FENTANYL
- Product NDC
- 55700-748
- Requested package NDC
- 55700-748-05
- 11-digit product format
- 557000748
- Labeler code
- 55700
- Product ID
- 55700-748_447be040-aac5-4a83-b6fb-f28f94f84c40
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- FENTANYL
- Dosage form
- PATCH, EXTENDED RELEASE
- Route
- TRANSDERMAL
- Labeler
- Quality Care Products, LLC
- Application
- ANDA077449
- Marketing category
- ANDA
- Marketing start
- 2019-05-17
- Marketing end
- 2026-02-28
- Substance
- FENTANYL
- Active strength
- 50 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 package | package | 55700-748 | 55700-748-05 | D | Discontinued by firm | 2026-08-07 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A077449-001 | FENTANYL-25 | FENTANYL | 25MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2008-10-20 | |
| A077449-002 | FENTANYL-50 | FENTANYL | 50MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2008-10-20 | |
| A077449-003 | FENTANYL-75 | FENTANYL | 75MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2008-10-20 | |
| A077449-004 | FENTANYL-100 | FENTANYL | 100MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2008-10-20 | |
| A077449-005 | FENTANYL-12 | FENTANYL | 12.5MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2015-09-11 | |
| A077449-006 | FENTANYL-37 | FENTANYL | 37.5MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2017-12-06 | |
| A077449-007 | FENTANYL-62 | FENTANYL | 62.5MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2017-12-06 | |
| A077449-008 | FENTANYL-87 | FENTANYL | 87.5MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2017-12-06 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A077449-001 | AB |
| A077449-002 | AB |
| A077449-003 | AB |
| A077449-004 | AB |
| A077449-005 | AB |
| A077449-006 | AB |
| A077449-007 | AB |
| A077449-008 | AB |
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 | A077449-001 | FENTANYL-25 | 25MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2008-10-20 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077449-002 | FENTANYL-50 | 50MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2008-10-20 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077449-003 | FENTANYL-75 | 75MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2008-10-20 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077449-004 | FENTANYL-100 | 100MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2008-10-20 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077449-005 | FENTANYL-12 | 12.5MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2015-09-11 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077449-006 | FENTANYL-37 | 37.5MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2017-12-06 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077449-007 | FENTANYL-62 | 62.5MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2017-12-06 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077449-008 | FENTANYL-87 | 87.5MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2017-12-06 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077449-001 | FENTANYL-25 | 25MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2008-10-20 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077449-002 | FENTANYL-50 | 50MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2008-10-20 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077449-003 | FENTANYL-75 | 75MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2008-10-20 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077449-004 | FENTANYL-100 | 100MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2008-10-20 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077449-005 | FENTANYL-12 | 12.5MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2015-09-11 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077449-006 | FENTANYL-37 | 37.5MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2017-12-06 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077449-007 | FENTANYL-62 | 62.5MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2017-12-06 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077449-008 | FENTANYL-87 | 87.5MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2017-12-06 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077449-001 | FENTANYL-25 | 25MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2008-10-20 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077449-002 | FENTANYL-50 | 50MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2008-10-20 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077449-003 | FENTANYL-75 | 75MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2008-10-20 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077449-004 | FENTANYL-100 | 100MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2008-10-20 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077449-005 | FENTANYL-12 | 12.5MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2015-09-11 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077449-006 | FENTANYL-37 | 37.5MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2017-12-06 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077449-007 | FENTANYL-62 | 62.5MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2017-12-06 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077449-008 | FENTANYL-87 | 87.5MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2017-12-06 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077449-001 | FENTANYL-25 | 25MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2008-10-20 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077449-002 | FENTANYL-50 | 50MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2008-10-20 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077449-003 | FENTANYL-75 | 75MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2008-10-20 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077449-004 | FENTANYL-100 | 100MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2008-10-20 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077449-005 | FENTANYL-12 | 12.5MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2015-09-11 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077449-006 | FENTANYL-37 | 37.5MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2017-12-06 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077449-007 | FENTANYL-62 | 62.5MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2017-12-06 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077449-008 | FENTANYL-87 | 87.5MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2017-12-06 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077449-001 | FENTANYL-25 | 25MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2008-10-20 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077449-002 | FENTANYL-50 | 50MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2008-10-20 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077449-003 | FENTANYL-75 | 75MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2008-10-20 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077449-004 | FENTANYL-100 | 100MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2008-10-20 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077449-005 | FENTANYL-12 | 12.5MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2015-09-11 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077449-006 | FENTANYL-37 | 37.5MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2017-12-06 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077449-007 | FENTANYL-62 | 62.5MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2017-12-06 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077449-008 | FENTANYL-87 | 87.5MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2017-12-06 | b8a1b40f171c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A077449-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A077449-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A077449-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A077449-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A077449-005 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A077449-006 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A077449-007 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A077449-008 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077449-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077449-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077449-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077449-004 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077449-005 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077449-006 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077449-007 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077449-008 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A077449-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A077449-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A077449-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A077449-004 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A077449-005 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A077449-006 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A077449-007 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A077449-008 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077449-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077449-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077449-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077449-004 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077449-005 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077449-006 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077449-007 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077449-008 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077449-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077449-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077449-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077449-004 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077449-005 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077449-006 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077449-007 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077449-008 | AB | 1 | b8a1b40f171c… |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 55700-748-05 | EA - Each | 55700-748 | 66b7cce7-f1f3-424b-a60e-c5d9cabe6f78 | 1 | 2019-06-19 |
DailyMed Dashboard NDC Coverage#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| FENTANYL | FENTANYL | Aveva Drug Delivery Systems Inc. | 73897c38-e4ec-40bc-9f41-3359ee23a5a8 | 2026-04-07 | Boxed warning, Warnings, Adverse reactions | 077449 ANDA077449 |
| FENTANYL | FENTANYL | INGENUS PHARMACEUTICALS, LLC | bf02ffd0-cc5d-446b-b648-378f6885052f | 2026-04-07 | Boxed warning, Warnings, Adverse reactions | 077449 ANDA077449 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 55700-748-05 | 55700074805 | 5 POUCH in 1 CARTON (55700-748-05) > 1 PATCH in 1 POUCH > 72 h in 1 PATCH | 5 pouch | 2019-05-17 | 2026-02-28 | No | No | Current |