tramadol hydrochloride

Generic: tramadol hydrochloride

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

Drug Facts

Product Profile

Brand Name tramadol hydrochloride
Generic Name tramadol hydrochloride
Labeler asclemed usa, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

tramadol hydrochloride 50 mg/1

Manufacturer
Asclemed USA, Inc.

Identifiers & Regulatory

Product NDC 76420-205
Product ID 76420-205_f9440001-dea9-2d5c-e053-6394a90aeb4d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075964
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2002-06-22

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 76420205
Hyphenated Format 76420-205

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 ANDA075964 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 1000 TABLET in 1 BOTTLE (76420-205-01)
  • 100 TABLET in 1 BOTTLE (76420-205-10)
  • 120 TABLET in 1 BOTTLE (76420-205-12)
  • 30 TABLET in 1 BOTTLE (76420-205-30)
  • 60 TABLET in 1 BOTTLE (76420-205-60)
  • 90 TABLET in 1 BOTTLE (76420-205-90)
source: ndc

Packages (6)

76420-205-01 1000 TABLET in 1 BOTTLE (76420-205-01) 76420-205-10 100 TABLET in 1 BOTTLE (76420-205-10) 76420-205-12 120 TABLET in 1 BOTTLE (76420-205-12) 76420-205-30 30 TABLET in 1 BOTTLE (76420-205-30) 76420-205-60 60 TABLET in 1 BOTTLE (76420-205-60) 76420-205-90 90 TABLET in 1 BOTTLE (76420-205-90)

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": "f9440001-dea9-2d5c-e053-6394a90aeb4d", "openfda": {"unii": ["9N7R477WCK"], "rxcui": ["835603"], "spl_set_id": ["c2bde858-47a3-4b4b-a153-42409ea5f4dc"], "manufacturer_name": ["Asclemed USA, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET in 1 BOTTLE (76420-205-01)", "package_ndc": "76420-205-01", "marketing_start_date": "20230127"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE (76420-205-10)", "package_ndc": "76420-205-10", "marketing_start_date": "20220418"}, {"sample": false, "description": "120 TABLET in 1 BOTTLE (76420-205-12)", "package_ndc": "76420-205-12", "marketing_start_date": "20230414"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (76420-205-30)", "package_ndc": "76420-205-30", "marketing_start_date": "20220727"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (76420-205-60)", "package_ndc": "76420-205-60", "marketing_start_date": "20220727"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (76420-205-90)", "package_ndc": "76420-205-90", "marketing_start_date": "20220727"}], "brand_name": "tramadol hydrochloride", "product_id": "76420-205_f9440001-dea9-2d5c-e053-6394a90aeb4d", "dosage_form": "TABLET", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "76420-205", "dea_schedule": "CIV", "generic_name": "tramadol hydrochloride", "labeler_name": "Asclemed USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "tramadol hydrochloride", "active_ingredients": [{"name": "TRAMADOL HYDROCHLORIDE", "strength": "50 mg/1"}], "application_number": "ANDA075964", "marketing_category": "ANDA", "marketing_start_date": "20020622", "listing_expiration_date": "20261231"}