lorazepam

Generic: lorazepam

Labeler: asclemed usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lorazepam
Generic Name lorazepam
Labeler asclemed usa, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

lorazepam .5 mg/1

Manufacturer
Asclemed USA, Inc.

Identifiers & Regulatory

Product NDC 76420-647
Product ID 76420-647_0b44d6cf-d204-741a-e063-6294a90a05ff
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078203
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2023-05-16

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 76420647
Hyphenated Format 76420-647

Supplemental Identifiers

RxCUI
197900
UNII
O26FZP769L
NUI
N0000175694 M0002356

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 ANDA078203 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (76420-647-01)
  • 30 TABLET in 1 BOTTLE (76420-647-30)
  • 60 TABLET in 1 BOTTLE (76420-647-60)
  • 90 TABLET in 1 BOTTLE (76420-647-90)
source: ndc

Packages (4)

76420-647-01 100 TABLET in 1 BOTTLE (76420-647-01) 76420-647-30 30 TABLET in 1 BOTTLE (76420-647-30) 76420-647-60 60 TABLET in 1 BOTTLE (76420-647-60) 76420-647-90 90 TABLET in 1 BOTTLE (76420-647-90)

Ingredients (1)

lorazepam (.5 mg/1)

Linked Drug Pages (1)

Lorazepam ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "0b44d6cf-d204-741a-e063-6294a90a05ff", "openfda": {"nui": ["N0000175694", "M0002356"], "unii": ["O26FZP769L"], "rxcui": ["197900"], "spl_set_id": ["91da80c8-3162-43f0-b53e-897070b26a54"], "pharm_class_cs": ["Benzodiazepines [CS]"], "pharm_class_epc": ["Benzodiazepine [EPC]"], "manufacturer_name": ["Asclemed USA, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (76420-647-01)", "package_ndc": "76420-647-01", "marketing_start_date": "20231129"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (76420-647-30)", "package_ndc": "76420-647-30", "marketing_start_date": "20231129"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (76420-647-60)", "package_ndc": "76420-647-60", "marketing_start_date": "20231129"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (76420-647-90)", "package_ndc": "76420-647-90", "marketing_start_date": "20231129"}], "brand_name": "Lorazepam", "product_id": "76420-647_0b44d6cf-d204-741a-e063-6294a90a05ff", "dosage_form": "TABLET", "pharm_class": ["Benzodiazepine [EPC]", "Benzodiazepines [CS]"], "product_ndc": "76420-647", "dea_schedule": "CIV", "generic_name": "Lorazepam", "labeler_name": "Asclemed USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lorazepam", "active_ingredients": [{"name": "LORAZEPAM", "strength": ".5 mg/1"}], "application_number": "ANDA078203", "marketing_category": "ANDA", "marketing_start_date": "20230516", "listing_expiration_date": "20261231"}