINE HYDROCHLORIDE", "strength": "25 mg/1"}], "application_number": "ANDA077670", "marketing_category": "ANDA", "marketing_start_date": "20070206", "listing_expiration_date": "20261231"}