lorazepam

Generic: lorazepam

Labeler: amneal pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lorazepam
Generic Name lorazepam
Labeler amneal pharmaceuticals llc
Dosage Form CONCENTRATE
Routes
ORAL
Active Ingredients

lorazepam 2 mg/mL

Manufacturer
Amneal Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 65162-687
Product ID 65162-687_99b5d0cb-3d61-497c-9b51-7d0939f923a0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091383
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2010-02-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65162687
Hyphenated Format 65162-687

Supplemental Identifiers

RxCUI
311376
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 ANDA091383 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/mL
source: ndc
Packaging
  • 30 mL in 1 BOTTLE, DROPPER (65162-687-84)
source: ndc

Packages (1)

65162-687-84 30 mL in 1 BOTTLE, DROPPER (65162-687-84)

Ingredients (1)

lorazepam (2 mg/mL)

Linked Drug Pages (1)

Lorazepam ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "99b5d0cb-3d61-497c-9b51-7d0939f923a0", "openfda": {"nui": ["N0000175694", "M0002356"], "unii": ["O26FZP769L"], "rxcui": ["311376"], "spl_set_id": ["bf265c2e-ab2f-42e5-96cf-3998eb5a644d"], "pharm_class_cs": ["Benzodiazepines [CS]"], "pharm_class_epc": ["Benzodiazepine [EPC]"], "manufacturer_name": ["Amneal Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 mL in 1 BOTTLE, DROPPER (65162-687-84)", "package_ndc": "65162-687-84", "marketing_start_date": "20100201"}], "brand_name": "Lorazepam", "product_id": "65162-687_99b5d0cb-3d61-497c-9b51-7d0939f923a0", "dosage_form": "CONCENTRATE", "pharm_class": ["Benzodiazepine [EPC]", "Benzodiazepines [CS]"], "product_ndc": "65162-687", "dea_schedule": "CIV", "generic_name": "Lorazepam", "labeler_name": "Amneal Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lorazepam", "active_ingredients": [{"name": "LORAZEPAM", "strength": "2 mg/mL"}], "application_number": "ANDA091383", "marketing_category": "ANDA", "marketing_start_date": "20100201", "listing_expiration_date": "20261231"}