EMBEDA
- Product NDC
- 60793-434
- 11-digit product format
- 607930434
- Labeler code
- 60793
- Product ID
- 60793-434_c44a9425-3894-424f-9f60-cbf08d358e3e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- MORPHINE SULFATE and NALTREXONE HYDROCHLORIDE
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Pfizer Laboratories Div Pfizer Inc
- Application
- NDA022321
- Marketing category
- NDA
- Marketing start
- 2009-08-13
- Marketing end
- 0000-00-00
- Substance
- MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE
- Active strength
- 60 mg/1; mg/1
- Pharmacologic classes
- Full Opioid Agonists [MoA],Opioid Agonist [EPC],Opioid Antagonist [EPC],Opioid Antagonists [MoA]
- DEA schedule
- CII
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- 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 | 60793-434 | D | Discontinued by firm | 2026-10-05 | ||
| excluded package | package | 60793-434 | 60793-434-20 | D | Discontinued by firm | 2026-10-05 |
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 | 60793-434-20 | 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 | 60793-434-20 | 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 | 60793-434-20 | 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 | 60793-434-20 | 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 | 60793-434-20 | 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 | 60793-434-20 | 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 | 60793-434-20 | 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 | 60793-434-20 | 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 | 60793-434-20 | 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 | 60793-434-20 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 60793-434-20 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 60793-434-20 | 557ba5c1ecfa… | 9c80585c8c6e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N022321-001 | EMBEDA | MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE | 20MG;0.8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2009-08-13 | |
| N022321-002 | EMBEDA | MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE | 30MG;1.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2009-08-13 | |
| N022321-003 | EMBEDA | MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE | 50MG;2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2009-08-13 | |
| N022321-004 | EMBEDA | MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE | 60MG;2.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2009-08-13 | |
| N022321-005 | EMBEDA | MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE | 80MG;3.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2009-08-13 | |
| N022321-006 | EMBEDA | MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE | 100MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2009-08-13 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N022321-001 | 7682633 | 2027-06-19 | U-1510 | ||
| N022321-001 | 7682634 | 2027-06-19 | Drug product | ||
| N022321-001 | 8158156 | 2027-06-19 | U-1510 | 2012-05-10 | |
| N022321-001 | 8846104 | 2027-06-19 | Drug product | 2014-10-28 | |
| N022321-001 | 8877247 | 2027-06-19 | Drug product | 2014-12-01 | |
| N022321-001 | 7815934 | 2027-12-12 | Drug product | 2010-10-19 | |
| N022321-001 | 8623418 | 2029-11-07 | U-1640 | 2015-01-22 | |
| N022321-002 | 7682633 | 2027-06-19 | U-1510 | ||
| N022321-002 | 7682634 | 2027-06-19 | Drug product | ||
| N022321-002 | 8158156 | 2027-06-19 | U-1510 | ||
| N022321-002 | 8846104 | 2027-06-19 | Drug product | 2014-10-28 | |
| N022321-002 | 8877247 | 2027-06-19 | Drug product | 2014-12-01 | |
| N022321-002 | 7815934 | 2027-12-12 | Drug product | ||
| N022321-002 | 8623418 | 2029-11-07 | U-1640 | 2015-01-22 | |
| N022321-003 | 7682633 | 2027-06-19 | U-1510 | ||
| N022321-003 | 7682634 | 2027-06-19 | Drug product | ||
| N022321-003 | 8158156 | 2027-06-19 | U-1510 | ||
| N022321-003 | 8846104 | 2027-06-19 | Drug product | 2014-10-28 | |
| N022321-003 | 8877247 | 2027-06-19 | Drug product | 2014-12-01 | |
| N022321-003 | 7815934 | 2027-12-12 | Drug product | ||
| N022321-003 | 8623418 | 2029-11-07 | U-1640 | 2015-01-22 | |
| N022321-004 | 7682633 | 2027-06-19 | U-1510 | ||
| N022321-004 | 7682634 | 2027-06-19 | Drug product | ||
| N022321-004 | 8158156 | 2027-06-19 | U-1510 | ||
| N022321-004 | 8846104 | 2027-06-19 | Drug product | 2014-10-28 | |
| N022321-004 | 8877247 | 2027-06-19 | Drug product | 2014-12-01 | |
| N022321-004 | 7815934 | 2027-12-12 | Drug product | ||
| N022321-004 | 8623418 | 2029-11-07 | U-1640 | 2015-01-22 | |
| N022321-005 | 7682633 | 2027-06-19 | U-1510 | ||
| N022321-005 | 7682634 | 2027-06-19 | Drug product | ||
| N022321-005 | 8158156 | 2027-06-19 | U-1510 | ||
| N022321-005 | 8846104 | 2027-06-19 | Drug product | 2014-10-28 | |
| N022321-005 | 8877247 | 2027-06-19 | Drug product | 2014-12-01 | |
| N022321-005 | 7815934 | 2027-12-12 | Drug product | ||
| N022321-005 | 8623418 | 2029-11-07 | U-1640 | 2015-01-22 | |
| N022321-006 | 7682633 | 2027-06-19 | U-1510 | ||
| N022321-006 | 7682634 | 2027-06-19 | Drug product | ||
| N022321-006 | 8158156 | 2027-06-19 | U-1510 | ||
| N022321-006 | 8846104 | 2027-06-19 | Drug product | 2014-10-28 | |
