Fentanyl
- Product NDC
- 68258-3040
- 11-digit product format
- 682583040
- Labeler code
- 68258
- Product ID
- 68258-3040_10d4c04c-52d8-4692-b1a7-660ddb87dff7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fentanyl
- Dosage form
- PATCH
- Route
- TRANSDERMAL
- Labeler
- Dispensing Solutions, Inc.
- Application
- NDA019813
- Marketing category
- NDA
- Marketing start
- 2004-10-01
- Marketing end
- 0000-00-00
- Substance
- FENTANYL
- Active strength
- 12 ug/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 | 68258-3040 | I | Inactivated by FDA | 2026-10-05 | ||
| excluded package | package | 68258-3040 | 68258-3040-1 | I | Inactivated by FDA | 2026-10-05 |
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 | 68258-3040-1 | 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 | 68258-3040-1 | 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 | 68258-3040-1 | 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 | 68258-3040-1 | 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 | 68258-3040-1 | 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 | 68258-3040-1 | 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 | 68258-3040-1 | 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 | 68258-3040-1 | 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 | 68258-3040-1 | 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 | 68258-3040-1 | 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 | 68258-3040-1 | 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 | 68258-3040-1 | 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 | 68258-3040-1 | 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 | 68258-3040-1 | 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 | 68258-3040-1 | 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 | 68258-3040-1 | 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 | 68258-3040-1 | 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 | 68258-3040-1 | 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 | 68258-3040-1 | 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 | 68258-3040-1 | 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 | 68258-3040-1 | 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 | 68258-3040-1 | 110d247fa046… | a55b01930146… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N019813-001 | DURAGESIC-100 | FENTANYL | 100MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1990-08-07 | |
| N019813-002 | DURAGESIC-75 | FENTANYL | 75MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1990-08-07 | |
| N019813-003 | DURAGESIC-50 | FENTANYL | 50MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1990-08-07 | |
| N019813-004 | DURAGESIC-25 | FENTANYL | 25MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1990-08-07 | |
| N019813-005 | DURAGESIC-12 | FENTANYL | 12.5MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 2005-02-04 | |
| N019813-006 | DURAGESIC-37 | FENTANYL | 37.5MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 2018-01-24 |
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 | N019813-001 | DURAGESIC-100 | 100MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1990-08-07 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N019813-002 | DURAGESIC-75 | 75MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1990-08-07 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N019813-003 | DURAGESIC-50 | 50MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1990-08-07 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N019813-004 | DURAGESIC-25 | 25MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1990-08-07 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N019813-005 | DURAGESIC-12 | 12.5MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 2005-02-04 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N019813-006 | DURAGESIC-37 | 37.5MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 2018-01-24 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N019813-001 | DURAGESIC-100 | 100MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1990-08-07 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N019813-002 | DURAGESIC-75 | 75MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1990-08-07 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N019813-003 | DURAGESIC-50 | 50MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1990-08-07 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N019813-004 | DURAGESIC-25 | 25MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1990-08-07 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N019813-005 | DURAGESIC-12 | 12.5MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 2005-02-04 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N019813-006 | DURAGESIC-37 | 37.5MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 2018-01-24 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N019813-001 | DURAGESIC-100 | 100MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1990-08-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N019813-002 | DURAGESIC-75 | 75MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1990-08-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N019813-003 | DURAGESIC-50 | 50MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1990-08-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N019813-004 | DURAGESIC-25 | 25MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1990-08-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N019813-005 | DURAGESIC-12 | 12.5MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 2005-02-04 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N019813-006 | DURAGESIC-37 | 37.5MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 2018-01-24 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019813-001 | DURAGESIC-100 | 100MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1990-08-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019813-002 | DURAGESIC-75 | 75MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1990-08-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019813-003 | DURAGESIC-50 | 50MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1990-08-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019813-004 | DURAGESIC-25 | 25MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1990-08-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019813-005 | DURAGESIC-12 | 12.5MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 2005-02-04 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019813-006 | DURAGESIC-37 | 37.5MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 2018-01-24 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N019813-001 | DURAGESIC-100 | 100MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1990-08-07 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N019813-002 | DURAGESIC-75 | 75MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1990-08-07 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N019813-003 | DURAGESIC-50 | 50MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1990-08-07 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N019813-004 | DURAGESIC-25 | 25MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1990-08-07 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N019813-005 | DURAGESIC-12 | 12.5MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 2005-02-04 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N019813-006 | DURAGESIC-37 | 37.5MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 2018-01-24 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019813-001 | DURAGESIC-100 | 100MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1990-08-07 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019813-002 | DURAGESIC-75 | 75MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1990-08-07 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019813-003 | DURAGESIC-50 | 50MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1990-08-07 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019813-004 | DURAGESIC-25 | 25MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1990-08-07 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019813-005 | DURAGESIC-12 | 12.5MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 2005-02-04 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019813-006 | DURAGESIC-37 | 37.5MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 2018-01-24 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019813-001 | DURAGESIC-100 | 100MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1990-08-07 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019813-002 | DURAGESIC-75 | 75MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1990-08-07 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019813-003 | DURAGESIC-50 | 50MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1990-08-07 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019813-004 | DURAGESIC-25 | 25MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1990-08-07 | b8a1b40f171c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | N019813-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N019813-002 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N019813-003 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N019813-004 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N019813-005 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N019813-006 | AB | 1 | 74a2ff9319b5… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N019813-001 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N019813-002 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N019813-003 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N019813-004 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N019813-005 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N019813-006 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N019813-001 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | N019813-002 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | N019813-003 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | N019813-004 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | N019813-005 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | N019813-006 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | N019813-001 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N019813-002 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N019813-003 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N019813-004 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N019813-005 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N019813-006 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N019813-001 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N019813-002 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N019813-003 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N019813-004 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N019813-005 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N019813-006 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | N019813-001 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N019813-002 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N019813-003 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N019813-004 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N019813-005 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N019813-006 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N019813-001 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N019813-002 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N019813-003 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N019813-004 | AB | 1 | b00525d2431f… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 77d14d2b-b9bf-4254-8dd6-c60dedb281d3 | Product name | 1 | 20231002 |
| a8df478d-5b88-9654-981b-87dff14dda8b | Product name | 2 | 20190801 |
| e9b48db2-e05b-8c2d-e4ac-a5a2efb26b57 | Product name | 2 | 20180118 |
| bb365072-425e-ca0a-021e-fd8b78162502 | Product name | 2 | 20161228 |
| 339915c8-cc8f-ceb4-1d3f-5ea267d21ea6 | Product name | 2 | 20160104 |
| 739fa0ac-b690-63c4-9904-e20dffbf78f9 | Product name | 1 | 20140508 |
| 7763fcbb-367d-ed06-b37f-e1529b6241be | Product name | 1 | 20140508 |
| d9ff6610-5d2e-d5c8-8a19-867d4a1efb77 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 68258-3040-1 | 2019-10-29 | C162847 | 48780-1 | 960f7f55-bf6f-8e05-e053-dbdaa90a074a | FENTANYL TRANSDERMAL SYSTEM CII |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68258-3040-1 | Fentanyl | 1 in 1 POUCH | PATCH | 1 | 1 | |
| 68258-3040-1 | Fentanyl | 5 in 1 BOX | PATCH | 5 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 68258-3040-1 | EA - Each | 68258-3040 | 3d521248-b731-487d-8b46-fb1ce67f726b | 1 | 2013-07-02 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| Fentanyl | ACTIVE INGREDIENT | UF599785JZ | FENTANYL PATCH [DISPENSING SOLUTIONS, INC.] | 1 | |
| Fentanyl | ACTIVE MOIETY | UF599785JZ | FENTANYL PATCH [DISPENSING SOLUTIONS, INC.] | 1 | |
| copovidone | INACTIVE INGREDIENT | D9C330MD8B | FENTANYL PATCH [DISPENSING SOLUTIONS, INC.] | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68258-3040 | FENTANYL PATCH [DISPENSING SOLUTIONS, INC.] | 1 | Legacy NDC, 2 package rows | 20110923_2a0092d8-f782-45ec-b8a8-c72156bbd5d5.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 577057 | fentaNYL 12 MCG/HR 72HR Transdermal System | PSN | 2a0092d8-f782-45ec-b8a8-c72156bbd5d5 | 1 |
| 577057 | 72 HR fentanyl 0.012 MG/HR Transdermal System | SCD | 2a0092d8-f782-45ec-b8a8-c72156bbd5d5 | 1 |
| 577057 | fentanyl 12 MCG/HR 3 Day Transdermal Patch | SY | 2a0092d8-f782-45ec-b8a8-c72156bbd5d5 | 1 |
| 577057 | fentanyl 12 MCG/HR 72HR Transdermal System | SY | 2a0092d8-f782-45ec-b8a8-c72156bbd5d5 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 68258-3040-1 | 68258304001 | 1 in 1 POUCH | Historical |