Memantine Hydrochloride
- Product NDC
- 63629-1983
- 11-digit product format
- 636291983
- Labeler code
- 63629
- Product ID
- 63629-1983_9278afce-29e9-493f-9bd0-21a50b6c7e17
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Memantine Hydrochloride
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA205365
- Marketing category
- ANDA
- Marketing start
- 2020-05-19
- Marketing end
- 0000-00-00
- Substance
- MEMANTINE HYDROCHLORIDE
- Active strength
- 14 mg/1
- Pharmacologic classes
- N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- 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.
Dataset, Scope, Product NDC table| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|
| excluded product | product | 63629-1983 | | D | Discontinued by firm | | 2026-07-31 |
| excluded package | package | 63629-1983 | 63629-1983-1 | D | Discontinued by firm | | 2026-07-31 |
Orange Book products#
Application-product, Trade name, Ingredient table| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|
| A205365-001 | MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | 7MG | CAPSULE, EXTENDED RELEASE / ORAL | | | 2020-02-28 |
| A205365-002 | MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | 14MG | CAPSULE, EXTENDED RELEASE / ORAL | | | 2020-02-28 |
| A205365-003 | MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | 21MG | CAPSULE, EXTENDED RELEASE / ORAL | | | 2020-02-28 |
| A205365-004 | MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | 28MG | CAPSULE, EXTENDED RELEASE / ORAL | | | 2020-02-28 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 63629-1983-1 | 63629198301 | 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63629-1983-1) | 2020-05-19 | 0000-00-00 | No | No | Current |