nucynta

Generic: tapentadol hydrochloride

Labeler: collegium pharmaceutical, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name nucynta
Generic Name tapentadol hydrochloride
Labeler collegium pharmaceutical, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

tapentadol hydrochloride 50 mg/1

Manufacturer
Collegium Pharmaceutical, Inc.

Identifiers & Regulatory

Product NDC 24510-050
Product ID 24510-050_3f155622-a850-4d63-9539-9e645a8fcc28
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA022304
DEA Schedule cii
Listing Expiration 2027-12-31
Marketing Start 2019-04-01

Pharmacologic Class

Classes
opioid agonist [epc] opioid agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 24510050
Hyphenated Format 24510-050

Supplemental Identifiers

RxCUI
825409 825411 825413 854140 854142 854144
UPC
0324510075106 0324510100105 0324510050103
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 nucynta (source: ndc)
Generic Name tapentadol hydrochloride (source: ndc)
Application Number NDA022304 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 10 BLISTER PACK in 1 CARTON (24510-050-01) / 10 TABLET, FILM COATED in 1 BLISTER PACK
  • 100 TABLET, FILM COATED in 1 BOTTLE (24510-050-10)
source: ndc

Packages (2)

24510-050-01 10 BLISTER PACK in 1 CARTON (24510-050-01) / 10 TABLET, FILM COATED in 1 BLISTER PACK 24510-050-10 100 TABLET, FILM COATED in 1 BOTTLE (24510-050-10)

Ingredients (1)

tapentadol hydrochloride (50 mg/1)

Linked Drug Pages (1)

Nucynta ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3f155622-a850-4d63-9539-9e645a8fcc28", "openfda": {"upc": ["0324510075106", "0324510100105", "0324510050103"], "unii": ["71204KII53"], "rxcui": ["825409", "825411", "825413", "854140", "854142", "854144"], "spl_set_id": ["80938c30-9fe3-4c7d-9d9c-5476638cfb2d"], "manufacturer_name": ["Collegium Pharmaceutical, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 BLISTER PACK in 1 CARTON (24510-050-01)  / 10 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "24510-050-01", "marketing_start_date": "20190401"}, {"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (24510-050-10)", "package_ndc": "24510-050-10", "marketing_start_date": "20190401"}], "brand_name": "Nucynta", "product_id": "24510-050_3f155622-a850-4d63-9539-9e645a8fcc28", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Opioid Agonist [EPC]", "Opioid Agonists [MoA]"], "product_ndc": "24510-050", "dea_schedule": "CII", "generic_name": "tapentadol hydrochloride", "labeler_name": "Collegium Pharmaceutical, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nucynta", "active_ingredients": [{"name": "TAPENTADOL HYDROCHLORIDE", "strength": "50 mg/1"}], "application_number": "NDA022304", "marketing_category": "NDA", "marketing_start_date": "20190401", "listing_expiration_date": "20271231"}