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 .5 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-654
Product ID 71610-654_e064bed4-48cf-4fac-b5f4-c62a4634984a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA072926
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2021-10-11

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71610654
Hyphenated Format 71610-654

Supplemental Identifiers

RxCUI
197900 197901 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 ANDA072926 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/1
source: ndc
Packaging
  • 10 TABLET in 1 BOTTLE, PLASTIC (71610-654-10)
  • 15 TABLET in 1 BOTTLE, PLASTIC (71610-654-15)
  • 20 TABLET in 1 BOTTLE, PLASTIC (71610-654-20)
  • 28 TABLET in 1 BOTTLE, PLASTIC (71610-654-28)
  • 30 TABLET in 1 BOTTLE, PLASTIC (71610-654-30)
  • 45 TABLET in 1 BOTTLE, PLASTIC (71610-654-45)
  • 60 TABLET in 1 BOTTLE, PLASTIC (71610-654-53)
  • 90 TABLET in 1 BOTTLE, PLASTIC (71610-654-60)
  • 120 TABLET in 1 BOTTLE, PLASTIC (71610-654-70)
  • 150 TABLET in 1 BOTTLE, PLASTIC (71610-654-75)
  • 180 TABLET in 1 BOTTLE, PLASTIC (71610-654-80)
  • 270 TABLET in 1 BOTTLE, PLASTIC (71610-654-92)
source: ndc

Packages (12)

71610-654-10 10 TABLET in 1 BOTTLE, PLASTIC (71610-654-10) 71610-654-15 15 TABLET in 1 BOTTLE, PLASTIC (71610-654-15) 71610-654-20 20 TABLET in 1 BOTTLE, PLASTIC (71610-654-20) 71610-654-28 28 TABLET in 1 BOTTLE, PLASTIC (71610-654-28) 71610-654-30 30 TABLET in 1 BOTTLE, PLASTIC (71610-654-30) 71610-654-45 45 TABLET in 1 BOTTLE, PLASTIC (71610-654-45) 71610-654-53 60 TABLET in 1 BOTTLE, PLASTIC (71610-654-53) 71610-654-60 90 TABLET in 1 BOTTLE, PLASTIC (71610-654-60) 71610-654-70 120 TABLET in 1 BOTTLE, PLASTIC (71610-654-70) 71610-654-75 150 TABLET in 1 BOTTLE, PLASTIC (71610-654-75) 71610-654-80 180 TABLET in 1 BOTTLE, PLASTIC (71610-654-80) 71610-654-92 270 TABLET in 1 BOTTLE, PLASTIC (71610-654-92)

Ingredients (1)

lorazepam (.5 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": "e064bed4-48cf-4fac-b5f4-c62a4634984a", "openfda": {"nui": ["N0000175694", "M0002356"], "unii": ["O26FZP769L"], "rxcui": ["197900", "197901", "197902"], "spl_set_id": ["3c20c89f-c8c3-43b3-837e-da413f449795"], "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, PLASTIC (71610-654-10)", "package_ndc": "71610-654-10", "marketing_start_date": "20220811"}, {"sample": false, "description": "15 TABLET in 1 BOTTLE, PLASTIC (71610-654-15)", "package_ndc": "71610-654-15", "marketing_start_date": "20220801"}, {"sample": false, "description": "20 TABLET in 1 BOTTLE, PLASTIC (71610-654-20)", "package_ndc": "71610-654-20", "marketing_start_date": "20220811"}, {"sample": false, "description": "28 TABLET in 1 BOTTLE, PLASTIC (71610-654-28)", "package_ndc": "71610-654-28", "marketing_start_date": "20250508"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (71610-654-30)", "package_ndc": "71610-654-30", "marketing_start_date": "20220801"}, {"sample": false, "description": "45 TABLET in 1 BOTTLE, PLASTIC (71610-654-45)", "package_ndc": "71610-654-45", "marketing_start_date": "20220801"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE, PLASTIC (71610-654-53)", "package_ndc": "71610-654-53", "marketing_start_date": "20220801"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE, PLASTIC (71610-654-60)", "package_ndc": "71610-654-60", "marketing_start_date": "20220801"}, {"sample": false, "description": "120 TABLET in 1 BOTTLE, PLASTIC (71610-654-70)", "package_ndc": "71610-654-70", "marketing_start_date": "20220801"}, {"sample": false, "description": "150 TABLET in 1 BOTTLE, PLASTIC (71610-654-75)", "package_ndc": "71610-654-75", "marketing_start_date": "20220801"}, {"sample": false, "description": "180 TABLET in 1 BOTTLE, PLASTIC (71610-654-80)", "package_ndc": "71610-654-80", "marketing_start_date": "20220801"}, {"sample": false, "description": "270 TABLET in 1 BOTTLE, PLASTIC (71610-654-92)", "package_ndc": "71610-654-92", "marketing_start_date": "20220811"}], "brand_name": "Lorazepam", "product_id": "71610-654_e064bed4-48cf-4fac-b5f4-c62a4634984a", "dosage_form": "TABLET", "pharm_class": ["Benzodiazepine [EPC]", "Benzodiazepines [CS]"], "product_ndc": "71610-654", "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": ".5 mg/1"}], "application_number": "ANDA072926", "marketing_category": "ANDA", "marketing_start_date": "20211011", "listing_expiration_date": "20261231"}