OPANA ER
- Product NDC
- 21695-949
- 11-digit product format
- 216950949
- Labeler code
- 21695
- Product ID
- 21695-949_b639732f-8eb2-4592-aca3-86faf7e5360b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Oxymorphone Hydrochloride
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Rebel Distributors Corp
- Application
- NDA021610
- Marketing category
- NDA
- Marketing start
- 2006-06-22
- Marketing end
- 0000-00-00
- Substance
- OXYMORPHONE HYDROCHLORIDE
- Active strength
- 10 mg/1
- Pharmacologic classes
- Full Opioid Agonists [MoA],Opioid Agonist [EPC]
- DEA schedule
- CII
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- 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 | 21695-949 | I | Inactivated by FDA | 2026-08-10 | ||
| excluded package | package | 21695-949 | 21695-949-60 | I | Inactivated by FDA | 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 | 21695-949-60 | 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 | 21695-949-60 | 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 | 21695-949-60 | 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 | 21695-949-60 | 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 | 21695-949-60 | 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 | 21695-949-60 | 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 | 21695-949-60 | 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 | 21695-949-60 | 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 | 21695-949-60 | 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 | 21695-949-60 | 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 | 21695-949-60 | 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 | 21695-949-60 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded product | product | 8af77b9d5b6f… | d9bbb34c5368… | |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 21695-949-60 | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded product | product | 834df4deac94… | adcc014656a3… | |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 21695-949-60 | 834df4deac94… | adcc014656a3… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded product | product | 1332a3947898… | d4bfe170f9cd… | |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 21695-949-60 | 1332a3947898… | d4bfe170f9cd… |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded product | product | fb8cb913e6d1… | eb8c232b6be0… | |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded package | package | 21695-949-60 | fb8cb913e6d1… | eb8c232b6be0… |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded product | product | 86f5da6cb304… | a595104c45d7… | |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded package | package | 21695-949-60 | 86f5da6cb304… | a595104c45d7… |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded product | product | bd6a592717d7… | 303034d00443… | |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded package | package | 21695-949-60 | bd6a592717d7… | 303034d00443… |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded product | product | 8dfbde2a14a4… | c9ff85d89658… | |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded package | package | 21695-949-60 | 8dfbde2a14a4… | c9ff85d89658… |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded product | product | e2bbac7714bc… | 27bdfed8d636… | |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded package | package | 21695-949-60 | e2bbac7714bc… | 27bdfed8d636… |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded product | product | 9bebd1f3094a… | 5416666fcb17… | |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded package | package | 21695-949-60 | 9bebd1f3094a… | 5416666fcb17… |
| 2019-12-08 06:16 UTC · source 2019-12-05 | excluded product | product | 110d247fa046… | a55b01930146… | |
| 2019-12-08 06:16 UTC · source 2019-12-05 | excluded package | package | 21695-949-60 | 110d247fa046… | a55b01930146… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N021610-001 | OPANA ER | OXYMORPHONE HYDROCHLORIDE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2006-06-22 | |
| N021610-002 | OPANA ER | OXYMORPHONE HYDROCHLORIDE | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2006-06-22 | |
| N021610-003 | OPANA ER | OXYMORPHONE HYDROCHLORIDE | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2006-06-22 | |
| N021610-004 | OPANA ER | OXYMORPHONE HYDROCHLORIDE | 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2006-06-22 | |
| N021610-005 | OPANA ER | OXYMORPHONE HYDROCHLORIDE | 7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2008-02-29 | |
| N021610-006 | OPANA ER | OXYMORPHONE HYDROCHLORIDE | 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2008-02-29 | |
| N021610-007 | OPANA ER | OXYMORPHONE HYDROCHLORIDE | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2008-02-29 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N021610-001 | 8808737 | 2027-06-21 | U-3085 | 2021-03-18 | |
| N021610-001 | 8871779 | 2029-11-22 | Drug substance | 2021-03-18 | |
| N021610-002 | 8808737 | 2027-06-21 | U-3085 | 2021-03-18 | |
| N021610-002 | 8871779 | 2029-11-22 | Drug substance | 2021-03-18 | |
| N021610-003 | 8808737 | 2027-06-21 | U-3085 | 2021-03-18 | |
| N021610-003 | 8871779 | 2029-11-22 | Drug substance | 2021-03-18 | |
| N021610-004 | 8808737 | 2027-06-21 | U-3085 | 2021-03-18 | |
| N021610-004 | 8871779 | 2029-11-22 | Drug substance | 2021-03-18 | |
| N021610-005 | 8808737 | 2027-06-21 | U-3085 | 2021-03-18 | |
| N021610-005 | 8871779 | 2029-11-22 | Drug substance | 2021-03-18 | |
| N021610-006 | 8808737 | 2027-06-21 | U-3085 | 2021-03-18 | |
| N021610-006 | 8871779 | 2029-11-22 | Drug substance | 2021-03-18 | |
| N021610-007 | 8808737 | 2027-06-21 | U-3085 | 2021-03-18 | |
| N021610-007 | 8871779 | 2029-11-22 | Drug substance | 2021-03-18 |
