concerta

Generic: methylphenidate hydrochloride

Labeler: janssen pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name concerta
Generic Name methylphenidate hydrochloride
Labeler janssen pharmaceuticals, inc.
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

methylphenidate hydrochloride 54 mg/1

Manufacturer
Janssen Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 50458-587
Product ID 50458-587_37e34ae6-39c5-4f74-89eb-eadec80792fd
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021121
DEA Schedule cii
Listing Expiration 2027-12-31
Marketing Start 2000-08-01

Pharmacologic Class

Classes
central nervous system stimulant [epc] central nervous system stimulation [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50458587
Hyphenated Format 50458-587

Supplemental Identifiers

RxCUI
1091155 1091157 1091170 1091172 1091185 1091187 1091210 1091212
UPC
0350458585018 0350458587012 0350458588019 0350458586015
UNII
4B3SC438HI

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 concerta (source: ndc)
Generic Name methylphenidate hydrochloride (source: ndc)
Application Number NDA021121 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 54 mg/1
source: ndc
Packaging
  • 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (50458-587-01)
source: ndc

Packages (1)

50458-587-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (50458-587-01)

Ingredients (1)

methylphenidate hydrochloride (54 mg/1)

Linked Drug Pages (1)

CONCERTA ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "37e34ae6-39c5-4f74-89eb-eadec80792fd", "openfda": {"upc": ["0350458585018", "0350458587012", "0350458588019", "0350458586015"], "unii": ["4B3SC438HI"], "rxcui": ["1091155", "1091157", "1091170", "1091172", "1091185", "1091187", "1091210", "1091212"], "spl_set_id": ["1a88218c-5b18-4220-8f56-526de1a276cd"], "manufacturer_name": ["Janssen Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (50458-587-01)", "package_ndc": "50458-587-01", "marketing_start_date": "20000801"}], "brand_name": "CONCERTA", "product_id": "50458-587_37e34ae6-39c5-4f74-89eb-eadec80792fd", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulation [PE]"], "product_ndc": "50458-587", "dea_schedule": "CII", "generic_name": "Methylphenidate hydrochloride", "labeler_name": "Janssen Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "CONCERTA", "active_ingredients": [{"name": "METHYLPHENIDATE HYDROCHLORIDE", "strength": "54 mg/1"}], "application_number": "NDA021121", "marketing_category": "NDA", "marketing_start_date": "20000801", "listing_expiration_date": "20271231"}