lorazepam

Generic: lorazepam

Labeler: leading pharma, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lorazepam
Generic Name lorazepam
Labeler leading pharma, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

lorazepam 2 mg/1

Manufacturer
Leading Pharma, LLC

Identifiers & Regulatory

Product NDC 69315-906
Product ID 69315-906_40249bb6-0d25-4b2f-aa4b-85c15af6bf8b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078203
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2023-05-16

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69315906
Hyphenated Format 69315-906

Supplemental Identifiers

RxCUI
197900 197901 197902
UPC
0369315905104 0369315904053 0369315904107 0369315906101 0369315906057 0369315905050 0369315904015 0369315905012 0369315906019
UNII
O26FZP769L
NUI
N0000175694 M0002356

Packaging Origin

Original Packager
true

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
  • 100 TABLET in 1 BOTTLE (69315-906-01)
  • 500 TABLET in 1 BOTTLE (69315-906-05)
  • 1000 TABLET in 1 BOTTLE (69315-906-10)
source: ndc

Packages (3)

69315-906-01 100 TABLET in 1 BOTTLE (69315-906-01) 69315-906-05 500 TABLET in 1 BOTTLE (69315-906-05) 69315-906-10 1000 TABLET in 1 BOTTLE (69315-906-10)

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": "40249bb6-0d25-4b2f-aa4b-85c15af6bf8b", "openfda": {"nui": ["N0000175694", "M0002356"], "upc": ["0369315905104", "0369315904053", "0369315904107", "0369315906101", "0369315906057", "0369315905050", "0369315904015", "0369315905012", "0369315906019"], "unii": ["O26FZP769L"], "rxcui": ["197900", "197901", "197902"], "spl_set_id": ["5ca13415-4b77-4131-a9d2-6db26bc49167"], "pharm_class_cs": ["Benzodiazepines [CS]"], "pharm_class_epc": ["Benzodiazepine [EPC]"], "manufacturer_name": ["Leading Pharma, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (69315-906-01)", "package_ndc": "69315-906-01", "marketing_start_date": "20230516"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (69315-906-05)", "package_ndc": "69315-906-05", "marketing_start_date": "20230516"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (69315-906-10)", "package_ndc": "69315-906-10", "marketing_start_date": "20230516"}], "brand_name": "Lorazepam", "product_id": "69315-906_40249bb6-0d25-4b2f-aa4b-85c15af6bf8b", "dosage_form": "TABLET", "pharm_class": ["Benzodiazepine [EPC]", "Benzodiazepines [CS]"], "product_ndc": "69315-906", "dea_schedule": "CIV", "generic_name": "Lorazepam", "labeler_name": "Leading Pharma, 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": "20230516", "listing_expiration_date": "20261231"}