tramadol hydrochloride

Generic: tramadol hydrochloride

Labeler: major pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

tramadol hydrochloride 50 mg/1

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-7496
Product ID 0904-7496_82c494ed-bc8b-45f5-a26d-5e4660f79feb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076003
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2024-11-22

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 09047496
Hyphenated Format 0904-7496

Supplemental Identifiers

RxCUI
835603
UNII
9N7R477WCK

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 BLISTER PACK in 1 CARTON (0904-7496-61) / 1 TABLET, COATED in 1 BLISTER PACK
source: ndc

Packages (1)

0904-7496-61 100 BLISTER PACK in 1 CARTON (0904-7496-61) / 1 TABLET, COATED in 1 BLISTER PACK

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": "82c494ed-bc8b-45f5-a26d-5e4660f79feb", "openfda": {"unii": ["9N7R477WCK"], "rxcui": ["835603"], "spl_set_id": ["6b0b95b2-ae4c-42e8-9f2e-bcdaffda62e2"], "manufacturer_name": ["Major Pharmaceuticals"]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 CARTON (0904-7496-61)  / 1 TABLET, COATED in 1 BLISTER PACK", "package_ndc": "0904-7496-61", "marketing_start_date": "20241122"}], "brand_name": "Tramadol Hydrochloride", "product_id": "0904-7496_82c494ed-bc8b-45f5-a26d-5e4660f79feb", "dosage_form": "TABLET, COATED", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "0904-7496", "dea_schedule": "CIV", "generic_name": "Tramadol Hydrochloride", "labeler_name": "Major Pharmaceuticals", "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": "20241122", "listing_expiration_date": "20261231"}