tramadol hydrochloride and acetaminophen

Generic: tramadol hydrochloride and acetaminophen

Labeler: nucare pharmaceuticals, inc.
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 nucare pharmaceuticals, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

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

Manufacturer
NuCare Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68071-3044
Product ID 68071-3044_1d8e1fca-6867-7c08-e063-6394a90a08b6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090460
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2012-10-15

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 680713044
Hyphenated Format 68071-3044

Supplemental Identifiers

RxCUI
836395
UPC
0368071304428
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 ANDA090460 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 325 mg/1
  • 37.5 mg/1
source: ndc
Packaging
  • 20 TABLET, FILM COATED in 1 BOTTLE (68071-3044-2)
  • 30 TABLET, FILM COATED in 1 BOTTLE (68071-3044-3)
  • 60 TABLET, FILM COATED in 1 BOTTLE (68071-3044-6)
source: ndc

Packages (3)

68071-3044-2 20 TABLET, FILM COATED in 1 BOTTLE (68071-3044-2) 68071-3044-3 30 TABLET, FILM COATED in 1 BOTTLE (68071-3044-3) 68071-3044-6 60 TABLET, FILM COATED in 1 BOTTLE (68071-3044-6)

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": "1d8e1fca-6867-7c08-e063-6394a90a08b6", "openfda": {"upc": ["0368071304428"], "unii": ["362O9ITL9D", "9N7R477WCK"], "rxcui": ["836395"], "spl_set_id": ["4a668406-d2fc-13c9-e054-00144ff88e88"], "manufacturer_name": ["NuCare Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "20 TABLET, FILM COATED in 1 BOTTLE (68071-3044-2)", "package_ndc": "68071-3044-2", "marketing_start_date": "20170310"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (68071-3044-3)", "package_ndc": "68071-3044-3", "marketing_start_date": "20170310"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (68071-3044-6)", "package_ndc": "68071-3044-6", "marketing_start_date": "20170310"}], "brand_name": "Tramadol Hydrochloride and Acetaminophen", "product_id": "68071-3044_1d8e1fca-6867-7c08-e063-6394a90a08b6", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "68071-3044", "dea_schedule": "CIV", "generic_name": "Tramadol Hydrochloride and Acetaminophen", "labeler_name": "NuCare Pharmaceuticals, Inc.", "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": "ANDA090460", "marketing_category": "ANDA", "marketing_start_date": "20121015", "listing_expiration_date": "20261231"}