sertraline hydrochloride

Generic: sertraline hydrochloride

Labeler: st. mary's medical park pharmacy
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sertraline hydrochloride
Generic Name sertraline hydrochloride
Labeler st. mary's medical park pharmacy
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

sertraline hydrochloride 50 mg/1

Manufacturer
ST. MARY'S MEDICAL PARK PHARMACY

Identifiers & Regulatory

Product NDC 60760-988
Product ID 60760-988_43d00c03-05b2-93d9-e063-6294a90ae261
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078403
Listing Expiration 2026-12-31
Marketing Start 2023-05-15

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 60760988
Hyphenated Format 60760-988

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 hydrochloride (source: ndc)
Generic Name sertraline hydrochloride (source: ndc)
Application Number ANDA078403 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-988-90)
source: ndc

Packages (1)

60760-988-90 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-988-90)

Ingredients (1)

sertraline hydrochloride (50 mg/1)

Linked Drug Pages (1)

Sertraline hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "43d00c03-05b2-93d9-e063-6294a90ae261", "openfda": {"unii": ["UTI8907Y6X"], "rxcui": ["312941"], "spl_set_id": ["1fcd3f6d-a71f-b131-e063-6394a90a4b26"], "manufacturer_name": ["ST. MARY'S MEDICAL PARK PHARMACY"]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-988-90)", "package_ndc": "60760-988-90", "marketing_start_date": "20240815"}], "brand_name": "Sertraline hydrochloride", "product_id": "60760-988_43d00c03-05b2-93d9-e063-6294a90ae261", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Cytochrome P450 2D6 Inhibitors [MoA]", "Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "60760-988", "generic_name": "Sertraline hydrochloride", "labeler_name": "ST. MARY'S MEDICAL PARK PHARMACY", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sertraline hydrochloride", "active_ingredients": [{"name": "SERTRALINE HYDROCHLORIDE", "strength": "50 mg/1"}], "application_number": "ANDA078403", "marketing_category": "ANDA", "marketing_start_date": "20230515", "listing_expiration_date": "20261231"}