Tramadol Hydrochloride

Generic: Tramadol Hydrochloride

Labeler: Teva Pharmaceuticals USA, Inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive

Drug Facts

Product Profile

Brand Name Tramadol Hydrochloride
Generic Name Tramadol Hydrochloride
Labeler Teva Pharmaceuticals USA, Inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

TRAMADOL HYDROCHLORIDE 50 mg/1

Identifiers & Regulatory

Product NDC 0093-0058
Product ID 0093-0058_406611bf-17cb-4c5c-8921-1f3203b79d81
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075977
DEA Schedule CIV
Marketing Start 2002-06-20
Marketing End 2026-02-28

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00930058
Hyphenated Format 0093-0058

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 ANDA075977 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 500 TABLET, FILM COATED in 1 BOTTLE (0093-0058-05)
source: ndc

Packages (1)

0093-0058-05 500 TABLET, FILM COATED in 1 BOTTLE (0093-0058-05)

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": "406611bf-17cb-4c5c-8921-1f3203b79d81", "openfda": {"upc": ["0300930058011"], "unii": ["9N7R477WCK"], "rxcui": ["835603"], "spl_set_id": ["6d3b4049-2bfd-4874-b984-8fb231bff27c"], "manufacturer_name": ["Teva Pharmaceuticals USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (0093-0058-05)", "package_ndc": "0093-0058-05", "marketing_end_date": "20260228", "marketing_start_date": "20020703"}], "brand_name": "Tramadol Hydrochloride", "product_id": "0093-0058_406611bf-17cb-4c5c-8921-1f3203b79d81", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "0093-0058", "dea_schedule": "CIV", "generic_name": "Tramadol Hydrochloride", "labeler_name": "Teva Pharmaceuticals USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tramadol Hydrochloride", "active_ingredients": [{"name": "TRAMADOL HYDROCHLORIDE", "strength": "50 mg/1"}], "application_number": "ANDA075977", "marketing_category": "ANDA", "marketing_end_date": "20260228", "marketing_start_date": "20020620"}