tramadol hcl

Generic: tramadol hcl

Labeler: advanced rx of tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tramadol hcl
Generic Name tramadol hcl
Labeler advanced rx of tennessee, llc
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

tramadol hydrochloride 50 mg/1

Manufacturer
Advanced Rx of Tennessee, LLC

Identifiers & Regulatory

Product NDC 80425-0057
Product ID 80425-0057_2a98da36-e8b2-759b-e063-6294a90ab33b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076003
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2010-11-15

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 804250057
Hyphenated Format 80425-0057

Supplemental Identifiers

RxCUI
835603
UNII
9N7R477WCK

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 tramadol hcl (source: ndc)
Generic Name tramadol hcl (source: ndc)
Application Number ANDA076003 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 30 TABLET, COATED in 1 BOTTLE (80425-0057-1)
  • 60 TABLET, COATED in 1 BOTTLE (80425-0057-2)
  • 90 TABLET, COATED in 1 BOTTLE (80425-0057-3)
  • 15 TABLET, COATED in 1 BOTTLE (80425-0057-4)
  • 120 TABLET, COATED in 1 BOTTLE (80425-0057-5)
source: ndc

Packages (5)

80425-0057-1 30 TABLET, COATED in 1 BOTTLE (80425-0057-1) 80425-0057-2 60 TABLET, COATED in 1 BOTTLE (80425-0057-2) 80425-0057-3 90 TABLET, COATED in 1 BOTTLE (80425-0057-3) 80425-0057-4 15 TABLET, COATED in 1 BOTTLE (80425-0057-4) 80425-0057-5 120 TABLET, COATED in 1 BOTTLE (80425-0057-5)

Ingredients (1)

tramadol hydrochloride (50 mg/1)

Linked Drug Pages (1)

Tramadol HCL ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2a98da36-e8b2-759b-e063-6294a90ab33b", "openfda": {"unii": ["9N7R477WCK"], "rxcui": ["835603"], "spl_set_id": ["af87fc31-07c2-b1f7-e053-2995a90a499f"], "manufacturer_name": ["Advanced Rx of Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, COATED in 1 BOTTLE (80425-0057-1)", "package_ndc": "80425-0057-1", "marketing_start_date": "20101115"}, {"sample": false, "description": "60 TABLET, COATED in 1 BOTTLE (80425-0057-2)", "package_ndc": "80425-0057-2", "marketing_start_date": "20101115"}, {"sample": false, "description": "90 TABLET, COATED in 1 BOTTLE (80425-0057-3)", "package_ndc": "80425-0057-3", "marketing_start_date": "20101115"}, {"sample": false, "description": "15 TABLET, COATED in 1 BOTTLE (80425-0057-4)", "package_ndc": "80425-0057-4", "marketing_start_date": "20101115"}, {"sample": false, "description": "120 TABLET, COATED in 1 BOTTLE (80425-0057-5)", "package_ndc": "80425-0057-5", "marketing_start_date": "20101115"}], "brand_name": "Tramadol HCL", "product_id": "80425-0057_2a98da36-e8b2-759b-e063-6294a90ab33b", "dosage_form": "TABLET, COATED", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "80425-0057", "dea_schedule": "CIV", "generic_name": "Tramadol HCL", "labeler_name": "Advanced Rx of Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tramadol HCL", "active_ingredients": [{"name": "TRAMADOL HYDROCHLORIDE", "strength": "50 mg/1"}], "application_number": "ANDA076003", "marketing_category": "ANDA", "marketing_start_date": "20101115", "listing_expiration_date": "20261231"}