sertraline

Generic: sertraline

Labeler: quality care products, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sertraline
Generic Name sertraline
Labeler quality care products, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

sertraline hydrochloride 50 mg/1

Manufacturer
Quality Care Products, LLC

Identifiers & Regulatory

Product NDC 55700-225
Product ID 55700-225_e5bbd1ab-183b-4c52-ac67-32693703e459
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077670
Marketing Start 2015-02-27
Marketing End 2027-05-31

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 55700225
Hyphenated Format 55700-225

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 BOTTLE (55700-225-30)
source: ndc

Packages (1)

55700-225-30 30 TABLET, FILM COATED in 1 BOTTLE (55700-225-30)

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": "e5bbd1ab-183b-4c52-ac67-32693703e459", "openfda": {"unii": ["UTI8907Y6X"], "rxcui": ["312941"], "spl_set_id": ["6ed2b9b7-e4af-4e28-a7d5-4ccb514af217"], "manufacturer_name": ["Quality Care Products, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (55700-225-30)", "package_ndc": "55700-225-30", "marketing_end_date": "20270531", "marketing_start_date": "20150227"}], "brand_name": "Sertraline", "product_id": "55700-225_e5bbd1ab-183b-4c52-ac67-32693703e459", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Cytochrome P450 2D6 Inhibitors [MoA]", "Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "55700-225", "generic_name": "Sertraline", "labeler_name": "Quality Care Products, LLC", "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_end_date": "20270531", "marketing_start_date": "20150227"}