tramadol hydrochloride

Generic: tramadol hydrochloride

Labeler: amneal pharmaceuticals ny llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tramadol hydrochloride
Generic Name tramadol hydrochloride
Labeler amneal pharmaceuticals ny llc
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

tramadol hydrochloride 50 mg/1

Manufacturer
Amneal Pharmaceuticals NY LLC

Identifiers & Regulatory

Product NDC 60219-2348
Product ID 60219-2348_b19b19c4-cb47-4cbc-a914-dc73d4b655fa
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076003
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2023-02-13

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 602192348
Hyphenated Format 60219-2348

Supplemental Identifiers

RxCUI
835603
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 ANDA076003 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 100 TABLET, COATED in 1 BOTTLE (60219-2348-1)
  • 10 TABLET, COATED in 1 BOTTLE (60219-2348-4)
  • 500 TABLET, COATED in 1 BOTTLE (60219-2348-5)
  • 1000 TABLET, COATED in 1 BOTTLE (60219-2348-7)
source: ndc

Packages (4)

60219-2348-1 100 TABLET, COATED in 1 BOTTLE (60219-2348-1) 60219-2348-4 10 TABLET, COATED in 1 BOTTLE (60219-2348-4) 60219-2348-5 500 TABLET, COATED in 1 BOTTLE (60219-2348-5) 60219-2348-7 1000 TABLET, COATED in 1 BOTTLE (60219-2348-7)

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": "b19b19c4-cb47-4cbc-a914-dc73d4b655fa", "openfda": {"unii": ["9N7R477WCK"], "rxcui": ["835603"], "spl_set_id": ["8ec4e4e5-a56e-4198-8428-6b770b9bf27d"], "manufacturer_name": ["Amneal Pharmaceuticals NY LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, COATED in 1 BOTTLE (60219-2348-1)", "package_ndc": "60219-2348-1", "marketing_start_date": "20230213"}, {"sample": false, "description": "10 TABLET, COATED in 1 BOTTLE (60219-2348-4)", "package_ndc": "60219-2348-4", "marketing_start_date": "20230213"}, {"sample": false, "description": "500 TABLET, COATED in 1 BOTTLE (60219-2348-5)", "package_ndc": "60219-2348-5", "marketing_start_date": "20230213"}, {"sample": false, "description": "1000 TABLET, COATED in 1 BOTTLE (60219-2348-7)", "package_ndc": "60219-2348-7", "marketing_start_date": "20230213"}], "brand_name": "Tramadol Hydrochloride", "product_id": "60219-2348_b19b19c4-cb47-4cbc-a914-dc73d4b655fa", "dosage_form": "TABLET, COATED", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "60219-2348", "dea_schedule": "CIV", "generic_name": "Tramadol Hydrochloride", "labeler_name": "Amneal Pharmaceuticals NY LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tramadol Hydrochloride", "active_ingredients": [{"name": "TRAMADOL HYDROCHLORIDE", "strength": "50 mg/1"}], "application_number": "ANDA076003", "marketing_category": "ANDA", "marketing_start_date": "20230213", "listing_expiration_date": "20261231"}