levorphanol tartrate

Generic: levorphanol tartrate

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

Drug Facts

Product Profile

Brand Name levorphanol tartrate
Generic Name levorphanol tartrate
Labeler hikma pharmaceuticals usa inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

levorphanol tartrate 2 mg/1

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0054-0438
Product ID 0054-0438_0bfc1a93-9279-415f-8510-9eaa522c0a5f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA074278
DEA Schedule cii
Listing Expiration 2027-12-31
Marketing Start 2000-03-31

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00540438
Hyphenated Format 0054-0438

Supplemental Identifiers

RxCUI
197873
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 ANDA074278 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE, PLASTIC (0054-0438-25)
source: ndc

Packages (1)

0054-0438-25 100 TABLET in 1 BOTTLE, PLASTIC (0054-0438-25)

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": "0bfc1a93-9279-415f-8510-9eaa522c0a5f", "openfda": {"unii": ["04WQU6T9QI"], "rxcui": ["197873"], "spl_set_id": ["b2ab70e4-ca0c-4a73-9c98-974bf94e890c"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE, PLASTIC (0054-0438-25)", "package_ndc": "0054-0438-25", "marketing_start_date": "20230202"}], "brand_name": "LEVORPHANOL TARTRATE", "product_id": "0054-0438_0bfc1a93-9279-415f-8510-9eaa522c0a5f", "dosage_form": "TABLET", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "0054-0438", "dea_schedule": "CII", "generic_name": "LEVORPHANOL TARTRATE", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "LEVORPHANOL TARTRATE", "active_ingredients": [{"name": "LEVORPHANOL TARTRATE", "strength": "2 mg/1"}], "application_number": "ANDA074278", "marketing_category": "ANDA", "marketing_start_date": "20000331", "listing_expiration_date": "20271231"}