escitalopram

Generic: escitalopram

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

Drug Facts

Product Profile

Brand Name escitalopram
Generic Name escitalopram
Labeler rising pharma holdings, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

escitalopram oxalate 20 mg/1

Manufacturer
Rising Pharma Holdings, Inc.

Identifiers & Regulatory

Product NDC 16571-757
Product ID 16571-757_9929f3a5-d78b-4d99-bf87-d2693a9ac47e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078777
Listing Expiration 2026-12-31
Marketing Start 2023-06-10

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 16571757
Hyphenated Format 16571-757

Supplemental Identifiers

RxCUI
349332 351249 351250
UPC
0316571756018
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 (source: ndc)
Application Number ANDA078777 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (16571-757-01)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (16571-757-10)
source: ndc

Packages (2)

16571-757-01 100 TABLET, FILM COATED in 1 BOTTLE (16571-757-01) 16571-757-10 1000 TABLET, FILM COATED in 1 BOTTLE (16571-757-10)

Ingredients (1)

escitalopram oxalate (20 mg/1)

Linked Drug Pages (1)

escitalopram ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "9929f3a5-d78b-4d99-bf87-d2693a9ac47e", "openfda": {"upc": ["0316571756018"], "unii": ["5U85DBW7LO"], "rxcui": ["349332", "351249", "351250"], "spl_set_id": ["ccbe97b5-da68-4fff-929a-240dd705fe6f"], "manufacturer_name": ["Rising Pharma Holdings, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (16571-757-01)", "package_ndc": "16571-757-01", "marketing_start_date": "20230610"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (16571-757-10)", "package_ndc": "16571-757-10", "marketing_start_date": "20230610"}], "brand_name": "escitalopram", "product_id": "16571-757_9929f3a5-d78b-4d99-bf87-d2693a9ac47e", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "16571-757", "generic_name": "escitalopram", "labeler_name": "Rising Pharma Holdings, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "escitalopram", "active_ingredients": [{"name": "ESCITALOPRAM OXALATE", "strength": "20 mg/1"}], "application_number": "ANDA078777", "marketing_category": "ANDA", "marketing_start_date": "20230610", "listing_expiration_date": "20261231"}