SUBSYS
- Product NDC
- 71500-002
- Requested package NDC
- 71500-002-30
- 11-digit product format
- 715000002
- Labeler code
- 71500
- Product ID
- 71500-002_c10a64fb-0dc8-b077-e053-2995a90a374f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- fentanyl
- Dosage form
- SPRAY
- Route
- SUBLINGUAL
- Labeler
- West Therapeutics Development, LLC
- Application
- NDA202788
- Marketing category
- NDA
- Marketing start
- 2021-03-10
- Marketing end
- 0000-00-00
- Substance
- FENTANYL
- Active strength
- 0 mg/1
- Pharmacologic classes
- Full Opioid Agonists [MoA],Opioid Agonist [EPC]
- DEA schedule
- CII
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- 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 | 71500-002 | 71500-002-30 | I | Inactivated by FDA | 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 | Snapshot | Source SHA-256 |
|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | 834df4deac94… | adcc014656a3… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | 1332a3947898… | d4bfe170f9cd… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N202788-001 | SUBSYS | FENTANYL | 0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-01-04 | |
| N202788-002 | SUBSYS | FENTANYL | 0.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-01-04 | |
| N202788-003 | SUBSYS | FENTANYL | 0.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-01-04 | |
| N202788-004 | SUBSYS | FENTANYL | 0.6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-01-04 | |
| N202788-005 | SUBSYS | FENTANYL | 0.8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-01-04 | |
| N202788-006 | SUBSYS | FENTANYL | 1.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-08-30 | |
| N202788-007 | SUBSYS | FENTANYL | 1.6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-08-30 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N202788-001 | 10016403 | 2027-01-25 | Drug product | 2018-08-10 | |
| N202788-001 | 10610523 | 2027-01-25 | Drug product | 2020-04-22 | |
| N202788-001 | 8835459 | 2027-01-25 | Drug product | 2014-09-24 | |
| N202788-001 | 8835460 | 2027-01-25 | U-55 | Drug product | 2014-09-24 |
| N202788-001 | 9241935 | 2027-01-25 | Drug product | 2016-02-18 | |
| N202788-001 | 9289387 | 2027-01-25 | U-55 | Drug product | 2017-05-15 |
| N202788-001 | 9642797 | 2027-01-25 | U-55 | Drug product | 2017-05-15 |
| N202788-001 | 9642844 | 2027-01-25 | Drug product | 2017-05-15 | |
| N202788-001 | 8486972 | 2030-04-27 | Drug product | 2013-07-30 | |
| N202788-001 | 8486973 | 2030-04-27 | U-55 | 2013-07-30 | |
| N202788-002 | 10016403 | 2027-01-25 | Drug product | 2018-08-10 | |
| N202788-002 | 10610523 | 2027-01-25 | Drug product | 2020-04-22 | |
| N202788-002 | 8835460 | 2027-01-25 | U-55 | Drug product | 2014-09-29 |
| N202788-002 | 9241935 | 2027-01-25 | Drug product | 2016-02-18 | |
| N202788-002 | 9289387 | 2027-01-25 | U-55 | Drug product | 2017-05-15 |
| N202788-002 | 9642797 | 2027-01-25 | U-55 | Drug product | 2017-05-15 |
| N202788-002 | 9642844 | 2027-01-25 | Drug product | 2017-05-15 | |
| N202788-002 | 8486972 | 2030-04-27 | Drug product | 2013-07-30 | |
| N202788-002 | 8486973 | 2030-04-27 | U-55 | 2013-07-30 | |
| N202788-003 | 10016403 | 2027-01-25 | Drug product | 2018-08-10 | |
| N202788-003 | 10610523 | 2027-01-25 | Drug product | 2020-04-22 | |
| N202788-003 | 8835459 | 2027-01-25 | Drug product | 2014-09-24 | |
| N202788-003 | 8835460 | 2027-01-25 | U-55 | Drug product | 2014-09-24 |
| N202788-003 | 9241935 | 2027-01-25 | Drug product | 2016-02-18 | |
| N202788-003 | 9289387 | 2027-01-25 | U-55 | Drug product | 2017-05-15 |
| N202788-003 | 9642797 | 2027-01-25 | U-55 | Drug product | 2017-05-15 |
| N202788-003 | 9642844 | 2027-01-25 | Drug product | 2017-05-15 | |
| N202788-003 | 8486972 | 2030-04-27 | Drug product | 2013-07-30 | |
| N202788-003 | 8486973 | 2030-04-27 | U-55 | 2013-07-30 | |
| N202788-004 | 10016403 | 2027-01-25 | Drug product | 2018-08-10 | |
| N202788-004 | 10610523 | 2027-01-25 | Drug product | 2020-04-22 | |
| N202788-004 | 8835459 | 2027-01-25 | Drug product | 2014-09-24 | |
| N202788-004 | 8835460 | 2027-01-25 | U-55 | Drug product | 2014-09-24 |
| N202788-004 | 9241935 | 2027-01-25 | Drug product | 2016-02-18 | |
| N202788-004 | 9289387 | 2027-01-25 | U-55 | Drug product | 2017-05-15 |
| N202788-004 | 9642797 | 2027-01-25 | U-55 | Drug product | 2017-05-15 |
| N202788-004 | 9642844 | 2027-01-25 | Drug product | 2017-05-15 | |
| N202788-004 | 8486972 | 2030-04-27 | Drug product | 2013-07-30 | |
| N202788-004 | 8486973 | 2030-04-27 | U-55 | 2013-07-30 | |
| N202788-005 | 10016403 | 2027-01-25 | Drug product | 2018-08-10 | |
| N202788-005 | 10610523 | 2027-01-25 | Drug product | 2020-04-22 | |
| N202788-005 | 8835460 | 2027-01-25 | U-55 | Drug product | 2014-09-24 |
| N202788-005 | 9241935 | 2027-01-25 | Drug product | 2016-02-18 | |
| N202788-005 | 9289387 | 2027-01-25 | U-55 | Drug product | 2017-05-15 |
| N202788-005 | 9642797 | 2027-01-25 | U-55 | Drug product | 2017-05-15 |
| N202788-005 | 9642844 | 2027-01-25 | Drug product | 2017-05-15 | |
| N202788-005 | 8486972 | 2030-04-27 | Drug product | 2013-07-30 | |
| N202788-005 | 8486973 | 2030-04-27 | U-55 | 2013-07-30 | |
| N202788-006 | 10016403 | 2027-01-25 | Drug product | 2018-08-10 | |
| N202788-006 | 10610523 | 2027-01-25 | Drug product | 2020-05-06 | |
| N202788-006 | 8835459 | 2027-01-25 | Drug product | 2014-09-24 | |
| N202788-006 | 8835460 | 2027-01-25 | U-55 | Drug product | 2014-09-24 |
| N202788-006 | 9241935 | 2027-01-25 | Drug product | 2016-02-18 | |
