Fentanyl System
- Product NDC
- 55700-973
- Requested package NDC
- 55700-973-05
- 11-digit product format
- 557000973
- Labeler code
- 55700
- Product ID
- 55700-973_0aade8f7-8563-4189-86b6-6804445ff89f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fentanyl
- Dosage form
- PATCH
- Route
- TRANSDERMAL
- Labeler
- Quality Care Products, LLC
- Application
- ANDA202097
- Marketing category
- ANDA
- Marketing start
- 2022-05-09
- Marketing end
- 0000-00-00
- Substance
- FENTANYL
- Active strength
- 50 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 package | package | 55700-973 | 55700-973-05 | D | Discontinued by firm | 2026-08-03 |
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 package | package | 55700-973 | 55700-973-05 | D | Discontinued by firm | excluded / ndc_excluded.zip | d630ba8d3edf… | 732f749b63fb… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 55700-973 | 55700-973-05 | D | Discontinued by firm | excluded / ndc_excluded.zip | f5e01cc5f278… | a2eaf40c39c3… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A202097-001 | FENTANYL-12 | FENTANYL | 12.5MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2016-11-04 | |
| A202097-002 | FENTANYL-25 | FENTANYL | 25MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2016-11-04 | |
| A202097-003 | FENTANYL-50 | FENTANYL | 50MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2016-11-04 | |
| A202097-004 | FENTANYL-75 | FENTANYL | 75MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2016-11-04 | |
| A202097-005 | FENTANYL-100 | FENTANYL | 100MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2016-11-04 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A202097-001 | AB |
| A202097-002 | AB |
| A202097-003 | AB |
| A202097-004 | AB |
| A202097-005 | 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 | A202097-001 | FENTANYL-12 | 12.5MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2016-11-04 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202097-002 | FENTANYL-25 | 25MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2016-11-04 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202097-003 | FENTANYL-50 | 50MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2016-11-04 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202097-004 | FENTANYL-75 | 75MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2016-11-04 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202097-005 | FENTANYL-100 | 100MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2016-11-04 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202097-001 | FENTANYL-12 | 12.5MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2016-11-04 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202097-002 | FENTANYL-25 | 25MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2016-11-04 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202097-003 | FENTANYL-50 | 50MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2016-11-04 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202097-004 | FENTANYL-75 | 75MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2016-11-04 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202097-005 | FENTANYL-100 | 100MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2016-11-04 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202097-001 | FENTANYL-12 | 12.5MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2016-11-04 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202097-002 | FENTANYL-25 | 25MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2016-11-04 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202097-003 | FENTANYL-50 | 50MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2016-11-04 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202097-004 | FENTANYL-75 | 75MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2016-11-04 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202097-005 | FENTANYL-100 | 100MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2016-11-04 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202097-001 | FENTANYL-12 | 12.5MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2016-11-04 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202097-002 | FENTANYL-25 | 25MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2016-11-04 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202097-003 | FENTANYL-50 | 50MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2016-11-04 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202097-004 | FENTANYL-75 | 75MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2016-11-04 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202097-005 | FENTANYL-100 | 100MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2016-11-04 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202097-001 | FENTANYL-12 | 12.5MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2016-11-04 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202097-002 | FENTANYL-25 | 25MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2016-11-04 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202097-003 | FENTANYL-50 | 50MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2016-11-04 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202097-004 | FENTANYL-75 | 75MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2016-11-04 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202097-005 | FENTANYL-100 | 100MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2016-11-04 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202097-001 | FENTANYL-12 | 12.5MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2016-11-04 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202097-002 | FENTANYL-25 | 25MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2016-11-04 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202097-003 | FENTANYL-50 | 50MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2016-11-04 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202097-004 | FENTANYL-75 | 75MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2016-11-04 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202097-005 | FENTANYL-100 | 100MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2016-11-04 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202097-001 | FENTANYL-12 | 12.5MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2016-11-04 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202097-002 | FENTANYL-25 | 25MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2016-11-04 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202097-003 | FENTANYL-50 | 50MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2016-11-04 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202097-004 | FENTANYL-75 | 75MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2016-11-04 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202097-005 | FENTANYL-100 | 100MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2016-11-04 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202097-001 | FENTANYL-12 | 12.5MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2016-11-04 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202097-002 | FENTANYL-25 | 25MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2016-11-04 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202097-003 | FENTANYL-50 | 50MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2016-11-04 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202097-004 | FENTANYL-75 | 75MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2016-11-04 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202097-005 | FENTANYL-100 | 100MCG/HR | FILM, EXTENDED RELEASE / TRANSDERMAL | AB | 2016-11-04 | 5bbf6a4d5a75… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A202097-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202097-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202097-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202097-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202097-005 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202097-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202097-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202097-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202097-004 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202097-005 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A202097-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202097-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202097-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202097-004 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202097-005 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202097-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202097-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202097-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202097-004 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202097-005 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202097-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202097-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202097-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202097-004 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202097-005 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202097-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202097-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202097-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202097-004 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202097-005 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202097-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202097-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202097-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202097-004 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202097-005 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202097-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202097-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202097-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202097-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202097-005 | AB | 1 | 5bbf6a4d5a75… |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 55700-973-05 | EA - Each | 55700-973 | 1da21f7b-ed07-42ef-a493-c376998af35f | 1 | 2022-09-12 |
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 system | FENTANYL | ALVOGEN | 242759ef-cb6d-4e3e-9f8d-5e31efa1f289 | 2026-03-02 | Boxed warning, Warnings, Adverse reactions | 202097 ANDA202097 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 55700-973-05 | 55700097305 | 1 POUCH in 1 CARTON (55700-973-05) > 5 PATCH in 1 POUCH | 1 pouch | 2022-05-09 | 0000-00-00 | No | No | Current |