levorphanol tartrate

Generic: levorphanol tartrate

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

Drug Facts

Product Profile

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

levorphanol tartrate 2 mg/1

Manufacturer
ACERTIS PHARMACEUTICALS, LLC

Identifiers & Regulatory

Product NDC 72989-417
Product ID 72989-417_13e399bd-0f7e-46d8-89fe-cc2c5854f3c3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211484
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2025-07-14

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72989417
Hyphenated Format 72989-417

Supplemental Identifiers

RxCUI
197873
UPC
0372989417101
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 (72989-417-10)
source: ndc

Packages (1)

72989-417-10 100 TABLET in 1 BOTTLE (72989-417-10)

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": "13e399bd-0f7e-46d8-89fe-cc2c5854f3c3", "openfda": {"upc": ["0372989417101"], "unii": ["04WQU6T9QI"], "rxcui": ["197873"], "spl_set_id": ["113a713f-830b-481c-bfa6-d44e3ac27f80"], "manufacturer_name": ["ACERTIS PHARMACEUTICALS, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (72989-417-10)", "package_ndc": "72989-417-10", "marketing_start_date": "20250714"}], "brand_name": "Levorphanol Tartrate", "product_id": "72989-417_13e399bd-0f7e-46d8-89fe-cc2c5854f3c3", "dosage_form": "TABLET", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "72989-417", "dea_schedule": "CII", "generic_name": "Levorphanol Tartrate", "labeler_name": "ACERTIS 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_start_date": "20250714", "listing_expiration_date": "20261231"}