Mirapex
- Product NDC
- 0597-0113
- Requested package NDC
- 0597-0113-17
- 11-digit product format
- 005970113
- Labeler code
- 0597
- Product ID
- 0597-0113_52132628-35e3-4594-a642-da7162158112
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- pramipexole dihydrochloride
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Boehringer Ingelheim Pharmaceuticals, Inc.
- Application
- NDA022421
- Marketing category
- NDA
- Marketing start
- 2010-02-22
- Marketing end
- 0000-00-00
- Substance
- PRAMIPEXOLE DIHYDROCHLORIDE
- Active strength
- 2 mg/1
- Pharmacologic classes
- Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]
- 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 | 0597-0113 | 0597-0113-17 | 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 | 0597-0113 | 0597-0113-17 | D | Discontinued by firm | excluded / ndc_excluded.zip | 367a005e9d99… | 383a685ebd0f… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 0597-0113 | 0597-0113-17 | 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 |
|---|---|---|---|---|---|---|---|
| N022421-001 | MIRAPEX ER | PRAMIPEXOLE DIHYDROCHLORIDE | 0.375MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-02-19 | |
| N022421-002 | MIRAPEX ER | PRAMIPEXOLE DIHYDROCHLORIDE | 0.75MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-02-19 | |
| N022421-003 | MIRAPEX ER | PRAMIPEXOLE DIHYDROCHLORIDE | 1.5MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-02-19 | |
| N022421-004 | MIRAPEX ER | PRAMIPEXOLE DIHYDROCHLORIDE | 3MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-02-19 | |
| N022421-005 | MIRAPEX ER | PRAMIPEXOLE DIHYDROCHLORIDE | 4.5MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-02-19 | |
| N022421-006 | MIRAPEX ER | PRAMIPEXOLE DIHYDROCHLORIDE | 2.25MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2011-06-17 | |
| N022421-007 | MIRAPEX ER | PRAMIPEXOLE DIHYDROCHLORIDE | 3.75MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2011-06-17 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N022421-001 | 7695734 | 2028-04-26 | Drug product | ||
| N022421-001 | 8679533 | 2029-09-08 | U-219 | Drug product | 2014-03-25 |
| N022421-002 | 7695734 | 2028-04-26 | Drug product | ||
| N022421-002 | 8679533 | 2029-09-08 | U-219 | Drug product | 2014-03-25 |
| N022421-003 | 7695734 | 2028-04-26 | Drug product | ||
| N022421-003 | 8679533 | 2029-09-08 | U-219 | Drug product | 2014-03-25 |
| N022421-004 | 7695734 | 2028-04-26 | Drug product | ||
| N022421-004 | 8679533 | 2029-09-08 | U-219 | Drug product | 2014-03-25 |
| N022421-005 | 7695734 | 2028-04-26 | Drug product | ||
| N022421-005 | 8679533 | 2029-09-08 | U-219 | Drug product | 2014-03-25 |
| N022421-006 | 7695734 | 2028-04-26 | Drug product | 2011-06-30 | |
| N022421-006 | 8679533 | 2029-09-08 | U-219 | Drug product | 2014-03-25 |
| N022421-007 | 7695734 | 2028-04-26 | Drug product | 2011-06-30 | |
| N022421-007 | 8679533 | 2029-09-08 | U-219 | Drug product | 2014-03-25 |
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 | N022421-001 | MIRAPEX ER | 0.375MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-02-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022421-002 | MIRAPEX ER | 0.75MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-02-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022421-003 | MIRAPEX ER | 1.5MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-02-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022421-004 | MIRAPEX ER | 3MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-02-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022421-005 | MIRAPEX ER | 4.5MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-02-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022421-006 | MIRAPEX ER | 2.25MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2011-06-17 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022421-007 | MIRAPEX ER | 3.75MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2011-06-17 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022421-001 | MIRAPEX ER | 0.375MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-02-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022421-002 | MIRAPEX ER | 0.75MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-02-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022421-003 | MIRAPEX ER | 1.5MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-02-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022421-004 | MIRAPEX ER | 3MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-02-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022421-005 | MIRAPEX ER | 4.5MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-02-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022421-006 | MIRAPEX ER | 2.25MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2011-06-17 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022421-007 | MIRAPEX ER | 3.75MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2011-06-17 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022421-001 | MIRAPEX ER | 0.375MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-02-19 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022421-002 | MIRAPEX ER | 0.75MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-02-19 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022421-003 | MIRAPEX ER | 1.5MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-02-19 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022421-004 | MIRAPEX ER | 3MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-02-19 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022421-005 | MIRAPEX ER | 4.5MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-02-19 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022421-006 | MIRAPEX ER | 2.25MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2011-06-17 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022421-007 | MIRAPEX ER | 3.75MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2011-06-17 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022421-001 | MIRAPEX ER | 0.375MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-02-19 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022421-002 | MIRAPEX ER | 0.75MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-02-19 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022421-003 | MIRAPEX ER | 1.5MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-02-19 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022421-004 | MIRAPEX ER | 3MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-02-19 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022421-005 | MIRAPEX ER | 4.5MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-02-19 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022421-006 | MIRAPEX ER | 2.25MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2011-06-17 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022421-007 | MIRAPEX ER | 3.75MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2011-06-17 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022421-001 | MIRAPEX ER | 0.375MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-02-19 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022421-002 | MIRAPEX ER | 0.75MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-02-19 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022421-003 | MIRAPEX ER | 1.5MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-02-19 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022421-004 | MIRAPEX ER | 3MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-02-19 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022421-005 | MIRAPEX ER | 4.5MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-02-19 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022421-006 | MIRAPEX ER | 2.25MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2011-06-17 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022421-007 | MIRAPEX ER | 3.75MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2011-06-17 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022421-001 | MIRAPEX ER | 0.375MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-02-19 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022421-002 | MIRAPEX ER | 0.75MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-02-19 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022421-003 | MIRAPEX ER | 1.5MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-02-19 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022421-004 | MIRAPEX ER | 3MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-02-19 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022421-005 | MIRAPEX ER | 4.5MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-02-19 | 03ed91905a0d… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N022421-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N022421-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N022421-003 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N022421-004 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N022421-005 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N022421-006 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N022421-007 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N022421-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N022421-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N022421-003 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N022421-004 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N022421-005 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N022421-006 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N022421-007 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N022421-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N022421-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N022421-003 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N022421-004 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N022421-005 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N022421-006 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N022421-007 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N022421-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N022421-002 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N022421-003 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N022421-004 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N022421-005 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N022421-006 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N022421-007 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022421-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022421-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022421-003 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022421-004 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022421-005 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022421-006 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022421-007 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N022421-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N022421-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N022421-003 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N022421-004 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N022421-005 | AB | 1 | 5d02ea3f76ae… |
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 | N022421-001 | 7695734 | 2028-04-26 | Drug product | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N022421-001 | 8679533 | 2029-09-08 | U-219 | Drug product | 2014-03-25 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N022421-002 | 7695734 | 2028-04-26 | Drug product | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N022421-002 | 8679533 | 2029-09-08 | U-219 | Drug product | 2014-03-25 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N022421-003 | 7695734 | 2028-04-26 | Drug product | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N022421-003 | 8679533 | 2029-09-08 | U-219 | Drug product | 2014-03-25 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N022421-004 | 7695734 | 2028-04-26 | Drug product | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N022421-004 | 8679533 | 2029-09-08 | U-219 | Drug product | 2014-03-25 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N022421-005 | 7695734 | 2028-04-26 | Drug product | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N022421-005 | 8679533 | 2029-09-08 | U-219 | Drug product | 2014-03-25 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N022421-006 | 7695734 | 2028-04-26 | Drug product | 2011-06-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022421-006 | 8679533 | 2029-09-08 | U-219 | Drug product | 2014-03-25 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N022421-007 | 7695734 | 2028-04-26 | Drug product | 2011-06-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022421-007 | 8679533 | 2029-09-08 | U-219 | Drug product | 2014-03-25 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022421-001 | 7695734 | 2028-04-26 | Drug product | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022421-001 | 8679533 | 2029-09-08 | U-219 | Drug product | 2014-03-25 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022421-002 | 7695734 | 2028-04-26 | Drug product | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022421-002 | 8679533 | 2029-09-08 | U-219 | Drug product | 2014-03-25 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022421-003 | 7695734 | 2028-04-26 | Drug product | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022421-003 | 8679533 | 2029-09-08 | U-219 | Drug product | 2014-03-25 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022421-004 | 7695734 | 2028-04-26 | Drug product | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022421-004 | 8679533 | 2029-09-08 | U-219 | Drug product | 2014-03-25 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022421-005 | 7695734 | 2028-04-26 | Drug product | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022421-005 | 8679533 | 2029-09-08 | U-219 | Drug product | 2014-03-25 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022421-006 | 7695734 | 2028-04-26 | Drug product | 2011-06-30 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022421-006 | 8679533 | 2029-09-08 | U-219 | Drug product | 2014-03-25 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022421-007 | 7695734 | 2028-04-26 | Drug product | 2011-06-30 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022421-007 | 8679533 | 2029-09-08 | U-219 | Drug product | 2014-03-25 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N022421-001 | 7695734 | 2028-04-26 | Drug product | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N022421-001 | 8679533 | 2029-09-08 | U-219 | Drug product | 2014-03-25 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N022421-002 | 7695734 | 2028-04-26 | Drug product | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N022421-002 | 8679533 | 2029-09-08 | U-219 | Drug product | 2014-03-25 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N022421-003 | 7695734 | 2028-04-26 | Drug product | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N022421-003 | 8679533 | 2029-09-08 | U-219 | Drug product | 2014-03-25 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N022421-004 | 7695734 | 2028-04-26 | Drug product | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N022421-004 | 8679533 | 2029-09-08 | U-219 | Drug product | 2014-03-25 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N022421-005 | 7695734 | 2028-04-26 | Drug product | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N022421-005 | 8679533 | 2029-09-08 | U-219 | Drug product | 2014-03-25 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N022421-006 | 7695734 | 2028-04-26 | Drug product | 2011-06-30 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022421-006 | 8679533 | 2029-09-08 | U-219 | Drug product | 2014-03-25 | 6a471c1ec25d… |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0597-0113-17 | EA - Each | 0597-0113 | f28187ca-73fd-43e1-8d35-efb84b84d99d | 1 | 2012-07-24 |
| 0597-0113-30 | EA - Each | 0597-0113 | 2426551c-2168-4c13-b71a-5aaaf86b7d77 | 1 | 2012-07-24 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 0597-0113-17 | 00597011317 | 1 BOTTLE, PLASTIC in 1 CARTON (0597-0113-17) > 7 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC | 2010-02-22 | 0000-00-00 | No | No | Current |