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 1 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-828
Product ID 71610-828_32454287-89bf-f90f-e063-6294a90a3091
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076045
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2023-10-26

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71610828
Hyphenated Format 71610-828

Supplemental Identifiers

RxCUI
197901
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 ANDA076045 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/1
source: ndc
Packaging
  • 10 TABLET in 1 BOTTLE (71610-828-10)
  • 15 TABLET in 1 BOTTLE (71610-828-15)
  • 28 TABLET in 1 BOTTLE (71610-828-28)
  • 30 TABLET in 1 BOTTLE (71610-828-30)
  • 45 TABLET in 1 BOTTLE (71610-828-45)
  • 60 TABLET in 1 BOTTLE (71610-828-53)
  • 75 TABLET in 1 BOTTLE (71610-828-55)
  • 90 TABLET in 1 BOTTLE (71610-828-60)
  • 120 TABLET in 1 BOTTLE (71610-828-70)
  • 150 TABLET in 1 BOTTLE (71610-828-75)
  • 180 TABLET in 1 BOTTLE (71610-828-80)
  • 270 TABLET in 1 BOTTLE (71610-828-92)
source: ndc

Packages (12)

71610-828-10 10 TABLET in 1 BOTTLE (71610-828-10) 71610-828-15 15 TABLET in 1 BOTTLE (71610-828-15) 71610-828-28 28 TABLET in 1 BOTTLE (71610-828-28) 71610-828-30 30 TABLET in 1 BOTTLE (71610-828-30) 71610-828-45 45 TABLET in 1 BOTTLE (71610-828-45) 71610-828-53 60 TABLET in 1 BOTTLE (71610-828-53) 71610-828-55 75 TABLET in 1 BOTTLE (71610-828-55) 71610-828-60 90 TABLET in 1 BOTTLE (71610-828-60) 71610-828-70 120 TABLET in 1 BOTTLE (71610-828-70) 71610-828-75 150 TABLET in 1 BOTTLE (71610-828-75) 71610-828-80 180 TABLET in 1 BOTTLE (71610-828-80) 71610-828-92 270 TABLET in 1 BOTTLE (71610-828-92)

Ingredients (1)

lorazepam (1 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": "32454287-89bf-f90f-e063-6294a90a3091", "openfda": {"nui": ["N0000175694", "M0002356"], "unii": ["O26FZP769L"], "rxcui": ["197901"], "spl_set_id": ["1791d5c9-9004-5c4b-e063-6294a90adf3d"], "pharm_class_cs": ["Benzodiazepines [CS]"], "pharm_class_epc": ["Benzodiazepine [EPC]"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "10 TABLET in 1 BOTTLE (71610-828-10)", "package_ndc": "71610-828-10", "marketing_start_date": "20240502"}, {"sample": false, "description": "15 TABLET in 1 BOTTLE (71610-828-15)", "package_ndc": "71610-828-15", "marketing_start_date": "20240614"}, {"sample": false, "description": "28 TABLET in 1 BOTTLE (71610-828-28)", "package_ndc": "71610-828-28", "marketing_start_date": "20240502"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (71610-828-30)", "package_ndc": "71610-828-30", "marketing_start_date": "20240502"}, {"sample": false, "description": "45 TABLET in 1 BOTTLE (71610-828-45)", "package_ndc": "71610-828-45", "marketing_start_date": "20240502"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (71610-828-53)", "package_ndc": "71610-828-53", "marketing_start_date": "20240502"}, {"sample": false, "description": "75 TABLET in 1 BOTTLE (71610-828-55)", "package_ndc": "71610-828-55", "marketing_start_date": "20250404"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (71610-828-60)", "package_ndc": "71610-828-60", "marketing_start_date": "20240502"}, {"sample": false, "description": "120 TABLET in 1 BOTTLE (71610-828-70)", "package_ndc": "71610-828-70", "marketing_start_date": "20240614"}, {"sample": false, "description": "150 TABLET in 1 BOTTLE (71610-828-75)", "package_ndc": "71610-828-75", "marketing_start_date": "20241206"}, {"sample": false, "description": "180 TABLET in 1 BOTTLE (71610-828-80)", "package_ndc": "71610-828-80", "marketing_start_date": "20240502"}, {"sample": false, "description": "270 TABLET in 1 BOTTLE (71610-828-92)", "package_ndc": "71610-828-92", "marketing_start_date": "20240502"}], "brand_name": "Lorazepam", "product_id": "71610-828_32454287-89bf-f90f-e063-6294a90a3091", "dosage_form": "TABLET", "pharm_class": ["Benzodiazepine [EPC]", "Benzodiazepines [CS]"], "product_ndc": "71610-828", "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": "1 mg/1"}], "application_number": "ANDA076045", "marketing_category": "ANDA", "marketing_start_date": "20231026", "listing_expiration_date": "20261231"}