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 | N021610-001 | OPANA ER | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2006-06-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021610-002 | OPANA ER | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2006-06-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021610-003 | OPANA ER | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2006-06-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021610-004 | OPANA ER | 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2006-06-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021610-005 | OPANA ER | 7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2008-02-29 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021610-006 | OPANA ER | 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2008-02-29 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021610-007 | OPANA ER | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2008-02-29 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021610-001 | OPANA ER | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2006-06-22 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021610-002 | OPANA ER | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2006-06-22 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021610-003 | OPANA ER | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2006-06-22 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021610-004 | OPANA ER | 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2006-06-22 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021610-005 | OPANA ER | 7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2008-02-29 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021610-006 | OPANA ER | 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2008-02-29 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021610-007 | OPANA ER | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2008-02-29 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021610-001 | OPANA ER | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2006-06-22 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021610-002 | OPANA ER | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2006-06-22 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021610-003 | OPANA ER | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2006-06-22 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021610-004 | OPANA ER | 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2006-06-22 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021610-005 | OPANA ER | 7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2008-02-29 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021610-006 | OPANA ER | 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2008-02-29 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021610-007 | OPANA ER | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2008-02-29 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021610-001 | OPANA ER | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2006-06-22 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021610-002 | OPANA ER | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2006-06-22 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021610-003 | OPANA ER | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2006-06-22 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021610-004 | OPANA ER | 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2006-06-22 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021610-005 | OPANA ER | 7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2008-02-29 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021610-006 | OPANA ER | 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2008-02-29 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021610-007 | OPANA ER | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2008-02-29 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021610-001 | OPANA ER | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2006-06-22 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021610-002 | OPANA ER | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2006-06-22 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021610-003 | OPANA ER | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2006-06-22 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021610-004 | OPANA ER | 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2006-06-22 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021610-005 | OPANA ER | 7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2008-02-29 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021610-006 | OPANA ER | 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2008-02-29 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021610-007 | OPANA ER | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2008-02-29 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021610-001 | OPANA ER | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2006-06-22 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021610-002 | OPANA ER | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2006-06-22 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021610-003 | OPANA ER | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2006-06-22 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021610-004 | OPANA ER | 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2006-06-22 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021610-005 | OPANA ER | 7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2008-02-29 | 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 | N021610-001 | 8808737 | 2027-06-21 | U-3085 | 2021-03-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021610-001 | 8871779 | 2029-11-22 | Drug substance | 2021-03-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021610-002 | 8808737 | 2027-06-21 | U-3085 | 2021-03-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021610-002 | 8871779 | 2029-11-22 | Drug substance | 2021-03-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021610-003 | 8808737 | 2027-06-21 | U-3085 | 2021-03-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021610-003 | 8871779 | 2029-11-22 | Drug substance | 2021-03-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021610-004 | 8808737 | 2027-06-21 | U-3085 | 2021-03-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021610-004 | 8871779 | 2029-11-22 | Drug substance | 