tramadol hydrochloride

Generic: tramadol hydrochloride

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tramadol hydrochloride
Generic Name tramadol hydrochloride
Labeler aurobindo pharma limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

tramadol hydrochloride 50 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 59651-441
Product ID 59651-441_7100e3d0-b751-47a1-a947-97c7573eec7a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203494
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2020-09-23

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 59651441
Hyphenated Format 59651-441

Supplemental Identifiers

RxCUI
835603
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 ANDA203494 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (59651-441-01)
  • 500 TABLET, FILM COATED in 1 BOTTLE (59651-441-05)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (59651-441-99)
source: ndc

Packages (3)

59651-441-01 100 TABLET, FILM COATED in 1 BOTTLE (59651-441-01) 59651-441-05 500 TABLET, FILM COATED in 1 BOTTLE (59651-441-05) 59651-441-99 1000 TABLET, FILM COATED in 1 BOTTLE (59651-441-99)

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": "7100e3d0-b751-47a1-a947-97c7573eec7a", "openfda": {"unii": ["9N7R477WCK"], "rxcui": ["835603"], "spl_set_id": ["e5005d9e-91cb-4ff8-bcf2-b5ee70cf4f3f"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (59651-441-01)", "package_ndc": "59651-441-01", "marketing_start_date": "20200923"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (59651-441-05)", "package_ndc": "59651-441-05", "marketing_start_date": "20200923"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (59651-441-99)", "package_ndc": "59651-441-99", "marketing_start_date": "20200923"}], "brand_name": "Tramadol Hydrochloride", "product_id": "59651-441_7100e3d0-b751-47a1-a947-97c7573eec7a", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "59651-441", "dea_schedule": "CIV", "generic_name": "Tramadol Hydrochloride", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tramadol Hydrochloride", "active_ingredients": [{"name": "TRAMADOL HYDROCHLORIDE", "strength": "50 mg/1"}], "application_number": "ANDA203494", "marketing_category": "ANDA", "marketing_start_date": "20200923", "listing_expiration_date": "20261231"}