Namenda XR
- Product NDC
- 68151-5829
- 11-digit product format
- 681515829
- Labeler code
- 68151
- Product ID
- 68151-5829_3a73e786-fa25-4c07-af56-2b4022b2cd2e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- memantine hydrochloride
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Carilion Materials Management
- Application
- NDA022525
- Marketing category
- NDA
- Marketing start
- 2011-10-31
- Marketing end
- 0000-00-00
- Substance
- MEMANTINE HYDROCHLORIDE
- Active strength
- 28 mg/1
- Pharmacologic classes
- NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC]
- NDC exclude flag
- E
- Listing certified through
- 2018-12-31
- 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 | 68151-5829 | I | Inactivated by FDA | 2026-08-03 | ||
| excluded package | package | 68151-5829 | 68151-5829-8 | I | Inactivated by FDA | 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 | Package NDC | Code | Status | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | I | Inactivated by FDA | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 68151-5829-8 | I | Inactivated by FDA | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 68151-5829-8 | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 68151-5829-8 | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 68151-5829-8 | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 68151-5829-8 | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 68151-5829-8 | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | I | Inactivated by FDA | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 68151-5829-8 | I | Inactivated by FDA | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | I | Inactivated by FDA | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 68151-5829-8 | I | Inactivated by FDA | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | I | Inactivated by FDA | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 68151-5829-8 | I | Inactivated by FDA | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | I | Inactivated by FDA | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 68151-5829-8 | I | Inactivated by FDA | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | I | Inactivated by FDA | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 68151-5829-8 | I | Inactivated by FDA | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | I | Inactivated by FDA | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 68151-5829-8 | I | Inactivated by FDA | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded product | product | I | Inactivated by FDA | 8af77b9d5b6f… | d9bbb34c5368… | |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 68151-5829-8 | I | Inactivated by FDA | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded product | product | I | Inactivated by FDA | 834df4deac94… | adcc014656a3… | |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 68151-5829-8 | I | Inactivated by FDA | 834df4deac94… | adcc014656a3… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded product | product | I | Inactivated by FDA | 1332a3947898… | d4bfe170f9cd… | |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 68151-5829-8 | I | Inactivated by FDA | 1332a3947898… | d4bfe170f9cd… |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded product | product | I | Inactivated by FDA | fb8cb913e6d1… | eb8c232b6be0… | |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded package | package | 68151-5829-8 | I | Inactivated by FDA | fb8cb913e6d1… | eb8c232b6be0… |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded product | product | I | Inactivated by FDA | 86f5da6cb304… | a595104c45d7… | |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded package | package | 68151-5829-8 | I | Inactivated by FDA | 86f5da6cb304… | a595104c45d7… |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded product | product | I | Inactivated by FDA | bd6a592717d7… | 303034d00443… | |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded package | package | 68151-5829-8 | I | Inactivated by FDA | bd6a592717d7… | 303034d00443… |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded product | product | I | Inactivated by FDA | 8dfbde2a14a4… | c9ff85d89658… | |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded package | package | 68151-5829-8 | I | Inactivated by FDA | 8dfbde2a14a4… | c9ff85d89658… |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded product | product | I | Inactivated by FDA | e2bbac7714bc… | 27bdfed8d636… | |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded package | package | 68151-5829-8 | I | Inactivated by FDA | e2bbac7714bc… | 27bdfed8d636… |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded product | product | I | Inactivated by FDA | 9bebd1f3094a… | 5416666fcb17… | |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded package | package | 68151-5829-8 | I | Inactivated by FDA | 9bebd1f3094a… | 5416666fcb17… |
| 2019-12-08 06:16 UTC · source 2019-12-05 | excluded product | product | E | Excluded after deficient or non-compliant submission was not corrected | 110d247fa046… | a55b01930146… | |
| 2019-12-08 06:16 UTC · source 2019-12-05 | excluded package | package | 68151-5829-8 | E | Excluded after deficient or non-compliant submission was not corrected | 110d247fa046… | a55b01930146… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N022525-001 | NAMENDA XR | MEMANTINE HYDROCHLORIDE | 7MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2010-06-21 | |
