tramadol hydrochloride and acetaminophen (76420-105)

Drug Facts

Product Profile

Brand Name tramadol hydrochloride and acetaminophen

Generic Name tramadol hydrochloride and acetaminophen

Labeler asclemed usa, inc.

Dosage Form TABLET, FILM COATED

Routes

ORAL

Active Ingredients

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

Manufacturer

Asclemed USA, Inc.

Identifiers & Regulatory

Product NDC 76420-105

Product ID 76420-105_b2ddcdd0-7229-99df-e053-2a95a90a8818

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA201952

DEA Schedule civ

Listing Expiration 2026-12-31

Marketing Start 2012-12-15

Pharmacologic Class

Classes

full opioid agonists [moa] opioid agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 76420105

Hyphenated Format 76420-105

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 ANDA201952 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

325 mg/1
37.5 mg/1

source: ndc

Packaging

1 TABLET, FILM COATED in 1 BOTTLE (76420-105-01)
2 TABLET, FILM COATED in 1 BOTTLE (76420-105-02)
3 TABLET, FILM COATED in 1 BOTTLE (76420-105-03)
10 TABLET, FILM COATED in 1 BOTTLE (76420-105-10)
30 TABLET, FILM COATED in 1 BOTTLE (76420-105-30)

source: ndc

Packages (5)

76420-105-01 1 TABLET, FILM COATED in 1 BOTTLE (76420-105-01) 76420-105-02 2 TABLET, FILM COATED in 1 BOTTLE (76420-105-02) 76420-105-03 3 TABLET, FILM COATED in 1 BOTTLE (76420-105-03) 76420-105-10 10 TABLET, FILM COATED in 1 BOTTLE (76420-105-10) 76420-105-30 30 TABLET, FILM COATED in 1 BOTTLE (76420-105-30)

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": "b2ddcdd0-7229-99df-e053-2a95a90a8818", "openfda": {"unii": ["362O9ITL9D", "9N7R477WCK"], "rxcui": ["836395"], "spl_set_id": ["82d8b70f-aebf-4b9a-89b1-183fc9e2ff59"], "manufacturer_name": ["Asclemed USA, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "1 TABLET, FILM COATED in 1 BOTTLE (76420-105-01)", "package_ndc": "76420-105-01", "marketing_start_date": "20201030"}, {"sample": false, "description": "2 TABLET, FILM COATED in 1 BOTTLE (76420-105-02)", "package_ndc": "76420-105-02", "marketing_start_date": "20201030"}, {"sample": false, "description": "3 TABLET, FILM COATED in 1 BOTTLE (76420-105-03)", "package_ndc": "76420-105-03", "marketing_start_date": "20201030"}, {"sample": false, "description": "10 TABLET, FILM COATED in 1 BOTTLE (76420-105-10)", "package_ndc": "76420-105-10", "marketing_start_date": "20201030"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (76420-105-30)", "package_ndc": "76420-105-30", "marketing_start_date": "20201030"}], "brand_name": "TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN", "product_id": "76420-105_b2ddcdd0-7229-99df-e053-2a95a90a8818", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "76420-105", "dea_schedule": "CIV", "generic_name": "TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN", "labeler_name": "Asclemed USA, 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": "ANDA201952", "marketing_category": "ANDA", "marketing_start_date": "20121215", "listing_expiration_date": "20261231"}