Memantine Hydrochloride
- Product NDC
- 0378-5436
- Requested package NDC
- 0378-5436-77
- 11-digit product format
- 003785436
- Labeler code
- 0378
- Product ID
- 0378-5436_642189b4-b4ad-424a-9c89-4dcbde5b2773
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- memantine
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA206032
- Marketing category
- ANDA
- Marketing start
- 2018-02-26
- Marketing end
- 0000-00-00
- Substance
- MEMANTINE HYDROCHLORIDE
- Active strength
- 14 mg/1
- Pharmacologic classes
- NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 0378-5436 | 0378-5436-77 | D | Discontinued by firm | 2026-08-03 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Archive | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 0378-5436 | 0378-5436-77 | D | Discontinued by firm | excluded / ndc_excluded.zip | d630ba8d3edf… | 732f749b63fb… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 0378-5436 | 0378-5436-77 | D | Discontinued by firm | excluded / ndc_excluded.zip | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 0378-5436 | 0378-5436-77 | D | Discontinued by firm | excluded / ndc_excluded.zip | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 0378-5436 | 0378-5436-77 | D | Discontinued by firm | excluded / ndc_excluded.zip | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 0378-5436 | 0378-5436-77 | D | Discontinued by firm | excluded / ndc_excluded.zip | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 0378-5436 | 0378-5436-77 | D | Discontinued by firm | excluded / ndc_excluded.zip | cdf11ea48f46… | ba0047e9e063… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 0378-5436 | 0378-5436-77 | D | Discontinued by firm | excluded / ndc_excluded.zip | 302b2466d912… | e7b80fea0513… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 0378-5436 | 0378-5436-77 | D | Discontinued by firm | excluded / ndc_excluded.zip | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 0378-5436 | 0378-5436-77 | D | Discontinued by firm | excluded / ndc_excluded.zip | 0efc9e666f02… | f202fb6c5f17… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 0378-5436 | 0378-5436-77 | D | Discontinued by firm | excluded / ndc_excluded.zip | ad56d346431e… | cc804d4bbf1e… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 0378-5436 | 0378-5436-77 | D | Discontinued by firm | excluded / ndc_excluded.zip | 367a005e9d99… | 383a685ebd0f… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 0378-5436 | 0378-5436-77 | D | Discontinued by firm | excluded / ndc_excluded.zip | 557ba5c1ecfa… | 9c80585c8c6e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A206032-001 | MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | 7MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2016-09-28 | |
| A206032-002 | MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | 14MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2016-09-28 | |
| A206032-003 | MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | 21MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2016-09-28 | |
| A206032-004 | MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | 28MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2016-09-28 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A206032-001 | AB |
| A206032-002 | AB |
| A206032-003 | AB |
| A206032-004 | 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 | A206032-001 | MEMANTINE HYDROCHLORIDE | 7MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2016-09-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A206032-002 | MEMANTINE HYDROCHLORIDE | 14MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2016-09-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A206032-003 | MEMANTINE HYDROCHLORIDE | 21MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2016-09-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A206032-004 | MEMANTINE HYDROCHLORIDE | 28MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2016-09-28 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206032-001 | MEMANTINE HYDROCHLORIDE | 7MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2016-09-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206032-002 | MEMANTINE HYDROCHLORIDE | 14MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2016-09-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206032-003 | MEMANTINE HYDROCHLORIDE | 21MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2016-09-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206032-004 | MEMANTINE HYDROCHLORIDE | 28MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2016-09-28 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A206032-001 | MEMANTINE HYDROCHLORIDE | 7MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2016-09-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A206032-002 | MEMANTINE HYDROCHLORIDE | 14MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2016-09-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A206032-003 | MEMANTINE HYDROCHLORIDE | 21MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2016-09-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A206032-004 | MEMANTINE HYDROCHLORIDE | 28MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2016-09-28 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206032-001 | MEMANTINE HYDROCHLORIDE | 7MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-09-28 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206032-002 | MEMANTINE HYDROCHLORIDE | 14MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-09-28 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206032-003 | MEMANTINE HYDROCHLORIDE | 21MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-09-28 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206032-004 | MEMANTINE HYDROCHLORIDE | 28MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-09-28 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206032-001 | MEMANTINE HYDROCHLORIDE | 7MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-09-28 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206032-002 | MEMANTINE HYDROCHLORIDE | 14MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-09-28 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206032-003 | MEMANTINE HYDROCHLORIDE | 21MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-09-28 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206032-004 | MEMANTINE HYDROCHLORIDE | 28MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-09-28 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206032-001 | MEMANTINE HYDROCHLORIDE | 7MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-09-28 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206032-002 | MEMANTINE HYDROCHLORIDE | 14MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-09-28 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206032-003 | MEMANTINE HYDROCHLORIDE | 21MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-09-28 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206032-004 | MEMANTINE HYDROCHLORIDE | 28MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-09-28 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206032-001 | MEMANTINE HYDROCHLORIDE | 7MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-09-28 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206032-002 | MEMANTINE HYDROCHLORIDE | 14MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-09-28 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206032-003 | MEMANTINE HYDROCHLORIDE | 21MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-09-28 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206032-004 | MEMANTINE HYDROCHLORIDE | 28MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-09-28 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A206032-001 | MEMANTINE HYDROCHLORIDE | 7MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-09-28 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A206032-002 | MEMANTINE HYDROCHLORIDE | 14MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-09-28 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A206032-003 | MEMANTINE HYDROCHLORIDE | 21MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-09-28 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A206032-004 | MEMANTINE HYDROCHLORIDE | 28MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-09-28 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A206032-001 | MEMANTINE HYDROCHLORIDE | 7MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-09-28 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A206032-002 | MEMANTINE HYDROCHLORIDE | 14MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-09-28 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A206032-003 | MEMANTINE HYDROCHLORIDE | 21MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-09-28 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A206032-004 | MEMANTINE HYDROCHLORIDE | 28MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-09-28 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A206032-001 | MEMANTINE HYDROCHLORIDE | 7MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-09-28 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A206032-002 | MEMANTINE HYDROCHLORIDE | 14MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-09-28 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A206032-003 | MEMANTINE HYDROCHLORIDE | 21MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-09-28 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A206032-004 | MEMANTINE HYDROCHLORIDE | 28MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-09-28 | 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 | A206032-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A206032-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A206032-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A206032-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206032-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206032-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206032-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206032-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A206032-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A206032-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A206032-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A206032-004 | AB | 1 | 6a471c1ec25d… |
| 2019-12-13 00:20 UTC | 2019-12 | A206032-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A206032-002 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A206032-003 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A206032-004 | AB | 1 | 74a2ff9319b5… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A206032-001 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A206032-002 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A206032-003 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A206032-004 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A206032-001 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A206032-002 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A206032-003 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A206032-004 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A206032-001 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A206032-002 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A206032-003 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A206032-004 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A206032-001 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A206032-002 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A206032-003 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A206032-004 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A206032-001 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A206032-002 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A206032-003 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A206032-004 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A206032-001 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A206032-002 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A206032-003 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A206032-004 | AB | 1 | b00525d2431f… |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0378-5436-77 | EA - Each | 0378-5436 | eac3bbc6-f635-41ef-b21d-830ddd23f1d2 | 1 | 2018-03-08 |
| 0378-5436-93 | EA - Each | 0378-5436 | 486b5b01-5e0e-4381-b2a4-c27b3dd64aa7 | 1 | 2018-03-08 |
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 | Rising Pharma Holdings, Inc. | a282fbed-8304-458e-a0e9-5eaccc95339b | 2025-04-30 | Warnings, Adverse reactions | 206032 ANDA206032 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 0378-5436-77 | 00378543677 | 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-5436-77) | 2018-02-26 | 0000-00-00 | No | No | Current |