Memantine Hydrochloride
- Product NDC
- 71034-007
- 11-digit product format
- 710340007
- Labeler code
- 71034
- Product ID
- 71034-007_ead45c12-3bc3-6c52-e053-2995a90ad798
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- memantine hydrochloride
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Xiamen LP Pharmaceutical Co., Ltd.
- Application
- ANDA213985
- Marketing category
- ANDA
- Marketing start
- 2022-10-21
- Marketing end
- 0000-00-00
- Substance
- MEMANTINE HYDROCHLORIDE
- Active strength
- 7 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
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A213985-001 | MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | 7MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2022-10-11 | |
| A213985-002 | MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | 14MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2022-10-11 | |
| A213985-003 | MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | 28MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2022-10-11 | |
| A213985-004 | MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | 21MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2024-02-06 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A213985-001 | AB |
| A213985-002 | AB |
| A213985-003 | AB |
| A213985-004 | AB |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A213985-001 | MEMANTINE HYDROCHLORIDE | 7MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2022-10-11 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A213985-002 | MEMANTINE HYDROCHLORIDE | 14MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2022-10-11 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A213985-003 | MEMANTINE HYDROCHLORIDE | 28MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2022-10-11 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A213985-004 | MEMANTINE HYDROCHLORIDE | 21MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2024-02-06 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213985-001 | MEMANTINE HYDROCHLORIDE | 7MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2022-10-11 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213985-002 | MEMANTINE HYDROCHLORIDE | 14MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2022-10-11 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213985-003 | MEMANTINE HYDROCHLORIDE | 28MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2022-10-11 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213985-004 | MEMANTINE HYDROCHLORIDE | 21MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2024-02-06 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A213985-001 | MEMANTINE HYDROCHLORIDE | 7MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2022-10-11 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A213985-002 | MEMANTINE HYDROCHLORIDE | 14MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2022-10-11 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A213985-003 | MEMANTINE HYDROCHLORIDE | 28MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2022-10-11 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A213985-004 | MEMANTINE HYDROCHLORIDE | 21MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2024-02-06 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213985-001 | MEMANTINE HYDROCHLORIDE | 7MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2022-10-11 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213985-002 | MEMANTINE HYDROCHLORIDE | 14MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2022-10-11 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213985-003 | MEMANTINE HYDROCHLORIDE | 28MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2022-10-11 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213985-004 | MEMANTINE HYDROCHLORIDE | 21MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2024-02-06 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213985-001 | MEMANTINE HYDROCHLORIDE | 7MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2022-10-11 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213985-002 | MEMANTINE HYDROCHLORIDE | 14MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2022-10-11 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213985-003 | MEMANTINE HYDROCHLORIDE | 28MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2022-10-11 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213985-004 | MEMANTINE HYDROCHLORIDE | 21MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2024-02-06 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213985-001 | MEMANTINE HYDROCHLORIDE | 7MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2022-10-11 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213985-002 | MEMANTINE HYDROCHLORIDE | 14MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2022-10-11 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213985-003 | MEMANTINE HYDROCHLORIDE | 28MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2022-10-11 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213985-004 | MEMANTINE HYDROCHLORIDE | 21MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2024-02-06 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213985-001 | MEMANTINE HYDROCHLORIDE | 7MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2022-10-11 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213985-002 | MEMANTINE HYDROCHLORIDE | 14MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2022-10-11 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213985-003 | MEMANTINE HYDROCHLORIDE | 28MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2022-10-11 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213985-004 | MEMANTINE HYDROCHLORIDE | 21MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2024-02-06 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213985-001 | MEMANTINE HYDROCHLORIDE | 7MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2022-10-11 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213985-002 | MEMANTINE HYDROCHLORIDE | 14MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2022-10-11 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213985-003 | MEMANTINE HYDROCHLORIDE | 28MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2022-10-11 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213985-004 | MEMANTINE HYDROCHLORIDE | 21MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2024-02-06 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213985-001 | MEMANTINE HYDROCHLORIDE | 7MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2022-10-11 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213985-002 | MEMANTINE HYDROCHLORIDE | 14MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2022-10-11 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213985-003 | MEMANTINE HYDROCHLORIDE | 28MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2022-10-11 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213985-004 | MEMANTINE HYDROCHLORIDE | 21MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2024-02-06 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A213985-001 | MEMANTINE HYDROCHLORIDE | 7MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2022-10-11 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A213985-002 | MEMANTINE HYDROCHLORIDE | 14MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2022-10-11 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A213985-003 | MEMANTINE HYDROCHLORIDE | 28MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2022-10-11 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A213985-004 | MEMANTINE HYDROCHLORIDE | 21MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2024-02-06 | d06236e962d9… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A213985-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A213985-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A213985-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A213985-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213985-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213985-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213985-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213985-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A213985-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A213985-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A213985-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A213985-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213985-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213985-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213985-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213985-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213985-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213985-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213985-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213985-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213985-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213985-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213985-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213985-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213985-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213985-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213985-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213985-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213985-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213985-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213985-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213985-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213985-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213985-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213985-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213985-004 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A213985-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A213985-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A213985-003 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A213985-004 | AB | 1 | d06236e962d9… |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Memantine Hydrochloride | MEMANTINE HYDROCHLORIDE | Vitruvias Therapeutics, Inc. | 0c7fd6ab-2ce5-4110-b6e6-9103c8da0765 | 2024-02-16 | Warnings, Adverse reactions | 213985 ANDA213985 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 71034-007-30 | 71034000730 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71034-007-30) | 2022-10-21 | 0000-00-00 | No | No | Current |