NDC 69238-1553

Memantine and Donepezil Hydrochlorides Extended-release

Memantine And Donepezil

Memantine and Donepezil Hydrochlorides Extended-release is a Oral Capsule, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Amneal Pharmaceuticals Ny Llc. The primary component is Memantine Hydrochloride; Donepezil Hydrochloride.

• Product ID: 69238-1553_397c2949-6b6e-4927-9e98-b0dfda3a5449
• NDC: 69238-1553
• Product Type: Human Prescription Drug
• Proprietary Name: Memantine and Donepezil Hydrochlorides Extended-release
• Generic Name: Memantine And Donepezil
• Dosage Form: Capsule, Extended Release
• Route of Administration: ORAL
• Marketing Start Date: 2017-02-01
• Marketing Category: ANDA / ANDA
• Application Number: ANDA208328
• Labeler Name: Amneal Pharmaceuticals NY LLC
• Substance Name: MEMANTINE HYDROCHLORIDE; DONEPEZIL HYDROCHLORIDE
• Active Ingredient Strength: 21 mg/1; mg/1
• Pharm Classes: NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC],Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 69238-1553-3

30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (69238-1553-3)

• Marketing Start Date: 2017-02-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 69238-1553-3 [69238155303]

Memantine and Donepezil Hydrochlorides Extended-release CAPSULE, EXTENDED RELEASE

• Marketing Category: ANDA
• Application Number: ANDA208328
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-02-01

NDC 69238-1553-9 [69238155309]

Memantine and Donepezil Hydrochlorides Extended-release CAPSULE, EXTENDED RELEASE

• Marketing Category: ANDA
• Application Number: ANDA208328
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-02-01

Drug Details

Active Ingredients

Ingredient	Strength
MEMANTINE HYDROCHLORIDE	21 mg/1

OpenFDA Data

• SPL SET ID: 2335950c-be3b-4248-ad04-e9763aee47d2
• Manufacturer:
  • Amneal Pharmaceuticals NY LLC
• UNII:
  • 3O2T2PJ89D
  • JY0WD0UA60
• RxNorm Concept Unique ID - RxCUI:
  • 1599805
  • 1599803
  • 1805425
  • 1805420
• UPC Code:
  • 0369238124897
  • 0369238155396
  • 0369238124798
  • 0369238155297

Pharmacological Class

• NMDA Receptor Antagonists [MoA]
• N-methyl-D-aspartate Receptor Antagonist [EPC]
• Cholinesterase Inhibitor [EPC]
• Cholinesterase Inhibitors [MoA]
• NMDA Receptor Antagonists [MoA]
• N-methyl-D-aspartate Receptor Antagonist [EPC]
• Cholinesterase Inhibitor [EPC]
• Cholinesterase Inhibitors [MoA]

NDC Crossover Matching brand name "Memantine and Donepezil Hydrochlorides Extended-release" or generic name "Memantine And Donepezil"

NDC	Brand Name	Generic Name
69238-1247	Memantine and Donepezil Hydrochlorides Extended-release	Memantine and Donepezil
69238-1248	Memantine and Donepezil Hydrochlorides Extended-release	Memantine and Donepezil
69238-1552	Memantine and Donepezil Hydrochlorides Extended-release	Memantine and Donepezil
69238-1553	Memantine and Donepezil Hydrochlorides Extended-release	Memantine and Donepezil