citalopram

Generic: citalopram hydrobromide

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

Drug Facts

Product Profile

Brand Name citalopram
Generic Name citalopram hydrobromide
Labeler quallent pharmaceuticals health llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

citalopram hydrobromide 40 mg/1

Manufacturer
QUALLENT PHARMACEUTICALS HEALTH LLC

Identifiers & Regulatory

Product NDC 82009-108
Product ID 82009-108_f85b3b65-e283-4270-895c-c601b6e7c6a6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077031
Listing Expiration 2026-12-31
Marketing Start 2023-08-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 82009108
Hyphenated Format 82009-108

Supplemental Identifiers

RxCUI
200371 283672 309314
UNII
I1E9D14F36

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 citalopram (source: ndc)
Generic Name citalopram hydrobromide (source: ndc)
Application Number ANDA077031 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 500 TABLET, FILM COATED in 1 BOTTLE (82009-108-05)
source: ndc

Packages (1)

82009-108-05 500 TABLET, FILM COATED in 1 BOTTLE (82009-108-05)

Ingredients (1)

citalopram hydrobromide (40 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": "f85b3b65-e283-4270-895c-c601b6e7c6a6", "openfda": {"unii": ["I1E9D14F36"], "rxcui": ["200371", "283672", "309314"], "spl_set_id": ["e0822069-9672-4d4c-bc1a-8739b0dd045c"], "manufacturer_name": ["QUALLENT PHARMACEUTICALS HEALTH LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (82009-108-05)", "package_ndc": "82009-108-05", "marketing_start_date": "20230801"}], "brand_name": "Citalopram", "product_id": "82009-108_f85b3b65-e283-4270-895c-c601b6e7c6a6", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "82009-108", "generic_name": "Citalopram Hydrobromide", "labeler_name": "QUALLENT PHARMACEUTICALS HEALTH LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Citalopram", "active_ingredients": [{"name": "CITALOPRAM HYDROBROMIDE", "strength": "40 mg/1"}], "application_number": "ANDA077031", "marketing_category": "ANDA", "marketing_start_date": "20230801", "listing_expiration_date": "20261231"}