NDC 50458-585

CONCERTA

Methylphenidate Hydrochloride

CONCERTA is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Janssen Pharmaceuticals, Inc.. The primary component is Methylphenidate Hydrochloride.

• Product ID: 50458-585_4d35b5ab-fa7a-476a-9d38-a18483a53bc4
• NDC: 50458-585
• Product Type: Human Prescription Drug
• Proprietary Name: CONCERTA
• Generic Name: Methylphenidate Hydrochloride
• Dosage Form: Tablet, Extended Release
• Route of Administration: ORAL
• Marketing Start Date: 2000-08-01
• Marketing Category: NDA / NDA
• Application Number: NDA021121
• Labeler Name: Janssen Pharmaceuticals, Inc.
• Substance Name: METHYLPHENIDATE HYDROCHLORIDE
• Active Ingredient Strength: 18 mg/1
• Pharm Classes: Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]
• DEA Schedule: CII
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 50458-585-01

100 TABLET, EXTENDED RELEASE in 1 BOTTLE (50458-585-01)

• Marketing Start Date: 2000-08-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50458-585-01 [50458058501]

CONCERTA TABLET, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA021121
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2000-08-01

Drug Details

Active Ingredients

Ingredient	Strength
METHYLPHENIDATE HYDROCHLORIDE	18 mg/1

OpenFDA Data

• SPL SET ID: 1a88218c-5b18-4220-8f56-526de1a276cd
• Manufacturer:
  • Janssen Pharmaceuticals, Inc.
• UNII:
  • 4B3SC438HI
• RxNorm Concept Unique ID - RxCUI:
  • 1091210
  • 1091212
  • 1091170
  • 1091172
  • 1091185
  • 1091157
  • 1091187
  • 1091155

Pharmacological Class

• Central Nervous System Stimulant [EPC]
• Central Nervous System Stimulation [PE]

Medicade Reported Pricing

50458058501 CONCERTA ER 18 MG TABLET

Pricing Unit: EA | Drug Type:

NDC Crossover Matching brand name "CONCERTA" or generic name "Methylphenidate Hydrochloride"

NDC	Brand Name	Generic Name
50458-588	CONCERTA	CONCERTA
50458-587	CONCERTA	CONCERTA
50458-585	CONCERTA	CONCERTA
50458-586	CONCERTA	CONCERTA
0093-3230	Methylphenidate Hydrochloride (LA)	Methylphenidate Hydrochloride
0093-3231	Methylphenidate Hydrochloride (LA)	Methylphenidate Hydrochloride
0093-3232	Methylphenidate Hydrochloride (LA)	Methylphenidate Hydrochloride
0078-0370	Ritalin	methylphenidate hydrochloride
0078-0371	Ritalin	methylphenidate hydrochloride
0078-0372	Ritalin	methylphenidate hydrochloride
0078-0424	Ritalin	methylphenidate hydrochloride
0078-0439	Ritalin	methylphenidate hydrochloride
0078-0440	Ritalin	methylphenidate hydrochloride
0078-0441	Ritalin	methylphenidate hydrochloride