| N022525-002 | NAMENDA XR | MEMANTINE HYDROCHLORIDE | 14MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2010-06-21 | |
| N022525-003 | NAMENDA XR | MEMANTINE HYDROCHLORIDE | 21MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2010-06-21 | |
| N022525-004 | NAMENDA XR | MEMANTINE HYDROCHLORIDE | 28MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2010-06-21 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N022525-001 | 8039009 | 2029-03-24 | U-539 | 2011-11-16 | |
| N022525-001 | 8039009*PED | 2029-09-24 | Pediatric extension | ||
| N022525-002 | 8039009 | 2029-03-24 | U-539 | ||
| N022525-002 | 8039009*PED | 2029-09-24 | Pediatric extension | ||
| N022525-003 | 8039009 | 2029-03-24 | U-539 | ||
| N022525-003 | 8039009*PED | 2029-09-24 | Pediatric extension | ||
| N022525-004 | 8039009 | 2029-03-24 | U-539 | ||
| N022525-004 | 8039009*PED | 2029-09-24 | Pediatric extension |
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 | N022525-001 | NAMENDA XR | 7MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2010-06-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022525-002 | NAMENDA XR | 14MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2010-06-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022525-003 | NAMENDA XR | 21MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2010-06-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022525-004 | NAMENDA XR | 28MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2010-06-21 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022525-001 | NAMENDA XR | 7MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2010-06-21 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022525-002 | NAMENDA XR | 14MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2010-06-21 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022525-003 | NAMENDA XR | 21MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2010-06-21 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022525-004 | NAMENDA XR | 28MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2010-06-21 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022525-001 | NAMENDA XR | 7MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2010-06-21 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022525-002 | NAMENDA XR | 14MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2010-06-21 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022525-003 | NAMENDA XR | 21MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2010-06-21 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022525-004 | NAMENDA XR | 28MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2010-06-21 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022525-001 | NAMENDA XR | 7MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2010-06-21 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022525-002 | NAMENDA XR | 14MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2010-06-21 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022525-003 | NAMENDA XR | 21MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2010-06-21 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022525-004 | NAMENDA XR | 28MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2010-06-21 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022525-001 | NAMENDA XR | 7MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2010-06-21 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022525-002 | NAMENDA XR | 14MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2010-06-21 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022525-003 | NAMENDA XR | 21MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2010-06-21 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022525-004 | NAMENDA XR | 28MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2010-06-21 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022525-001 | NAMENDA XR | 7MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2010-06-21 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022525-002 | NAMENDA XR | 14MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2010-06-21 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022525-003 | NAMENDA XR | 21MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2010-06-21 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022525-004 | NAMENDA XR | 28MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2010-06-21 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022525-001 | NAMENDA XR | 7MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2010-06-21 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022525-002 | NAMENDA XR | 14MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2010-06-21 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022525-003 | NAMENDA XR | 21MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2010-06-21 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022525-004 | NAMENDA XR | 28MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2010-06-21 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022525-001 | NAMENDA XR | 7MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2010-06-21 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022525-002 | NAMENDA XR | 14MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2010-06-21 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022525-003 | NAMENDA XR | 21MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2010-06-21 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022525-004 | NAMENDA XR | 28MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2010-06-21 