sertraline hydrochloride

Generic: sertraline hydrochloride

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

Drug Facts

Product Profile

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

sertraline hydrochloride 50 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 71205-028
Product ID 71205-028_cbf2683a-b8ea-49b3-a0a0-63c69d70f2fb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202825
Listing Expiration 2026-12-31
Marketing Start 2017-02-09

Pharmacologic Class

Classes
serotonin reuptake inhibitor [epc] serotonin uptake inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71205028
Hyphenated Format 71205-028

Supplemental Identifiers

RxCUI
312938 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 ANDA202825 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (71205-028-30)
  • 60 TABLET, FILM COATED in 1 BOTTLE (71205-028-60)
  • 90 TABLET, FILM COATED in 1 BOTTLE (71205-028-90)
source: ndc

Packages (3)

71205-028-30 30 TABLET, FILM COATED in 1 BOTTLE (71205-028-30) 71205-028-60 60 TABLET, FILM COATED in 1 BOTTLE (71205-028-60) 71205-028-90 90 TABLET, FILM COATED in 1 BOTTLE (71205-028-90)

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": "cbf2683a-b8ea-49b3-a0a0-63c69d70f2fb", "openfda": {"unii": ["UTI8907Y6X"], "rxcui": ["312938", "312941"], "spl_set_id": ["6b532e6a-b040-4a10-a242-fb6d8dfc0852"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (71205-028-30)", "package_ndc": "71205-028-30", "marketing_start_date": "20180501"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (71205-028-60)", "package_ndc": "71205-028-60", "marketing_start_date": "20180501"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (71205-028-90)", "package_ndc": "71205-028-90", "marketing_start_date": "20180501"}], "brand_name": "SERTRALINE HYDROCHLORIDE", "product_id": "71205-028_cbf2683a-b8ea-49b3-a0a0-63c69d70f2fb", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "71205-028", "generic_name": "SERTRALINE HYDROCHLORIDE", "labeler_name": "Proficient Rx LP", "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"}