NDC 0781-2363

Methylphenidate

Methylphenidate

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

• Product ID: 0781-2363_2c0c77e1-92d7-4fde-8159-140539f1961f
• NDC: 0781-2363
• Product Type: Human Prescription Drug
• Proprietary Name: Methylphenidate
• Generic Name: Methylphenidate
• Dosage Form: Capsule, Extended Release
• Route of Administration: ORAL
• Marketing Start Date: 2015-11-24
• Marketing Category: NDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
• Application Number: NDA021284
• Labeler Name: Sandoz Inc
• Substance Name: METHYLPHENIDATE HYDROCHLORIDE
• Active Ingredient Strength: 30 mg/1
• Pharm Classes: Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]
• DEA Schedule: CII
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 0781-2363-01

100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0781-2363-01)

• Marketing Start Date: 2015-11-24
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0781-2363-01 [00781236301]

Methylphenidate CAPSULE, EXTENDED RELEASE

• Marketing Category: NDA authorized generic
• Application Number: NDA021284
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2015-11-24

Drug Details

Active Ingredients

Ingredient	Strength
METHYLPHENIDATE HYDROCHLORIDE	30 mg/1

OpenFDA Data

• SPL SET ID: 1f8983ce-71b8-4c62-830d-e4692ddededa
• Manufacturer:
  • Sandoz Inc
• UNII:
  • 4B3SC438HI
• RxNorm Concept Unique ID - RxCUI:
  • 1806179
  • 1806183
  • 1806195
  • 1806177

Pharmacological Class

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

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

NDC	Brand Name	Generic Name
0378-8260	Methylphenidate	Methylphenidate
0378-8261	Methylphenidate	Methylphenidate
0378-8262	Methylphenidate	Methylphenidate
0378-8263	Methylphenidate	Methylphenidate
0781-2361	Methylphenidate	methylphenidate
0781-2362	Methylphenidate	methylphenidate
0781-2363	Methylphenidate	methylphenidate
0781-2364	Methylphenidate	methylphenidate
10702-163	Methylphenidate	Methylphenidate Hydrochloride
10702-164	Methylphenidate	Methylphenidate Hydrochloride
68968-5552	Daytrana	methylphenidate
68968-5553	Daytrana	methylphenidate
68968-5554	Daytrana	methylphenidate
68968-5555	Daytrana	methylphenidate