tramadol hydrochloride extended-release

Generic: tramadol hydrochloride

Labeler: trigen laboratories, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name tramadol hydrochloride extended-release
Generic Name tramadol hydrochloride
Labeler trigen laboratories, llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

tramadol hydrochloride 200 mg/1

Manufacturer
Trigen Laboratories, LLC

Identifiers & Regulatory

Product NDC 13811-690
Product ID 13811-690_0e535876-333d-4ac4-8cdf-847613083c06
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA022370
DEA Schedule civ
Listing Expiration 2027-12-31
Marketing Start 2015-06-22

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 13811690
Hyphenated Format 13811-690

Supplemental Identifiers

RxCUI
1148478 1148485 1148489
UNII
9N7R477WCK

Packaging Origin

Original Packager
true

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 extended-release (source: ndc)
Generic Name tramadol hydrochloride (source: ndc)
Application Number NDA022370 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 30 CAPSULE in 1 BOTTLE, PLASTIC (13811-690-30)
source: ndc

Packages (1)

13811-690-30 30 CAPSULE in 1 BOTTLE, PLASTIC (13811-690-30)

Ingredients (1)

tramadol hydrochloride (200 mg/1)

Linked Drug Pages (1)

Tramadol Hydrochloride Extended-Release ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "0e535876-333d-4ac4-8cdf-847613083c06", "openfda": {"unii": ["9N7R477WCK"], "rxcui": ["1148478", "1148485", "1148489"], "spl_set_id": ["c0bc7218-3fd0-4646-96f4-25355fc84aa9"], "manufacturer_name": ["Trigen Laboratories, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BOTTLE, PLASTIC (13811-690-30)", "package_ndc": "13811-690-30", "marketing_start_date": "20150622"}], "brand_name": "Tramadol Hydrochloride Extended-Release", "product_id": "13811-690_0e535876-333d-4ac4-8cdf-847613083c06", "dosage_form": "CAPSULE", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "13811-690", "dea_schedule": "CIV", "generic_name": "tramadol hydrochloride", "labeler_name": "Trigen Laboratories, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tramadol Hydrochloride", "brand_name_suffix": "Extended-Release", "active_ingredients": [{"name": "TRAMADOL HYDROCHLORIDE", "strength": "200 mg/1"}], "application_number": "NDA022370", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20150622", "listing_expiration_date": "20271231"}