lorazepam

Generic: lorazepam

Labeler: advanced rx of tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lorazepam
Generic Name lorazepam
Labeler advanced rx of tennessee, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

lorazepam 1 mg/1

Manufacturer
Advanced Rx of Tennessee, LLC

Identifiers & Regulatory

Product NDC 80425-0465
Product ID 80425-0465_2a57e551-1ed3-718f-e063-6394a90a30e1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203572
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2024-12-28

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 804250465
Hyphenated Format 80425-0465

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 ANDA203572 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (80425-0465-1)
  • 60 TABLET in 1 BOTTLE (80425-0465-2)
  • 90 TABLET in 1 BOTTLE (80425-0465-3)
source: ndc

Packages (3)

80425-0465-1 30 TABLET in 1 BOTTLE (80425-0465-1) 80425-0465-2 60 TABLET in 1 BOTTLE (80425-0465-2) 80425-0465-3 90 TABLET in 1 BOTTLE (80425-0465-3)

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": "2a57e551-1ed3-718f-e063-6394a90a30e1", "openfda": {"nui": ["N0000175694", "M0002356"], "unii": ["O26FZP769L"], "rxcui": ["197901"], "spl_set_id": ["2a57e549-390b-5482-e063-6394a90aeb3b"], "pharm_class_cs": ["Benzodiazepines [CS]"], "pharm_class_epc": ["Benzodiazepine [EPC]"], "manufacturer_name": ["Advanced Rx of Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (80425-0465-1)", "package_ndc": "80425-0465-1", "marketing_start_date": "20241228"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (80425-0465-2)", "package_ndc": "80425-0465-2", "marketing_start_date": "20241228"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (80425-0465-3)", "package_ndc": "80425-0465-3", "marketing_start_date": "20241228"}], "brand_name": "LORAZEPAM", "product_id": "80425-0465_2a57e551-1ed3-718f-e063-6394a90a30e1", "dosage_form": "TABLET", "pharm_class": ["Benzodiazepine [EPC]", "Benzodiazepines [CS]"], "product_ndc": "80425-0465", "dea_schedule": "CIV", "generic_name": "LORAZEPAM", "labeler_name": "Advanced Rx of Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "LORAZEPAM", "active_ingredients": [{"name": "LORAZEPAM", "strength": "1 mg/1"}], "application_number": "ANDA203572", "marketing_category": "ANDA", "marketing_start_date": "20241228", "listing_expiration_date": "20261231"}