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 02:08:19
Label at a glance#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 63459-541-04 | EA - Each | 63459-541 | 804cd5fa-a951-4a48-8f9d-c478e0978331 | 1 | 2012-07-24 |
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 63459-541 | 63459-541-04 |
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 |
|---|---|---|---|---|---|---|---|
| N021947-001 | FENTORA | FENTANYL CITRATE | EQ 0.1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / BUCCAL, SUBLINGUAL | RLD | 2006-09-25 | |
| N021947-002 | FENTORA | FENTANYL CITRATE | EQ 0.2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / BUCCAL, SUBLINGUAL | RLD | 2006-09-25 | |
| N021947-003 | FENTORA | FENTANYL CITRATE | EQ 0.4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / BUCCAL, SUBLINGUAL | RLD | 2006-09-25 | |
| N021947-004 | FENTORA | FENTANYL CITRATE | EQ 0.6MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / BUCCAL, SUBLINGUAL | RLD | 2006-09-25 | |
| N021947-005 | FENTORA | FENTANYL CITRATE | EQ 0.8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / BUCCAL, SUBLINGUAL | RLD | 2006-09-25 | |
| N021947-006 | FENTORA | FENTANYL CITRATE | EQ 0.3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / BUCCAL, SUBLINGUAL | RLD | 2007-03-02 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N021947-001 | 7862832 | 2028-06-15 | Drug product | 2011-04-25 | |
| N021947-001 | 7862833 | 2028-06-15 | Drug product | 2011-04-25 | |
| N021947-002 | 7862832 | 2028-06-15 | Drug product | ||
| N021947-002 | 7862833 | 2028-06-15 | Drug product | ||
| N021947-003 | 7862832 | 2028-06-15 | Drug product | ||
| N021947-003 | 7862833 | 2028-06-15 | Drug product | ||
| N021947-004 | 7862832 | 2028-06-15 | Drug product | ||
| N021947-004 | 7862833 | 2028-06-15 | Drug product | ||
| N021947-005 | 7862832 | 2028-06-15 | Drug product | 2011-04-25 | |
| N021947-005 | 7862833 | 2028-06-15 | Drug product | 2011-04-25 |
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 | N021947-001 | FENTORA | EQ 0.1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / BUCCAL, SUBLINGUAL | RLD | 2006-09-25 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N021947-002 | FENTORA | EQ 0.2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / BUCCAL, SUBLINGUAL | RLD | 2006-09-25 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N021947-003 | FENTORA | EQ 0.4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / BUCCAL, SUBLINGUAL | RLD | 2006-09-25 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N021947-004 | FENTORA | EQ 0.6MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / BUCCAL, SUBLINGUAL | RLD | 2006-09-25 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N021947-005 | FENTORA | EQ 0.8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / BUCCAL, SUBLINGUAL | RLD | 2006-09-25 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N021947-006 | FENTORA | EQ 0.3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / BUCCAL, SUBLINGUAL | RLD | 2007-03-02 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N021947-001 | FENTORA | EQ 0.1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / BUCCAL, SUBLINGUAL | RLD | 2006-09-25 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N021947-002 | FENTORA | EQ 0.2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / BUCCAL, SUBLINGUAL | RLD | 2006-09-25 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N021947-003 | FENTORA | EQ 0.4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / BUCCAL, SUBLINGUAL | RLD | 2006-09-25 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N021947-004 | FENTORA | EQ 0.6MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / BUCCAL, SUBLINGUAL | RLD | 2006-09-25 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N021947-005 | FENTORA | EQ 0.8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / BUCCAL, SUBLINGUAL | RLD | 2006-09-25 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N021947-006 | FENTORA | EQ 0.3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / BUCCAL, SUBLINGUAL | RLD | 2007-03-02 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021947-001 | FENTORA | EQ 0.1MG BASE | TABLET / BUCCAL, SUBLINGUAL | RLD | 2006-09-25 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021947-002 | FENTORA | EQ 0.2MG BASE | TABLET / BUCCAL, SUBLINGUAL | RLD | 2006-09-25 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021947-003 | FENTORA | EQ 0.4MG BASE | TABLET / BUCCAL, SUBLINGUAL | RLD | 2006-09-25 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021947-004 | FENTORA | EQ 0.6MG BASE | TABLET / BUCCAL, SUBLINGUAL | RLD | 2006-09-25 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021947-005 | FENTORA | EQ 0.8MG BASE | TABLET / BUCCAL, SUBLINGUAL | RLD | 2006-09-25 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021947-006 | FENTORA | EQ 0.3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / BUCCAL, SUBLINGUAL | RLD | 2007-03-02 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021947-001 | FENTORA | EQ 0.1MG BASE | TABLET / BUCCAL, SUBLINGUAL | RLD | 2006-09-25 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021947-002 | FENTORA | EQ 0.2MG BASE | TABLET / BUCCAL, SUBLINGUAL | RLD | 2006-09-25 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021947-003 | FENTORA | EQ 0.4MG BASE | TABLET / BUCCAL, SUBLINGUAL | RLD | 2006-09-25 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021947-004 | FENTORA | EQ 0.6MG BASE | TABLET / BUCCAL, SUBLINGUAL | RLD | 2006-09-25 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021947-005 | FENTORA | EQ 0.8MG BASE | TABLET / BUCCAL, SUBLINGUAL | RLD | 2006-09-25 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021947-006 | FENTORA | EQ 0.3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / BUCCAL, SUBLINGUAL | RLD | 2007-03-02 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021947-001 | FENTORA | EQ 0.1MG BASE | TABLET / BUCCAL, SUBLINGUAL | RLD | 2006-09-25 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021947-002 | FENTORA | EQ 0.2MG BASE | TABLET / BUCCAL, SUBLINGUAL | RLD | 2006-09-25 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021947-003 | FENTORA | EQ 0.4MG BASE | TABLET / BUCCAL, SUBLINGUAL | RLD | 2006-09-25 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021947-004 | FENTORA | EQ 0.6MG BASE | TABLET / BUCCAL, SUBLINGUAL | RLD | 2006-09-25 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021947-005 | FENTORA | EQ 0.8MG BASE | TABLET / BUCCAL, SUBLINGUAL | RLD | 2006-09-25 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021947-006 | FENTORA | EQ 0.3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / BUCCAL, SUBLINGUAL | RLD | 2007-03-02 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021947-001 | FENTORA | EQ 0.1MG BASE | TABLET / BUCCAL, SUBLINGUAL | RLD | 2006-09-25 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021947-002 | FENTORA | EQ 0.2MG BASE | TABLET / BUCCAL, SUBLINGUAL | RLD | 2006-09-25 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021947-003 | FENTORA | EQ 0.4MG BASE | TABLET / BUCCAL, SUBLINGUAL | RLD | 2006-09-25 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021947-004 | FENTORA | EQ 0.6MG BASE | TABLET / BUCCAL, SUBLINGUAL | RLD | 2006-09-25 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021947-005 | FENTORA | EQ 0.8MG BASE | TABLET / BUCCAL, SUBLINGUAL | RLD | 2006-09-25 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021947-006 | FENTORA | EQ 0.3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / BUCCAL, SUBLINGUAL | RLD | 2007-03-02 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021947-001 | FENTORA | EQ 0.1MG BASE | TABLET / BUCCAL, SUBLINGUAL | RLD | 2006-09-25 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021947-002 | FENTORA | EQ 0.2MG BASE | TABLET / BUCCAL, SUBLINGUAL | RLD | 2006-09-25 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021947-003 | FENTORA | EQ 0.4MG BASE | TABLET / BUCCAL, SUBLINGUAL | RLD | 2006-09-25 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021947-004 | FENTORA | EQ 0.6MG BASE | TABLET / BUCCAL, SUBLINGUAL | RLD | 2006-09-25 | b8a1b40f171c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2022-10-28 04:53 UTC | 2022-10 | N021947-001 | AB | 1 | f41ea6bd6efb… |
| 2022-10-28 04:53 UTC | 2022-10 | N021947-002 | AB | 1 | f41ea6bd6efb… |
| 2022-10-28 04:53 UTC | 2022-10 | N021947-003 | AB | 1 | f41ea6bd6efb… |
| 2022-10-28 04:53 UTC | 2022-10 | N021947-004 | AB | 1 | f41ea6bd6efb… |
| 2022-10-28 04:53 UTC | 2022-10 | N021947-005 | AB | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | N021947-001 | AB | 1 | e64feba35796… |
| 2022-09-29 23:25 UTC | 2022-09 | N021947-002 | AB | 1 | e64feba35796… |
| 2022-09-29 23:25 UTC | 2022-09 | N021947-003 | AB | 1 | e64feba35796… |
| 2022-09-29 23:25 UTC | 2022-09 | N021947-004 | AB | 1 | e64feba35796… |
| 2022-09-29 23:25 UTC | 2022-09 | N021947-005 | AB | 1 | e64feba35796… |
