tramadol hydrochloride

Generic: tramadol hydrochloride

Labeler: aphena pharma solutions - tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tramadol hydrochloride
Generic Name tramadol hydrochloride
Labeler aphena pharma solutions - tennessee, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

tramadol hydrochloride 50 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-006
Product ID 71610-006_069eec8b-6cca-435c-9d3f-fbdc75a813a0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075977
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2017-08-24

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71610006
Hyphenated Format 71610-006

Supplemental Identifiers

RxCUI
835603
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 ANDA075977 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 15 TABLET, FILM COATED in 1 BOTTLE (71610-006-15)
  • 20 TABLET, FILM COATED in 1 BOTTLE (71610-006-20)
  • 224 TABLET, FILM COATED in 1 BOTTLE (71610-006-24)
  • 28 TABLET, FILM COATED in 1 BOTTLE (71610-006-28)
  • 30 TABLET, FILM COATED in 1 BOTTLE (71610-006-30)
  • 40 TABLET, FILM COATED in 1 BOTTLE (71610-006-40)
  • 45 TABLET, FILM COATED in 1 BOTTLE (71610-006-45)
  • 56 TABLET, FILM COATED in 1 BOTTLE (71610-006-46)
  • 480 TABLET, FILM COATED in 1 BOTTLE (71610-006-48)
  • 50 TABLET, FILM COATED in 1 BOTTLE (71610-006-50)
  • 60 TABLET, FILM COATED in 1 BOTTLE (71610-006-53)
  • 84 TABLET, FILM COATED in 1 BOTTLE (71610-006-54)
  • 80 TABLET, FILM COATED in 1 BOTTLE (71610-006-57)
  • 90 TABLET, FILM COATED in 1 BOTTLE (71610-006-60)
  • 100 TABLET, FILM COATED in 1 BOTTLE (71610-006-65)
  • 168 TABLET, FILM COATED in 1 BOTTLE (71610-006-67)
  • 120 TABLET, FILM COATED in 1 BOTTLE (71610-006-70)
  • 112 TABLET, FILM COATED in 1 BOTTLE (71610-006-72)
  • 135 TABLET, FILM COATED in 1 BOTTLE (71610-006-73)
  • 150 TABLET, FILM COATED in 1 BOTTLE (71610-006-75)
  • 180 TABLET, FILM COATED in 1 BOTTLE (71610-006-80)
  • 200 TABLET, FILM COATED in 1 BOTTLE (71610-006-85)
  • 720 TABLET, FILM COATED in 1 BOTTLE (71610-006-89)
  • 240 TABLET, FILM COATED in 1 BOTTLE (71610-006-90)
  • 270 TABLET, FILM COATED in 1 BOTTLE (71610-006-92)
  • 360 TABLET, FILM COATED in 1 BOTTLE (71610-006-94)
  • 540 TABLET, FILM COATED in 1 BOTTLE (71610-006-98)
source: ndc

Packages (27)

71610-006-15 15 TABLET, FILM COATED in 1 BOTTLE (71610-006-15) 71610-006-20 20 TABLET, FILM COATED in 1 BOTTLE (71610-006-20) 71610-006-24 224 TABLET, FILM COATED in 1 BOTTLE (71610-006-24) 71610-006-28 28 TABLET, FILM COATED in 1 BOTTLE (71610-006-28) 71610-006-30 30 TABLET, FILM COATED in 1 BOTTLE (71610-006-30) 71610-006-40 40 TABLET, FILM COATED in 1 BOTTLE (71610-006-40) 71610-006-45 45 TABLET, FILM COATED in 1 BOTTLE (71610-006-45) 71610-006-46 56 TABLET, FILM COATED in 1 BOTTLE (71610-006-46) 71610-006-48 480 TABLET, FILM COATED in 1 BOTTLE (71610-006-48) 71610-006-50 50 TABLET, FILM COATED in 1 BOTTLE (71610-006-50) 71610-006-53 60 TABLET, FILM COATED in 1 BOTTLE (71610-006-53) 71610-006-54 84 TABLET, FILM COATED in 1 BOTTLE (71610-006-54) 71610-006-57 80 TABLET, FILM COATED in 1 BOTTLE (71610-006-57) 71610-006-60 90 TABLET, FILM COATED in 1 BOTTLE (71610-006-60) 71610-006-65 100 TABLET, FILM COATED in 1 BOTTLE (71610-006-65) 71610-006-67 168 TABLET, FILM COATED in 1 BOTTLE (71610-006-67) 71610-006-70 120 TABLET, FILM COATED in 1 BOTTLE (71610-006-70) 71610-006-72 112 TABLET, FILM COATED in 1 BOTTLE (71610-006-72) 71610-006-73 135 TABLET, FILM COATED in 1 BOTTLE (71610-006-73) 71610-006-75 150 TABLET, FILM COATED in 1 BOTTLE (71610-006-75) 71610-006-80 180 TABLET, FILM COATED in 1 BOTTLE (71610-006-80) 71610-006-85 200 TABLET, FILM COATED in 1 BOTTLE (71610-006-85) 71610-006-89 720 TABLET, FILM COATED in 1 BOTTLE (71610-006-89) 71610-006-90 240 TABLET, FILM COATED in 1 BOTTLE (71610-006-90) 71610-006-92 270 TABLET, FILM COATED in 1 BOTTLE (71610-006-92) 71610-006-94 360 TABLET, FILM COATED in 1 BOTTLE (71610-006-94) 71610-006-98 540 TABLET, FILM COATED in 1 BOTTLE (71610-006-98)

