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, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

tramadol hydrochloride 100 mg/1

Manufacturer
Preferred Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68788-8367
Product ID 68788-8367_1ba78592-5daf-4d80-ae65-c71d84b7a06e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA200503
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2023-02-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 687888367
Hyphenated Format 68788-8367

Supplemental Identifiers

RxCUI
833709
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 ANDA200503 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 20 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8367-2)
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8367-3)
  • 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8367-6)
  • 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8367-9)
source: ndc

Packages (4)

68788-8367-2 20 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8367-2) 68788-8367-3 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8367-3) 68788-8367-6 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8367-6) 68788-8367-9 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8367-9)

Ingredients (1)

tramadol hydrochloride (100 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": "1ba78592-5daf-4d80-ae65-c71d84b7a06e", "openfda": {"unii": ["9N7R477WCK"], "rxcui": ["833709"], "spl_set_id": ["c30f6e9e-8014-40fc-9615-a6b8654137c1"], "manufacturer_name": ["Preferred Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "20 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8367-2)", "package_ndc": "68788-8367-2", "marketing_start_date": "20230201"}, {"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8367-3)", "package_ndc": "68788-8367-3", "marketing_start_date": "20230201"}, {"sample": false, "description": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8367-6)", "package_ndc": "68788-8367-6", "marketing_start_date": "20230201"}, {"sample": false, "description": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8367-9)", "package_ndc": "68788-8367-9", "marketing_start_date": "20230201"}], "brand_name": "TRAMADOL HYDROCHLORIDE", "product_id": "68788-8367_1ba78592-5daf-4d80-ae65-c71d84b7a06e", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "68788-8367", "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": "100 mg/1"}], "application_number": "ANDA200503", "marketing_category": "ANDA", "marketing_start_date": "20230201", "listing_expiration_date": "20261231"}