National Council for Prescription Drug Programs indexing - billing unit
- Manufacturer
- National Council for Prescription Drug Programs
- Effective date
- 2012-07-24
- Label type
- Indexing - Billing Unit
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-05 03:12:13
Label at a glance#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50458-860-01 | EA - Each | 50458-860 | fbd2d729-d8f9-42e5-b34d-813fb217b29a | 1 | 2012-07-24 |
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 50458-860 | 50458-860-01 |
Source Document#
Orange Book application contexts#
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N200533-001 | NUCYNTA ER | EQ 50MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2011-08-25 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N200533-002 | NUCYNTA ER | EQ 100MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2011-08-25 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N200533-003 | NUCYNTA ER | EQ 150MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2011-08-25 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N200533-004 | NUCYNTA ER | EQ 200MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2011-08-25 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N200533-005 | NUCYNTA ER | EQ 250MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2011-08-25 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N200533-001 | NUCYNTA ER | EQ 50MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2011-08-25 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N200533-002 | NUCYNTA ER | EQ 100MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2011-08-25 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N200533-003 | NUCYNTA ER | EQ 150MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2011-08-25 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N200533-004 | NUCYNTA ER | EQ 200MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2011-08-25 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N200533-005 | NUCYNTA ER | EQ 250MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2011-08-25 | caaa826d4ba7… | |
| 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… |
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 | N200533-001 | 11344512 | 2028-04-21 | U-3391 | 2022-06-29 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N200533-001 | 11344512 | 2028-04-21 | U-3392 | 2022-06-29 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N200533-001 | 8536130 | 2028-09-22 | U-1276 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N200533-001 | 11344512*PED | 2028-10-21 | Pediatric extension | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N200533-001 | 8536130*PED | 2029-03-22 | Pediatric extension | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N200533-002 | 11344512 | 2028-04-21 | U-3392 | 2022-06-29 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N200533-002 | 11344512 | 2028-04-21 | U-3391 | 2022-06-29 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N200533-002 | 8536130 | 2028-09-22 | U-1276 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N200533-002 | 11344512*PED | 2028-10-21 | Pediatric extension | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N200533-002 | 8536130*PED | 2029-03-22 | Pediatric extension | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N200533-003 | 11344512 | 2028-04-21 | U-3392 | 2022-06-29 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N200533-003 | 11344512 | 2028-04-21 | U-3391 | 2022-06-29 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N200533-003 | 8536130 | 2028-09-22 | U-1276 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N200533-003 | 11344512*PED | 2028-10-21 | Pediatric extension | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N200533-003 | 8536130*PED | 2029-03-22 | Pediatric extension | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N200533-004 | 11344512 | 2028-04-21 | U-3392 | 2022-06-29 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N200533-004 | 11344512 | 2028-04-21 | U-3391 | 2022-06-29 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N200533-004 | 8536130 | 2028-09-22 | U-1276 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N200533-004 | 11344512*PED | 2028-10-21 | Pediatric extension | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N200533-004 | 8536130*PED | 2029-03-22 | Pediatric extension | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N200533-005 | 11344512 | 2028-04-21 | U-3392 | 2022-06-29 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N200533-005 | 11344512 | 2028-04-21 | U-3391 | 2022-06-29 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N200533-005 | 8536130 | 2028-09-22 | U-1276 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N200533-005 | 11344512*PED | 2028-10-21 | Pediatric extension | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N200533-005 | 8536130*PED | 2029-03-22 | Pediatric extension | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | N200533-001 | 11344512 | 2028-04-21 | U-3391 | 2022-06-29 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N200533-001 | 11344512 | 2028-04-21 | U-3392 | 2022-06-29 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N200533-001 | 8536130 | 2028-09-22 | U-1276 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N200533-001 | 11344512*PED | 2028-10-21 | Pediatric extension | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N200533-001 | 8536130*PED | 2029-03-22 | Pediatric extension | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N200533-002 | 11344512 | 2028-04-21 | U-3392 | 2022-06-29 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N200533-002 | 11344512 | 2028-04-21 | U-3391 | 2022-06-29 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N200533-002 | 8536130 | 2028-09-22 | U-1276 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N200533-002 | 11344512*PED | 2028-10-21 | Pediatric extension | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N200533-002 | 8536130*PED | 2029-03-22 | Pediatric extension | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N200533-003 | 11344512 | 2028-04-21 | U-3392 | 2022-06-29 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N200533-003 | 11344512 | 2028-04-21 | U-3391 | 2022-06-29 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N200533-003 | 8536130 | 2028-09-22 | U-1276 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N200533-003 | 11344512*PED | 2028-10-21 | Pediatric extension | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N200533-003 | 8536130*PED | 2029-03-22 | Pediatric extension | caaa826d4ba7… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.