NDC 0456-3421

Namenda XR

Memantine Hydrochloride

Namenda XR is a Oral Capsule, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Allergan, Inc.. The primary component is Memantine Hydrochloride.

• Product ID: 0456-3421_3fae1fd7-ac36-4564-9de9-84533cea4636
• NDC: 0456-3421
• Product Type: Human Prescription Drug
• Proprietary Name: Namenda XR
• Generic Name: Memantine Hydrochloride
• Dosage Form: Capsule, Extended Release
• Route of Administration: ORAL
• Marketing Start Date: 2011-10-31
• Marketing Category: NDA / NDA
• Application Number: NDA022525
• Labeler Name: Allergan, Inc.
• Substance Name: MEMANTINE HYDROCHLORIDE
• Active Ingredient Strength: 21 mg/1
• Pharm Classes: NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 0456-3421-33

30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0456-3421-33)

• Marketing Start Date: 2011-10-31
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0456-3421-33 [00456342133]

Namenda XR CAPSULE, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA022525
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2011-10-31

Drug Details

Active Ingredients

Ingredient	Strength
MEMANTINE HYDROCHLORIDE	21 mg/1

OpenFDA Data

• SPL SET ID: 710f523f-0158-4639-8ce7-57598247d48c
• Manufacturer:
  • Allergan, Inc.
• UNII:
  • JY0WD0UA60
• RxNorm Concept Unique ID - RxCUI:
  • 996594
  • 996624
  • 996603
  • 996605
  • 996633
  • 996617
  • 996609
  • 996615
  • 996611
  • 996597

Pharmacological Class

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

NDC Crossover Matching brand name "Namenda XR" or generic name "Memantine Hydrochloride"

NDC	Brand Name	Generic Name
68151-5755	Namenda XR	Namenda XR
68151-5817	Namenda XR	Namenda XR
68151-5829	Namenda XR	Namenda XR
0121-0850	Memantine Hydrochloride	Memantine Hydrochloride
0527-1221	Memantine Hydrochloride	Memantine Hydrochloride
0527-1222	Memantine Hydrochloride	Memantine Hydrochloride
0527-1943	Memantine Hydrochloride	Memantine Hydrochloride
0591-3011	memantine hydrochloride	memantine hydrochloride
0591-3870	memantine hydrochloride	memantine hydrochloride
0456-3200	Namenda	Memantine Hydrochloride
0456-3205	Namenda	memantine hydrochloride
0456-3210	Namenda	memantine hydrochloride
0456-3400	Namenda	memantine hydrochloride
0456-3407	Namenda	memantine hydrochloride
0456-3414	Namenda	memantine hydrochloride
0456-3421	Namenda	memantine hydrochloride
0456-3428	Namenda	memantine hydrochloride