| N202788-006 | 9289387 | 2027-01-25 | U-55 | Drug product | 2017-05-15 |
| N202788-006 | 9642797 | 2027-01-25 | U-55 | Drug product | 2017-05-15 |
| N202788-006 | 9642844 | 2027-01-25 | Drug product | 2017-05-15 | |
| N202788-006 | 8486972 | 2030-04-27 | Drug product | 2013-07-30 | |
| N202788-006 | 8486973 | 2030-04-27 | U-55 | 2013-07-30 | |
| N202788-007 | 10016403 | 2027-01-25 | Drug product | 2018-08-10 | |
| N202788-007 | 10610523 | 2027-01-25 | Drug product | 2020-05-06 | |
| N202788-007 | 8835459 | 2027-01-25 | Drug product | 2014-09-24 | |
| N202788-007 | 8835460 | 2027-01-25 | U-55 | Drug product | 2014-09-29 |
| N202788-007 | 9241935 | 2027-01-25 | Drug product | 2016-02-18 | |
| N202788-007 | 9289387 | 2027-01-25 | U-55 | Drug product | 2017-05-15 |
| N202788-007 | 9642797 | 2027-01-25 | U-55 | Drug product | 2017-05-15 |
| N202788-007 | 9642844 | 2027-01-25 | Drug product | 2017-05-15 | |
| N202788-007 | 8486972 | 2030-04-27 | Drug product | 2013-07-30 | |
| N202788-007 | 8486973 | 2030-04-27 | U-55 | 2013-07-30 |
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 | N202788-001 | SUBSYS | 0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-01-04 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202788-002 | SUBSYS | 0.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-01-04 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202788-003 | SUBSYS | 0.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-01-04 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202788-004 | SUBSYS | 0.6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-01-04 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202788-005 | SUBSYS | 0.8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-01-04 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202788-006 | SUBSYS | 1.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-08-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202788-007 | SUBSYS | 1.6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-08-30 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202788-001 | SUBSYS | 0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-01-04 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202788-002 | SUBSYS | 0.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-01-04 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202788-003 | SUBSYS | 0.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-01-04 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202788-004 | SUBSYS | 0.6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-01-04 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202788-005 | SUBSYS | 0.8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-01-04 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202788-006 | SUBSYS | 1.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-08-30 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202788-007 | SUBSYS | 1.6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-08-30 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N202788-001 | SUBSYS | 0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-01-04 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N202788-002 | SUBSYS | 0.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-01-04 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N202788-003 | SUBSYS | 0.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-01-04 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N202788-004 | SUBSYS | 0.6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-01-04 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N202788-005 | SUBSYS | 0.8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-01-04 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N202788-006 | SUBSYS | 1.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-08-30 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N202788-007 | SUBSYS | 1.6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-08-30 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N202788-001 | SUBSYS | 0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-01-04 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N202788-002 | SUBSYS | 0.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-01-04 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N202788-003 | SUBSYS | 0.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-01-04 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N202788-004 | SUBSYS | 0.6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-01-04 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N202788-005 | SUBSYS | 0.8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-01-04 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N202788-006 | SUBSYS | 1.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-08-30 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N202788-007 | SUBSYS | 1.6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-08-30 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N202788-001 | SUBSYS | 0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-01-04 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N202788-002 | SUBSYS | 0.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-01-04 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N202788-003 | SUBSYS | 0.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-01-04 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N202788-004 | SUBSYS | 0.6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-01-04 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N202788-005 | SUBSYS | 0.8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-01-04 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N202788-006 | SUBSYS | 1.