FENTANYL
- Product NDC
- 55700-402
- 11-digit product format
- 557000402
- Labeler code
- 55700
- Product ID
- 55700-402_cdb0d55e-4716-4fc3-b837-7c68cacbb91d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- FENTANYL
- Dosage form
- PATCH, EXTENDED RELEASE
- Route
- TRANSDERMAL
- Labeler
- Lake Erie Medical DBA Quality Care Products LLC
- Application
- ANDA077449
- Marketing category
- ANDA
- Marketing start
- 2013-04-04
- Marketing end
- 0000-00-00
- Substance
- FENTANYL
- Active strength
- 25 ug/h
- Pharmacologic classes
- Full Opioid Agonists [MoA],Opioid Agonist [EPC]
- DEA schedule
- CII
- NDC exclude flag
- E
- Listing certified through
- 2018-12-31
- 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 | 55700-402 | D | Discontinued by firm | 2026-08-07 | ||
| excluded package | package | 55700-402 | 55700-402-05 | 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 | Package NDC | Code | Status | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | D | Discontinued by firm | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 55700-402-05 | D | Discontinued by firm | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | D | Discontinued by firm | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 55700-402-05 | D | Discontinued by firm | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | D | Discontinued by firm | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 55700-402-05 | D | Discontinued by firm | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | D | Discontinued by firm | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 55700-402-05 | D | Discontinued by firm | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | D | Discontinued by firm | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 55700-402-05 | D | Discontinued by firm | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | D | Discontinued by firm | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 55700-402-05 | D | Discontinued by firm | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | D | Discontinued by firm | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 55700-402-05 | D | Discontinued by firm | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | D | Discontinued by firm | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 55700-402-05 | D | Discontinued by firm | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | D | Discontinued by firm | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 55700-402-05 | D | Discontinued by firm | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | D | Discontinued by firm | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 55700-402-05 | D | Discontinued by firm | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | D | Discontinued by firm | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 55700-402-05 | D | Discontinued by firm | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | D | Discontinued by firm | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 55700-402-05 | D | Discontinued by firm | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2019-12-08 06:16 UTC · source 2019-12-05 | excluded product | product | E | Excluded after deficient or non-compliant submission was not corrected | 110d247fa046… | a55b01930146… | |
| 2019-12-08 06:16 UTC · source 2019-12-05 | excluded package | package | 55700-402-05 | E | Excluded after deficient or non-compliant submission was not corrected | 110d247fa046… | a55b01930146… |
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 |
|---|---|---|---|---|---|
| 55700-402-05 | EA - Each | 55700-402 | 0782c04a-484a-4465-a1f0-5b6d7d9f286f | 1 | 2017-03-06 |
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 |