tramadol hydrochloride (72888-163)

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 75 mg/1

Manufacturer

Advagen Pharma Limited

Identifiers & Regulatory

Product NDC 72888-163

Product ID 72888-163_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 72888163

Hyphenated Format 72888-163

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

75 mg/1

source: ndc

Packaging

1000 TABLET, COATED in 1 BOTTLE (72888-163-00)
100 TABLET, COATED in 1 BOTTLE (72888-163-01)
500 TABLET, COATED in 1 BOTTLE (72888-163-05)
30 TABLET, COATED in 1 BOTTLE (72888-163-30)

source: ndc

Packages (4)

72888-163-00 1000 TABLET, COATED in 1 BOTTLE (72888-163-00) 72888-163-01 100 TABLET, COATED in 1 BOTTLE (72888-163-01) 72888-163-05 500 TABLET, COATED in 1 BOTTLE (72888-163-05) 72888-163-30 30 TABLET, COATED in 1 BOTTLE (72888-163-30)

Ingredients (1)

tramadol hydrochloride (75 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 (72888-163-00)", "package_ndc": "72888-163-00", "marketing_start_date": "20230724"}, {"sample": false, "description": "100 TABLET, COATED in 1 BOTTLE (72888-163-01)", "package_ndc": "72888-163-01", "marketing_start_date": "20230724"}, {"sample": false, "description": "500 TABLET, COATED in 1 BOTTLE (72888-163-05)", "package_ndc": "72888-163-05", "marketing_start_date": "20230724"}, {"sample": false, "description": "30 TABLET, COATED in 1 BOTTLE (72888-163-30)", "package_ndc": "72888-163-30", "marketing_start_date": "20230724"}], "brand_name": "Tramadol Hydrochloride", "product_id": "72888-163_47c74a4e-51f2-e294-e063-6394a90aa70b", "dosage_form": "TABLET, COATED", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "72888-163", "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": "75 mg/1"}], "application_number": "ANDA208708", "marketing_category": "ANDA", "marketing_start_date": "20230724", "listing_expiration_date": "20271231"}