tramadol hydrochloride

Generic: tramadol hydrochloride

Labeler: a-s medication solutions
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tramadol hydrochloride
Generic Name tramadol hydrochloride
Labeler a-s medication solutions
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

tramadol hydrochloride 50 mg/1

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-5790
Product ID 50090-5790_831d953a-7e6c-42ca-a018-41a5a62429dd
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211825
DEA Schedule civ
Listing Expiration 2027-12-31
Marketing Start 2019-08-09

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 500905790
Hyphenated Format 50090-5790

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 ANDA211825 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 90 TABLET, FILM COATED in 1 BOTTLE (50090-5790-1)
  • 10 TABLET, FILM COATED in 1 BOTTLE (50090-5790-2)
  • 180 TABLET, FILM COATED in 1 BOTTLE (50090-5790-3)
source: ndc

Packages (3)

50090-5790-1 90 TABLET, FILM COATED in 1 BOTTLE (50090-5790-1) 50090-5790-2 10 TABLET, FILM COATED in 1 BOTTLE (50090-5790-2) 50090-5790-3 180 TABLET, FILM COATED in 1 BOTTLE (50090-5790-3)

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": "831d953a-7e6c-42ca-a018-41a5a62429dd", "openfda": {"unii": ["9N7R477WCK"], "rxcui": ["835603"], "spl_set_id": ["4a525cf7-2c0c-47c6-aed3-3a395a7120ec"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (50090-5790-1)", "package_ndc": "50090-5790-1", "marketing_start_date": "20220208"}, {"sample": false, "description": "10 TABLET, FILM COATED in 1 BOTTLE (50090-5790-2)", "package_ndc": "50090-5790-2", "marketing_start_date": "20211008"}, {"sample": false, "description": "180 TABLET, FILM COATED in 1 BOTTLE (50090-5790-3)", "package_ndc": "50090-5790-3", "marketing_start_date": "20220629"}], "brand_name": "Tramadol Hydrochloride", "product_id": "50090-5790_831d953a-7e6c-42ca-a018-41a5a62429dd", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "50090-5790", "dea_schedule": "CIV", "generic_name": "Tramadol Hydrochloride", "labeler_name": "A-S Medication Solutions", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tramadol Hydrochloride", "active_ingredients": [{"name": "TRAMADOL HYDROCHLORIDE", "strength": "50 mg/1"}], "application_number": "ANDA211825", "marketing_category": "ANDA", "marketing_start_date": "20190809", "listing_expiration_date": "20271231"}