levorphanol tartrate

Generic: levorphanol tartrate

Labeler: virtus pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name levorphanol tartrate
Generic Name levorphanol tartrate
Labeler virtus pharmaceuticals, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

levorphanol tartrate 2 mg/1

Manufacturer
Virtus Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 69543-417
Product ID 69543-417_42f6d390-228a-4790-8372-2e822b5d7e9d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211484
DEA Schedule cii
Marketing Start 2020-09-01
Marketing End 2027-07-31

Pharmacologic Class

Classes
full opioid agonists [moa] opioid agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69543417
Hyphenated Format 69543-417

Supplemental Identifiers

RxCUI
197873
UPC
0369543417103
UNII
04WQU6T9QI

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 levorphanol tartrate (source: ndc)
Generic Name levorphanol tartrate (source: ndc)
Application Number ANDA211484 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (69543-417-10)
source: ndc

Packages (1)

69543-417-10 100 TABLET in 1 BOTTLE (69543-417-10)

Ingredients (1)

levorphanol tartrate (2 mg/1)

Linked Drug Pages (1)

Levorphanol Tartrate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "42f6d390-228a-4790-8372-2e822b5d7e9d", "openfda": {"upc": ["0369543417103"], "unii": ["04WQU6T9QI"], "rxcui": ["197873"], "spl_set_id": ["6e7ca993-c8b9-4510-a2b0-5bcc678d2571"], "manufacturer_name": ["Virtus Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (69543-417-10)", "package_ndc": "69543-417-10", "marketing_end_date": "20270731", "marketing_start_date": "20200901"}], "brand_name": "Levorphanol Tartrate", "product_id": "69543-417_42f6d390-228a-4790-8372-2e822b5d7e9d", "dosage_form": "TABLET", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "69543-417", "dea_schedule": "CII", "generic_name": "Levorphanol Tartrate", "labeler_name": "Virtus Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Levorphanol Tartrate", "active_ingredients": [{"name": "LEVORPHANOL TARTRATE", "strength": "2 mg/1"}], "application_number": "ANDA211484", "marketing_category": "ANDA", "marketing_end_date": "20270731", "marketing_start_date": "20200901"}