tapentadol hydrochloride

Generic: tapentadol hydrochloride

Labeler: epic pharma llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tapentadol hydrochloride
Generic Name tapentadol hydrochloride
Labeler epic pharma llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

tapentadol hydrochloride 100 mg/1

Manufacturer
EPIC PHARMA LLC

Identifiers & Regulatory

Product NDC 42806-628
Product ID 42806-628_120aa46b-8c91-4460-8e91-85cbaac53d20
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214378
DEA Schedule cii
Listing Expiration 2027-12-31
Marketing Start 2021-12-31

Pharmacologic Class

Classes
opioid agonist [epc] opioid agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42806628
Hyphenated Format 42806-628

Supplemental Identifiers

RxCUI
825409 825411 825413
UPC
0342806628010 0342806626016 0342806627013
UNII
71204KII53

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 tapentadol hydrochloride (source: ndc)
Generic Name tapentadol hydrochloride (source: ndc)
Application Number ANDA214378 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (42806-628-01)
source: ndc

Packages (1)

42806-628-01 100 TABLET, FILM COATED in 1 BOTTLE (42806-628-01)

Ingredients (1)

tapentadol hydrochloride (100 mg/1)

Linked Drug Pages (1)

Tapentadol Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "120aa46b-8c91-4460-8e91-85cbaac53d20", "openfda": {"upc": ["0342806628010", "0342806626016", "0342806627013"], "unii": ["71204KII53"], "rxcui": ["825409", "825411", "825413"], "spl_set_id": ["fecd2104-5bf3-47ed-a6f0-5c6ebb0a17b4"], "manufacturer_name": ["EPIC PHARMA LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (42806-628-01)", "package_ndc": "42806-628-01", "marketing_start_date": "20211231"}], "brand_name": "Tapentadol Hydrochloride", "product_id": "42806-628_120aa46b-8c91-4460-8e91-85cbaac53d20", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Opioid Agonist [EPC]", "Opioid Agonists [MoA]"], "product_ndc": "42806-628", "dea_schedule": "CII", "generic_name": "Tapentadol Hydrochloride", "labeler_name": "EPIC PHARMA LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tapentadol Hydrochloride", "active_ingredients": [{"name": "TAPENTADOL HYDROCHLORIDE", "strength": "100 mg/1"}], "application_number": "ANDA214378", "marketing_category": "ANDA", "marketing_start_date": "20211231", "listing_expiration_date": "20271231"}