tramadol hydrochloride

Generic: tramadol hydrochloride

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

Drug Facts

Product Profile

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

tramadol hydrochloride 50 mg/1

Manufacturer
Advanced Rx of Tennessee, LLC

Identifiers & Regulatory

Product NDC 80425-0548
Product ID 80425-0548_4641b78d-bdc6-12d5-e063-6394a90a728a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211825
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2025-08-27

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 804250548
Hyphenated Format 80425-0548

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 hydrochloride (source: ndc)
Generic Name tramadol hydrochloride (source: ndc)
Application Number ANDA211825 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (80425-0548-1)
  • 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (80425-0548-2)
  • 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (80425-0548-3)
  • 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (80425-0548-4)
  • 120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (80425-0548-5)
  • 40 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (80425-0548-6)
  • 180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (80425-0548-7)
  • 240 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (80425-0548-8)
source: ndc

Packages (8)

80425-0548-1 15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (80425-0548-1) 80425-0548-2 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (80425-0548-2) 80425-0548-3 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (80425-0548-3) 80425-0548-4 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (80425-0548-4) 80425-0548-5 120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (80425-0548-5) 80425-0548-6 40 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (80425-0548-6) 80425-0548-7 180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (80425-0548-7) 80425-0548-8 240 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (80425-0548-8)

Ingredients (1)

tramadol hydrochloride (50 mg/1)

Linked Drug Pages (1)

Tramadol Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4641b78d-bdc6-12d5-e063-6394a90a728a", "openfda": {"unii": ["9N7R477WCK"], "rxcui": ["835603"], "spl_set_id": ["3d719560-7449-f970-e063-6294a90a9bd8"], "manufacturer_name": ["Advanced Rx of Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (80425-0548-1)", "package_ndc": "80425-0548-1", "marketing_start_date": "20250827"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (80425-0548-2)", "package_ndc": "80425-0548-2", "marketing_start_date": "20250827"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (80425-0548-3)", "package_ndc": "80425-0548-3", "marketing_start_date": "20250827"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (80425-0548-4)", "package_ndc": "80425-0548-4", "marketing_start_date": "20250827"}, {"sample": false, "description": "120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (80425-0548-5)", "package_ndc": "80425-0548-5", "marketing_start_date": "20250827"}, {"sample": false, "description": "40 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (80425-0548-6)", "package_ndc": "80425-0548-6", "marketing_start_date": "20250827"}, {"sample": false, "description": "180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (80425-0548-7)", "package_ndc": "80425-0548-7", "marketing_start_date": "20250827"}, {"sample": false, "description": "240 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (80425-0548-8)", "package_ndc": "80425-0548-8", "marketing_start_date": "20250827"}], "brand_name": "Tramadol Hydrochloride", "product_id": "80425-0548_4641b78d-bdc6-12d5-e063-6394a90a728a", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "80425-0548", "dea_schedule": "CIV", "generic_name": "Tramadol Hydrochloride", "labeler_name": "Advanced Rx of Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tramadol Hydrochloride", "active_ingredients": [{"name": "TRAMADOL HYDROCHLORIDE", "strength": "50 mg/1"}], "application_number": "ANDA211825", "marketing_category": "ANDA", "marketing_start_date": "20250827", "listing_expiration_date": "20261231"}