escitalopram oxalate

Generic: escitalopram oxalate

Labeler: quallent pharmaceuticals health llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name escitalopram oxalate
Generic Name escitalopram oxalate
Labeler quallent pharmaceuticals health llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

escitalopram oxalate 10 mg/1

Manufacturer
Quallent Pharmaceuticals Health LLC

Identifiers & Regulatory

Product NDC 82009-036
Product ID 82009-036_8535cead-aff5-4a22-b788-1d5926e02097
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090939
Listing Expiration 2026-12-31
Marketing Start 2023-03-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 82009036
Hyphenated Format 82009-036

Supplemental Identifiers

RxCUI
349332 351249 351250
UPC
0382009036106
UNII
5U85DBW7LO

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 escitalopram oxalate (source: ndc)
Generic Name escitalopram oxalate (source: ndc)
Application Number ANDA090939 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 1000 TABLET in 1 BOTTLE (82009-036-10)
source: ndc

Packages (1)

82009-036-10 1000 TABLET in 1 BOTTLE (82009-036-10)

Ingredients (1)

escitalopram oxalate (10 mg/1)

Linked Drug Pages (1)

escitalopram oxalate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "8535cead-aff5-4a22-b788-1d5926e02097", "openfda": {"upc": ["0382009036106"], "unii": ["5U85DBW7LO"], "rxcui": ["349332", "351249", "351250"], "spl_set_id": ["d8e22060-4d06-42bf-a881-caaf65ecc3e3"], "manufacturer_name": ["Quallent Pharmaceuticals Health LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET in 1 BOTTLE (82009-036-10)", "package_ndc": "82009-036-10", "marketing_start_date": "20230301"}], "brand_name": "escitalopram oxalate", "product_id": "82009-036_8535cead-aff5-4a22-b788-1d5926e02097", "dosage_form": "TABLET", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "82009-036", "generic_name": "escitalopram oxalate", "labeler_name": "Quallent Pharmaceuticals Health LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "escitalopram oxalate", "active_ingredients": [{"name": "ESCITALOPRAM OXALATE", "strength": "10 mg/1"}], "application_number": "ANDA090939", "marketing_category": "ANDA", "marketing_start_date": "20230301", "listing_expiration_date": "20261231"}