tramadol hydrochloride

Generic: tramadol hydrochloride

Labeler: medsource pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tramadol hydrochloride
Generic Name tramadol hydrochloride
Labeler medsource pharmaceuticals
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

tramadol hydrochloride 300 mg/1

Manufacturer
Medsource Pharmaceuticals

Identifiers & Regulatory

Product NDC 45865-184
Product ID 45865-184_12789848-2a06-0414-e063-6394a90a3d50
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 45865184
Hyphenated Format 45865-184

Supplemental Identifiers

RxCUI
833713
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 ANDA200503 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (45865-184-30)
source: ndc

Packages (1)

45865-184-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (45865-184-30)

Ingredients (1)

tramadol hydrochloride (300 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": "12789848-2a06-0414-e063-6394a90a3d50", "openfda": {"unii": ["9N7R477WCK"], "rxcui": ["833713"], "spl_set_id": ["1278980b-4068-df57-e063-6394a90a8742"], "manufacturer_name": ["Medsource Pharmaceuticals"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (45865-184-30)", "package_ndc": "45865-184-30", "marketing_start_date": "20210528"}], "brand_name": "TRAMADOL HYDROCHLORIDE", "product_id": "45865-184_12789848-2a06-0414-e063-6394a90a3d50", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "45865-184", "dea_schedule": "CIV", "generic_name": "TRAMADOL HYDROCHLORIDE", "labeler_name": "Medsource Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "TRAMADOL HYDROCHLORIDE", "active_ingredients": [{"name": "TRAMADOL HYDROCHLORIDE", "strength": "300 mg/1"}], "application_number": "ANDA200503", "marketing_category": "ANDA", "marketing_start_date": "20140819", "listing_expiration_date": "20261231"}