tramadol hcl er

Generic: tramadol hcl

Labeler: advanced rx pharmacy of tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tramadol hcl er
Generic Name tramadol hcl
Labeler advanced rx pharmacy of tennessee, llc
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

tramadol hydrochloride 100 mg/1

Manufacturer
Advanced Rx Pharmacy of Tennessee, LLC

Identifiers & Regulatory

Product NDC 80425-0108
Product ID 80425-0108_2760a808-b074-5887-e063-6294a90a79ae
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA200503
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2014-08-19

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 804250108
Hyphenated Format 80425-0108

Supplemental Identifiers

RxCUI
833709
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 hcl er (source: ndc)
Generic Name tramadol hcl (source: ndc)
Application Number ANDA200503 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (80425-0108-1)
  • 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (80425-0108-2)
  • 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (80425-0108-3)
source: ndc

Packages (3)

80425-0108-1 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (80425-0108-1) 80425-0108-2 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (80425-0108-2) 80425-0108-3 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (80425-0108-3)

Ingredients (1)

tramadol hydrochloride (100 mg/1)

Linked Drug Pages (1)

Tramadol HCL ER ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2760a808-b074-5887-e063-6294a90a79ae", "openfda": {"unii": ["9N7R477WCK"], "rxcui": ["833709"], "spl_set_id": ["b4cd4b64-7db5-da44-e053-2995a90a8953"], "manufacturer_name": ["Advanced Rx Pharmacy of Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (80425-0108-1)", "package_ndc": "80425-0108-1", "marketing_start_date": "20140819"}, {"sample": false, "description": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE (80425-0108-2)", "package_ndc": "80425-0108-2", "marketing_start_date": "20140819"}, {"sample": false, "description": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (80425-0108-3)", "package_ndc": "80425-0108-3", "marketing_start_date": "20241120"}], "brand_name": "Tramadol HCL ER", "product_id": "80425-0108_2760a808-b074-5887-e063-6294a90a79ae", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "80425-0108", "dea_schedule": "CIV", "generic_name": "Tramadol HCL", "labeler_name": "Advanced Rx Pharmacy of Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tramadol HCL", "brand_name_suffix": "ER", "active_ingredients": [{"name": "TRAMADOL HYDROCHLORIDE", "strength": "100 mg/1"}], "application_number": "ANDA200503", "marketing_category": "ANDA", "marketing_start_date": "20140819", "listing_expiration_date": "20261231"}