tramadol hydrochloride and acetaminophen

Generic: tramadol hydrochloride and acetaminophen

Labeler: amneal pharmaceuticals of new york llc
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 amneal pharmaceuticals of new york llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

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

Manufacturer
Amneal Pharmaceuticals of New York LLC

Identifiers & Regulatory

Product NDC 53746-617
Product ID 53746-617_288548d0-fd1c-4c33-bb0e-f35e47f314aa
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 53746617
Hyphenated Format 53746-617

Supplemental Identifiers

RxCUI
836395
UPC
0353746617309
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 ANDA090485 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 325 mg/1
  • 37.5 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (53746-617-01)
  • 500 TABLET in 1 BOTTLE (53746-617-05)
  • 1000 TABLET in 1 BOTTLE (53746-617-10)
  • 30 TABLET in 1 BOTTLE (53746-617-30)
source: ndc

Packages (4)

53746-617-01 100 TABLET in 1 BOTTLE (53746-617-01) 53746-617-05 500 TABLET in 1 BOTTLE (53746-617-05) 53746-617-10 1000 TABLET in 1 BOTTLE (53746-617-10) 53746-617-30 30 TABLET in 1 BOTTLE (53746-617-30)

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": "288548d0-fd1c-4c33-bb0e-f35e47f314aa", "openfda": {"upc": ["0353746617309"], "unii": ["362O9ITL9D", "9N7R477WCK"], "rxcui": ["836395"], "spl_set_id": ["d51600e2-2f73-483c-9b2e-f142bafff16d"], "manufacturer_name": ["Amneal Pharmaceuticals of New York LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (53746-617-01)", "package_ndc": "53746-617-01", "marketing_start_date": "20091217"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (53746-617-05)", "package_ndc": "53746-617-05", "marketing_start_date": "20091217"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (53746-617-10)", "package_ndc": "53746-617-10", "marketing_start_date": "20091217"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (53746-617-30)", "package_ndc": "53746-617-30", "marketing_start_date": "20091217"}], "brand_name": "Tramadol Hydrochloride and Acetaminophen", "product_id": "53746-617_288548d0-fd1c-4c33-bb0e-f35e47f314aa", "dosage_form": "TABLET", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "53746-617", "dea_schedule": "CIV", "generic_name": "Tramadol Hydrochloride and Acetaminophen", "labeler_name": "Amneal Pharmaceuticals of New York LLC", "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"}