lorazepam

Generic: lorazepam

Labeler: clinical solutions wholesale, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lorazepam
Generic Name lorazepam
Labeler clinical solutions wholesale, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

lorazepam .5 mg/1

Manufacturer
Clinical Solutions Wholesale, LLC

Identifiers & Regulatory

Product NDC 58118-0904
Product ID 58118-0904_0e85cd9d-0f29-8950-e063-6294a90a33f7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078203
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2019-02-15

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 581180904
Hyphenated Format 58118-0904

Supplemental Identifiers

RxCUI
197900 197901 197902
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
  • 30 TABLET in 1 BLISTER PACK (58118-0904-8)
source: ndc

Packages (1)

58118-0904-8 30 TABLET in 1 BLISTER PACK (58118-0904-8)

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": "0e85cd9d-0f29-8950-e063-6294a90a33f7", "openfda": {"nui": ["N0000175694", "M0002356"], "unii": ["O26FZP769L"], "rxcui": ["197900", "197901", "197902"], "spl_set_id": ["fdc11b95-2233-42b4-b5f3-9390b5e9e1b2"], "pharm_class_cs": ["Benzodiazepines [CS]"], "pharm_class_epc": ["Benzodiazepine [EPC]"], "manufacturer_name": ["Clinical Solutions Wholesale, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BLISTER PACK (58118-0904-8)", "package_ndc": "58118-0904-8", "marketing_start_date": "20190215"}], "brand_name": "Lorazepam", "product_id": "58118-0904_0e85cd9d-0f29-8950-e063-6294a90a33f7", "dosage_form": "TABLET", "pharm_class": ["Benzodiazepine [EPC]", "Benzodiazepines [CS]"], "product_ndc": "58118-0904", "dea_schedule": "CIV", "generic_name": "Lorazepam", "labeler_name": "Clinical Solutions Wholesale, LLC", "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": "20190215", "listing_expiration_date": "20261231"}