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
Routes
ORAL
Active Ingredients

sertraline hydrochloride 100 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 63187-795
Product ID 63187-795_46242389-2faa-4900-a43a-643cf388a6d7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077397
Listing Expiration 2026-12-31
Marketing Start 2016-07-21

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63187795
Hyphenated Format 63187-795

Supplemental Identifiers

RxCUI
312938
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 ANDA077397 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (63187-795-30)
  • 60 TABLET in 1 BOTTLE (63187-795-60)
  • 90 TABLET in 1 BOTTLE (63187-795-90)
source: ndc

Packages (3)

63187-795-30 30 TABLET in 1 BOTTLE (63187-795-30) 63187-795-60 60 TABLET in 1 BOTTLE (63187-795-60) 63187-795-90 90 TABLET in 1 BOTTLE (63187-795-90)

Ingredients (1)

sertraline hydrochloride (100 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": "46242389-2faa-4900-a43a-643cf388a6d7", "openfda": {"unii": ["UTI8907Y6X"], "rxcui": ["312938"], "spl_set_id": ["787a683a-091c-4908-a643-ecbc8fd467eb"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (63187-795-30)", "package_ndc": "63187-795-30", "marketing_start_date": "20161201"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (63187-795-60)", "package_ndc": "63187-795-60", "marketing_start_date": "20161201"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (63187-795-90)", "package_ndc": "63187-795-90", "marketing_start_date": "20161201"}], "brand_name": "Sertraline Hydrochloride", "product_id": "63187-795_46242389-2faa-4900-a43a-643cf388a6d7", "dosage_form": "TABLET", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "63187-795", "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": "100 mg/1"}], "application_number": "ANDA077397", "marketing_category": "ANDA", "marketing_start_date": "20160721", "listing_expiration_date": "20261231"}