tramadol hydrochloride

Generic: tramadol hydrochloride

Labeler: asclemed usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tramadol hydrochloride
Generic Name tramadol hydrochloride
Labeler asclemed usa, inc.
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

tramadol hydrochloride 100 mg/1

Manufacturer
Asclemed USA, Inc.

Identifiers & Regulatory

Product NDC 76420-734
Product ID 76420-734_3c537239-67e9-1101-e063-6394a90a397f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208708
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2020-02-24

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 76420734
Hyphenated Format 76420-734

Supplemental Identifiers

RxCUI
835603 2179635 2670390
UNII
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 (source: ndc)
Generic Name tramadol hydrochloride (source: ndc)
Application Number ANDA208708 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 1000 TABLET, COATED in 1 BOTTLE (76420-734-00)
  • 100 TABLET, COATED in 1 BOTTLE (76420-734-01)
  • 500 TABLET, COATED in 1 BOTTLE (76420-734-05)
  • 30 TABLET, COATED in 1 BOTTLE (76420-734-30)
  • 60 TABLET, COATED in 1 BOTTLE (76420-734-60)
  • 90 TABLET, COATED in 1 BOTTLE (76420-734-90)
source: ndc

Packages (6)

76420-734-00 1000 TABLET, COATED in 1 BOTTLE (76420-734-00) 76420-734-01 100 TABLET, COATED in 1 BOTTLE (76420-734-01) 76420-734-05 500 TABLET, COATED in 1 BOTTLE (76420-734-05) 76420-734-30 30 TABLET, COATED in 1 BOTTLE (76420-734-30) 76420-734-60 60 TABLET, COATED in 1 BOTTLE (76420-734-60) 76420-734-90 90 TABLET, COATED in 1 BOTTLE (76420-734-90)

Ingredients (1)

tramadol hydrochloride (100 mg/1)

Linked Drug Pages (1)

Tramadol Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3c537239-67e9-1101-e063-6394a90a397f", "openfda": {"unii": ["9N7R477WCK"], "rxcui": ["835603", "2179635", "2670390"], "spl_set_id": ["6a60bd36-7dcc-49c3-b6de-b263fdaa312c"], "manufacturer_name": ["Asclemed USA, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET, COATED in 1 BOTTLE (76420-734-00)", "package_ndc": "76420-734-00", "marketing_start_date": "20240522"}, {"sample": false, "description": "100 TABLET, COATED in 1 BOTTLE (76420-734-01)", "package_ndc": "76420-734-01", "marketing_start_date": "20240522"}, {"sample": false, "description": "500 TABLET, COATED in 1 BOTTLE (76420-734-05)", "package_ndc": "76420-734-05", "marketing_start_date": "20240522"}, {"sample": false, "description": "30 TABLET, COATED in 1 BOTTLE (76420-734-30)", "package_ndc": "76420-734-30", "marketing_start_date": "20240522"}, {"sample": false, "description": "60 TABLET, COATED in 1 BOTTLE (76420-734-60)", "package_ndc": "76420-734-60", "marketing_start_date": "20240522"}, {"sample": false, "description": "90 TABLET, COATED in 1 BOTTLE (76420-734-90)", "package_ndc": "76420-734-90", "marketing_start_date": "20240522"}], "brand_name": "Tramadol Hydrochloride", "product_id": "76420-734_3c537239-67e9-1101-e063-6394a90a397f", "dosage_form": "TABLET, COATED", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "76420-734", "dea_schedule": "CIV", "generic_name": "Tramadol Hydrochloride", "labeler_name": "Asclemed USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tramadol Hydrochloride", "active_ingredients": [{"name": "TRAMADOL HYDROCHLORIDE", "strength": "100 mg/1"}], "application_number": "ANDA208708", "marketing_category": "ANDA", "marketing_start_date": "20200224", "listing_expiration_date": "20261231"}