Nucynta
- Product NDC
- 55700-555
- 11-digit product format
- 557000555
- Labeler code
- 55700
- Product ID
- 55700-555_f64b307c-c6d0-4746-a6f4-a955abfbfab6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- tapentadol hydrochloride
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
- Application
- NDA200533
- Marketing category
- NDA
- Marketing start
- 2017-06-16
- Marketing end
- 0000-00-00
- Substance
- TAPENTADOL HYDROCHLORIDE
- Active strength
- 100 mg/1
- Pharmacologic classes
- Opioid Agonist [EPC],Opioid Agonists [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 | 55700-555 | D | Discontinued by firm | 2026-08-11 | ||
| excluded package | package | 55700-555 | 55700-555-60 | D | Discontinued by firm | 2026-08-11 |
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 | 55700-555-60 | 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 | 55700-555-60 | 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 | 55700-555-60 | 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 | 55700-555-60 | 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 | 55700-555-60 | 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 | 55700-555-60 | 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 | 55700-555-60 | 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 | 55700-555-60 | 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 | 55700-555-60 | 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 | 55700-555-60 | 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 | 55700-555-60 | 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 | 55700-555-60 | 557ba5c1ecfa… | 9c80585c8c6e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N200533-001 | NUCYNTA ER | TAPENTADOL HYDROCHLORIDE | EQ 50MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2011-08-25 | |
| N200533-002 | NUCYNTA ER | TAPENTADOL HYDROCHLORIDE | EQ 100MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2011-08-25 | |
| N200533-003 | NUCYNTA ER | TAPENTADOL HYDROCHLORIDE | EQ 150MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2011-08-25 | |
| N200533-004 | NUCYNTA ER | TAPENTADOL HYDROCHLORIDE | EQ 200MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2011-08-25 | |
| N200533-005 | NUCYNTA ER | TAPENTADOL HYDROCHLORIDE | EQ 250MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2011-08-25 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N200533-001 | 11344512 | 2028-04-21 | U-3391 | 2022-06-29 | |
| N200533-001 | 11344512 | 2028-04-21 | U-3392 | 2022-06-29 | |
| N200533-001 | 8536130 | 2028-09-22 | U-1276 | ||
| N200533-001 | 11344512*PED | 2028-10-21 | Pediatric extension | ||
| N200533-001 | 8536130*PED | 2029-03-22 | Pediatric extension | ||
| N200533-002 | 11344512 | 2028-04-21 | U-3391 | 2022-06-29 | |
| N200533-002 | 11344512 | 2028-04-21 | U-3392 | 2022-06-29 | |
| N200533-002 | 8536130 | 2028-09-22 | U-1276 | ||
| N200533-002 | 11344512*PED | 2028-10-21 | Pediatric extension | ||
| N200533-002 | 8536130*PED | 2029-03-22 | Pediatric extension | ||
| N200533-003 | 11344512 | 2028-04-21 | U-3391 | 2022-06-29 | |
| N200533-003 | 11344512 | 2028-04-21 | U-3392 | 2022-06-29 | |
| N200533-003 | 8536130 | 2028-09-22 | U-1276 | ||
| N200533-003 | 11344512*PED | 2028-10-21 | Pediatric extension | ||
| N200533-003 | 8536130*PED | 2029-03-22 | Pediatric extension | ||
| N200533-004 | 11344512 | 2028-04-21 | U-3391 | 2022-06-29 | |
| N200533-004 | 11344512 | 2028-04-21 | U-3392 | 2022-06-29 | |
| N200533-004 | 8536130 | 2028-09-22 | U-1276 | ||
| N200533-004 | 11344512*PED | 2028-10-21 | Pediatric extension | ||
| N200533-004 | 8536130*PED | 2029-03-22 | Pediatric extension | ||
| N200533-005 | 11344512 | 2028-04-21 | U-3391 | 2022-06-29 | |
| N200533-005 | 11344512 | 2028-04-21 | U-3392 | 2022-06-29 | |
| N200533-005 | 8536130 | 2028-09-22 | U-1276 | ||
| N200533-005 | 11344512*PED | 2028-10-21 | Pediatric extension | ||
| N200533-005 | 8536130*PED | 2029-03-22 | Pediatric extension |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N200533-001 | NUCYNTA ER | EQ 50MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2011-08-25 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N200533-002 | NUCYNTA ER | EQ 100MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2011-08-25 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N200533-003 | NUCYNTA ER | EQ 150MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2011-08-25 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N200533-004 | NUCYNTA ER | EQ 200MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2011-08-25 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N200533-005 | NUCYNTA ER | EQ 250MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2011-08-25 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N200533-001 | NUCYNTA ER | EQ 50MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2011-08-25 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N200533-002 | NUCYNTA ER | EQ 100MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2011-08-25 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N200533-003 | NUCYNTA ER | EQ 150MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2011-08-25 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N200533-004 | NUCYNTA ER | EQ 200MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2011-08-25 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N200533-005 | NUCYNTA ER | EQ 250MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2011-08-25 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N200533-001 | NUCYNTA ER | EQ 50MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2011-08-25 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N200533-002 | NUCYNTA ER | EQ 100MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2011-08-25 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N200533-003 | NUCYNTA ER | EQ 150MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2011-08-25 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N200533-004 | NUCYNTA ER | EQ 200MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2011-08-25 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N200533-005 | NUCYNTA ER | EQ 250MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2011-08-25 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N200533-001 | NUCYNTA ER | EQ 50MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2011-08-25 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N200533-002 | NUCYNTA ER | EQ 100MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2011-08-25 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N200533-003 | NUCYNTA ER | EQ 150MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2011-08-25 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N200533-004 | NUCYNTA ER | EQ 200MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2011-08-25 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N200533-005 | NUCYNTA ER | EQ 250MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2011-08-25 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N200533-001 | NUCYNTA ER | EQ 50MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2011-08-25 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N200533-002 | NUCYNTA ER | EQ 100MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2011-08-25 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N200533-003 | NUCYNTA ER | EQ 150MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2011-08-25 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N200533-004 | NUCYNTA ER | EQ 200MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2011-08-25 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N200533-005 | NUCYNTA ER | EQ 250MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2011-08-25 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N200533-001 | NUCYNTA ER | EQ 50MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2011-08-25 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N200533-002 | NUCYNTA ER | EQ 100MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2011-08-25 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N200533-003 | NUCYNTA ER | EQ 150MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2011-08-25 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N200533-004 | NUCYNTA ER | EQ 200MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2011-08-25 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N200533-005 | NUCYNTA ER | EQ 250MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2011-08-25 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N200533-001 | NUCYNTA ER | EQ 50MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2011-08-25 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N200533-002 | NUCYNTA ER | EQ 100MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2011-08-25 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N200533-003 | NUCYNTA ER | EQ 150MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2011-08-25 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N200533-004 | NUCYNTA ER | EQ 200MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2011-08-25 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N200533-005 | NUCYNTA ER | EQ 250MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2011-08-25 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N200533-001 | NUCYNTA ER | EQ 50MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2011-08-25 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N200533-002 | NUCYNTA ER | EQ 100MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2011-08-25 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N200533-003 | NUCYNTA ER | EQ 150MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2011-08-25 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N200533-004 | NUCYNTA ER | EQ 200MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2011-08-25 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N200533-005 | NUCYNTA ER | EQ 250MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2011-08-25 | 5bbf6a4d5a75… |
