39328-154 NDC - METHYLPHENIDATE HCL

Drug Information

  • Product NDC: 39328-154
  • Proprietary Name: Methylphenidate HCl
  • Non Proprietary Name: Methylphenidate HCl
  • Active Ingredient(s): 10 mg/5mL METHYLPHENIDATE HYDROCHLORIDE
  • Administration Route(s): ORAL
  • Dosage Form(s): SOLUTION
  • Pharmacy Class(es): Central Nervous System Stimulant [EPC]; Central Nervous System Stimulation [PE]

Labeler Information

Field Name Field Value
Labeler Name: Patrin Pharma, Inc.
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: ANDA210764
Marketing Category: ANDA
Start Marketing Date:4/23/2020
DEA Schedule:CII

Package Information

No. Package Code Package Description Billing Unit
139328-154-50500 mL in 1 BOTTLE (39328-154-50)

NDC Record

Field Name Field Value Definition
PRODUCT NDC39328-154This is the date that the labeler indicates was the start of its marketing of the drug product.
PRODUCT TYPE NAMEHUMAN PRESCRIPTION DRUGProduct 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.
PROPRIETARY NAMEMethylphenidate HClThis corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
NON PROPRIETARY NAMEMethylphenidate HClName of Company corresponding to the labeler code segment of the Product NDC.
DOSAGE FORM NAMESOLUTIONAn 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.
ROUTE NAMEORAL 
START MARKETING DATE4/23/2020This 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 NUMBERANDA210764This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
LABELER NAMEPatrin Pharma, 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 STRENGTH10 
ACTIVE INGRED UNITmg/5mL 
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: 12/6/2025

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