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 71610-655
Product ID 71610-655_e064bed4-48cf-4fac-b5f4-c62a4634984a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA072928
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2021-07-20

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71610655
Hyphenated Format 71610-655

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 ANDA072928 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/1
source: ndc
Packaging
  • 15 TABLET in 1 BOTTLE, PLASTIC (71610-655-15)
  • 30 TABLET in 1 BOTTLE, PLASTIC (71610-655-30)
  • 45 TABLET in 1 BOTTLE, PLASTIC (71610-655-45)
  • 60 TABLET in 1 BOTTLE, PLASTIC (71610-655-53)
  • 90 TABLET in 1 BOTTLE, PLASTIC (71610-655-60)
  • 120 TABLET in 1 BOTTLE, PLASTIC (71610-655-70)
  • 180 TABLET in 1 BOTTLE, PLASTIC (71610-655-80)
source: ndc

Packages (7)

71610-655-15 15 TABLET in 1 BOTTLE, PLASTIC (71610-655-15) 71610-655-30 30 TABLET in 1 BOTTLE, PLASTIC (71610-655-30) 71610-655-45 45 TABLET in 1 BOTTLE, PLASTIC (71610-655-45) 71610-655-53 60 TABLET in 1 BOTTLE, PLASTIC (71610-655-53) 71610-655-60 90 TABLET in 1 BOTTLE, PLASTIC (71610-655-60) 71610-655-70 120 TABLET in 1 BOTTLE, PLASTIC (71610-655-70) 71610-655-80 180 TABLET in 1 BOTTLE, PLASTIC (71610-655-80)

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": "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": "15 TABLET in 1 BOTTLE, PLASTIC (71610-655-15)", "package_ndc": "71610-655-15", "marketing_start_date": "20221123"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (71610-655-30)", "package_ndc": "71610-655-30", "marketing_start_date": "20220801"}, {"sample": false, "description": "45 TABLET in 1 BOTTLE, PLASTIC (71610-655-45)", "package_ndc": "71610-655-45", "marketing_start_date": "20221123"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE, PLASTIC (71610-655-53)", "package_ndc": "71610-655-53", "marketing_start_date": "20220801"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE, PLASTIC (71610-655-60)", "package_ndc": "71610-655-60", "marketing_start_date": "20220801"}, {"sample": false, "description": "120 TABLET in 1 BOTTLE, PLASTIC (71610-655-70)", "package_ndc": "71610-655-70", "marketing_start_date": "20220801"}, {"sample": false, "description": "180 TABLET in 1 BOTTLE, PLASTIC (71610-655-80)", "package_ndc": "71610-655-80", "marketing_start_date": "20221123"}], "brand_name": "Lorazepam", "product_id": "71610-655_e064bed4-48cf-4fac-b5f4-c62a4634984a", "dosage_form": "TABLET", "pharm_class": ["Benzodiazepine [EPC]", "Benzodiazepines [CS]"], "product_ndc": "71610-655", "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": "ANDA072928", "marketing_category": "ANDA", "marketing_start_date": "20210720", "listing_expiration_date": "20261231"}