sertraline hydrochloride

Generic: sertraline hydrochloride

Labeler: rising pharma holdings, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sertraline hydrochloride
Generic Name sertraline hydrochloride
Labeler rising pharma holdings, inc.
Dosage Form SOLUTION, CONCENTRATE
Routes
ORAL
Active Ingredients

sertraline hydrochloride 20 mg/mL

Manufacturer
Rising Pharma Holdings, Inc.

Identifiers & Regulatory

Product NDC 64980-409
Product ID 64980-409_eccbd1a5-caba-4b22-b964-95ccb8dadeac
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078861
Listing Expiration 2026-12-31
Marketing Start 2008-10-31

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 64980409
Hyphenated Format 64980-409

Supplemental Identifiers

RxCUI
861064
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 ANDA078861 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 CARTON (64980-409-06) / 60 mL in 1 BOTTLE, PLASTIC
source: ndc

Packages (1)

64980-409-06 1 BOTTLE, PLASTIC in 1 CARTON (64980-409-06) / 60 mL in 1 BOTTLE, PLASTIC

Ingredients (1)

sertraline hydrochloride (20 mg/mL)

Linked Drug Pages (1)

Sertraline Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "eccbd1a5-caba-4b22-b964-95ccb8dadeac", "openfda": {"unii": ["UTI8907Y6X"], "rxcui": ["861064"], "spl_set_id": ["af2c75a3-131e-4bde-83fd-310fd2c01161"], "manufacturer_name": ["Rising Pharma Holdings, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (64980-409-06)  / 60 mL in 1 BOTTLE, PLASTIC", "package_ndc": "64980-409-06", "marketing_start_date": "20081031"}], "brand_name": "Sertraline Hydrochloride", "product_id": "64980-409_eccbd1a5-caba-4b22-b964-95ccb8dadeac", "dosage_form": "SOLUTION, CONCENTRATE", "pharm_class": ["Cytochrome P450 2D6 Inhibitors [MoA]", "Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "64980-409", "generic_name": "Sertraline Hydrochloride", "labeler_name": "Rising Pharma Holdings, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sertraline Hydrochloride", "active_ingredients": [{"name": "SERTRALINE HYDROCHLORIDE", "strength": "20 mg/mL"}], "application_number": "ANDA078861", "marketing_category": "ANDA", "marketing_start_date": "20081031", "listing_expiration_date": "20261231"}