tramadol hydrochloride

Generic: tramadol hydrochloride

Labeler: bryant ranch prepack
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tramadol hydrochloride
Generic Name tramadol hydrochloride
Labeler bryant ranch prepack
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

tramadol hydrochloride 300 mg/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 63629-8324
Product ID 63629-8324_26ffeba7-4dcc-420d-a3f0-64d5a0cc6c9e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201384
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2011-12-12

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 636298324
Hyphenated Format 63629-8324

Supplemental Identifiers

RxCUI
833713
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 ANDA201384 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-8324-1)
  • 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-8324-2)
  • 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-8324-3)
  • 120 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-8324-4)
source: ndc

Packages (4)

63629-8324-1 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-8324-1) 63629-8324-2 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-8324-2) 63629-8324-3 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-8324-3) 63629-8324-4 120 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-8324-4)

Ingredients (1)

tramadol hydrochloride (300 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": "26ffeba7-4dcc-420d-a3f0-64d5a0cc6c9e", "openfda": {"unii": ["9N7R477WCK"], "rxcui": ["833713"], "spl_set_id": ["a77b0dba-8ac7-418a-b435-16a0e6c22804"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-8324-1)", "package_ndc": "63629-8324-1", "marketing_start_date": "20200622"}, {"sample": false, "description": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-8324-2)", "package_ndc": "63629-8324-2", "marketing_start_date": "20211004"}, {"sample": false, "description": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-8324-3)", "package_ndc": "63629-8324-3", "marketing_start_date": "20240403"}, {"sample": false, "description": "120 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-8324-4)", "package_ndc": "63629-8324-4", "marketing_start_date": "20240403"}], "brand_name": "TRAMADOL HYDROCHLORIDE", "product_id": "63629-8324_26ffeba7-4dcc-420d-a3f0-64d5a0cc6c9e", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "63629-8324", "dea_schedule": "CIV", "generic_name": "TRAMADOL HYDROCHLORIDE", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "TRAMADOL HYDROCHLORIDE", "active_ingredients": [{"name": "TRAMADOL HYDROCHLORIDE", "strength": "300 mg/1"}], "application_number": "ANDA201384", "marketing_category": "ANDA", "marketing_start_date": "20111212", "listing_expiration_date": "20261231"}