| N022321-006 | 8877247 | 2027-06-19 | Drug product | 2014-12-01 | |
| N022321-006 | 7815934 | 2027-12-12 | Drug product | ||
| N022321-006 | 8623418 | 2029-11-07 | U-1640 | 2015-01-22 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N022321-001 | EMBEDA | 20MG;0.8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2009-08-13 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022321-002 | EMBEDA | 30MG;1.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2009-08-13 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022321-003 | EMBEDA | 50MG;2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2009-08-13 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022321-004 | EMBEDA | 60MG;2.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2009-08-13 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022321-005 | EMBEDA | 80MG;3.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2009-08-13 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022321-006 | EMBEDA | 100MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2009-08-13 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N022321-001 | EMBEDA | 20MG;0.8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2009-08-13 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022321-002 | EMBEDA | 30MG;1.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2009-08-13 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022321-003 | EMBEDA | 50MG;2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2009-08-13 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022321-004 | EMBEDA | 60MG;2.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2009-08-13 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022321-005 | EMBEDA | 80MG;3.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2009-08-13 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022321-006 | EMBEDA | 100MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2009-08-13 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022321-001 | EMBEDA | 20MG;0.8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2009-08-13 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022321-002 | EMBEDA | 30MG;1.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2009-08-13 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022321-003 | EMBEDA | 50MG;2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2009-08-13 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022321-004 | EMBEDA | 60MG;2.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2009-08-13 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022321-005 | EMBEDA | 80MG;3.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2009-08-13 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022321-006 | EMBEDA | 100MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2009-08-13 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022321-001 | EMBEDA | 20MG;0.8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2009-08-13 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022321-002 | EMBEDA | 30MG;1.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2009-08-13 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022321-003 | EMBEDA | 50MG;2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2009-08-13 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022321-004 | EMBEDA | 60MG;2.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2009-08-13 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022321-005 | EMBEDA | 80MG;3.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2009-08-13 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022321-006 | EMBEDA | 100MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2009-08-13 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022321-001 | EMBEDA | 20MG;0.8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2009-08-13 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022321-002 | EMBEDA | 30MG;1.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2009-08-13 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022321-003 | EMBEDA | 50MG;2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2009-08-13 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022321-004 | EMBEDA | 60MG;2.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2009-08-13 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022321-005 | EMBEDA | 80MG;3.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2009-08-13 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022321-006 | EMBEDA | 100MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2009-08-13 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022321-001 | EMBEDA | 20MG;0.8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2009-08-13 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022321-002 | EMBEDA | 30MG;1.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2009-08-13 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022321-003 | EMBEDA | 50MG;2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2009-08-13 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022321-004 | EMBEDA | 60MG;2.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2009-08-13 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022321-005 | EMBEDA | 80MG;3.