tramadol hydrochloride

Generic: tramadol hydrochloride

Labeler: trupharma llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

tramadol hydrochloride 100 mg/1

Manufacturer
TRUPHARMA LLC

Identifiers & Regulatory

Product NDC 52817-196
Product ID 52817-196_bb37b29d-c827-d710-e053-2995a90acf1d
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 52817196
Hyphenated Format 52817-196

Supplemental Identifiers

RxCUI
835603 2179635
UPC
0352817196101 0352817196002 0352817195005 0352817196507 0352817195500 0352817195104
UNII
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 (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 (52817-196-00)
  • 100 TABLET, COATED in 1 BOTTLE (52817-196-10)
  • 500 TABLET, COATED in 1 BOTTLE (52817-196-50)
source: ndc

Packages (3)

52817-196-00 1000 TABLET, COATED in 1 BOTTLE (52817-196-00) 52817-196-10 100 TABLET, COATED in 1 BOTTLE (52817-196-10) 52817-196-50 500 TABLET, COATED in 1 BOTTLE (52817-196-50)

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": "bb37b29d-c827-d710-e053-2995a90acf1d", "openfda": {"upc": ["0352817196101", "0352817196002", "0352817195005", "0352817196507", "0352817195500", "0352817195104"], "unii": ["9N7R477WCK"], "rxcui": ["835603", "2179635"], "spl_set_id": ["61fb5ba7-6896-4ee4-83de-caee69b06a8e"], "manufacturer_name": ["TRUPHARMA LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET, COATED in 1 BOTTLE (52817-196-00)", "package_ndc": "52817-196-00", "marketing_start_date": "20200224"}, {"sample": false, "description": "100 TABLET, COATED in 1 BOTTLE (52817-196-10)", "package_ndc": "52817-196-10", "marketing_start_date": "20200224"}, {"sample": false, "description": "500 TABLET, COATED in 1 BOTTLE (52817-196-50)", "package_ndc": "52817-196-50", "marketing_start_date": "20200224"}], "brand_name": "Tramadol Hydrochloride", "product_id": "52817-196_bb37b29d-c827-d710-e053-2995a90acf1d", "dosage_form": "TABLET, COATED", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "52817-196", "dea_schedule": "CIV", "generic_name": "Tramadol Hydrochloride", "labeler_name": "TRUPHARMA LLC", "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"}