tramadol hydrochloride

Generic: tramadol hydrochloride

Labeler: advagen pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tramadol hydrochloride
Generic Name tramadol hydrochloride
Labeler advagen pharma limited
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

tramadol hydrochloride 50 mg/1

Manufacturer
Advagen Pharma Limited

Identifiers & Regulatory

Product NDC 72888-080
Product ID 72888-080_47c74a4e-51f2-e294-e063-6394a90aa70b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208708
DEA Schedule civ
Listing Expiration 2027-12-31
Marketing Start 2023-07-24

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72888080
Hyphenated Format 72888-080

Supplemental Identifiers

RxCUI
835603 2179635 2670390 2692878
UPC
0372888163000 0372888008059 0372888080055 0372888163307 0372888008011 0372888008004 0372888162300 0372888163055 0372888080017 0372888162003 0372888162010 0372888080000 0372888163017 0372888162058
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 ANDA208708 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 1000 TABLET, COATED in 1 BOTTLE (72888-080-00)
  • 100 TABLET, COATED in 1 BOTTLE (72888-080-01)
  • 500 TABLET, COATED in 1 BOTTLE (72888-080-05)
source: ndc

Packages (3)

72888-080-00 1000 TABLET, COATED in 1 BOTTLE (72888-080-00) 72888-080-01 100 TABLET, COATED in 1 BOTTLE (72888-080-01) 72888-080-05 500 TABLET, COATED in 1 BOTTLE (72888-080-05)

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": "47c74a4e-51f2-e294-e063-6394a90aa70b", "openfda": {"upc": ["0372888163000", "0372888008059", "0372888080055", "0372888163307", "0372888008011", "0372888008004", "0372888162300", "0372888163055", "0372888080017", "0372888162003", "0372888162010", "0372888080000", "0372888163017", "0372888162058"], "unii": ["9N7R477WCK"], "rxcui": ["835603", "2179635", "2670390", "2692878"], "spl_set_id": ["93b12089-3a0f-4b57-abb1-2429cf31995d"], "manufacturer_name": ["Advagen Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET, COATED in 1 BOTTLE (72888-080-00)", "package_ndc": "72888-080-00", "marketing_start_date": "20230724"}, {"sample": false, "description": "100 TABLET, COATED in 1 BOTTLE (72888-080-01)", "package_ndc": "72888-080-01", "marketing_start_date": "20230724"}, {"sample": false, "description": "500 TABLET, COATED in 1 BOTTLE (72888-080-05)", "package_ndc": "72888-080-05", "marketing_start_date": "20230724"}], "brand_name": "Tramadol Hydrochloride", "product_id": "72888-080_47c74a4e-51f2-e294-e063-6394a90aa70b", "dosage_form": "TABLET, COATED", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "72888-080", "dea_schedule": "CIV", "generic_name": "Tramadol Hydrochloride", "labeler_name": "Advagen Pharma Limited", "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_start_date": "20230724", "listing_expiration_date": "20271231"}