Memantine Hydrochloride
- Product NDC
- 60505-6210
- Requested package NDC
- 60505-6210-3
- 11-digit product format
- 605056210
- Labeler code
- 60505
- Product ID
- 60505-6210_6cfcef62-aadf-4c12-9fa7-2e8cb65f8d54
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- memantine hydrochloride
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Apotex Corp
- Application
- NDA022525
- Marketing category
- NDA
- Marketing start
- 2019-05-09
- Marketing end
- 0000-00-00
- Substance
- MEMANTINE HYDROCHLORIDE
- Active strength
- 21 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. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 60505-6210 | 60505-6210-3 | D | Discontinued by firm | 2026-08-03 |
Observed NDC auxiliary status history#
Observed captured status history: Rows come only from successfully parsed FDA auxiliary ZIP captures. They show the state present in that artifact, not a continuous regulatory timeline. Absence before, after, or between captures is not proof of status, and a known non-data HTTP 403 capture is preserved in backfill provenance but cannot produce a status row.
| Captured / source date | Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Archive | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|---|
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 60505-6210 | 60505-6210-3 | D | Discontinued by firm | excluded / ndc_excluded.zip | 367a005e9d99… | 383a685ebd0f… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 60505-6210 | 60505-6210-3 | 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 |
|---|---|---|---|---|---|---|---|
| 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 Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 60505-6210-3 | EA - Each | 60505-6210 | 2e01f522-1c5c-4fae-a742-1c22d4280616 | 1 | 2019-06-19 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 60505-6210-3 | 60505621003 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (60505-6210-3) | 2019-05-09 | 0000-00-00 | No | No | Current |