levorphanol tartrate

Generic: levorphanol tartrate

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name levorphanol tartrate
Generic Name levorphanol tartrate
Labeler sun pharmaceutical industries, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

levorphanol tartrate 2 mg/1

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 57664-762
Product ID 57664-762_48471dc2-bdd9-2263-e063-6294a90a9e03
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213906
DEA Schedule cii
Listing Expiration 2027-12-31
Marketing Start 2022-04-26

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 57664762
Hyphenated Format 57664-762

Supplemental Identifiers

RxCUI
197873 2058845
UPC
0357664058886
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 ANDA213906 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (57664-762-88)
source: ndc

Packages (1)

57664-762-88 100 TABLET in 1 BOTTLE (57664-762-88)

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": "48471dc2-bdd9-2263-e063-6294a90a9e03", "openfda": {"upc": ["0357664058886"], "unii": ["04WQU6T9QI"], "rxcui": ["197873", "2058845"], "spl_set_id": ["438cf3ea-04fe-4626-9f0f-adcda7633651"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (57664-762-88)", "package_ndc": "57664-762-88", "marketing_start_date": "20220426"}], "brand_name": "Levorphanol Tartrate", "product_id": "57664-762_48471dc2-bdd9-2263-e063-6294a90a9e03", "dosage_form": "TABLET", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "57664-762", "dea_schedule": "CII", "generic_name": "Levorphanol Tartrate", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Levorphanol Tartrate", "active_ingredients": [{"name": "LEVORPHANOL TARTRATE", "strength": "2 mg/1"}], "application_number": "ANDA213906", "marketing_category": "ANDA", "marketing_start_date": "20220426", "listing_expiration_date": "20271231"}