NDC 51862-612

Methylphenidate Hydrochloride (LA)

Methylphenidate Hydrochloride

Methylphenidate Hydrochloride (LA) is a Oral Capsule, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Mayne Pharma. The primary component is Methylphenidate Hydrochloride.

• Product ID: 51862-612_298af4ea-31db-41d8-9ff9-aebed31dbd34
• NDC: 51862-612
• Product Type: Human Prescription Drug
• Proprietary Name: Methylphenidate Hydrochloride (LA)
• Generic Name: Methylphenidate Hydrochloride
• Dosage Form: Capsule, Extended Release
• Route of Administration: ORAL
• Marketing Start Date: 2018-12-06
• Marketing Category: ANDA / ANDA
• Application Number: ANDA078458
• Labeler Name: Mayne Pharma
• Substance Name: METHYLPHENIDATE HYDROCHLORIDE
• Active Ingredient Strength: 40 mg/1
• Pharm Classes: Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]
• DEA Schedule: CII
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 51862-612-01

100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (51862-612-01)

• Marketing Start Date: 2019-06-10
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 51862-612-01 [51862061201]

Methylphenidate Hydrochloride (LA) CAPSULE, EXTENDED RELEASE

• Marketing Category: ANDA
• Application Number: ANDA078458
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2019-06-10

Drug Details

Active Ingredients

Ingredient	Strength
METHYLPHENIDATE HYDROCHLORIDE	40 mg/1

OpenFDA Data

• SPL SET ID: e5db854a-1c77-4faf-9e60-daf9c9b6cfa0
• Manufacturer:
  • Mayne Pharma
• UNII:
  • 4B3SC438HI
• RxNorm Concept Unique ID - RxCUI:
  • 1806195
  • 1806185
• UPC Code:
  • 0351862611010
  • 0351862612017
  • 0351862610013
  • 0351862614301

Pharmacological Class

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

NDC Crossover Matching brand name "Methylphenidate Hydrochloride (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
0093-5346	Methylphenidate Hydrochloride (LA)	Methylphenidate Hydrochloride (LA)
0093-5347	Methylphenidate Hydrochloride (LA)	Methylphenidate Hydrochloride (LA)
0093-5348	Methylphenidate Hydrochloride (LA)	Methylphenidate Hydrochloride (LA)
51862-263	Methylphenidate Hydrochloride (LA)	Methylphenidate Hydrochloride (LA)
51862-614	Methylphenidate Hydrochloride (LA)	Methylphenidate Hydrochloride (LA)
51862-264	Methylphenidate Hydrochloride (LA)	Methylphenidate Hydrochloride (LA)
51862-267	Methylphenidate Hydrochloride (LA)	Methylphenidate Hydrochloride (LA)
51862-262	Methylphenidate Hydrochloride (LA)	Methylphenidate Hydrochloride (LA)
51862-265	Methylphenidate Hydrochloride (LA)	Methylphenidate Hydrochloride (LA)
51862-609	Methylphenidate Hydrochloride (LA)	Methylphenidate Hydrochloride (LA)
51862-610	Methylphenidate Hydrochloride (LA)	Methylphenidate Hydrochloride (LA)
51862-612	Methylphenidate Hydrochloride (LA)	Methylphenidate Hydrochloride (LA)
51862-611	Methylphenidate Hydrochloride (LA)	Methylphenidate Hydrochloride (LA)
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