FENTORA
- Product NDC
- 63459-544
- 11-digit product format
- 634590544
- Labeler code
- 63459
- Product ID
- 63459-544_37976b20-73f5-4be6-87fe-a8a7e53d4cb4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fentanyl
- Dosage form
- TABLET
- Route
- BUCCAL; SUBLINGUAL
- Labeler
- Cephalon, LLC
- Application
- NDA021947
- Marketing category
- NDA
- Marketing start
- 2006-10-02
- Marketing end
- 0000-00-00
- Substance
- FENTANYL CITRATE
- Active strength
- 400 ug/1
- Pharmacologic classes
- Full Opioid Agonists [MoA], Opioid Agonist [EPC]
- DEA schedule
- CII
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- 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 | 63459-544 | D | Discontinued by firm | 2026-08-07 | ||
| excluded package | package | 63459-544 | 63459-544-28 | D | Discontinued by firm | 2026-08-07 |
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 | Product NDC | Package NDC | Code | Status | Reporting period | Archive | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | 63459-544 | D | Discontinued by firm | excluded / ndc_excluded.zip | d630ba8d3edf… | 732f749b63fb… | ||
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 63459-544 | 63459-544-28 | D | Discontinued by firm | excluded / ndc_excluded.zip | d630ba8d3edf… | 732f749b63fb… |
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| FENTORA | FENTANYL CITRATE | EQ 0.1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / BUCCAL, SUBLINGUAL | RLD | 2006-09-25 | |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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 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… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021947-005 | FENTORA | EQ 0.8MG BASE | TABLET / BUCCAL, SUBLINGUAL | RLD | 2006-09-25 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | 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 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021947-001 | FENTORA | EQ 0.1MG BASE | TABLET / BUCCAL, SUBLINGUAL | RLD | 2006-09-25 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021947-002 | FENTORA | EQ 0.2MG BASE | TABLET / BUCCAL, SUBLINGUAL | RLD | 2006-09-25 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021947-003 | FENTORA | EQ 0.4MG BASE | TABLET / BUCCAL, SUBLINGUAL | RLD | 2006-09-25 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021947-004 | FENTORA | EQ 0.6MG BASE | TABLET / BUCCAL, SUBLINGUAL | RLD | 2006-09-25 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021947-005 | FENTORA | EQ 0.8MG BASE | TABLET / BUCCAL, SUBLINGUAL | RLD | 2006-09-25 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | 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 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021947-001 | FENTORA | EQ 0.1MG BASE | TABLET / BUCCAL, SUBLINGUAL | RLD | 2006-09-25 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021947-002 | FENTORA | EQ 0.2MG BASE | TABLET / BUCCAL, SUBLINGUAL | RLD | 2006-09-25 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021947-003 | FENTORA | EQ 0.4MG BASE | TABLET / BUCCAL, SUBLINGUAL | RLD | 2006-09-25 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021947-004 | FENTORA | EQ 0.6MG BASE | TABLET / BUCCAL, SUBLINGUAL | RLD | 2006-09-25 | 2680178bc6a6… |
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 |
|---|---|---|---|---|---|---|---|---|
| 2026-02-19 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… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021947-001 | 7862832 | 2028-06-15 | Drug product | 2011-04-25 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021947-001 | 7862833 | 2028-06-15 | Drug product | 2011-04-25 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021947-002 | 7862832 | 2028-06-15 | Drug product | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N021947-002 | 7862833 | 2028-06-15 | Drug product | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N021947-003 | 7862832 | 2028-06-15 | Drug product | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N021947-003 | 7862833 | 2028-06-15 | Drug product | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N021947-004 | 7862832 | 2028-06-15 | Drug product | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N021947-004 | 7862833 | 2028-06-15 | Drug product | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N021947-005 | 7862832 | 2028-06-15 | Drug product | 2011-04-25 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021947-005 | 7862833 | 2028-06-15 | Drug product | 2011-04-25 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021947-001 | 7862832 | 2028-06-15 | Drug product | 2011-04-25 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021947-001 | 7862833 | 2028-06-15 | Drug product | 2011-04-25 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021947-002 | 7862832 | 2028-06-15 | Drug product | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021947-002 | 7862833 | 2028-06-15 | Drug product | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021947-003 | 7862832 | 2028-06-15 | Drug product | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021947-003 | 7862833 | 2028-06-15 | Drug product | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021947-004 | 7862832 | 2028-06-15 | Drug product | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021947-004 | 7862833 | 2028-06-15 | Drug product | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021947-005 | 7862832 | 2028-06-15 | Drug product | 2011-04-25 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021947-005 | 7862833 | 2028-06-15 | Drug product | 2011-04-25 | fd3edfee7708… |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 63459-544-04 | EA - Each | 63459-544 | 70de21f9-f329-40ae-8371-2ca1d047f893 | 1 | 2012-07-24 |
| 63459-544-28 | EA - Each | 63459-544 | c32f64ff-5ff3-451c-9b77-1ecdaddc6eda | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| FENTANYL CITRATE | ACTIVE INGREDIENT | MUN5LYG46H | FENTORA (FENTANYL CITRATE) TABLET [CEPHALON, INC.] | 10 | |
| FENTANYL | ACTIVE MOIETY | UF599785JZ | FENTORA (FENTANYL CITRATE) TABLET [CEPHALON, INC.] | 10 | |
| CITRIC ACID MONOHYDRATE | INACTIVE INGREDIENT | 2968PHW8QP | FENTORA (FENTANYL CITRATE) TABLET [CEPHALON, INC.] | 10 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | FENTORA (FENTANYL CITRATE) TABLET [CEPHALON, INC.] | 10 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | FENTORA (FENTANYL CITRATE) TABLET [CEPHALON, INC.] | 10 | |
| SODIUM BICARBONATE | INACTIVE INGREDIENT | 8MDF5V39QO | FENTORA (FENTANYL CITRATE) TABLET [CEPHALON, INC.] | 10 | |
| SODIUM CARBONATE | INACTIVE INGREDIENT | 45P3261C7T | FENTORA (FENTANYL CITRATE) TABLET [CEPHALON, INC.] | 10 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | FENTORA (FENTANYL CITRATE) TABLET [CEPHALON, INC.] | 10 |
DailyMed Dashboard NDC Coverage#
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 63459-544-28 | 63459054428 | 28 BLISTER PACK in 1 CARTON (63459-544-28) > 1 TABLET in 1 BLISTER PACK (63459-544-04) | 28 blister pack | 2006-10-02 | 0000-00-00 | No | No | Current |