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": "069eec8b-6cca-435c-9d3f-fbdc75a813a0", "openfda": {"unii": ["9N7R477WCK"], "rxcui": ["835603"], "spl_set_id": ["bbd6c0d4-110c-4bda-9d9f-89ab7ce4c18e"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "15 TABLET, FILM COATED in 1 BOTTLE (71610-006-15)", "package_ndc": "71610-006-15", "marketing_start_date": "20171006"}, {"sample": false, "description": "20 TABLET, FILM COATED in 1 BOTTLE (71610-006-20)", "package_ndc": "71610-006-20", "marketing_start_date": "20171006"}, {"sample": false, "description": "224 TABLET, FILM COATED in 1 BOTTLE (71610-006-24)", "package_ndc": "71610-006-24", "marketing_start_date": "20171006"}, {"sample": false, "description": "28 TABLET, FILM COATED in 1 BOTTLE (71610-006-28)", "package_ndc": "71610-006-28", "marketing_start_date": "20171006"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (71610-006-30)", "package_ndc": "71610-006-30", "marketing_start_date": "20171006"}, {"sample": false, "description": "40 TABLET, FILM COATED in 1 BOTTLE (71610-006-40)", "package_ndc": "71610-006-40", "marketing_start_date": "20171006"}, {"sample": false, "description": "45 TABLET, FILM COATED in 1 BOTTLE (71610-006-45)", "package_ndc": "71610-006-45", "marketing_start_date": "20171006"}, {"sample": false, "description": "56 TABLET, FILM COATED in 1 BOTTLE (71610-006-46)", "package_ndc": "71610-006-46", "marketing_start_date": "20171006"}, {"sample": false, "description": "480 TABLET, FILM COATED in 1 BOTTLE (71610-006-48)", "package_ndc": "71610-006-48", "marketing_start_date": "20171006"}, {"sample": false, "description": "50 TABLET, FILM COATED in 1 BOTTLE (71610-006-50)", "package_ndc": "71610-006-50", "marketing_start_date": "20171006"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (71610-006-53)", "package_ndc": "71610-006-53", "marketing_start_date": "20171006"}, {"sample": false, "description": "84 TABLET, FILM COATED in 1 BOTTLE (71610-006-54)", "package_ndc": "71610-006-54", "marketing_start_date": "20171006"}, {"sample": false, "description": "80 TABLET, FILM COATED in 1 BOTTLE (71610-006-57)", "package_ndc": "71610-006-57", "marketing_start_date": "20170824"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (71610-006-60)", "package_ndc": "71610-006-60", "marketing_start_date": "20171006"}, {"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (71610-006-65)", "package_ndc": "71610-006-65", "marketing_start_date": "20171006"}, {"sample": false, "description": "168 TABLET, FILM COATED in 1 BOTTLE (71610-006-67)", "package_ndc": "71610-006-67", "marketing_start_date": "20171006"}, {"sample": false, "description": "120 TABLET, FILM COATED in 1 BOTTLE (71610-006-70)", "package_ndc": "71610-006-70", "marketing_start_date": "20171006"}, {"sample": false, "description": "112 TABLET, FILM COATED in 1 BOTTLE (71610-006-72)", "package_ndc": "71610-006-72", "marketing_start_date": "20171006"}, {"sample": false, "description": "135 TABLET, FILM COATED in 1 BOTTLE (71610-006-73)", "package_ndc": "71610-006-73", "marketing_start_date": "20171006"}, {"sample": false, "description": "150 TABLET, FILM COATED in 1 BOTTLE (71610-006-75)", "package_ndc": "71610-006-75", "marketing_start_date": "20171006"}, {"sample": false, "description": "180 TABLET, FILM COATED in 1 BOTTLE (71610-006-80)", "package_ndc": "71610-006-80", "marketing_start_date": "20171006"}, {"sample": false, "description": "200 TABLET, FILM COATED in 1 BOTTLE (71610-006-85)", "package_ndc": "71610-006-85", "marketing_start_date": "20171006"}, {"sample": false, "description": "720 TABLET, FILM COATED in 1 BOTTLE (71610-006-89)", "package_ndc": "71610-006-89", "marketing_start_date": "20171006"}, {"sample": false, "description": "240 TABLET, FILM COATED in 1 BOTTLE (71610-006-90)", "package_ndc": "71610-006-90", "marketing_start_date": "20171006"}, {"sample": false, "description": "270 TABLET, FILM COATED in 1 BOTTLE (71610-006-92)", "package_ndc": "71610-006-92", "marketing_start_date": "20171006"}, {"sample": false, "description": "360 TABLET, FILM COATED in 1 BOTTLE (71610-006-94)", "package_ndc": "71610-006-94", "marketing_start_date": "20171006"}, {"sample": false, "description": "540 TABLET, FILM COATED in 1 BOTTLE (71610-006-98)", "package_ndc": "71610-006-98", "marketing_start_date": "20171006"}], "brand_name": "Tramadol Hydrochloride", "product_id": "71610-006_069eec8b-6cca-435c-9d3f-fbdc75a813a0", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "71610-006", "dea_schedule": "CIV", "generic_name": "Tramadol Hydrochloride", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tramadol Hydrochloride", "active_ingredients": [{"name": "TRAMADOL HYDROCHLORIDE", "strength": "50 mg/1"}], "application_number": "ANDA075977", "marketing_category": "ANDA", "marketing_start_date": "20170824", "listing_expiration_date": "20261231"}