NDC 0093-5298

Methylphenidate Hydrochloride (CD)

Methylphenidate Hydrochloride

Methylphenidate Hydrochloride (CD) is a Oral Capsule, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Teva Pharmaceuticals Usa, Inc.. The primary component is Methylphenidate Hydrochloride.

Product ID0093-5298_1ba1b804-f5f3-47e9-9d38-fe1a4fe68e69
NDC0093-5298
Product TypeHuman Prescription Drug
Proprietary NameMethylphenidate Hydrochloride (CD)
Generic NameMethylphenidate Hydrochloride
Dosage FormCapsule, Extended Release
Route of AdministrationORAL
Marketing Start Date2012-09-27
Marketing CategoryANDA / ANDA
Application NumberANDA078873
Labeler NameTeva Pharmaceuticals USA, Inc.
Substance NameMETHYLPHENIDATE HYDROCHLORIDE
Active Ingredient Strength40 mg/1
Pharm ClassesCentral Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]
DEA ScheduleCII
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 0093-5298-01

100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0093-5298-01)
Marketing Start Date2012-09-27
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0093-5298-01 [00093529801]

Methylphenidate Hydrochloride (CD) CAPSULE, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA078873
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-09-27

Drug Details

Active Ingredients

IngredientStrength
METHYLPHENIDATE HYDROCHLORIDE40 mg/1

OpenFDA Data

SPL SET ID:b7941137-6f70-4501-9428-de726b3e7ae8
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1806181
  • 1806187
  • 1806189
  • 1806197
  • 1806193
  • 1806191
  • Pharmacological Class

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

    NDC Crossover Matching brand name "Methylphenidate Hydrochloride (CD)" or generic name "Methylphenidate Hydrochloride"

    NDCBrand NameGeneric Name
    0093-5293Methylphenidate Hydrochloride (CD)Methylphenidate Hydrochloride (CD)
    0093-5296Methylphenidate Hydrochloride (CD)Methylphenidate Hydrochloride (CD)
    0093-5298Methylphenidate Hydrochloride (CD)Methylphenidate Hydrochloride (CD)
    0093-5297Methylphenidate Hydrochloride (CD)Methylphenidate Hydrochloride (CD)
    0093-5295Methylphenidate Hydrochloride (CD)Methylphenidate Hydrochloride (CD)
    0093-5292Methylphenidate Hydrochloride (CD)Methylphenidate Hydrochloride (CD)
    0093-3230Methylphenidate Hydrochloride (LA)Methylphenidate Hydrochloride
    0093-3231Methylphenidate Hydrochloride (LA)Methylphenidate Hydrochloride
    0093-3232Methylphenidate Hydrochloride (LA)Methylphenidate Hydrochloride
    0078-0370Ritalinmethylphenidate hydrochloride
    0078-0371Ritalinmethylphenidate hydrochloride
    0078-0372Ritalinmethylphenidate hydrochloride
    0078-0424Ritalinmethylphenidate hydrochloride
    0078-0439Ritalinmethylphenidate hydrochloride
    0078-0440Ritalinmethylphenidate hydrochloride
    0078-0441Ritalinmethylphenidate hydrochloride

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.