tramadol hydrochloride

Generic: tramadol hydrochloride

Labeler: macleods pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tramadol hydrochloride
Generic Name tramadol hydrochloride
Labeler macleods pharmaceuticals limited
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

tramadol hydrochloride 300 mg/1

Manufacturer
Macleods Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 33342-271
Product ID 33342-271_0f59cb5b-586f-41de-866f-e2386f4d0178
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209404
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2025-01-31

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 33342271
Hyphenated Format 33342-271

Supplemental Identifiers

RxCUI
833709 833711 833713
UPC
0333342271112 0333342269119
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 ANDA209404 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (33342-271-07)
  • 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (33342-271-10)
  • 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (33342-271-11)
source: ndc

Packages (3)

33342-271-07 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (33342-271-07) 33342-271-10 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (33342-271-10) 33342-271-11 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (33342-271-11)

Ingredients (1)

tramadol hydrochloride (300 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": "0f59cb5b-586f-41de-866f-e2386f4d0178", "openfda": {"upc": ["0333342271112", "0333342269119"], "unii": ["9N7R477WCK"], "rxcui": ["833709", "833711", "833713"], "spl_set_id": ["a07ed444-54e4-4d45-b6a1-6ea2f6dedc61"], "manufacturer_name": ["Macleods Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (33342-271-07)", "package_ndc": "33342-271-07", "marketing_start_date": "20250131"}, {"sample": false, "description": "90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (33342-271-10)", "package_ndc": "33342-271-10", "marketing_start_date": "20250131"}, {"sample": false, "description": "100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (33342-271-11)", "package_ndc": "33342-271-11", "marketing_start_date": "20250131"}], "brand_name": "Tramadol Hydrochloride", "product_id": "33342-271_0f59cb5b-586f-41de-866f-e2386f4d0178", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "33342-271", "dea_schedule": "CIV", "generic_name": "Tramadol Hydrochloride", "labeler_name": "Macleods Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tramadol Hydrochloride", "active_ingredients": [{"name": "TRAMADOL HYDROCHLORIDE", "strength": "300 mg/1"}], "application_number": "ANDA209404", "marketing_category": "ANDA", "marketing_start_date": "20250131", "listing_expiration_date": "20261231"}