tramadol hydrochloride

Generic: tramadol hydrochloride

Labeler: asclemed usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tramadol hydrochloride
Generic Name tramadol hydrochloride
Labeler asclemed usa, inc.
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

tramadol hydrochloride 100 mg/1

Manufacturer
Asclemed USA, Inc.

Identifiers & Regulatory

Product NDC 76420-536
Product ID 76420-536_f4ca3781-8aec-9696-e053-2a95a90adf9f
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 76420536
Hyphenated Format 76420-536

Supplemental Identifiers

RxCUI
833709 833711 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
  • 100 mg/1
source: ndc
Packaging
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (76420-536-30)
  • 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (76420-536-60)
  • 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (76420-536-90)
source: ndc

Packages (3)

76420-536-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (76420-536-30) 76420-536-60 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (76420-536-60) 76420-536-90 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (76420-536-90)

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": "f4ca3781-8aec-9696-e053-2a95a90adf9f", "openfda": {"unii": ["9N7R477WCK"], "rxcui": ["833709", "833711", "833713"], "spl_set_id": ["a26ca887-e26c-4c32-8dbd-1fa2eb6db9dc"], "manufacturer_name": ["Asclemed USA, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (76420-536-30)", "package_ndc": "76420-536-30", "marketing_start_date": "20230216"}, {"sample": false, "description": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE (76420-536-60)", "package_ndc": "76420-536-60", "marketing_start_date": "20230216"}, {"sample": false, "description": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (76420-536-90)", "package_ndc": "76420-536-90", "marketing_start_date": "20230216"}], "brand_name": "TRAMADOL HYDROCHLORIDE", "product_id": "76420-536_f4ca3781-8aec-9696-e053-2a95a90adf9f", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "76420-536", "dea_schedule": "CIV", "generic_name": "TRAMADOL HYDROCHLORIDE", "labeler_name": "Asclemed USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "TRAMADOL HYDROCHLORIDE", "active_ingredients": [{"name": "TRAMADOL HYDROCHLORIDE", "strength": "100 mg/1"}], "application_number": "ANDA200503", "marketing_category": "ANDA", "marketing_start_date": "20140819", "listing_expiration_date": "20261231"}