tramadol hydrochloride and acetaminophen

Generic: tramadol hydrochloride and acetaminophen

Labeler: proficient rx lp
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 proficient rx lp
Dosage Form TABLET
Routes
ORAL
Active Ingredients

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

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 63187-084
Product ID 63187-084_07437d1c-92eb-437a-8740-24a126006667
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090485
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2009-12-17

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63187084
Hyphenated Format 63187-084

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
  • 30 TABLET in 1 BOTTLE (63187-084-30)
  • 60 TABLET in 1 BOTTLE (63187-084-60)
source: ndc

Packages (2)

63187-084-30 30 TABLET in 1 BOTTLE (63187-084-30) 63187-084-60 60 TABLET in 1 BOTTLE (63187-084-60)

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": "07437d1c-92eb-437a-8740-24a126006667", "openfda": {"unii": ["362O9ITL9D", "9N7R477WCK"], "rxcui": ["836395"], "spl_set_id": ["1ad89537-3e59-438c-b646-b3c93b790853"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (63187-084-30)", "package_ndc": "63187-084-30", "marketing_start_date": "20190101"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (63187-084-60)", "package_ndc": "63187-084-60", "marketing_start_date": "20190101"}], "brand_name": "Tramadol Hydrochloride and Acetaminophen", "product_id": "63187-084_07437d1c-92eb-437a-8740-24a126006667", "dosage_form": "TABLET", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "63187-084", "dea_schedule": "CIV", "generic_name": "Tramadol Hydrochloride and Acetaminophen", "labeler_name": "Proficient Rx LP", "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_start_date": "20091217", "listing_expiration_date": "20261231"}