NDC 54838-221

Memantine Hydrochloride

Memantine Hydrochloride

Memantine Hydrochloride is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Silarx Pharmaceuticals, Inc.. The primary component is Memantine Hydrochloride.

• Product ID: 54838-221_7fd7dbb6-a186-4b03-90f2-f76e6f4c0c41
• NDC: 54838-221
• Product Type: Human Prescription Drug
• Proprietary Name: Memantine Hydrochloride
• Generic Name: Memantine Hydrochloride
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2016-11-10
• Marketing Category: ANDA / ANDA
• Application Number: ANDA207236
• Labeler Name: Silarx Pharmaceuticals, Inc.
• Substance Name: MEMANTINE HYDROCHLORIDE
• Active Ingredient Strength: 5 mg/1
• Pharm Classes: NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 54838-221-06

60 TABLET in 1 BOTTLE, PLASTIC (54838-221-06)

• Marketing Start Date: 2016-11-10
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 54838-221-13 [54838022113]

Memantine Hydrochloride TABLET

• Marketing Category: ANDA
• Application Number: ANDA207236
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2016-11-10
• Inactivation Date: 2020-01-31

NDC 54838-221-06 [54838022106]

Memantine Hydrochloride TABLET

• Marketing Category: ANDA
• Application Number: ANDA207236
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2016-11-10
• Inactivation Date: 2020-01-31

NDC 54838-221-52 [54838022152]

Memantine Hydrochloride TABLET

• Marketing Category: ANDA
• Application Number: ANDA207236
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2016-11-10
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
MEMANTINE HYDROCHLORIDE	5 mg/1

OpenFDA Data

• SPL SET ID: 2d5dcee8-8028-4131-ad64-de5bd6384036
• Manufacturer:
  • Silarx Pharmaceuticals, Inc.
• UNII:
  • JY0WD0UA60
• RxNorm Concept Unique ID - RxCUI:
  • 996561
  • 996571
• UPC Code:
  • 0354838221060

Pharmacological Class

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

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

NDC	Brand Name	Generic Name
0121-0850	Memantine Hydrochloride	Memantine Hydrochloride
0378-1103	Memantine Hydrochloride	memantine
0378-1104	Memantine Hydrochloride	memantine
0378-5435	Memantine Hydrochloride	memantine
0378-5436	Memantine Hydrochloride	memantine
0378-5437	Memantine Hydrochloride	memantine
0378-5438	Memantine Hydrochloride	memantine
0527-1221	Memantine Hydrochloride	Memantine Hydrochloride
68180-246	memantine hydrochloride	memantine hydrochloride
68180-229	Memantine hydrochloride	Memantine hydrochloride
68180-230	Memantine hydrochloride	Memantine hydrochloride
68180-248	memantine hydrochloride	memantine hydrochloride
68180-247	memantine hydrochloride	memantine hydrochloride
68180-249	memantine hydrochloride	memantine hydrochloride
68382-546	Memantine hydrochloride	Memantine hydrochloride
68382-548	Memantine hydrochloride	Memantine hydrochloride
68382-388	Memantine Hydrochloride	Memantine Hydrochloride
68382-389	Memantine Hydrochloride	Memantine Hydrochloride
68382-547	Memantine hydrochloride	Memantine hydrochloride
68382-549	Memantine hydrochloride	Memantine hydrochloride
68788-7165	Memantine Hydrochloride	Memantine Hydrochloride
0527-1222	Memantine Hydrochloride	Memantine Hydrochloride
0527-1943	Memantine Hydrochloride	Memantine Hydrochloride
0591-3870	memantine hydrochloride	memantine hydrochloride
0591-3900	memantine hydrochloride	memantine hydrochloride
0591-3875	memantine hydrochloride	memantine hydrochloride
70771-1323	Memantine hydrochloride	Memantine hydrochloride
70771-1119	Memantine Hydrochloride	Memantine Hydrochloride
70771-1322	Memantine hydrochloride	Memantine hydrochloride
70771-1321	Memantine hydrochloride	Memantine hydrochloride
70771-1324	Memantine hydrochloride	Memantine hydrochloride
70771-1120	Memantine Hydrochloride	Memantine Hydrochloride
71335-0346	Memantine Hydrochloride	Memantine Hydrochloride
71610-011	memantine hydrochloride	memantine hydrochloride
72578-004	Memantine Hydrochloride	Memantine Hydrochloride
72578-003	Memantine Hydrochloride	Memantine Hydrochloride
0615-8264	memantine hydrochloride	memantine hydrochloride
0832-1113	Memantine Hydrochloride	Memantine Hydrochloride
0832-1112	Memantine Hydrochloride	Memantine Hydrochloride
0904-6736	memantine hydrochloride	memantine hydrochloride
0904-6735	memantine hydrochloride	memantine hydrochloride
10370-347	Memantine Hydrochloride	Memantine Hydrochloride
10370-348	Memantine Hydrochloride	Memantine Hydrochloride
10370-349	Memantine Hydrochloride	Memantine Hydrochloride
10370-346	Memantine Hydrochloride	Memantine Hydrochloride
13668-222	Memantine hydrochloride	Memantine hydrochloride
13668-223	Memantine hydrochloride	Memantine hydrochloride
13668-573	Memantine Hydrochloride	Memantine Hydrochloride
27241-071	Memantine Hydrochloride	Memantine Hydrochloride
27241-070	Memantine Hydrochloride	Memantine Hydrochloride