tramadol hydrochloride

Generic: tramadol hydrochloride

Labeler: proficient rx lp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tramadol hydrochloride
Generic Name tramadol hydrochloride
Labeler proficient rx lp
Dosage Form TABLET
Routes
ORAL
Active Ingredients

tramadol hydrochloride 50 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 82804-114
Product ID 82804-114_2236031d-8596-4c21-8b16-83aa3e4122c1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202075
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2018-03-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 82804114
Hyphenated Format 82804-114

Supplemental Identifiers

RxCUI
835603
UPC
0382804114788
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 ANDA202075 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 15 TABLET in 1 BOTTLE (82804-114-15)
  • 20 TABLET in 1 BOTTLE (82804-114-20)
  • 30 TABLET in 1 BOTTLE (82804-114-30)
  • 40 TABLET in 1 BOTTLE (82804-114-40)
  • 60 TABLET in 1 BOTTLE (82804-114-60)
  • 240 TABLET in 1 BOTTLE (82804-114-64)
  • 120 TABLET in 1 BOTTLE (82804-114-72)
  • 180 TABLET in 1 BOTTLE (82804-114-78)
  • 90 TABLET in 1 BOTTLE (82804-114-90)
source: ndc

Packages (9)

82804-114-15 15 TABLET in 1 BOTTLE (82804-114-15) 82804-114-20 20 TABLET in 1 BOTTLE (82804-114-20) 82804-114-30 30 TABLET in 1 BOTTLE (82804-114-30) 82804-114-40 40 TABLET in 1 BOTTLE (82804-114-40) 82804-114-60 60 TABLET in 1 BOTTLE (82804-114-60) 82804-114-64 240 TABLET in 1 BOTTLE (82804-114-64) 82804-114-72 120 TABLET in 1 BOTTLE (82804-114-72) 82804-114-78 180 TABLET in 1 BOTTLE (82804-114-78) 82804-114-90 90 TABLET in 1 BOTTLE (82804-114-90)

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": "2236031d-8596-4c21-8b16-83aa3e4122c1", "openfda": {"upc": ["0382804114788"], "unii": ["9N7R477WCK"], "rxcui": ["835603"], "spl_set_id": ["2236031d-8596-4c21-8b16-83aa3e4122c1"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "15 TABLET in 1 BOTTLE (82804-114-15)", "package_ndc": "82804-114-15", "marketing_start_date": "20240702"}, {"sample": false, "description": "20 TABLET in 1 BOTTLE (82804-114-20)", "package_ndc": "82804-114-20", "marketing_start_date": "20240702"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (82804-114-30)", "package_ndc": "82804-114-30", "marketing_start_date": "20240702"}, {"sample": false, "description": "40 TABLET in 1 BOTTLE (82804-114-40)", "package_ndc": "82804-114-40", "marketing_start_date": "20240702"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (82804-114-60)", "package_ndc": "82804-114-60", "marketing_start_date": "20240702"}, {"sample": false, "description": "240 TABLET in 1 BOTTLE (82804-114-64)", "package_ndc": "82804-114-64", "marketing_start_date": "20240702"}, {"sample": false, "description": "120 TABLET in 1 BOTTLE (82804-114-72)", "package_ndc": "82804-114-72", "marketing_start_date": "20240702"}, {"sample": false, "description": "180 TABLET in 1 BOTTLE (82804-114-78)", "package_ndc": "82804-114-78", "marketing_start_date": "20240702"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (82804-114-90)", "package_ndc": "82804-114-90", "marketing_start_date": "20240702"}], "brand_name": "tramadol hydrochloride", "product_id": "82804-114_2236031d-8596-4c21-8b16-83aa3e4122c1", "dosage_form": "TABLET", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "82804-114", "dea_schedule": "CIV", "generic_name": "tramadol hydrochloride", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "tramadol hydrochloride", "active_ingredients": [{"name": "TRAMADOL HYDROCHLORIDE", "strength": "50 mg/1"}], "application_number": "ANDA202075", "marketing_category": "ANDA", "marketing_start_date": "20180301", "listing_expiration_date": "20261231"}