lorazepam

Generic: lorazepam

Labeler: hikma pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name lorazepam
Generic Name lorazepam
Labeler hikma pharmaceuticals usa inc.
Dosage Form INJECTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

lorazepam 2 mg/mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0641-6207
Product ID 0641-6207_4f2988b1-2854-4051-962f-07cc925608ab
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA018140
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 1980-07-25

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 06416207
Hyphenated Format 0641-6207

Supplemental Identifiers

RxCUI
238100
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 NDA018140 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 2 mg/mL
source: ndc
Packaging
  • 25 VIAL in 1 CARTON (0641-6207-25) / 1 mL in 1 VIAL (0641-6207-01)
source: ndc

Packages (1)

0641-6207-25 25 VIAL in 1 CARTON (0641-6207-25) / 1 mL in 1 VIAL (0641-6207-01)

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": "4f2988b1-2854-4051-962f-07cc925608ab", "openfda": {"nui": ["N0000175694", "M0002356"], "unii": ["O26FZP769L"], "rxcui": ["238100"], "spl_set_id": ["b79b38ee-c29d-4099-964f-000031f47f5a"], "pharm_class_cs": ["Benzodiazepines [CS]"], "pharm_class_epc": ["Benzodiazepine [EPC]"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL in 1 CARTON (0641-6207-25)  / 1 mL in 1 VIAL (0641-6207-01)", "package_ndc": "0641-6207-25", "marketing_start_date": "19800725"}], "brand_name": "Lorazepam", "product_id": "0641-6207_4f2988b1-2854-4051-962f-07cc925608ab", "dosage_form": "INJECTION", "pharm_class": ["Benzodiazepine [EPC]", "Benzodiazepines [CS]"], "product_ndc": "0641-6207", "dea_schedule": "CIV", "generic_name": "Lorazepam", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lorazepam", "active_ingredients": [{"name": "LORAZEPAM", "strength": "2 mg/mL"}], "application_number": "NDA018140", "marketing_category": "NDA", "marketing_start_date": "19800725", "listing_expiration_date": "20261231"}