tramadol hydrochloride

Generic: tramadol hydrochloride

Labeler: teva pharmaceuticals usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tramadol hydrochloride
Generic Name tramadol hydrochloride
Labeler teva pharmaceuticals usa, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

tramadol hydrochloride 50 mg/1

Manufacturer
Teva Pharmaceuticals USA, Inc.

Identifiers & Regulatory

Product NDC 0093-3301
Product ID 0093-3301_502158c7-0bbc-4818-aa36-c6532bde9110
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075977
DEA Schedule civ
Listing Expiration 2027-12-31
Marketing Start 2024-09-12

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00933301
Hyphenated Format 0093-3301

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 ANDA075977 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (0093-3301-01)
  • 500 TABLET, FILM COATED in 1 BOTTLE (0093-3301-05)
source: ndc

Packages (2)

0093-3301-01 100 TABLET, FILM COATED in 1 BOTTLE (0093-3301-01) 0093-3301-05 500 TABLET, FILM COATED in 1 BOTTLE (0093-3301-05)

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": "502158c7-0bbc-4818-aa36-c6532bde9110", "openfda": {"unii": ["9N7R477WCK"], "rxcui": ["835603"], "spl_set_id": ["561f00e5-f69c-4369-ae4d-5eff86c4499f"], "manufacturer_name": ["Teva Pharmaceuticals USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (0093-3301-01)", "package_ndc": "0093-3301-01", "marketing_start_date": "20240917"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (0093-3301-05)", "package_ndc": "0093-3301-05", "marketing_start_date": "20240912"}], "brand_name": "Tramadol Hydrochloride", "product_id": "0093-3301_502158c7-0bbc-4818-aa36-c6532bde9110", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "0093-3301", "dea_schedule": "CIV", "generic_name": "Tramadol Hydrochloride", "labeler_name": "Teva Pharmaceuticals USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tramadol Hydrochloride", "active_ingredients": [{"name": "TRAMADOL HYDROCHLORIDE", "strength": "50 mg/1"}], "application_number": "ANDA075977", "marketing_category": "ANDA", "marketing_start_date": "20240912", "listing_expiration_date": "20271231"}