NDC 0078-0424

Ritalin LA

Methylphenidate Hydrochloride

Ritalin LA is a Oral Capsule, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Novartis Pharmaceuticals Corporation. The primary component is Methylphenidate Hydrochloride.

• Product ID: 0078-0424_238e17d0-f928-47d5-a6c8-1b846f994b9f
• NDC: 0078-0424
• Product Type: Human Prescription Drug
• Proprietary Name: Ritalin LA
• Generic Name: Methylphenidate Hydrochloride
• Dosage Form: Capsule, Extended Release
• Route of Administration: ORAL
• Marketing Start Date: 2002-06-05
• Marketing Category: NDA / NDA
• Application Number: NDA021284
• Labeler Name: Novartis Pharmaceuticals Corporation
• Substance Name: METHYLPHENIDATE HYDROCHLORIDE
• Active Ingredient Strength: 10 mg/1
• Pharm Classes: Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]
• DEA Schedule: CII
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 0078-0424-05

100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0078-0424-05)

• Marketing Start Date: 2002-06-05
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0078-0424-05 [00078042405]

Ritalin LA CAPSULE, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA021284
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2002-06-05

Drug Details

Active Ingredients

Ingredient	Strength
METHYLPHENIDATE HYDROCHLORIDE	10 mg/1

OpenFDA Data

• SPL SET ID: effd952d-ac94-47bb-b107-589a4934dcca
• Manufacturer:
  • Novartis Pharmaceuticals Corporation
• UNII:
  • 4B3SC438HI
• RxNorm Concept Unique ID - RxCUI:
  • 1806183
  • 1091167
  • 1091143
  • 1806177
  • 1806179
  • 1806195
  • 1091197
  • 1091182

Pharmacological Class

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

NDC Crossover Matching brand name "Ritalin LA" or generic name "Methylphenidate Hydrochloride"

NDC	Brand Name	Generic Name
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