tramadol hydrochloride and acetaminophen

Generic: tramadol hydrochloride and acetaminophen

Labeler: aurobindo pharma limited
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 aurobindo pharma limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

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

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-922
Product ID 65862-922_e0a5c380-895e-4f05-9eaf-b27b17ad41e1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207152
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2017-03-22

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65862922
Hyphenated Format 65862-922

Supplemental Identifiers

RxCUI
836395
UNII
362O9ITL9D 9N7R477WCK

Packaging Origin

Original Packager
true

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 ANDA207152 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 325 mg/1
  • 37.5 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (65862-922-01)
  • 500 TABLET, FILM COATED in 1 BOTTLE (65862-922-05)
  • 30 TABLET, FILM COATED in 1 BOTTLE (65862-922-30)
  • 10 BLISTER PACK in 1 CARTON (65862-922-78) / 10 TABLET, FILM COATED in 1 BLISTER PACK (65862-922-10)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (65862-922-99)
source: ndc

Packages (5)

65862-922-01 100 TABLET, FILM COATED in 1 BOTTLE (65862-922-01) 65862-922-05 500 TABLET, FILM COATED in 1 BOTTLE (65862-922-05) 65862-922-30 30 TABLET, FILM COATED in 1 BOTTLE (65862-922-30) 65862-922-78 10 BLISTER PACK in 1 CARTON (65862-922-78) / 10 TABLET, FILM COATED in 1 BLISTER PACK (65862-922-10) 65862-922-99 1000 TABLET, FILM COATED in 1 BOTTLE (65862-922-99)

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": "e0a5c380-895e-4f05-9eaf-b27b17ad41e1", "openfda": {"unii": ["362O9ITL9D", "9N7R477WCK"], "rxcui": ["836395"], "spl_set_id": ["6c2894df-eeeb-4b22-ab32-8ce1601bfdfa"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (65862-922-01)", "package_ndc": "65862-922-01", "marketing_start_date": "20170322"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (65862-922-05)", "package_ndc": "65862-922-05", "marketing_start_date": "20170322"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (65862-922-30)", "package_ndc": "65862-922-30", "marketing_start_date": "20170322"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (65862-922-78)  / 10 TABLET, FILM COATED in 1 BLISTER PACK (65862-922-10)", "package_ndc": "65862-922-78", "marketing_start_date": "20170322"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (65862-922-99)", "package_ndc": "65862-922-99", "marketing_start_date": "20170322"}], "brand_name": "Tramadol Hydrochloride and Acetaminophen", "product_id": "65862-922_e0a5c380-895e-4f05-9eaf-b27b17ad41e1", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "65862-922", "dea_schedule": "CIV", "generic_name": "Tramadol Hydrochloride and Acetaminophen", "labeler_name": "Aurobindo Pharma Limited", "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": "ANDA207152", "marketing_category": "ANDA", "marketing_start_date": "20170322", "listing_expiration_date": "20261231"}