tramadol hydrochloride and acetaminophen

Generic: tramadol hydrochloride and acetaminophen

Labeler: avpak
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tramadol hydrochloride and acetaminophen
Generic Name tramadol hydrochloride and acetaminophen
Labeler avpak
Dosage Form TABLET
Routes
ORAL
Active Ingredients

acetaminophen 325 mg/1, tramadol hydrochloride 37.5 mg/1

Manufacturer
AvPAK

Identifiers & Regulatory

Product NDC 50268-774
Product ID 50268-774_48365501-3c10-9da0-e063-6394a90a25d3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090485
DEA Schedule civ
Marketing Start 2015-01-14
Marketing End 2027-03-31

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50268774
Hyphenated Format 50268-774

Supplemental Identifiers

RxCUI
836395
UNII
362O9ITL9D 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 and acetaminophen (source: ndc)
Generic Name tramadol hydrochloride and acetaminophen (source: ndc)
Application Number ANDA090485 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 325 mg/1
  • 37.5 mg/1
source: ndc
Packaging
  • 50 BLISTER PACK in 1 BOX (50268-774-15) / 1 TABLET in 1 BLISTER PACK (50268-774-11)
source: ndc

Packages (1)

50268-774-15 50 BLISTER PACK in 1 BOX (50268-774-15) / 1 TABLET in 1 BLISTER PACK (50268-774-11)

Ingredients (2)

acetaminophen (325 mg/1) tramadol hydrochloride (37.5 mg/1)

Linked Drug Pages (1)

Tramadol Hydrochloride and Acetaminophen ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "48365501-3c10-9da0-e063-6394a90a25d3", "openfda": {"unii": ["362O9ITL9D", "9N7R477WCK"], "rxcui": ["836395"], "spl_set_id": ["244f6e5d-e1b4-ba8b-ca6f-af2d8a31d5f0"], "manufacturer_name": ["AvPAK"]}, "finished": true, "packaging": [{"sample": false, "description": "50 BLISTER PACK in 1 BOX (50268-774-15)  / 1 TABLET in 1 BLISTER PACK (50268-774-11)", "package_ndc": "50268-774-15", "marketing_end_date": "20270331", "marketing_start_date": "20150114"}], "brand_name": "Tramadol Hydrochloride and Acetaminophen", "product_id": "50268-774_48365501-3c10-9da0-e063-6394a90a25d3", "dosage_form": "TABLET", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "50268-774", "dea_schedule": "CIV", "generic_name": "Tramadol Hydrochloride and Acetaminophen", "labeler_name": "AvPAK", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tramadol Hydrochloride and Acetaminophen", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "325 mg/1"}, {"name": "TRAMADOL HYDROCHLORIDE", "strength": "37.5 mg/1"}], "application_number": "ANDA090485", "marketing_category": "ANDA", "marketing_end_date": "20270331", "marketing_start_date": "20150114"}