lorazepam

Generic: lorazepam

Labeler: ani pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lorazepam
Generic Name lorazepam
Labeler ani pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

lorazepam 2 mg/1

Manufacturer
ANI Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 62559-197
Product ID 62559-197_14501e2f-99a6-44c0-ba71-12c12d02888b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077396
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2024-12-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 62559197
Hyphenated Format 62559-197

Supplemental Identifiers

RxCUI
197900 197901 197902
UPC
0362559196109 0362559195058 0362559195102 0362559197052 0362559196055 0362559195010 0362559197014 0362559196017
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 ANDA077396 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (62559-197-01)
  • 500 TABLET in 1 BOTTLE (62559-197-05)
  • 1000 TABLET in 1 BOTTLE (62559-197-10)
source: ndc

Packages (3)

Ingredients (1)

lorazepam (2 mg/1)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "14501e2f-99a6-44c0-ba71-12c12d02888b", "openfda": {"nui": ["N0000175694", "M0002356"], "upc": ["0362559196109", "0362559195058", "0362559195102", "0362559197052", "0362559196055", "0362559195010", "0362559197014", "0362559196017"], "unii": ["O26FZP769L"], "rxcui": ["197900", "197901", "197902"], "spl_set_id": ["787240e9-67b5-4af3-b16d-7cf314e3f2e3"], "pharm_class_cs": ["Benzodiazepines [CS]"], "pharm_class_epc": ["Benzodiazepine [EPC]"], "manufacturer_name": ["ANI Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (62559-197-01)", "package_ndc": "62559-197-01", "marketing_start_date": "20241201"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (62559-197-05)", "package_ndc": "62559-197-05", "marketing_start_date": "20241201"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (62559-197-10)", "package_ndc": "62559-197-10", "marketing_start_date": "20241201"}], "brand_name": "Lorazepam", "product_id": "62559-197_14501e2f-99a6-44c0-ba71-12c12d02888b", "dosage_form": "TABLET", "pharm_class": ["Benzodiazepine [EPC]", "Benzodiazepines [CS]"], "product_ndc": "62559-197", "dea_schedule": "CIV", "generic_name": "Lorazepam", "labeler_name": "ANI Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lorazepam", "active_ingredients": [{"name": "LORAZEPAM", "strength": "2 mg/1"}], "application_number": "ANDA077396", "marketing_category": "ANDA", "marketing_start_date": "20241201", "listing_expiration_date": "20261231"}