sertraline hydrochloride

Generic: sertraline hydrochloride

Labeler: ascent pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sertraline hydrochloride
Generic Name sertraline hydrochloride
Labeler ascent pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

sertraline hydrochloride 50 mg/1

Manufacturer
Ascent Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 43602-980
Product ID 43602-980_91447af3-b3d6-4ffe-8c89-1869a22373ba
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214790
Listing Expiration 2026-12-31
Marketing Start 2021-05-03

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 43602980
Hyphenated Format 43602-980

Supplemental Identifiers

RxCUI
312938 312940 312941
UPC
0343602464055 0343602462051 0343602463058 0010100002194
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 ANDA214790 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (43602-980-15)
  • 500 TABLET in 1 BOTTLE (43602-980-16)
source: ndc

Packages (2)

43602-980-15 30 TABLET in 1 BOTTLE (43602-980-15) 43602-980-16 500 TABLET in 1 BOTTLE (43602-980-16)

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": "91447af3-b3d6-4ffe-8c89-1869a22373ba", "openfda": {"upc": ["0343602464055", "0343602462051", "0343602463058", "0010100002194"], "unii": ["UTI8907Y6X"], "rxcui": ["312938", "312940", "312941"], "spl_set_id": ["056191ca-999a-4c9b-93b9-64db44b8e628"], "manufacturer_name": ["Ascent Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (43602-980-15)", "package_ndc": "43602-980-15", "marketing_start_date": "20210503"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (43602-980-16)", "package_ndc": "43602-980-16", "marketing_start_date": "20210503"}], "brand_name": "SERTRALINE HYDROCHLORIDE", "product_id": "43602-980_91447af3-b3d6-4ffe-8c89-1869a22373ba", "dosage_form": "TABLET", "pharm_class": ["Cytochrome P450 2D6 Inhibitors [MoA]", "Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "43602-980", "generic_name": "sertraline hydrochloride", "labeler_name": "Ascent Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "SERTRALINE HYDROCHLORIDE", "active_ingredients": [{"name": "SERTRALINE HYDROCHLORIDE", "strength": "50 mg/1"}], "application_number": "ANDA214790", "marketing_category": "ANDA", "marketing_start_date": "20210503", "listing_expiration_date": "20261231"}