tramadol hydrochloride

Generic: tramadol hydrochloride

Labeler: clinical solutions wholesale, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tramadol hydrochloride
Generic Name tramadol hydrochloride
Labeler clinical solutions wholesale, llc
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

tramadol hydrochloride 50 mg/1

Manufacturer
Clinical Solutions Wholesale, LLC

Identifiers & Regulatory

Product NDC 58118-2348
Product ID 58118-2348_2d7afbeb-0877-e7df-e063-6394a90a2e55
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076003
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2023-02-13

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 581182348
Hyphenated Format 58118-2348

Supplemental Identifiers

RxCUI
835603
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 ANDA076003 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 30 TABLET, COATED in 1 BLISTER PACK (58118-2348-8)
source: ndc

Packages (1)

58118-2348-8 30 TABLET, COATED in 1 BLISTER PACK (58118-2348-8)

Ingredients (1)

tramadol hydrochloride (50 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": "2d7afbeb-0877-e7df-e063-6394a90a2e55", "openfda": {"unii": ["9N7R477WCK"], "rxcui": ["835603"], "spl_set_id": ["728157e2-d153-4ea0-81eb-36599dc7dfda"], "manufacturer_name": ["Clinical Solutions Wholesale, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, COATED in 1 BLISTER PACK (58118-2348-8)", "package_ndc": "58118-2348-8", "marketing_start_date": "20250206"}], "brand_name": "Tramadol Hydrochloride", "product_id": "58118-2348_2d7afbeb-0877-e7df-e063-6394a90a2e55", "dosage_form": "TABLET, COATED", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "58118-2348", "dea_schedule": "CIV", "generic_name": "Tramadol Hydrochloride", "labeler_name": "Clinical Solutions Wholesale, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tramadol Hydrochloride", "active_ingredients": [{"name": "TRAMADOL HYDROCHLORIDE", "strength": "50 mg/1"}], "application_number": "ANDA076003", "marketing_category": "ANDA", "marketing_start_date": "20230213", "listing_expiration_date": "20261231"}