Opana
- Product NDC
- 63481-812
- 11-digit product format
- 634810812
- Labeler code
- 63481
- Product ID
- 63481-812_a9737e83-4dc5-4189-9100-dd1612d83191
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- oxymorphone hydrochloride
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Endo Pharmaceuticals Inc.
- Application
- NDA201655
- Marketing category
- NDA
- Marketing start
- 2012-03-20
- Marketing end
- 2020-02-01
- Substance
- OXYMORPHONE HYDROCHLORIDE
- Active strength
- 5 mg/1
- Pharmacologic classes
- Full Opioid Agonists [MoA],Opioid Agonist [EPC]
- DEA schedule
- CII
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- 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 | 63481-812 | D | Discontinued by firm | 2026-08-10 | ||
| excluded package | package | 63481-812 | 63481-812-20 | D | Discontinued by firm | 2026-08-10 | |
| excluded package | package | 63481-812 | 63481-812-60 | D | Discontinued by firm | 2026-08-10 | |
| excluded package | package | 63481-812 | 63481-812-70 | D | Discontinued by firm | 2026-08-10 |
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 | 63481-812-70 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 63481-812-20 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 63481-812-60 | 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 | 63481-812-70 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 63481-812-20 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 63481-812-60 | 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 | 63481-812-70 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 63481-812-20 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 63481-812-60 | 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 | 63481-812-70 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 63481-812-20 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 63481-812-60 | 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 | 63481-812-70 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 63481-812-20 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 63481-812-60 | 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 | 63481-812-70 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 63481-812-20 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 63481-812-60 | 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 | 63481-812-70 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 63481-812-20 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 63481-812-60 | 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 | 63481-812-70 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 63481-812-20 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 63481-812-60 | 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 | 63481-812-70 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 63481-812-20 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 63481-812-60 | 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 | 63481-812-70 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 63481-812-20 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 63481-812-60 | 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 | 63481-812-70 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 63481-812-20 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 63481-812-60 | 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 | 63481-812-70 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 63481-812-20 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 63481-812-60 | 557ba5c1ecfa… | 9c80585c8c6e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N201655-001 | OPANA ER | OXYMORPHONE HYDROCHLORIDE | 5MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2011-12-09 | |
| N201655-002 | OPANA ER | OXYMORPHONE HYDROCHLORIDE | 7.5MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2011-12-09 | |
| N201655-003 | OPANA ER | OXYMORPHONE HYDROCHLORIDE | 10MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2011-12-09 | |
| N201655-004 | OPANA ER | OXYMORPHONE HYDROCHLORIDE | 15MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2011-12-09 | |
| N201655-005 | OPANA ER | OXYMORPHONE HYDROCHLORIDE | 20MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2011-12-09 | |
| N201655-006 | OPANA ER | OXYMORPHONE HYDROCHLORIDE | 30MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2011-12-09 | |
| N201655-007 | OPANA ER | OXYMORPHONE HYDROCHLORIDE | 40MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2011-12-09 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N201655-001 | 8808737 | 2027-06-21 | U-1598 | 2014-11-07 | |
| N201655-001 | 7851482 | 2029-07-10 | Drug substance | 2012-03-22 | |
| N201655-001 | 8871779 | 2029-11-22 | Drug substance | 2014-11-07 | |
| N201655-002 | 8808737 | 2027-06-21 | U-1598 | 2014-11-07 | |
| N201655-002 | 7851482 | 2029-07-10 | Drug substance | ||
| N201655-002 | 8871779 | 2029-11-22 | Drug substance | 2014-11-07 | |
| N201655-003 | 8808737 | 2027-06-21 | U-1598 | 2014-11-07 | |
| N201655-003 | 7851482 | 2029-07-10 | Drug substance | ||
| N201655-003 | 8871779 | 2029-11-22 | Drug substance | 2014-11-07 | |
| N201655-004 | 8808737 | 2027-06-21 | U-1598 | 2014-11-07 | |
| N201655-004 | 7851482 | 2029-07-10 | Drug substance | ||
| N201655-004 | 8871779 | 2029-11-22 | Drug substance | 2014-11-07 | |
| N201655-005 | 8808737 | 2027-06-21 | U-1598 | 2014-11-07 | |
| N201655-005 | 7851482 | 2029-07-10 | Drug substance | ||
| N201655-005 | 8871779 | 2029-11-22 | Drug substance | 2014-11-07 | |
| N201655-006 | 8808737 | 2027-06-21 | U-1598 | 2014-11-07 | |
| N201655-006 | 7851482 | 2029-07-10 | Drug substance | ||
| N201655-006 | 8871779 | 2029-11-22 | Drug substance | 2014-11-07 | |
| N201655-007 | 8808737 | 2027-06-21 | U-1598 | 2014-11-07 | |
| N201655-007 | 7851482 | 2029-07-10 | Drug substance | ||
| N201655-007 | 8871779 | 2029-11-22 | Drug substance | 2014-11-07 |
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 | N201655-001 | OPANA ER | 5MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2011-12-09 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N201655-002 | OPANA ER | 7.5MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2011-12-09 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N201655-003 | OPANA ER | 10MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2011-12-09 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N201655-004 | OPANA ER | 15MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2011-12-09 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N201655-005 | OPANA ER | 20MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2011-12-09 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N201655-006 | OPANA ER | 30MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2011-12-09 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N201655-007 | OPANA ER | 40MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2011-12-09 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N201655-001 | OPANA ER | 5MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2011-12-09 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N201655-002 | OPANA ER | 7.5MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2011-12-09 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N201655-003 | OPANA ER | 10MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2011-12-09 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N201655-004 | OPANA ER | 15MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2011-12-09 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N201655-005 | OPANA ER | 20MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2011-12-09 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N201655-006 | OPANA ER | 30MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2011-12-09 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N201655-007 | OPANA ER | 40MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2011-12-09 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N201655-001 | OPANA ER | 5MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2011-12-09 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N201655-002 | OPANA ER | 7.5MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2011-12-09 