methylphenidate transdermal system

Generic: methylphenidate

Labeler: padagis us llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name methylphenidate transdermal system
Generic Name methylphenidate
Labeler padagis us llc
Dosage Form PATCH
Routes
TRANSDERMAL
Active Ingredients

methylphenidate 82.5 mg/mg

Manufacturer
PADAGIS US LLC

Identifiers & Regulatory

Product NDC 0574-2430
Product ID 0574-2430_b743ef45-2fc0-4086-8a02-6078e6a09eaa
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA021514
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2023-06-05

Pharmacologic Class

Established (EPC)
central nervous system stimulant [epc]
Physiologic Effect
central nervous system stimulation [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 05742430
Hyphenated Format 0574-2430

Supplemental Identifiers

RxCUI
753436 753438 753440 753441
UNII
207ZZ9QZ49
NUI
N0000175739 N0000175729

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 methylphenidate transdermal system (source: ndc)
Generic Name methylphenidate (source: ndc)
Application Number NDA021514 (source: ndc)
Routes
TRANSDERMAL
source: ndc

Resolved Composition

Strengths
  • 82.5 mg/mg
source: ndc
Packaging
  • 1 TRAY in 1 CARTON (0574-2430-65) / 30 POUCH in 1 TRAY / 1 PATCH in 1 POUCH / 82.5 mg in 1 PATCH
source: ndc

Packages (1)

0574-2430-65 1 TRAY in 1 CARTON (0574-2430-65) / 30 POUCH in 1 TRAY / 1 PATCH in 1 POUCH / 82.5 mg in 1 PATCH

Ingredients (1)

methylphenidate (82.5 mg/mg)

Linked Drug Pages (1)

Methylphenidate Transdermal System ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TRANSDERMAL"], "spl_id": "b743ef45-2fc0-4086-8a02-6078e6a09eaa", "openfda": {"nui": ["N0000175739", "N0000175729"], "unii": ["207ZZ9QZ49"], "rxcui": ["753436", "753438", "753440", "753441"], "spl_set_id": ["7bcff873-1fc2-45bc-a8e4-5db4edeb9bfb"], "pharm_class_pe": ["Central Nervous System Stimulation [PE]"], "pharm_class_epc": ["Central Nervous System Stimulant [EPC]"], "manufacturer_name": ["PADAGIS US LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TRAY in 1 CARTON (0574-2430-65)  / 30 POUCH in 1 TRAY / 1 PATCH in 1 POUCH / 82.5 mg in 1 PATCH", "package_ndc": "0574-2430-65", "marketing_start_date": "20230605"}], "brand_name": "Methylphenidate Transdermal System", "product_id": "0574-2430_b743ef45-2fc0-4086-8a02-6078e6a09eaa", "dosage_form": "PATCH", "pharm_class": ["Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulation [PE]"], "product_ndc": "0574-2430", "dea_schedule": "CII", "generic_name": "methylphenidate", "labeler_name": "PADAGIS US LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Methylphenidate Transdermal System", "active_ingredients": [{"name": "METHYLPHENIDATE", "strength": "82.5 mg/mg"}], "application_number": "NDA021514", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20230605", "listing_expiration_date": "20261231"}