tramadol hydrochloride

Generic: tramadol hydrochloride

Labeler: preferred pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

tramadol hydrochloride 50 mg/1

Manufacturer
Preferred Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 68788-4035
Product ID 68788-4035_e6e275c3-1e16-4a00-b7fd-608ae6cbd515
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211825
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2025-09-29

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 687884035
Hyphenated Format 68788-4035

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 ANDA211825 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-4035-1)
  • 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-4035-2)
  • 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-4035-3)
  • 40 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-4035-4)
  • 15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-4035-5)
  • 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-4035-6)
  • 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-4035-7)
  • 120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-4035-8)
  • 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-4035-9)
source: ndc

Packages (9)

68788-4035-1 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-4035-1) 68788-4035-2 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-4035-2) 68788-4035-3 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-4035-3) 68788-4035-4 40 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-4035-4) 68788-4035-5 15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-4035-5) 68788-4035-6 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-4035-6) 68788-4035-7 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-4035-7) 68788-4035-8 120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-4035-8) 68788-4035-9 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-4035-9)

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": "e6e275c3-1e16-4a00-b7fd-608ae6cbd515", "openfda": {"unii": ["9N7R477WCK"], "rxcui": ["835603"], "spl_set_id": ["e6e275c3-1e16-4a00-b7fd-608ae6cbd515"], "manufacturer_name": ["Preferred Pharmaceuticals Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-4035-1)", "package_ndc": "68788-4035-1", "marketing_start_date": "20250929"}, {"sample": false, "description": "20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-4035-2)", "package_ndc": "68788-4035-2", "marketing_start_date": "20250929"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-4035-3)", "package_ndc": "68788-4035-3", "marketing_start_date": "20250929"}, {"sample": false, "description": "40 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-4035-4)", "package_ndc": "68788-4035-4", "marketing_start_date": "20250929"}, {"sample": false, "description": "15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-4035-5)", "package_ndc": "68788-4035-5", "marketing_start_date": "20250929"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-4035-6)", "package_ndc": "68788-4035-6", "marketing_start_date": "20250929"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-4035-7)", "package_ndc": "68788-4035-7", "marketing_start_date": "20250929"}, {"sample": false, "description": "120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-4035-8)", "package_ndc": "68788-4035-8", "marketing_start_date": "20250929"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-4035-9)", "package_ndc": "68788-4035-9", "marketing_start_date": "20250929"}], "brand_name": "Tramadol Hydrochloride", "product_id": "68788-4035_e6e275c3-1e16-4a00-b7fd-608ae6cbd515", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "68788-4035", "dea_schedule": "CIV", "generic_name": "Tramadol Hydrochloride", "labeler_name": "Preferred Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tramadol Hydrochloride", "active_ingredients": [{"name": "TRAMADOL HYDROCHLORIDE", "strength": "50 mg/1"}], "application_number": "ANDA211825", "marketing_category": "ANDA", "marketing_start_date": "20250929", "listing_expiration_date": "20261231"}