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 71610-178
Product ID 71610-178_8328a536-b498-4fcb-8a49-19d79fa25f29
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078203
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2007-10-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71610178
Hyphenated Format 71610-178

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 (71610-178-15)
  • 30 TABLET in 1 BOTTLE (71610-178-30)
  • 45 TABLET in 1 BOTTLE (71610-178-45)
  • 60 TABLET in 1 BOTTLE (71610-178-53)
  • 90 TABLET in 1 BOTTLE (71610-178-60)
  • 120 TABLET in 1 BOTTLE (71610-178-70)
  • 180 TABLET in 1 BOTTLE (71610-178-80)
source: ndc

Packages (7)

71610-178-15 15 TABLET in 1 BOTTLE (71610-178-15) 71610-178-30 30 TABLET in 1 BOTTLE (71610-178-30) 71610-178-45 45 TABLET in 1 BOTTLE (71610-178-45) 71610-178-53 60 TABLET in 1 BOTTLE (71610-178-53) 71610-178-60 90 TABLET in 1 BOTTLE (71610-178-60) 71610-178-70 120 TABLET in 1 BOTTLE (71610-178-70) 71610-178-80 180 TABLET in 1 BOTTLE (71610-178-80)

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": "8328a536-b498-4fcb-8a49-19d79fa25f29", "openfda": {"nui": ["N0000175694", "M0002356"], "unii": ["O26FZP769L"], "rxcui": ["197902"], "spl_set_id": ["08bd30b0-a1c1-4ec3-bb9c-b1d55ac59f75"], "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 (71610-178-15)", "package_ndc": "71610-178-15", "marketing_start_date": "20181024"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (71610-178-30)", "package_ndc": "71610-178-30", "marketing_start_date": "20181024"}, {"sample": false, "description": "45 TABLET in 1 BOTTLE (71610-178-45)", "package_ndc": "71610-178-45", "marketing_start_date": "20181024"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (71610-178-53)", "package_ndc": "71610-178-53", "marketing_start_date": "20181024"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (71610-178-60)", "package_ndc": "71610-178-60", "marketing_start_date": "20181024"}, {"sample": false, "description": "120 TABLET in 1 BOTTLE (71610-178-70)", "package_ndc": "71610-178-70", "marketing_start_date": "20181024"}, {"sample": false, "description": "180 TABLET in 1 BOTTLE (71610-178-80)", "package_ndc": "71610-178-80", "marketing_start_date": "20181024"}], "brand_name": "Lorazepam", "product_id": "71610-178_8328a536-b498-4fcb-8a49-19d79fa25f29", "dosage_form": "TABLET", "pharm_class": ["Benzodiazepine [EPC]", "Benzodiazepines [CS]"], "product_ndc": "71610-178", "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": "20071001", "listing_expiration_date": "20261231"}