methylphenidate

Generic: methylphenidate

Labeler: mylan pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name methylphenidate
Generic Name methylphenidate
Labeler mylan pharmaceuticals inc.
Dosage Form PATCH
Routes
TRANSDERMAL
Active Ingredients

methylphenidate 1.1 mg/h

Manufacturer
Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0378-8260
Product ID 0378-8260_435703f5-35b9-4d50-a12a-89546888c61a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206497
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2022-06-27

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 03788260
Hyphenated Format 0378-8260

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 (source: ndc)
Generic Name methylphenidate (source: ndc)
Application Number ANDA206497 (source: ndc)
Routes
TRANSDERMAL
source: ndc

Resolved Composition

Strengths
  • 1.1 mg/h
source: ndc
Packaging
  • 30 POUCH in 1 CARTON (0378-8260-93) / 1 PATCH in 1 POUCH (0378-8260-16) / 9 h in 1 PATCH
source: ndc

Packages (1)

0378-8260-93 30 POUCH in 1 CARTON (0378-8260-93) / 1 PATCH in 1 POUCH (0378-8260-16) / 9 h in 1 PATCH

Ingredients (1)

methylphenidate (1.1 mg/h)

Linked Drug Pages (1)

Methylphenidate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TRANSDERMAL"], "spl_id": "435703f5-35b9-4d50-a12a-89546888c61a", "openfda": {"nui": ["N0000175739", "N0000175729"], "unii": ["207ZZ9QZ49"], "rxcui": ["753436", "753438", "753440", "753441"], "spl_set_id": ["1643b6a5-80da-4d4f-8c5f-feb907875702"], "pharm_class_pe": ["Central Nervous System Stimulation [PE]"], "pharm_class_epc": ["Central Nervous System Stimulant [EPC]"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 POUCH in 1 CARTON (0378-8260-93)  / 1 PATCH in 1 POUCH (0378-8260-16)  / 9 h in 1 PATCH", "package_ndc": "0378-8260-93", "marketing_start_date": "20220627"}], "brand_name": "Methylphenidate", "product_id": "0378-8260_435703f5-35b9-4d50-a12a-89546888c61a", "dosage_form": "PATCH", "pharm_class": ["Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulation [PE]"], "product_ndc": "0378-8260", "dea_schedule": "CII", "generic_name": "Methylphenidate", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Methylphenidate", "active_ingredients": [{"name": "METHYLPHENIDATE", "strength": "1.1 mg/h"}], "application_number": "ANDA206497", "marketing_category": "ANDA", "marketing_start_date": "20220627", "listing_expiration_date": "20261231"}