sertraline hydrochloride

Generic: sertraline hydrochloride

Labeler: pd-rx pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sertraline hydrochloride
Generic Name sertraline hydrochloride
Labeler pd-rx pharmaceuticals, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

sertraline hydrochloride 50 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 43063-855
Product ID 43063-855_415c1542-4103-5b90-e063-6294a90a3fd8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202825
Listing Expiration 2026-12-31
Marketing Start 2017-02-09

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 43063855
Hyphenated Format 43063-855

Supplemental Identifiers

RxCUI
312941
UPC
0343063855300
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 ANDA202825 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-855-30)
  • 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-855-60)
  • 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-855-90)
source: ndc

Packages (3)

43063-855-30 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-855-30) 43063-855-60 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-855-60) 43063-855-90 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-855-90)

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": "415c1542-4103-5b90-e063-6294a90a3fd8", "openfda": {"upc": ["0343063855300"], "unii": ["UTI8907Y6X"], "rxcui": ["312941"], "spl_set_id": ["aa13261f-46a7-4381-8084-b3ad46221e2f"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-855-30)", "package_ndc": "43063-855-30", "marketing_start_date": "20180709"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-855-60)", "package_ndc": "43063-855-60", "marketing_start_date": "20180709"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-855-90)", "package_ndc": "43063-855-90", "marketing_start_date": "20180529"}], "brand_name": "SERTRALINE HYDROCHLORIDE", "product_id": "43063-855_415c1542-4103-5b90-e063-6294a90a3fd8", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Cytochrome P450 2D6 Inhibitors [MoA]", "Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "43063-855", "generic_name": "SERTRALINE HYDROCHLORIDE", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "SERTRALINE HYDROCHLORIDE", "active_ingredients": [{"name": "SERTRALINE HYDROCHLORIDE", "strength": "50 mg/1"}], "application_number": "ANDA202825", "marketing_category": "ANDA", "marketing_start_date": "20170209", "listing_expiration_date": "20261231"}