tramadol hydrochloride

Generic: tramadol hydrochloride

Labeler: amneal pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tramadol hydrochloride
Generic Name tramadol hydrochloride
Labeler amneal pharmaceuticals llc
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

tramadol hydrochloride 50 mg/1

Manufacturer
Amneal Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 65162-627
Product ID 65162-627_b0cfacfd-b823-4d43-93cc-2c30baa39fe5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076003
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2010-11-15

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65162627
Hyphenated Format 65162-627

Supplemental Identifiers

RxCUI
835603
UPC
0365162627503
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 ANDA076003 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 10 TABLET, COATED in 1 BOTTLE (65162-627-01)
  • 100 TABLET, COATED in 1 BOTTLE (65162-627-10)
  • 1000 TABLET, COATED in 1 BOTTLE (65162-627-11)
  • 500 TABLET, COATED in 1 BOTTLE (65162-627-50)
source: ndc

Packages (4)

65162-627-01 10 TABLET, COATED in 1 BOTTLE (65162-627-01) 65162-627-10 100 TABLET, COATED in 1 BOTTLE (65162-627-10) 65162-627-11 1000 TABLET, COATED in 1 BOTTLE (65162-627-11) 65162-627-50 500 TABLET, COATED in 1 BOTTLE (65162-627-50)

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": "b0cfacfd-b823-4d43-93cc-2c30baa39fe5", "openfda": {"upc": ["0365162627503"], "unii": ["9N7R477WCK"], "rxcui": ["835603"], "spl_set_id": ["58b802cb-2443-4f5b-9718-7d54c6d50cb4"], "manufacturer_name": ["Amneal Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 TABLET, COATED in 1 BOTTLE (65162-627-01)", "package_ndc": "65162-627-01", "marketing_start_date": "20101115"}, {"sample": false, "description": "100 TABLET, COATED in 1 BOTTLE (65162-627-10)", "package_ndc": "65162-627-10", "marketing_start_date": "20101115"}, {"sample": false, "description": "1000 TABLET, COATED in 1 BOTTLE (65162-627-11)", "package_ndc": "65162-627-11", "marketing_start_date": "20101115"}, {"sample": false, "description": "500 TABLET, COATED in 1 BOTTLE (65162-627-50)", "package_ndc": "65162-627-50", "marketing_start_date": "20101115"}], "brand_name": "Tramadol Hydrochloride", "product_id": "65162-627_b0cfacfd-b823-4d43-93cc-2c30baa39fe5", "dosage_form": "TABLET, COATED", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "65162-627", "dea_schedule": "CIV", "generic_name": "Tramadol Hydrochloride", "labeler_name": "Amneal Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tramadol Hydrochloride", "active_ingredients": [{"name": "TRAMADOL HYDROCHLORIDE", "strength": "50 mg/1"}], "application_number": "ANDA076003", "marketing_category": "ANDA", "marketing_start_date": "20101115", "listing_expiration_date": "20261231"}