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 | N021947-001 | 7862832 | 2028-06-15 | Drug product | 2011-04-25 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N021947-001 | 7862833 | 2028-06-15 | Drug product | 2011-04-25 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N021947-002 | 7862832 | 2028-06-15 | Drug product | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N021947-002 | 7862833 | 2028-06-15 | Drug product | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N021947-003 | 7862832 | 2028-06-15 | Drug product | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N021947-003 | 7862833 | 2028-06-15 | Drug product | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N021947-004 | 7862832 | 2028-06-15 | Drug product | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N021947-004 | 7862833 | 2028-06-15 | Drug product | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N021947-005 | 7862832 | 2028-06-15 | Drug product | 2011-04-25 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N021947-005 | 7862833 | 2028-06-15 | Drug product | 2011-04-25 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N021947-001 | 7862832 | 2028-06-15 | Drug product | 2011-04-25 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N021947-001 | 7862833 | 2028-06-15 | Drug product | 2011-04-25 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N021947-002 | 7862832 | 2028-06-15 | Drug product | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N021947-002 | 7862833 | 2028-06-15 | Drug product | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N021947-003 | 7862832 | 2028-06-15 | Drug product | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N021947-003 | 7862833 | 2028-06-15 | Drug product | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N021947-004 | 7862832 | 2028-06-15 | Drug product | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N021947-004 | 7862833 | 2028-06-15 | Drug product | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N021947-005 | 7862832 | 2028-06-15 | Drug product | 2011-04-25 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N021947-005 | 7862833 | 2028-06-15 | Drug product | 2011-04-25 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021947-001 | 7862832 | 2028-06-15 | Drug product | 2011-04-25 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021947-001 | 7862833 | 2028-06-15 | Drug product | 2011-04-25 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021947-002 | 7862832 | 2028-06-15 | Drug product | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N021947-002 | 7862833 | 2028-06-15 | Drug product | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N021947-003 | 7862832 | 2028-06-15 | Drug product | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N021947-003 | 7862833 | 2028-06-15 | Drug product | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N021947-004 | 7862832 | 2028-06-15 | Drug product | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N021947-004 | 7862833 | 2028-06-15 | Drug product | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N021947-005 | 7862832 | 2028-06-15 | Drug product | 2011-04-25 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021947-005 | 7862833 | 2028-06-15 | Drug product | 2011-04-25 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021947-001 | 7862832 | 2028-06-15 | Drug product | 2011-04-25 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021947-001 | 7862833 | 2028-06-15 | Drug product | 2011-04-25 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021947-002 | 7862832 | 2028-06-15 | Drug product | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021947-002 | 7862833 | 2028-06-15 | Drug product | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021947-003 | 7862832 | 2028-06-15 | Drug product | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021947-003 | 7862833 | 2028-06-15 | Drug product | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021947-004 | 7862832 | 2028-06-15 | Drug product | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021947-004 | 7862833 | 2028-06-15 | Drug product | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021947-005 | 7862832 | 2028-06-15 | Drug product | 2011-04-25 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021947-005 | 7862833 | 2028-06-15 | Drug product | 2011-04-25 | 31067a03dcf5… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.