Fentanyl
- Product NDC
- 0591-3198
- 11-digit product format
- 005913198
- Labeler code
- 0591
- Product ID
- 0591-3198_89a9c234-ef0a-4c40-8473-3ccd17c9640b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fentanyl
- Dosage form
- PATCH, EXTENDED RELEASE
- Route
- TRANSDERMAL
- Labeler
- Actavis Pharma, Inc.
- Application
- ANDA076709
- Marketing category
- ANDA
- Marketing start
- 2007-08-21
- Marketing end
- 2019-08-31
- Substance
- FENTANYL
- Active strength
- 25 ug/h
- Pharmacologic classes
- Full Opioid Agonists [MoA],Opioid Agonist [EPC]
- DEA schedule
- CII
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- 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 | 0591-3198 | D | Discontinued by firm | 2026-08-11 | ||
| excluded package | package | 0591-3198 | 0591-3198-72 | 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 | 0591-3198-72 | 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 | 0591-3198-72 | 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 | 0591-3198-72 | 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 | 0591-3198-72 | 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 | 0591-3198-72 | 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 | 0591-3198-72 | 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 | 0591-3198-72 | 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 | 0591-3198-72 | 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 | 0591-3198-72 | 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 | 0591-3198-72 | 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 | 0591-3198-72 | 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 | 0591-3198-72 | 557ba5c1ecfa… | 9c80585c8c6e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A076709-001 | FENTANYL-25 | FENTANYL | 25MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2007-08-20 | ||
| A076709-002 | FENTANYL-50 | FENTANYL | 50MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2007-08-20 | ||
| A076709-003 | FENTANYL-75 | FENTANYL | 75MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2007-08-20 | ||
| A076709-004 | FENTANYL-100 | FENTANYL | 100MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2007-08-20 |
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 | A076709-001 | FENTANYL-25 | 25MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2007-08-20 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076709-002 | FENTANYL-50 | 50MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2007-08-20 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076709-003 | FENTANYL-75 | 75MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2007-08-20 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076709-004 | FENTANYL-100 | 100MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2007-08-20 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076709-001 | FENTANYL-25 | 25MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2007-08-20 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076709-002 | FENTANYL-50 | 50MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2007-08-20 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076709-003 | FENTANYL-75 | 75MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2007-08-20 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076709-004 | FENTANYL-100 | 100MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2007-08-20 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076709-001 | FENTANYL-25 | 25MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2007-08-20 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076709-002 | FENTANYL-50 | 50MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2007-08-20 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076709-003 | FENTANYL-75 | 75MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2007-08-20 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076709-004 | FENTANYL-100 | 100MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2007-08-20 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076709-001 | FENTANYL-25 | 25MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2007-08-20 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076709-002 | FENTANYL-50 | 50MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2007-08-20 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076709-003 | FENTANYL-75 | 75MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2007-08-20 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076709-004 | FENTANYL-100 | 100MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2007-08-20 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076709-001 | FENTANYL-25 | 25MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2007-08-20 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076709-002 | FENTANYL-50 | 50MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2007-08-20 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076709-003 | FENTANYL-75 | 75MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2007-08-20 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076709-004 | FENTANYL-100 | 100MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2007-08-20 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076709-001 | FENTANYL-25 | 25MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2007-08-20 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076709-002 | FENTANYL-50 | 50MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2007-08-20 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076709-003 | FENTANYL-75 | 75MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2007-08-20 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076709-004 | FENTANYL-100 | 100MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2007-08-20 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076709-001 | FENTANYL-25 | 25MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2007-08-20 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076709-002 | FENTANYL-50 | 50MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2007-08-20 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076709-003 | FENTANYL-75 | 75MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2007-08-20 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076709-004 | FENTANYL-100 | 100MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2007-08-20 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076709-001 | FENTANYL-25 | 25MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2007-08-20 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076709-002 | FENTANYL-50 | 50MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2007-08-20 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076709-003 | FENTANYL-75 | 75MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2007-08-20 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076709-004 | FENTANYL-100 | 100MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2007-08-20 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076709-001 | FENTANYL-25 | 25MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2007-08-20 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076709-002 | FENTANYL-50 | 50MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2007-08-20 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076709-003 | FENTANYL-75 | 75MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2007-08-20 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076709-004 | FENTANYL-100 | 100MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2007-08-20 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A076709-001 | FENTANYL-25 | 25MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2007-08-20 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A076709-002 | FENTANYL-50 | 50MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2007-08-20 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A076709-003 | FENTANYL-75 | 75MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2007-08-20 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A076709-004 | FENTANYL-100 | 100MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | 2007-08-20 | d06236e962d9… |
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 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0591-3198-54 | EA - Each | 0591-3198 | ea7abb22-a4f9-493f-b676-0c3964fad40e | 1 | 2012-07-24 |
| 0591-3198-72 | EA - Each | 0591-3198 | 6cd2b478-332b-480c-af20-ac40e6a1c938 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| FENTANYL | ACTIVE INGREDIENT | UF599785JZ | FENTANYL PATCH, EXTENDED RELEASE [STAT RX USA LLC] | 4 | |
| FENTANYL | ACTIVE MOIETY | UF599785JZ | FENTANYL PATCH, EXTENDED RELEASE [STAT RX USA LLC] | 4 | |
| ALCOHOL | INACTIVE INGREDIENT | 3K9958V90M | FENTANYL PATCH, EXTENDED RELEASE [STAT RX USA LLC] | 4 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 245134 | fentaNYL 25 MCG/HR 72HR Transdermal System | PSN | 9cb25b46-ca9a-4fb4-bf3d-a7d3074275d5 | 4 |
| 245135 | fentaNYL 50 MCG/HR 72HR Transdermal System | PSN | 9cb25b46-ca9a-4fb4-bf3d-a7d3074275d5 | 4 |
| 245134 | 72 HR fentanyl 0.025 MG/HR Transdermal System | SCD | 9cb25b46-ca9a-4fb4-bf3d-a7d3074275d5 | 4 |
| 245135 | 72 HR fentanyl 0.05 MG/HR Transdermal System | SCD | 9cb25b46-ca9a-4fb4-bf3d-a7d3074275d5 | 4 |
| 245134 | fentanyl 25 MCG/HR 3 Day Transdermal Patch | SY | 9cb25b46-ca9a-4fb4-bf3d-a7d3074275d5 | 4 |
| 245134 | fentanyl 25 MCG/HR 72HR Transdermal System | SY | 9cb25b46-ca9a-4fb4-bf3d-a7d3074275d5 | 4 |
| 245135 | fentanyl 50 MCG/HR 3 Day Transdermal Patch | SY | 9cb25b46-ca9a-4fb4-bf3d-a7d3074275d5 | 4 |
| 245135 | fentanyl 50 MCG/HR 72HR Transdermal System | SY | 9cb25b46-ca9a-4fb4-bf3d-a7d3074275d5 | 4 |