2021-03-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021610-005 | 8808737 | 2027-06-21 | U-3085 | 2021-03-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021610-005 | 8871779 | 2029-11-22 | Drug substance | 2021-03-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021610-006 | 8808737 | 2027-06-21 | U-3085 | 2021-03-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021610-006 | 8871779 | 2029-11-22 | Drug substance | 2021-03-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021610-007 | 8808737 | 2027-06-21 | U-3085 | 2021-03-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021610-007 | 8871779 | 2029-11-22 | Drug substance | 2021-03-18 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021610-001 | 8808737 | 2027-06-21 | U-3085 | 2021-03-18 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021610-001 | 8871779 | 2029-11-22 | Drug substance | 2021-03-18 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021610-002 | 8808737 | 2027-06-21 | U-3085 | 2021-03-18 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021610-002 | 8871779 | 2029-11-22 | Drug substance | 2021-03-18 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021610-003 | 8808737 | 2027-06-21 | U-3085 | 2021-03-18 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021610-003 | 8871779 | 2029-11-22 | Drug substance | 2021-03-18 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021610-004 | 8808737 | 2027-06-21 | U-3085 | 2021-03-18 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021610-004 | 8871779 | 2029-11-22 | Drug substance | 2021-03-18 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021610-005 | 8808737 | 2027-06-21 | U-3085 | 2021-03-18 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021610-005 | 8871779 | 2029-11-22 | Drug substance | 2021-03-18 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021610-006 | 8808737 | 2027-06-21 | U-3085 | 2021-03-18 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021610-006 | 8871779 | 2029-11-22 | Drug substance | 2021-03-18 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021610-007 | 8808737 | 2027-06-21 | U-3085 | 2021-03-18 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021610-007 | 8871779 | 2029-11-22 | Drug substance | 2021-03-18 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021610-001 | 8808737 | 2027-06-21 | U-3085 | 2021-03-18 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021610-001 | 8871779 | 2029-11-22 | Drug substance | 2021-03-18 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021610-002 | 8808737 | 2027-06-21 | U-3085 | 2021-03-18 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021610-002 | 8871779 | 2029-11-22 | Drug substance | 2021-03-18 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021610-003 | 8808737 | 2027-06-21 | U-3085 | 2021-03-18 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021610-003 | 8871779 | 2029-11-22 | Drug substance | 2021-03-18 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021610-004 | 8808737 | 2027-06-21 | U-3085 | 2021-03-18 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021610-004 | 8871779 | 2029-11-22 | Drug substance | 2021-03-18 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021610-005 | 8808737 | 2027-06-21 | U-3085 | 2021-03-18 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021610-005 | 8871779 | 2029-11-22 | Drug substance | 2021-03-18 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021610-006 | 8808737 | 2027-06-21 | U-3085 | 2021-03-18 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021610-006 | 8871779 | 2029-11-22 | Drug substance | 2021-03-18 | 6a471c1ec25d… |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 52f0f025-f368-4487-8f9b-49af2656aeeb | Product name | 3 | 20201015 |
| 3792daf4-c308-47ef-a996-98dc7faa1671 | Product name | 2 | 20150511 |
| 0476a93f-c9eb-691e-8ebf-e5b816d8f47b | Product name | 1 | 20140508 |
| a4b9889e-23ea-ee9f-05f6-4b861fda077b | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 21695-949-60 | 2019-09-24 | C162847 | 48780-1 | 934fe258-48ff-48b1-e053-8cdaa90a720a | OPANA ® ER (Oxymorphone Hydrochloride) Extended-Release Tablets 5mg, 10mg, 20mg, and 40mg CII Rx Only |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 21695-949-60 | OPANA ER | 60 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 60 | 1 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 977876 | OPANA ER 10 MG 12HR Extended Release Oral Tablet | PSN | b639732f-8eb2-4592-aca3-86faf7e5360b | 1 |
| 977925 | OPANA ER 5 MG 12HR Extended Release Oral Tablet | PSN | b639732f-8eb2-4592-aca3-86faf7e5360b | 1 |
| 977874 | oxyMORphone HCl 10 MG 12HR Extended Release Oral Tablet | PSN | b639732f-8eb2-4592-aca3-86faf7e5360b | 1 |
| 977923 | oxyMORphone HCl 5 MG 12HR Extended Release Oral Tablet | PSN | b639732f-8eb2-4592-aca3-86faf7e5360b | 1 |
| 977876 | 12 HR oxymorphone hydrochloride 10 MG Extended Release Oral Tablet [Opana] | SBD | b639732f-8eb2-4592-aca3-86faf7e5360b | 1 |
| 977925 | 12 HR oxymorphone hydrochloride 5 MG Extended Release Oral Tablet [Opana] | SBD | b639732f-8eb2-4592-aca3-86faf7e5360b | 1 |
| 977874 | 12 HR oxymorphone hydrochloride 10 MG Extended Release Oral Tablet | SCD | b639732f-8eb2-4592-aca3-86faf7e5360b | 1 |
| 977923 | 12 HR oxymorphone hydrochloride 5 MG Extended Release Oral Tablet | SCD | b639732f-8eb2-4592-aca3-86faf7e5360b | 1 |
| 977876 | 12 HR Opana 10 MG Extended Release Oral Tablet | SY | b639732f-8eb2-4592-aca3-86faf7e5360b | 1 |
| 977925 | 12 HR Opana 5 MG Extended Release Oral Tablet | SY | b639732f-8eb2-4592-aca3-86faf7e5360b | 1 |
| 977876 | Opana ER 10 MG 12 HR Extended Release Oral Tablet | SY | b639732f-8eb2-4592-aca3-86faf7e5360b | 1 |
| 977925 | Opana ER 5 MG 12 HR Extended Release Oral Tablet | SY | b639732f-8eb2-4592-aca3-86faf7e5360b | 1 |
| 977874 | oxymorphone hydrochloride 10 MG 12 HR Extended Release Oral Tablet | SY | b639732f-8eb2-4592-aca3-86faf7e5360b | 1 |
| 977923 | oxymorphone hydrochloride 5 MG 12 HR Extended Release Oral Tablet | SY | b639732f-8eb2-4592-aca3-86faf7e5360b | 1 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 21695-949-60 | 21695094960 | 60 in 1 BOTTLE | Historical |