sertraline hydrochloride

Generic: sertraline hydrochloride

Labeler: aphena pharma solutions - tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sertraline hydrochloride
Generic Name sertraline hydrochloride
Labeler aphena pharma solutions - tennessee, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

sertraline hydrochloride 100 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-886
Product ID 71610-886_30b94d78-0158-ff43-e063-6294a90a030b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077397
Listing Expiration 2026-12-31
Marketing Start 2016-07-21

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 71610886
Hyphenated Format 71610-886

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
  • 15 TABLET in 1 BOTTLE (71610-886-15)
  • 45 TABLET in 1 BOTTLE (71610-886-45)
  • 90 TABLET in 1 BOTTLE (71610-886-60)
  • 135 TABLET in 1 BOTTLE (71610-886-73)
  • 180 TABLET in 1 BOTTLE (71610-886-80)
source: ndc

Packages (5)

71610-886-15 15 TABLET in 1 BOTTLE (71610-886-15) 71610-886-45 45 TABLET in 1 BOTTLE (71610-886-45) 71610-886-60 90 TABLET in 1 BOTTLE (71610-886-60) 71610-886-73 135 TABLET in 1 BOTTLE (71610-886-73) 71610-886-80 180 TABLET in 1 BOTTLE (71610-886-80)

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": "30b94d78-0158-ff43-e063-6294a90a030b", "openfda": {"unii": ["UTI8907Y6X"], "rxcui": ["312938"], "spl_set_id": ["30b94d67-0000-a045-e063-6394a90ade32"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "15 TABLET in 1 BOTTLE (71610-886-15)", "package_ndc": "71610-886-15", "marketing_start_date": "20250318"}, {"sample": false, "description": "45 TABLET in 1 BOTTLE (71610-886-45)", "package_ndc": "71610-886-45", "marketing_start_date": "20250318"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (71610-886-60)", "package_ndc": "71610-886-60", "marketing_start_date": "20250318"}, {"sample": false, "description": "135 TABLET in 1 BOTTLE (71610-886-73)", "package_ndc": "71610-886-73", "marketing_start_date": "20250318"}, {"sample": false, "description": "180 TABLET in 1 BOTTLE (71610-886-80)", "package_ndc": "71610-886-80", "marketing_start_date": "20250318"}], "brand_name": "Sertraline Hydrochloride", "product_id": "71610-886_30b94d78-0158-ff43-e063-6294a90a030b", "dosage_form": "TABLET", "pharm_class": ["Cytochrome P450 2D6 Inhibitors [MoA]", "Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "71610-886", "generic_name": "Sertraline Hydrochloride", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "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"}