citalopram hydrobromide

Generic: citalopram

Labeler: aphena pharma solutions - tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name citalopram hydrobromide
Generic Name citalopram
Labeler aphena pharma solutions - tennessee, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

citalopram hydrobromide 40 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 43353-112
Product ID 43353-112_4c38f808-9a23-b5b5-e063-6394a90ae44b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077534
Listing Expiration 2027-12-31
Marketing Start 2012-10-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43353112
Hyphenated Format 43353-112

Supplemental Identifiers

RxCUI
200371 309314
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 hydrobromide (source: ndc)
Generic Name citalopram (source: ndc)
Application Number ANDA077534 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 15 TABLET in 1 BOTTLE (43353-112-15)
  • 30 TABLET in 1 BOTTLE (43353-112-30)
  • 45 TABLET in 1 BOTTLE (43353-112-45)
  • 60 TABLET in 1 BOTTLE (43353-112-53)
  • 90 TABLET in 1 BOTTLE (43353-112-60)
source: ndc

Packages (5)

43353-112-15 15 TABLET in 1 BOTTLE (43353-112-15) 43353-112-30 30 TABLET in 1 BOTTLE (43353-112-30) 43353-112-45 45 TABLET in 1 BOTTLE (43353-112-45) 43353-112-53 60 TABLET in 1 BOTTLE (43353-112-53) 43353-112-60 90 TABLET in 1 BOTTLE (43353-112-60)

Ingredients (1)

citalopram hydrobromide (40 mg/1)

Linked Drug Pages (1)

CITALOPRAM HYDROBROMIDE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4c38f808-9a23-b5b5-e063-6394a90ae44b", "openfda": {"unii": ["I1E9D14F36"], "rxcui": ["200371", "309314"], "spl_set_id": ["7307df53-d570-4e26-971d-e97522ccce7f"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "15 TABLET in 1 BOTTLE (43353-112-15)", "package_ndc": "43353-112-15", "marketing_start_date": "20151009"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (43353-112-30)", "package_ndc": "43353-112-30", "marketing_start_date": "20151009"}, {"sample": false, "description": "45 TABLET in 1 BOTTLE (43353-112-45)", "package_ndc": "43353-112-45", "marketing_start_date": "20151009"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (43353-112-53)", "package_ndc": "43353-112-53", "marketing_start_date": "20151009"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (43353-112-60)", "package_ndc": "43353-112-60", "marketing_start_date": "20151009"}], "brand_name": "CITALOPRAM HYDROBROMIDE", "product_id": "43353-112_4c38f808-9a23-b5b5-e063-6394a90ae44b", "dosage_form": "TABLET", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "43353-112", "generic_name": "CITALOPRAM", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "CITALOPRAM HYDROBROMIDE", "active_ingredients": [{"name": "CITALOPRAM HYDROBROMIDE", "strength": "40 mg/1"}], "application_number": "ANDA077534", "marketing_category": "ANDA", "marketing_start_date": "20121001", "listing_expiration_date": "20271231"}