escitalopram

Generic: escitslopram

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

Drug Facts

Product Profile

Brand Name escitalopram
Generic Name escitslopram
Labeler lupin pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

escitalopram oxalate 5 mg/1

Manufacturer
Lupin Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68180-137
Product ID 68180-137_a752cb19-7de3-4b6d-aa44-03b7027ea60b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078169
Listing Expiration 2026-12-31
Marketing Start 2012-09-10

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68180137
Hyphenated Format 68180-137

Supplemental Identifiers

RxCUI
349332 351249 351250
UPC
0368180135012 0368180136019
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 escitslopram (source: ndc)
Application Number ANDA078169 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied Tablets Each film coated round tablet contains escitalopram oxalate equivalent to the labeled amount of escitalopram as follows 5 mg Tablets: White to off-white, round, film coated tablets, debossed with "LU" on one side and "W21" on the other side Bottles of 100 NDC 68180-137-01 10 mg Tablets: White to off-white, round, film coated tablets, debossed with 'L' and 'U' either side of the scoreline on one side and 'W22' on the other side. Bottles of 100 NDC 68180-135-01 20 mg Tablets: White to off-white, round, film coated tablets, debossed with 'L' and 'U' either side of the scoreline on one side and 'W23' on the other side. Bottles of 100 NDC 68180-136-01 Storage and Handling Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Escitalopram Tablets USP 5 mg - Bottle of 100s NDC- 68180-137-06 Escitalopram Tablets USP 10 mg - Bottle of 100s NDC- 68180-135-01 Escitalopram Tablets USP 20 mg - Bottle of 100s NDC- 68180-136-01 Image-02 Image-03 Image-04
source: label

Packages (0)

No package records.

Ingredients (1)

escitalopram oxalate (5 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": "a752cb19-7de3-4b6d-aa44-03b7027ea60b", "openfda": {"upc": ["0368180135012", "0368180136019"], "unii": ["5U85DBW7LO"], "rxcui": ["349332", "351249", "351250"], "spl_set_id": ["41f7392a-1f5c-4542-9c5c-f9e109851381"], "manufacturer_name": ["Lupin Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [], "brand_name": "Escitalopram", "product_id": "68180-137_a752cb19-7de3-4b6d-aa44-03b7027ea60b", "dosage_form": "TABLET", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "68180-137", "generic_name": "Escitslopram", "labeler_name": "Lupin Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Escitalopram", "active_ingredients": [{"name": "ESCITALOPRAM OXALATE", "strength": "5 mg/1"}], "application_number": "ANDA078169", "marketing_category": "ANDA", "marketing_start_date": "20120910", "listing_expiration_date": "20261231"}