sertraline hydrochloride

Generic: sertraline hydrochloride

Labeler: accord healthcare, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sertraline hydrochloride
Generic Name sertraline hydrochloride
Labeler accord healthcare, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

sertraline hydrochloride 50 mg/1

Manufacturer
Accord Healthcare, Inc.

Identifiers & Regulatory

Product NDC 16729-216
Product ID 16729-216_46293a9f-fad8-a06b-e063-6294a90acb9a
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 16729216
Hyphenated Format 16729-216

Supplemental Identifiers

RxCUI
312938 312940 312941
UNII
UTI8907Y6X

Packaging Origin

Original Packager
true

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
  • 90 TABLET, FILM COATED in 1 BOTTLE (16729-216-15)
  • 500 TABLET, FILM COATED in 1 BOTTLE (16729-216-16)
source: ndc

Packages (2)

16729-216-15 90 TABLET, FILM COATED in 1 BOTTLE (16729-216-15) 16729-216-16 500 TABLET, FILM COATED in 1 BOTTLE (16729-216-16)

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": "46293a9f-fad8-a06b-e063-6294a90acb9a", "openfda": {"unii": ["UTI8907Y6X"], "rxcui": ["312938", "312940", "312941"], "spl_set_id": ["205ecf52-8138-44a7-ad9a-b3aa7f4fa11a"], "manufacturer_name": ["Accord Healthcare, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (16729-216-15)", "package_ndc": "16729-216-15", "marketing_start_date": "20170209"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (16729-216-16)", "package_ndc": "16729-216-16", "marketing_start_date": "20170213"}], "brand_name": "SERTRALINE HYDROCHLORIDE", "product_id": "16729-216_46293a9f-fad8-a06b-e063-6294a90acb9a", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Cytochrome P450 2D6 Inhibitors [MoA]", "Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "16729-216", "generic_name": "SERTRALINE HYDROCHLORIDE", "labeler_name": "Accord Healthcare, 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"}