tramadol hydrochloride

Generic: tramadol hydrochloride

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

Drug Facts

Product Profile

Brand Name tramadol hydrochloride
Generic Name tramadol hydrochloride
Labeler trupharma, llc
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

tramadol hydrochloride 5 mg/mL

Manufacturer
TruPharma, LLC

Identifiers & Regulatory

Product NDC 52817-615
Product ID 52817-615_f7fd27bd-cd40-704c-e053-6394a90a6a6f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA214044
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2020-09-11

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 52817615
Hyphenated Format 52817-615

Supplemental Identifiers

RxCUI
2395808
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 (source: ndc)
Generic Name tramadol hydrochloride (source: ndc)
Application Number NDA214044 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 473 mL in 1 BOTTLE (52817-615-16)
source: ndc

Packages (1)

52817-615-16 473 mL in 1 BOTTLE (52817-615-16)

Ingredients (1)

tramadol hydrochloride (5 mg/mL)

Linked Drug Pages (1)

Tramadol Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "f7fd27bd-cd40-704c-e053-6394a90a6a6f", "openfda": {"unii": ["9N7R477WCK"], "rxcui": ["2395808"], "spl_set_id": ["aea56ff9-94ac-47a8-8f15-8790d538973b"], "manufacturer_name": ["TruPharma, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "473 mL in 1 BOTTLE (52817-615-16)", "package_ndc": "52817-615-16", "marketing_start_date": "20230125"}], "brand_name": "Tramadol Hydrochloride", "product_id": "52817-615_f7fd27bd-cd40-704c-e053-6394a90a6a6f", "dosage_form": "SOLUTION", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "52817-615", "dea_schedule": "CIV", "generic_name": "tramadol hydrochloride", "labeler_name": "TruPharma, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tramadol Hydrochloride", "active_ingredients": [{"name": "TRAMADOL HYDROCHLORIDE", "strength": "5 mg/mL"}], "application_number": "NDA214044", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20200911", "listing_expiration_date": "20261231"}