lorazepam

Generic: lorazepam

Labeler: international medication systems, limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lorazepam
Generic Name lorazepam
Labeler international medication systems, limited
Dosage Form INJECTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

lorazepam 2 mg/mL

Manufacturer
International Medication Systems, Limited

Identifiers & Regulatory

Product NDC 76329-8261
Product ID 76329-8261_b85a6695-55b9-4780-a803-33f8f2464138
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076150
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2012-12-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 763298261
Hyphenated Format 76329-8261

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 ANDA076150 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 2 mg/mL
source: ndc
Packaging
  • 10 VIAL in 1 CARTON (76329-8261-1) / 10 mL in 1 VIAL
source: ndc

Packages (1)

76329-8261-1 10 VIAL in 1 CARTON (76329-8261-1) / 10 mL in 1 VIAL

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": "b85a6695-55b9-4780-a803-33f8f2464138", "openfda": {"nui": ["N0000175694", "M0002356"], "unii": ["O26FZP769L"], "rxcui": ["238100"], "spl_set_id": ["7dda070d-7809-46c4-8592-eb4e4c509707"], "pharm_class_cs": ["Benzodiazepines [CS]"], "pharm_class_epc": ["Benzodiazepine [EPC]"], "manufacturer_name": ["International Medication Systems, Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 CARTON (76329-8261-1)  / 10 mL in 1 VIAL", "package_ndc": "76329-8261-1", "marketing_start_date": "20121201"}], "brand_name": "Lorazepam", "product_id": "76329-8261_b85a6695-55b9-4780-a803-33f8f2464138", "dosage_form": "INJECTION", "pharm_class": ["Benzodiazepine [EPC]", "Benzodiazepines [CS]"], "product_ndc": "76329-8261", "dea_schedule": "CIV", "generic_name": "Lorazepam", "labeler_name": "International Medication Systems, Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lorazepam", "active_ingredients": [{"name": "LORAZEPAM", "strength": "2 mg/mL"}], "application_number": "ANDA076150", "marketing_category": "ANDA", "marketing_start_date": "20121201", "listing_expiration_date": "20261231"}