escitalopram

Generic: escitalopram oxalate

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name escitalopram
Generic Name escitalopram oxalate
Labeler sun pharmaceutical industries, inc.
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

escitalopram oxalate 5 mg/5mL

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 51672-1348
Product ID 51672-1348_38e51a59-5806-77a6-e063-6394a90af6c6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA079121
Listing Expiration 2026-12-31
Marketing Start 2012-05-03

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 516721348
Hyphenated Format 51672-1348

Supplemental Identifiers

RxCUI
351285
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 (source: ndc)
Generic Name escitalopram oxalate (source: ndc)
Application Number ANDA079121 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/5mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (51672-1348-1) / 240 mL in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (51672-1348-8) / 120 mL in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (51672-1348-9) / 480 mL in 1 BOTTLE
source: ndc

Packages (3)

51672-1348-1 1 BOTTLE in 1 CARTON (51672-1348-1) / 240 mL in 1 BOTTLE 51672-1348-8 1 BOTTLE in 1 CARTON (51672-1348-8) / 120 mL in 1 BOTTLE 51672-1348-9 1 BOTTLE in 1 CARTON (51672-1348-9) / 480 mL in 1 BOTTLE

Ingredients (1)

escitalopram oxalate (5 mg/5mL)

Linked Drug Pages (1)

Escitalopram ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "38e51a59-5806-77a6-e063-6394a90af6c6", "openfda": {"unii": ["5U85DBW7LO"], "rxcui": ["351285"], "spl_set_id": ["c871d3fe-5ca2-410c-976d-9ec4b72c878f"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (51672-1348-1)  / 240 mL in 1 BOTTLE", "package_ndc": "51672-1348-1", "marketing_start_date": "20120503"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (51672-1348-8)  / 120 mL in 1 BOTTLE", "package_ndc": "51672-1348-8", "marketing_start_date": "20120503"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (51672-1348-9)  / 480 mL in 1 BOTTLE", "package_ndc": "51672-1348-9", "marketing_start_date": "20120503"}], "brand_name": "Escitalopram", "product_id": "51672-1348_38e51a59-5806-77a6-e063-6394a90af6c6", "dosage_form": "SOLUTION", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "51672-1348", "generic_name": "Escitalopram Oxalate", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Escitalopram", "active_ingredients": [{"name": "ESCITALOPRAM OXALATE", "strength": "5 mg/5mL"}], "application_number": "ANDA079121", "marketing_category": "ANDA", "marketing_start_date": "20120503", "listing_expiration_date": "20261231"}