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 | N200533-001 | 11344512 | 2028-04-21 | U-3391 | 2022-06-29 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N200533-001 | 11344512 | 2028-04-21 | U-3392 | 2022-06-29 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N200533-001 | 8536130 | 2028-09-22 | U-1276 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N200533-001 | 11344512*PED | 2028-10-21 | Pediatric extension | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N200533-001 | 8536130*PED | 2029-03-22 | Pediatric extension | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N200533-002 | 11344512 | 2028-04-21 | U-3392 | 2022-06-29 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N200533-002 | 11344512 | 2028-04-21 | U-3391 | 2022-06-29 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N200533-002 | 8536130 | 2028-09-22 | U-1276 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N200533-002 | 11344512*PED | 2028-10-21 | Pediatric extension | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N200533-002 | 8536130*PED | 2029-03-22 | Pediatric extension | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N200533-003 | 11344512 | 2028-04-21 | U-3392 | 2022-06-29 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N200533-003 | 11344512 | 2028-04-21 | U-3391 | 2022-06-29 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N200533-003 | 8536130 | 2028-09-22 | U-1276 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N200533-003 | 11344512*PED | 2028-10-21 | Pediatric extension | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N200533-003 | 8536130*PED | 2029-03-22 | Pediatric extension | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N200533-004 | 11344512 | 2028-04-21 | U-3392 | 2022-06-29 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N200533-004 | 11344512 | 2028-04-21 | U-3391 | 2022-06-29 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N200533-004 | 8536130 | 2028-09-22 | U-1276 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N200533-004 | 11344512*PED | 2028-10-21 | Pediatric extension | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N200533-004 | 8536130*PED | 2029-03-22 | Pediatric extension | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N200533-005 | 11344512 | 2028-04-21 | U-3392 | 2022-06-29 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N200533-005 | 11344512 | 2028-04-21 | U-3391 | 2022-06-29 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N200533-005 | 8536130 | 2028-09-22 | U-1276 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N200533-005 | 11344512*PED | 2028-10-21 | Pediatric extension | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N200533-005 | 8536130*PED | 2029-03-22 | Pediatric extension | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N200533-001 | 7994364 | 2025-06-27 | U-1276 | Drug substance, Drug product | 2011-09-02 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N200533-001 | 7994364 | 2025-06-27 | U-1178 | Drug substance, Drug product | 2011-09-02 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N200533-001 | 7994364*PED | 2025-12-27 | Pediatric extension | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N200533-001 | 11344512 | 2028-04-21 | U-3391 | 2022-06-29 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N200533-001 | 11344512 | 2028-04-21 | U-3392 | 2022-06-29 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N200533-001 | 8536130 | 2028-09-22 | U-1276 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N200533-001 | 11344512*PED | 2028-10-21 | Pediatric extension | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N200533-001 | 8536130*PED | 2029-03-22 | Pediatric extension | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N200533-002 | 7994364 | 2025-06-27 | U-1178 | Drug substance, Drug product | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N200533-002 | 7994364 | 2025-06-27 | U-1276 | Drug substance, Drug product | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N200533-002 | 7994364*PED | 2025-12-27 | Pediatric extension | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N200533-002 | 11344512 | 2028-04-21 | U-3392 | 2022-06-29 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N200533-002 | 11344512 | 2028-04-21 | U-3391 | 2022-06-29 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N200533-002 | 8536130 | 2028-09-22 | U-1276 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N200533-002 | 11344512*PED | 2028-10-21 | Pediatric extension | 31067a03dcf5… |
FDA-Initiated Inactive NDC Indexing#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 55700-555-60 | EA - Each | 55700-555 | e3136e2a-69fe-4baf-8c9a-629a83434336 | 1 | 2017-11-06 |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| TAPENTADOL | TAPENTADOL HYDROCHLORIDE | Hikma Pharmaceuticals USA Inc. | 38de863e-56ff-4c43-9ab8-9b3e1ba82858 | 2026-02-26 | Boxed warning, Warnings, Adverse reactions | 200533 NDA200533 |
| Nucynta ER | TAPENTADOL HYDROCHLORIDE | Collegium Pharmaceutical, Inc. | c3d04d70-0155-4147-9ce4-a3b1fad4b373 | 2025-12-30 | Boxed warning, Warnings, Adverse reactions | 200533 NDA200533 |