Memantine Hydrochloride
- Product NDC
- 68382-388
- 11-digit product format
- 683820388
- Labeler code
- 68382
- Product ID
- 68382-388_5cf85a8a-effe-4207-8b72-e91e8c4f4650
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Memantine Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Zydus Pharmaceuticals (USA) Inc.
- Application
- ANDA090961
- Marketing category
- ANDA
- Marketing start
- 2017-09-28
- Marketing end
- 0000-00-00
- Substance
- MEMANTINE HYDROCHLORIDE
- Active strength
- 5 mg/1
- Pharmacologic classes
- NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- 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 product | product | 68382-388 | D | Discontinued by firm | 2026-08-17 | ||
| excluded package | package | 68382-388 | 68382-388-01 | D | Discontinued by firm | 2026-08-17 | |
| excluded package | package | 68382-388 | 68382-388-05 | D | Discontinued by firm | 2026-08-17 | |
| excluded package | package | 68382-388 | 68382-388-10 | D | Discontinued by firm | 2026-08-17 | |
| excluded package | package | 68382-388 | 68382-388-14 | D | Discontinued by firm | 2026-08-17 | |
| excluded package | package | 68382-388 | 68382-388-77 | D | Discontinued by firm | 2026-08-17 |
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 | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 68382-388-01 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 68382-388-10 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 68382-388-05 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 68382-388-14 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 68382-388-77 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 68382-388-01 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 68382-388-10 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 68382-388-05 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 68382-388-14 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 68382-388-77 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 68382-388-01 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 68382-388-10 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 68382-388-05 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 68382-388-14 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 68382-388-77 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 68382-388-01 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 68382-388-10 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 68382-388-05 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 68382-388-14 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 68382-388-77 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 68382-388-01 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 68382-388-10 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 68382-388-05 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 68382-388-14 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 68382-388-77 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 68382-388-01 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 68382-388-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 68382-388-05 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 68382-388-14 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 68382-388-77 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 68382-388-01 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 68382-388-10 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 68382-388-05 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 68382-388-14 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 68382-388-77 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 68382-388-01 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 68382-388-10 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 68382-388-05 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 68382-388-14 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 68382-388-77 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 68382-388-01 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 68382-388-10 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 68382-388-05 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 68382-388-14 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 68382-388-77 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 68382-388-01 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 68382-388-10 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 68382-388-05 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 68382-388-14 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 68382-388-77 | ad56d346431e… | cc804d4bbf1e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A090961-001 | MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2017-07-10 | |
| A090961-002 | MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2017-07-10 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A090961-001 | AB |
| A090961-002 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A090961-001 | MEMANTINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2017-07-10 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A090961-002 | MEMANTINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2017-07-10 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A090961-001 | MEMANTINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2017-07-10 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A090961-002 | MEMANTINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2017-07-10 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090961-001 | MEMANTINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2017-07-10 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090961-002 | MEMANTINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2017-07-10 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A090961-001 | MEMANTINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2017-07-10 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A090961-002 | MEMANTINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2017-07-10 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090961-001 | MEMANTINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2017-07-10 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090961-002 | MEMANTINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2017-07-10 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090961-001 | MEMANTINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2017-07-10 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090961-002 | MEMANTINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2017-07-10 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090961-001 | MEMANTINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2017-07-10 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090961-002 | MEMANTINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2017-07-10 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090961-001 | MEMANTINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2017-07-10 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090961-002 | MEMANTINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2017-07-10 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090961-001 | MEMANTINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2017-07-10 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090961-002 | MEMANTINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2017-07-10 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090961-001 | MEMANTINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2017-07-10 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090961-002 | MEMANTINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2017-07-10 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A090961-001 | MEMANTINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2017-07-10 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A090961-002 | MEMANTINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2017-07-10 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090961-001 | MEMANTINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2017-07-10 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090961-002 | MEMANTINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2017-07-10 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090961-001 | MEMANTINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2017-07-10 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090961-002 | MEMANTINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2017-07-10 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090961-001 | MEMANTINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2017-07-10 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090961-002 | MEMANTINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2017-07-10 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A090961-001 | MEMANTINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2017-07-10 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A090961-002 | MEMANTINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2017-07-10 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A090961-001 | MEMANTINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2017-07-10 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A090961-002 | MEMANTINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2017-07-10 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A090961-001 | MEMANTINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2017-07-10 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A090961-002 | MEMANTINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2017-07-10 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A090961-001 | MEMANTINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2017-07-10 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A090961-002 | MEMANTINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2017-07-10 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A090961-001 | MEMANTINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2017-07-10 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A090961-002 | MEMANTINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2017-07-10 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A090961-001 | MEMANTINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2017-07-10 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A090961-002 | MEMANTINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2017-07-10 | bb7c543d1eb4… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A090961-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A090961-002 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A090961-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A090961-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090961-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090961-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A090961-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A090961-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090961-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090961-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090961-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090961-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090961-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090961-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090961-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090961-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090961-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090961-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090961-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090961-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A090961-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A090961-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090961-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090961-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090961-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090961-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090961-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090961-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A090961-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A090961-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A090961-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A090961-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A090961-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A090961-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A090961-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A090961-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A090961-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A090961-002 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A090961-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A090961-002 | AB | 1 | bb7c543d1eb4… |
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 | REMEDYREPACK INC. | cbfd9d95-f50b-45ff-9857-9f1712c45e56 | 2026-08-06 | Warnings, Adverse reactions | 090961 ANDA090961 |
| MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | DirectRx | d0839a2d-35f1-1f14-e053-2995a90ad549 | 2026-03-06 | Warnings, Adverse reactions | 090961 ANDA090961 |
| Memantine Hydrochloride | MEMANTINE HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 3662b11a-354a-b683-e063-6394a90a0086 | 2025-05-30 | Warnings, Adverse reactions | 090961 ANDA090961 |
| Memantine Hydrochloride | MEMANTINE HYDROCHLORIDE | Coupler LLC | 2d54be77-75b2-76b3-e063-6294a90a0cc0 | 2025-02-04 | Warnings, Adverse reactions | 090961 ANDA090961 |
| Memantine Hydrochloride | MEMANTINE HYDROCHLORIDE | Zydus Lifesciences Limited | 514421f3-f525-43e8-aecc-8b2bbffd00dc | 2024-08-16 | 090961 ANDA090961 | |
| Memantine Hydrochloride | MEMANTINE HYDROCHLORIDE | A-S Medication Solutions | f05e381f-850d-42ea-9dd8-6d1f8dac4f62 | 2024-05-30 | Warnings, Adverse reactions | 090961 ANDA090961 |
| Memantine Hydrochloride | MEMANTINE HYDROCHLORIDE | Bryant Ranch Prepack | 0ad2246a-ffa0-43a0-8094-58279d3e3a74 | 2024-02-06 | Warnings, Adverse reactions | 090961 ANDA090961 |
| Memantine Hydrochloride | MEMANTINE HYDROCHLORIDE | Bryant Ranch Prepack | be919d34-e9f4-49c8-8145-2dcafb7cb88c | 2024-02-06 | Warnings, Adverse reactions | 090961 ANDA090961 |
| Memantine Hydrochloride | MEMANTINE HYDROCHLORIDE | Bryant Ranch Prepack | 9cfddd01-6e1d-4ee0-9310-3fb371724e3d | 2023-10-04 | Warnings, Adverse reactions | 090961 ANDA090961 |
| Memantine Hydrochloride | MEMANTINE HYDROCHLORIDE | Bryant Ranch Prepack | bf395152-2885-4633-bf3f-2da46e7b79f1 | 2023-03-30 | Warnings, Adverse reactions | 090961 ANDA090961 |
| Memantine Hydrochloride | MEMANTINE HYDROCHLORIDE | Bryant Ranch Prepack | 8bd5b908-f46a-4ced-9408-45984d716149 | 2023-03-24 | Warnings, Adverse reactions | 090961 ANDA090961 |
| Memantine Hydrochloride | MEMANTINE HYDROCHLORIDE | Bryant Ranch Prepack | 2bd37a6f-bdeb-42c2-9f03-fbf06b45cfe0 | 2023-03-03 | Warnings, Adverse reactions | 090961 ANDA090961 |
| Memantine Hydrochloride | MEMANTINE HYDROCHLORIDE | Bryant Ranch Prepack | 54a12ddf-306b-4eb7-a7c3-c7b58df3b372 | 2023-03-03 | Warnings, Adverse reactions | 090961 ANDA090961 |
| Memantine Hydrochloride | MEMANTINE HYDROCHLORIDE | Bryant Ranch Prepack | fac8c59b-5bf5-478e-8223-a5ecaa400625 | 2023-03-03 | Warnings, Adverse reactions | 090961 ANDA090961 |
| Memantine Hydrochloride | MEMANTINE HYDROCHLORIDE | Bryant Ranch Prepack | c8f96b24-de66-4a17-b798-42b42a25e84c | 2023-03-03 | Warnings, Adverse reactions | 090961 ANDA090961 |
| Memantine Hydrochloride | MEMANTINE HYDROCHLORIDE | Viona Pharmaceuticals Inc | dcbdb62a-a4e2-4058-b73c-46005f2a5d51 | 2022-10-08 | Warnings, Adverse reactions | 090961 ANDA090961 |