citalopram

Generic: citalopram

Labeler: advanced rx of tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name citalopram
Generic Name citalopram
Labeler advanced rx of tennessee, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

citalopram hydrobromide 10 mg/1

Manufacturer
Advanced Rx of Tennessee, LLC

Identifiers & Regulatory

Product NDC 80425-0557
Product ID 80425-0557_43408cc0-4400-3827-e063-6394a90adcfe
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078216
Listing Expiration 2026-12-31
Marketing Start 2025-11-07

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 804250557
Hyphenated Format 80425-0557

Supplemental Identifiers

RxCUI
283672
UNII
I1E9D14F36

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 citalopram (source: ndc)
Generic Name citalopram (source: ndc)
Application Number ANDA078216 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (80425-0557-1)
  • 60 TABLET, FILM COATED in 1 BOTTLE (80425-0557-2)
  • 90 TABLET, FILM COATED in 1 BOTTLE (80425-0557-3)
source: ndc

Packages (3)

80425-0557-1 30 TABLET, FILM COATED in 1 BOTTLE (80425-0557-1) 80425-0557-2 60 TABLET, FILM COATED in 1 BOTTLE (80425-0557-2) 80425-0557-3 90 TABLET, FILM COATED in 1 BOTTLE (80425-0557-3)

Ingredients (1)

citalopram hydrobromide (10 mg/1)

Linked Drug Pages (1)

Citalopram ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "43408cc0-4400-3827-e063-6394a90adcfe", "openfda": {"unii": ["I1E9D14F36"], "rxcui": ["283672"], "spl_set_id": ["434094b4-fa3b-385a-e063-6394a90ac638"], "manufacturer_name": ["Advanced Rx of Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (80425-0557-1)", "package_ndc": "80425-0557-1", "marketing_start_date": "20251107"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (80425-0557-2)", "package_ndc": "80425-0557-2", "marketing_start_date": "20251107"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (80425-0557-3)", "package_ndc": "80425-0557-3", "marketing_start_date": "20251107"}], "brand_name": "Citalopram", "product_id": "80425-0557_43408cc0-4400-3827-e063-6394a90adcfe", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "80425-0557", "generic_name": "Citalopram", "labeler_name": "Advanced Rx of Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Citalopram", "active_ingredients": [{"name": "CITALOPRAM HYDROBROMIDE", "strength": "10 mg/1"}], "application_number": "ANDA078216", "marketing_category": "ANDA", "marketing_start_date": "20251107", "listing_expiration_date": "20261231"}