tramadol hydrochloride

Generic: tramadol hydrochloride

Labeler: quality care products, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tramadol hydrochloride
Generic Name tramadol hydrochloride
Labeler quality care products, llc
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

tramadol hydrochloride 50 mg/1

Manufacturer
Quality Care Products, LLC

Identifiers & Regulatory

Product NDC 55700-997
Product ID 55700-997_47fed614-6d8f-440b-af12-51ffa022167d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208708
DEA Schedule civ
Marketing Start 2023-02-07
Marketing End 2026-11-30

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 55700997
Hyphenated Format 55700-997

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 ANDA208708 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 120 TABLET, COATED in 1 BOTTLE (55700-997-01)
  • 15 TABLET, COATED in 1 BOTTLE (55700-997-15)
  • 180 TABLET, COATED in 1 BOTTLE (55700-997-18)
  • 30 TABLET, COATED in 1 BOTTLE (55700-997-30)
  • 60 TABLET, COATED in 1 BOTTLE (55700-997-60)
  • 90 TABLET, COATED in 1 BOTTLE (55700-997-90)
source: ndc

Packages (6)

55700-997-01 120 TABLET, COATED in 1 BOTTLE (55700-997-01) 55700-997-15 15 TABLET, COATED in 1 BOTTLE (55700-997-15) 55700-997-18 180 TABLET, COATED in 1 BOTTLE (55700-997-18) 55700-997-30 30 TABLET, COATED in 1 BOTTLE (55700-997-30) 55700-997-60 60 TABLET, COATED in 1 BOTTLE (55700-997-60) 55700-997-90 90 TABLET, COATED in 1 BOTTLE (55700-997-90)

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": "47fed614-6d8f-440b-af12-51ffa022167d", "openfda": {"unii": ["9N7R477WCK"], "rxcui": ["835603"], "spl_set_id": ["f79fda81-f09a-4a08-babc-6bd3bb3ee661"], "manufacturer_name": ["Quality Care Products, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "120 TABLET, COATED in 1 BOTTLE (55700-997-01)", "package_ndc": "55700-997-01", "marketing_end_date": "20261130", "marketing_start_date": "20230207"}, {"sample": false, "description": "15 TABLET, COATED in 1 BOTTLE (55700-997-15)", "package_ndc": "55700-997-15", "marketing_end_date": "20260630", "marketing_start_date": "20230207"}, {"sample": false, "description": "180 TABLET, COATED in 1 BOTTLE (55700-997-18)", "package_ndc": "55700-997-18", "marketing_end_date": "20261130", "marketing_start_date": "20230207"}, {"sample": false, "description": "30 TABLET, COATED in 1 BOTTLE (55700-997-30)", "package_ndc": "55700-997-30", "marketing_end_date": "20261130", "marketing_start_date": "20230207"}, {"sample": false, "description": "60 TABLET, COATED in 1 BOTTLE (55700-997-60)", "package_ndc": "55700-997-60", "marketing_end_date": "20261130", "marketing_start_date": "20230207"}, {"sample": false, "description": "90 TABLET, COATED in 1 BOTTLE (55700-997-90)", "package_ndc": "55700-997-90", "marketing_end_date": "20261130", "marketing_start_date": "20230207"}], "brand_name": "Tramadol Hydrochloride", "product_id": "55700-997_47fed614-6d8f-440b-af12-51ffa022167d", "dosage_form": "TABLET, COATED", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "55700-997", "dea_schedule": "CIV", "generic_name": "Tramadol Hydrochloride", "labeler_name": "Quality Care Products, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tramadol Hydrochloride", "active_ingredients": [{"name": "TRAMADOL HYDROCHLORIDE", "strength": "50 mg/1"}], "application_number": "ANDA208708", "marketing_category": "ANDA", "marketing_end_date": "20261130", "marketing_start_date": "20230207"}