memantine hydrochloride
- Product NDC
- 0591-3011
- 11-digit product format
- 005913011
- Labeler code
- 0591
- Product ID
- 0591-3011_8bfb83c3-e896-456f-a95d-a56e97d5e906
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- memantine hydrochloride
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Actavis Pharma, Inc
- Application
- NDA021487
- Marketing category
- NDA
- Marketing start
- 2015-04-01
- Marketing end
- 0000-00-00
- Substance
- MEMANTINE HYDRO
- Active strength
- 2 mg/mL
- Pharmacologic classes
- NMDA Receptor A
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 0591-3011 | D | Discontinued by firm | 2026-07-31 | ||
| excluded package | package | 0591-3011 | 0591-3011-07 | D | Discontinued by firm | 2026-07-31 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N021487-001 | NAMENDA | MEMANTINE HYDROCHLORIDE | 5MG | TABLET / ORAL | RLD | 2003-10-16 | |
| N021487-002 | NAMENDA | MEMANTINE HYDROCHLORIDE | 10MG | TABLET / ORAL | RLD | 2003-10-16 |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | N021487-001 | NAMENDA | 5MG | TABLET / ORAL | RLD | 2003-10-16 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | N021487-002 | NAMENDA | 10MG | TABLET / ORAL | RLD | 2003-10-16 | a50c72e98297… |
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| memantine hydrochloride | MEMANTINE HYDROCHLORIDE | Cardinal Health 107, LLC | e5754973-e73b-4a25-abb4-80f91880f018 | 2026-06-05 | Warnings, Adverse reactions | 021487 NDA021487 |
| memantine hydrochloride | MEMANTINE HYDROCHLORIDE | Actavis Pharma, Inc. | 72973b46-f307-4a9e-8fb1-ad2cbccfd736 | 2018-11-01 | Warnings, Adverse reactions | 021487 NDA021487 |
| memantine hydrochloride | MEMANTINE HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | c8f5c20b-4573-44c5-89fc-4da11b2e1fe1 | 2017-11-30 | Warnings, Adverse reactions | 021487 NDA021487 |