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N201655-003 | OPANA ER | 10MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2011-12-09 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N201655-004 | OPANA ER | 15MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2011-12-09 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N201655-005 | OPANA ER | 20MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2011-12-09 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N201655-006 | OPANA ER | 30MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2011-12-09 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N201655-007 | OPANA ER | 40MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2011-12-09 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N201655-001 | OPANA ER | 5MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2011-12-09 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N201655-002 | OPANA ER | 7.5MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2011-12-09 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N201655-003 | OPANA ER | 10MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2011-12-09 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N201655-004 | OPANA ER | 15MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2011-12-09 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N201655-005 | OPANA ER | 20MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2011-12-09 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N201655-006 | OPANA ER | 30MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2011-12-09 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N201655-007 | OPANA ER | 40MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2011-12-09 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N201655-001 | OPANA ER | 5MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2011-12-09 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N201655-002 | OPANA ER | 7.5MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2011-12-09 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N201655-003 | OPANA ER | 10MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2011-12-09 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N201655-004 | OPANA ER | 15MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2011-12-09 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N201655-005 | OPANA ER | 20MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2011-12-09 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N201655-006 | OPANA ER | 30MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2011-12-09 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N201655-007 | OPANA ER | 40MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2011-12-09 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N201655-001 | OPANA ER | 5MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2011-12-09 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N201655-002 | OPANA ER | 7.5MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2011-12-09 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N201655-003 | OPANA ER | 10MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2011-12-09 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N201655-004 | OPANA ER | 15MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2011-12-09 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N201655-005 | OPANA ER | 20MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2011-12-09 | 03ed91905a0d… |
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 | N201655-001 | 8808737 | 2027-06-21 | U-1598 | 2014-11-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N201655-001 | 7851482 | 2029-07-10 | Drug substance | 2012-03-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N201655-001 | 8871779 | 2029-11-22 | Drug substance | 2014-11-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N201655-002 | 8808737 | 2027-06-21 | U-1598 | 2014-11-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N201655-002 | 7851482 | 2029-07-10 | Drug substance | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N201655-002 | 8871779 | 2029-11-22 | Drug substance | 2014-11-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N201655-003 | 8808737 | 2027-06-21 | U-1598 | 2014-11-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N201655-003 | 7851482 | 2029-07-10 | Drug substance | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N201655-003 | 8871779 | 2029-11-22 | Drug substance | 2014-11-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N201655-004 | 8808737 | 2027-06-21 | U-1598 | 2014-11-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N201655-004 | 7851482 | 2029-07-10 | Drug substance | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N201655-004 | 8871779 | 2029-11-22 | Drug substance | 2014-11-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N201655-005 | 8808737 | 2027-06-21 | U-1598 | 2014-11-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N201655-005 | 7851482 | 2029-07-10 | Drug substance | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N201655-005 | 8871779 | 2029-11-22 | Drug substance | 2014-11-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N201655-006 | 8808737 | 2027-06-21 | U-1598 | 2014-11-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N201655-006 | 7851482 | 2029-07-10 | Drug substance | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N201655-006 | 8871779 | 2029-11-22 | Drug substance | 2014-11-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N201655-007 | 8808737 | 2027-06-21 | U-1598 | 2014-11-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N201655-007 | 7851482 | 2029-07-10 | Drug substance | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N201655-007 | 8871779 | 2029-11-22 | Drug substance | 2014-11-07 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N201655-001 | 8192722 | 2025-09-15 | Drug product | 2012-06-05 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N201655-001 | 8808737 | 2027-06-21 | U-1598 | 2014-11-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N201655-001 | 7851482 | 2029-07-10 | Drug substance | 2012-03-22 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N201655-001 | 8871779 | 2029-11-22 | Drug substance | 2014-11-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N201655-002 | 8192722 | 2025-09-15 | Drug product | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N201655-002 | 8808737 | 2027-06-21 | U-1598 | 2014-11-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N201655-002 | 7851482 | 2029-07-10 | Drug substance | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N201655-002 | 8871779 | 2029-11-22 | Drug substance | 2014-11-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N201655-003 | 8192722 | 2025-09-15 | Drug product | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N201655-003 | 8808737 | 2027-06-21 | U-1598 | 2014-11-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N201655-003 | 7851482 | 2029-07-10 | Drug substance | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N201655-003 | 8871779 | 2029-11-22 | Drug substance | 2014-11-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N201655-004 | 8192722 | 2025-09-15 | Drug product | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N201655-004 | 8808737 | 2027-06-21 | U-1598 | 2014-11-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N201655-004 | 7851482 | 2029-07-10 | Drug substance | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N201655-004 | 8871779 | 2029-11-22 | Drug substance | 2014-11-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N201655-005 | 8192722 | 2025-09-15 | Drug product | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N201655-005 | 8808737 | 2027-06-21 | U-1598 | 2014-11-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N201655-005 | 7851482 | 2029-07-10 | Drug substance | 31067a03dcf5… |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 63481-812-20 | EA - Each | 63481-812 | d8163a03-15f7-4178-be80-849bd253542f | 1 | 2013-07-02 |
| 63481-812-60 | EA - Each | 63481-812 | 8d422e90-27dd-4947-a40a-2359cd14297c | 1 | 2012-07-24 |