62175-312 NDC - METHYLPHENIDATE HYDROCHLORIDE

Drug Information

  • Product NDC: 62175-312
  • Proprietary Name: Methylphenidate Hydrochloride
  • Non Proprietary Name: Methylphenidate Hydrochloride
  • Active Ingredient(s): 36 mg/1 METHYLPHENIDATE HYDROCHLORIDE
  • Administration Route(s): ORAL
  • Dosage Form(s): TABLET, EXTENDED RELEASE
  • Pharmacy Class(es): Central Nervous System Stimulant [EPC]; Central Nervous System Stimulation [PE]

Labeler Information

Field Name Field Value
Labeler Name: Lannett Company, Inc.
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: ANDA091695
Marketing Category: ANDA
Start Marketing Date:9/23/2013
DEA Schedule:CII

Package Information

No. Package Code Package Description Billing Unit
162175-312-37100 TABLET, EXTENDED RELEASE in 1 BOTTLE (62175-312-37)EA

NDC Record

Field Name Field Value Definition
PRODUCT NDC62175-312Name of Company corresponding to the labeler code segment of the Product NDC.
PRODUCT TYPE NAMEHUMAN PRESCRIPTION DRUGAn active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
PROPRIETARY NAMEMethylphenidate HydrochlorideName of Company corresponding to the labeler code segment of the Product NDC.
NON PROPRIETARY NAMEMethylphenidate Hydrochloride 
DOSAGE FORM NAMETABLET, EXTENDED RELEASEThe translation of the dosage form Code submitted by the firm.
ROUTE NAMEORALThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE9/23/2013This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEANDAProduct types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
APPLICATION NUMBERANDA091695 
LABELER NAMELannett Company, Inc.Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEMETHYLPHENIDATE HYDROCHLORIDEAn active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
ACTIVE NUMERATOR STRENGTH36 
ACTIVE INGRED UNITmg/1 
PHARM CLASSESCentral Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE] 
DEA SCHEDULECIIThis is the assigned DEA Schedule number as reported by the labeler. Values are CI, CII, CIII, CIV, and CV.

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This page was last updated on: 4/14/2026

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