tramadol hydrochloride

Generic: tramadol hydrochloride

Labeler: Strides Pharma Science Limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Active

Drug Facts

Product Profile

Brand Name tramadol hydrochloride
Generic Name tramadol hydrochloride
Labeler Strides Pharma Science Limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

TRAMADOL HYDROCHLORIDE 50 mg/1

Identifiers & Regulatory

Product NDC 64380-718
Product ID 64380-718_0f4caac6-033d-478b-87f4-a736c902e532
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202075
DEA Schedule CIV
Listing Expiration 2026-12-31
Marketing Start 2025-06-01

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 64380718
Hyphenated Format 64380-718

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 ANDA202075 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (64380-718-01)
  • 500 TABLET in 1 BOTTLE (64380-718-02)
  • 1000 TABLET in 1 BOTTLE (64380-718-03)
source: ndc

Packages (3)

64380-718-01 100 TABLET in 1 BOTTLE (64380-718-01) 64380-718-02 500 TABLET in 1 BOTTLE (64380-718-02) 64380-718-03 1000 TABLET in 1 BOTTLE (64380-718-03)

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": "0f4caac6-033d-478b-87f4-a736c902e532", "openfda": {"unii": ["9N7R477WCK"], "rxcui": ["835603"], "spl_set_id": ["24152345-b761-4f22-81a9-83a2b278a267"], "manufacturer_name": ["Strides Pharma Science Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (64380-718-01)", "package_ndc": "64380-718-01", "marketing_start_date": "20250601"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (64380-718-02)", "package_ndc": "64380-718-02", "marketing_start_date": "20250601"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (64380-718-03)", "package_ndc": "64380-718-03", "marketing_start_date": "20250601"}], "brand_name": "tramadol hydrochloride", "product_id": "64380-718_0f4caac6-033d-478b-87f4-a736c902e532", "dosage_form": "TABLET", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "64380-718", "dea_schedule": "CIV", "generic_name": "tramadol hydrochloride", "labeler_name": "Strides Pharma Science Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "tramadol hydrochloride", "active_ingredients": [{"name": "TRAMADOL HYDROCHLORIDE", "strength": "50 mg/1"}], "application_number": "ANDA202075", "marketing_category": "ANDA", "marketing_start_date": "20250601", "listing_expiration_date": "20261231"}