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2009-08-13 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022321-006 | EMBEDA | 100MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2009-08-13 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022321-001 | EMBEDA | 20MG;0.8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2009-08-13 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022321-002 | EMBEDA | 30MG;1.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2009-08-13 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022321-003 | EMBEDA | 50MG;2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2009-08-13 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022321-004 | EMBEDA | 60MG;2.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2009-08-13 | b8a1b40f171c… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N022321-001 | 7682633 | 2027-06-19 | U-1510 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N022321-001 | 7682634 | 2027-06-19 | Drug product | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N022321-001 | 8158156 | 2027-06-19 | U-1510 | 2012-05-10 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022321-001 | 8846104 | 2027-06-19 | Drug product | 2014-10-28 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022321-001 | 8877247 | 2027-06-19 | Drug product | 2014-12-01 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022321-001 | 7815934 | 2027-12-12 | Drug product | 2010-10-19 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022321-001 | 8623418 | 2029-11-07 | U-1640 | 2015-01-22 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022321-002 | 7682633 | 2027-06-19 | U-1510 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N022321-002 | 7682634 | 2027-06-19 | Drug product | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N022321-002 | 8158156 | 2027-06-19 | U-1510 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N022321-002 | 8846104 | 2027-06-19 | Drug product | 2014-10-28 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022321-002 | 8877247 | 2027-06-19 | Drug product | 2014-12-01 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022321-002 | 7815934 | 2027-12-12 | Drug product | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N022321-002 | 8623418 | 2029-11-07 | U-1640 | 2015-01-22 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022321-003 | 7682633 | 2027-06-19 | U-1510 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N022321-003 | 7682634 | 2027-06-19 | Drug product | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N022321-003 | 8158156 | 2027-06-19 | U-1510 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N022321-003 | 8846104 | 2027-06-19 | Drug product | 2014-10-28 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022321-003 | 8877247 | 2027-06-19 | Drug product | 2014-12-01 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022321-003 | 7815934 | 2027-12-12 | Drug product | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N022321-003 | 8623418 | 2029-11-07 | U-1640 | 2015-01-22 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022321-004 | 7682633 | 2027-06-19 | U-1510 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N022321-004 | 7682634 | 2027-06-19 | Drug product | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N022321-004 | 8158156 | 2027-06-19 | U-1510 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N022321-004 | 8846104 | 2027-06-19 | Drug product | 2014-10-28 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022321-004 | 8877247 | 2027-06-19 | Drug product | 2014-12-01 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022321-004 | 7815934 | 2027-12-12 | Drug product | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N022321-004 | 8623418 | 2029-11-07 | U-1640 | 2015-01-22 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022321-005 | 7682633 | 2027-06-19 | U-1510 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N022321-005 | 7682634 | 2027-06-19 | Drug product | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N022321-005 | 8158156 | 2027-06-19 | U-1510 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N022321-005 | 8846104 | 2027-06-19 | Drug product | 2014-10-28 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022321-005 | 8877247 | 2027-06-19 | Drug product | 2014-12-01 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022321-005 | 7815934 | 2027-12-12 | Drug product | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N022321-005 | 8623418 | 2029-11-07 | U-1640 | 2015-01-22 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022321-006 | 7682633 | 2027-06-19 | U-1510 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N022321-006 | 7682634 | 2027-06-19 | Drug product | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N022321-006 | 8158156 | 2027-06-19 | U-1510 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N022321-006 | 8846104 | 2027-06-19 | Drug product | 2014-10-28 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022321-006 | 8877247 | 2027-06-19 | Drug product | 2014-12-01 | 84e616aacf4f… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 60793-434-01 | EA - Each | 60793-434 | 3f5c93a0-70b5-4da2-a16c-62bd54b0a2da | 1 | 2012-07-24 |
| 60793-434-20 | EA - Each | 60793-434 | 1353f479-ec0b-4cc5-b008-f01a52355533 | 1 | 2015-02-02 |