lorazepam

Generic: lorazepam

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lorazepam
Generic Name lorazepam
Labeler fresenius kabi usa, llc
Dosage Form INJECTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

lorazepam 2 mg/mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 65219-368
Product ID 65219-368_5cd2d0d8-9639-4e96-aafd-4991ad35fabc
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217598
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2024-12-13

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65219368
Hyphenated Format 65219-368

Supplemental Identifiers

RxCUI
1665188
UPC
0365219368014
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 ANDA217598 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 2 mg/mL
source: ndc
Packaging
  • 25 VIAL in 1 TRAY (65219-368-02) / 1 mL in 1 VIAL (65219-368-01)
source: ndc

Packages (1)

65219-368-02 25 VIAL in 1 TRAY (65219-368-02) / 1 mL in 1 VIAL (65219-368-01)

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": ["INTRAMUSCULAR", "INTRAVENOUS"], "spl_id": "5cd2d0d8-9639-4e96-aafd-4991ad35fabc", "openfda": {"nui": ["N0000175694", "M0002356"], "upc": ["0365219368014"], "unii": ["O26FZP769L"], "rxcui": ["1665188"], "spl_set_id": ["b2487467-a63f-48b5-b0de-3a6ce6672d50"], "pharm_class_cs": ["Benzodiazepines [CS]"], "pharm_class_epc": ["Benzodiazepine [EPC]"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL in 1 TRAY (65219-368-02)  / 1 mL in 1 VIAL (65219-368-01)", "package_ndc": "65219-368-02", "marketing_start_date": "20241213"}], "brand_name": "Lorazepam", "product_id": "65219-368_5cd2d0d8-9639-4e96-aafd-4991ad35fabc", "dosage_form": "INJECTION", "pharm_class": ["Benzodiazepine [EPC]", "Benzodiazepines [CS]"], "product_ndc": "65219-368", "dea_schedule": "CIV", "generic_name": "Lorazepam", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lorazepam", "active_ingredients": [{"name": "LORAZEPAM", "strength": "2 mg/mL"}], "application_number": "ANDA217598", "marketing_category": "ANDA", "marketing_start_date": "20241213", "listing_expiration_date": "20261231"}