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022525-001 | NAMENDA XR | 7MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2010-06-21 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022525-002 | NAMENDA XR | 14MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2010-06-21 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022525-003 | NAMENDA XR | 21MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2010-06-21 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022525-004 | NAMENDA XR | 28MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2010-06-21 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N022525-001 | NAMENDA XR | 7MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2010-06-21 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N022525-002 | NAMENDA XR | 14MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2010-06-21 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N022525-003 | NAMENDA XR | 21MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2010-06-21 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N022525-004 | NAMENDA XR | 28MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2010-06-21 | d06236e962d9… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N022525-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N022525-003 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N022525-004 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N022525-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N022525-003 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N022525-004 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N022525-002 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N022525-003 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N022525-004 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022525-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022525-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022525-003 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022525-004 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N022525-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N022525-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N022525-003 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N022525-004 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N022525-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N022525-002 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N022525-003 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N022525-004 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N022525-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N022525-002 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N022525-003 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N022525-004 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N022525-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | N022525-002 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | N022525-003 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | N022525-004 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N022525-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | N022525-002 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | N022525-003 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | N022525-004 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N022525-001 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N022525-002 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N022525-003 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N022525-004 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N022525-001 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | N022525-002 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | N022525-003 | AB | 1 | 5aa47cf7b7d7… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N022525-001 | 8039009 | 2029-03-24 | U-539 | 2011-11-16 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022525-001 | 8039009*PED | 2029-09-24 | Pediatric extension | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N022525-002 | 8039009 | 2029-03-24 | U-539 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N022525-002 | 8039009*PED | 2029-09-24 | Pediatric extension | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N022525-003 | 8039009 | 2029-03-24 | U-539 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N022525-003 | 8039009*PED | 2029-09-24 | Pediatric extension | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N022525-004 | 8039009 | 2029-03-24 | U-539 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N022525-004 | 8039009*PED | 2029-09-24 | Pediatric extension | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022525-001 | 8039009 | 2029-03-24 | U-539 | 2011-11-16 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022525-001 | 8039009*PED | 2029-09-24 | Pediatric extension | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022525-002 | 8039009 | 2029-03-24 | U-539 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022525-002 | 8039009*PED | 2029-09-24 | Pediatric extension | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022525-003 | 8039009 | 2029-03-24 | U-539 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022525-003 | 8039009*PED | 2029-09-24 | Pediatric extension | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022525-004 | 8039009 | 2029-03-24 | U-539 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022525-004 | 8039009*PED | 2029-09-24 | Pediatric extension | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N022525-001 | 8039009 | 2029-03-24 | U-539 | 2011-11-16 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022525-001 | 8039009*PED | 2029-09-24 | Pediatric extension | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N022525-002 | 8039009 | 2029-03-24 | U-539 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N022525-002 | 8039009*PED | 2029-09-24 | Pediatric extension | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N022525-003 | 8039009 | 2029-03-24 | U-539 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N022525-003 | 8039009*PED | 2029-09-24 | Pediatric extension | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N022525-004 | 8039009 | 2029-03-24 | U-539 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N022525-004 | 8039009*PED | 2029-09-24 | Pediatric extension | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022525-001 | 8039009 | 2029-03-24 | U-539 | 2011-11-16 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022525-001 | 8039009*PED | 2029-09-24 | Pediatric extension | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022525-002 | 8039009 | 2029-03-24 | U-539 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022525-002 | 8039009*PED | 2029-09-24 | Pediatric extension | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022525-003 | 8039009 | 2029-03-24 | U-539 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022525-003 | 8039009*PED | 2029-09-24 | Pediatric extension | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022525-004 | 8039009 | 2029-03-24 | U-539 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022525-004 | 8039009*PED | 2029-09-24 | Pediatric extension | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022525-001 | 8039009 | 2029-03-24 | U-539 | 2011-11-16 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022525-001 | 8039009*PED | 2029-09-24 | Pediatric extension | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022525-002 | 8039009 | 2029-03-24 | U-539 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022525-002 | 8039009*PED | 2029-09-24 | Pediatric extension | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022525-003 | 8039009 | 2029-03-24 | U-539 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022525-003 | 8039009*PED | 2029-09-24 | Pediatric extension | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022525-004 | 8039009 | 2029-03-24 | U-539 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022525-004 | 8039009*PED | 2029-09-24 | Pediatric extension | b8a1b40f171c… |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 94db636e-a074-45fd-8e8d-331920a99436 | Product name | 4 | 20250103 |
| 941773f8-a40e-0684-da08-ff9a143e6368 | Product name | 7 | 20231219 |
| 5b597f00-4538-4686-aa4e-3c60ed3788c8 | Product name | 2 | 20210511 |
| 1836e79a-a4d1-4087-2f2e-f878e8a1fef2 | Product name | 9 | 20151209 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 68151-5829-8 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-ee2d-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use NAMENDA XR capsules safely and effectively. See full prescribing information for NAMENDA XR capsules. NAMENDA XR (memantine hydrochloride) extended release capsules, for oral use Initial U.S. Approval: 2003 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68151-5829-8 | Namenda XR | 1 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 1 | 6 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68151-5829 | NAMENDA XR (MEMANTINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE NAMENDA XR (MEMANTINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT] | 6 | Legacy NDC, 1 package rows | 20180228_1fa2b7bc-94e5-4566-a7c5-419f8fd393a7.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 996594 | memantine HCl 14 MG 24HR Extended Release Oral Capsule | PSN | 1fa2b7bc-94e5-4566-a7c5-419f8fd393a7 | 6 |
| 996609 | memantine HCl 28 MG 24HR Extended Release Oral Capsule | PSN | 1fa2b7bc-94e5-4566-a7c5-419f8fd393a7 | 6 |
| 996597 | Namenda XR 14 MG 24HR Extended Release Oral Capsule | PSN | 1fa2b7bc-94e5-4566-a7c5-419f8fd393a7 | 6 |
| 996611 | Namenda XR 28 MG 24HR Extended Release Oral Capsule | PSN | 1fa2b7bc-94e5-4566-a7c5-419f8fd393a7 | 6 |
| 996597 | 24 HR memantine hydrochloride 14 MG Extended Release Oral Capsule [Namenda] | SBD | 1fa2b7bc-94e5-4566-a7c5-419f8fd393a7 | 6 |
| 996611 | 24 HR memantine hydrochloride 28 MG Extended Release Oral Capsule [Namenda] | SBD | 1fa2b7bc-94e5-4566-a7c5-419f8fd393a7 | 6 |
| 996594 | 24 HR memantine hydrochloride 14 MG Extended Release Oral Capsule | SCD | 1fa2b7bc-94e5-4566-a7c5-419f8fd393a7 | 6 |
| 996609 | 24 HR memantine hydrochloride 28 MG Extended Release Oral Capsule | SCD | 1fa2b7bc-94e5-4566-a7c5-419f8fd393a7 | 6 |
| 996597 | 24 HR Namenda 14 MG Extended Release Oral Capsule | SY | 1fa2b7bc-94e5-4566-a7c5-419f8fd393a7 | 6 |
| 996611 | 24 HR Namenda 28 MG Extended Release Oral Capsule | SY | 1fa2b7bc-94e5-4566-a7c5-419f8fd393a7 | 6 |
| 996594 | memantine hydrochloride 14 MG 24 HR Extended Release Oral Capsule | SY | 1fa2b7bc-94e5-4566-a7c5-419f8fd393a7 | 6 |
| 996609 | memantine hydrochloride 28 MG 24 HR Extended Release Oral Capsule | SY | 1fa2b7bc-94e5-4566-a7c5-419f8fd393a7 | 6 |
| 996597 | Namenda XR 14 MG 24 HR Extended Release Oral Capsule | SY | 1fa2b7bc-94e5-4566-a7c5-419f8fd393a7 | 6 |
| 996611 | Namenda XR 28 MG 24 HR Extended Release Oral Capsule | SY | 1fa2b7bc-94e5-4566-a7c5-419f8fd393a7 | 6 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 68151-5829-8 | 68151582908 | 1 in 1 BOTTLE | Historical |