NDC 0456-3428
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 | 0456-3428_3fae1fd7-ac36-4564-9de9-84533cea4636 |
| NDC | 0456-3428 |
| 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 | 28 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 0456-3428-33
30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0456-3428-33)
| Marketing Start Date | 2011-10-31 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 0456-3428-33 [00456342833]
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 |
NDC 0456-3428-11 [00456342811]
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 |
NDC 0456-3428-90 [00456342890]
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 |
NDC 0456-3428-63 [00456342863]
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 |
| Marketing End Date | 2016-09-06 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| MEMANTINE HYDROCHLORIDE | 28 mg/1 |
OpenFDA Data
| SPL SET ID: | 710f523f-0158-4639-8ce7-57598247d48c |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
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 |
Trademark Results [Namenda]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NAMENDA 78093238 2843824 Live/Registered |
MERZ PHARMA GMBH & CO. KGAA 2001-11-14 |
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