lorazepam

Generic: lorazepam

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

Drug Facts

Product Profile

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

lorazepam 2 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 43353-255
Product ID 43353-255_241fa37f-a839-42e7-8f99-7f33ea809be0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078203
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2009-10-09

Pharmacologic Class

Established (EPC)
benzodiazepine [epc]
Chemical Structure
benzodiazepines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43353255
Hyphenated Format 43353-255

Supplemental Identifiers

RxCUI
197902
UNII
O26FZP769L
NUI
N0000175694 M0002356

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 lorazepam (source: ndc)
Generic Name lorazepam (source: ndc)
Application Number ANDA078203 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/1
source: ndc
Packaging
  • 15 TABLET in 1 BOTTLE (43353-255-15)
  • 30 TABLET in 1 BOTTLE (43353-255-30)
  • 45 TABLET in 1 BOTTLE (43353-255-45)
  • 60 TABLET in 1 BOTTLE (43353-255-53)
  • 90 TABLET in 1 BOTTLE (43353-255-60)
  • 120 TABLET in 1 BOTTLE (43353-255-70)
  • 150 TABLET in 1 BOTTLE (43353-255-75)
  • 180 TABLET in 1 BOTTLE (43353-255-80)
  • 240 TABLET in 1 BOTTLE (43353-255-90)
  • 270 TABLET in 1 BOTTLE (43353-255-92)
source: ndc

Packages (10)

43353-255-15 15 TABLET in 1 BOTTLE (43353-255-15) 43353-255-30 30 TABLET in 1 BOTTLE (43353-255-30) 43353-255-45 45 TABLET in 1 BOTTLE (43353-255-45) 43353-255-53 60 TABLET in 1 BOTTLE (43353-255-53) 43353-255-60 90 TABLET in 1 BOTTLE (43353-255-60) 43353-255-70 120 TABLET in 1 BOTTLE (43353-255-70) 43353-255-75 150 TABLET in 1 BOTTLE (43353-255-75) 43353-255-80 180 TABLET in 1 BOTTLE (43353-255-80) 43353-255-90 240 TABLET in 1 BOTTLE (43353-255-90) 43353-255-92 270 TABLET in 1 BOTTLE (43353-255-92)

Ingredients (1)

lorazepam (2 mg/1)

Linked Drug Pages (1)

Lorazepam ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "241fa37f-a839-42e7-8f99-7f33ea809be0", "openfda": {"nui": ["N0000175694", "M0002356"], "unii": ["O26FZP769L"], "rxcui": ["197902"], "spl_set_id": ["b87db9c4-0375-49b3-b914-615e2fe275d6"], "pharm_class_cs": ["Benzodiazepines [CS]"], "pharm_class_epc": ["Benzodiazepine [EPC]"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "15 TABLET in 1 BOTTLE (43353-255-15)", "package_ndc": "43353-255-15", "marketing_start_date": "20181022"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (43353-255-30)", "package_ndc": "43353-255-30", "marketing_start_date": "20181022"}, {"sample": false, "description": "45 TABLET in 1 BOTTLE (43353-255-45)", "package_ndc": "43353-255-45", "marketing_start_date": "20181022"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (43353-255-53)", "package_ndc": "43353-255-53", "marketing_start_date": "20181022"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (43353-255-60)", "package_ndc": "43353-255-60", "marketing_start_date": "20181022"}, {"sample": false, "description": "120 TABLET in 1 BOTTLE (43353-255-70)", "package_ndc": "43353-255-70", "marketing_start_date": "20181022"}, {"sample": false, "description": "150 TABLET in 1 BOTTLE (43353-255-75)", "package_ndc": "43353-255-75", "marketing_start_date": "20181022"}, {"sample": false, "description": "180 TABLET in 1 BOTTLE (43353-255-80)", "package_ndc": "43353-255-80", "marketing_start_date": "20181022"}, {"sample": false, "description": "240 TABLET in 1 BOTTLE (43353-255-90)", "package_ndc": "43353-255-90", "marketing_start_date": "20181022"}, {"sample": false, "description": "270 TABLET in 1 BOTTLE (43353-255-92)", "package_ndc": "43353-255-92", "marketing_start_date": "20181022"}], "brand_name": "Lorazepam", "product_id": "43353-255_241fa37f-a839-42e7-8f99-7f33ea809be0", "dosage_form": "TABLET", "pharm_class": ["Benzodiazepine [EPC]", "Benzodiazepines [CS]"], "product_ndc": "43353-255", "dea_schedule": "CIV", "generic_name": "Lorazepam", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lorazepam", "active_ingredients": [{"name": "LORAZEPAM", "strength": "2 mg/1"}], "application_number": "ANDA078203", "marketing_category": "ANDA", "marketing_start_date": "20091009", "listing_expiration_date": "20261231"}