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-08-30 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N202788-007 | SUBSYS | 1.6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-08-30 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N202788-001 | SUBSYS | 0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-01-04 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N202788-002 | SUBSYS | 0.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-01-04 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N202788-003 | SUBSYS | 0.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-01-04 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N202788-004 | SUBSYS | 0.6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-01-04 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N202788-005 | SUBSYS | 0.8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-01-04 | 03ed91905a0d… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N202788-001 | 10016403 | 2027-01-25 | Drug product | 2018-08-10 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202788-001 | 10610523 | 2027-01-25 | Drug product | 2020-04-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202788-001 | 8835459 | 2027-01-25 | Drug product | 2014-09-24 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202788-001 | 8835460 | 2027-01-25 | U-55 | Drug product | 2014-09-24 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N202788-001 | 9241935 | 2027-01-25 | Drug product | 2016-02-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202788-001 | 9289387 | 2027-01-25 | U-55 | Drug product | 2017-05-15 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N202788-001 | 9642797 | 2027-01-25 | U-55 | Drug product | 2017-05-15 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N202788-001 | 9642844 | 2027-01-25 | Drug product | 2017-05-15 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202788-001 | 8486972 | 2030-04-27 | Drug product | 2013-07-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202788-001 | 8486973 | 2030-04-27 | U-55 | 2013-07-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202788-002 | 10016403 | 2027-01-25 | Drug product | 2018-08-10 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202788-002 | 10610523 | 2027-01-25 | Drug product | 2020-04-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202788-002 | 8835460 | 2027-01-25 | U-55 | Drug product | 2014-09-29 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N202788-002 | 9241935 | 2027-01-25 | Drug product | 2016-02-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202788-002 | 9289387 | 2027-01-25 | U-55 | Drug product | 2017-05-15 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N202788-002 | 9642797 | 2027-01-25 | U-55 | Drug product | 2017-05-15 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N202788-002 | 9642844 | 2027-01-25 | Drug product | 2017-05-15 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202788-002 | 8486972 | 2030-04-27 | Drug product | 2013-07-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202788-002 | 8486973 | 2030-04-27 | U-55 | 2013-07-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202788-003 | 10016403 | 2027-01-25 | Drug product | 2018-08-10 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202788-003 | 10610523 | 2027-01-25 | Drug product | 2020-04-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202788-003 | 8835459 | 2027-01-25 | Drug product | 2014-09-24 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202788-003 | 8835460 | 2027-01-25 | U-55 | Drug product | 2014-09-24 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N202788-003 | 9241935 | 2027-01-25 | Drug product | 2016-02-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202788-003 | 9289387 | 2027-01-25 | U-55 | Drug product | 2017-05-15 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N202788-003 | 9642797 | 2027-01-25 | U-55 | Drug product | 2017-05-15 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N202788-003 | 9642844 | 2027-01-25 | Drug product | 2017-05-15 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202788-003 | 8486972 | 2030-04-27 | Drug product | 2013-07-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202788-003 | 8486973 | 2030-04-27 | U-55 | 2013-07-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202788-004 | 10016403 | 2027-01-25 | Drug product | 2018-08-10 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202788-004 | 10610523 | 2027-01-25 | Drug product | 2020-04-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202788-004 | 8835459 | 2027-01-25 | Drug product | 2014-09-24 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202788-004 | 8835460 | 2027-01-25 | U-55 | Drug product | 2014-09-24 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N202788-004 | 9241935 | 2027-01-25 | Drug product | 2016-02-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202788-004 | 9289387 | 2027-01-25 | U-55 | Drug product | 2017-05-15 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N202788-004 | 9642797 | 2027-01-25 | U-55 | Drug product | 2017-05-15 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N202788-004 | 9642844 | 2027-01-25 | Drug product | 2017-05-15 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202788-004 | 8486972 | 2030-04-27 | Drug product | 2013-07-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202788-004 | 8486973 | 2030-04-27 | U-55 | 2013-07-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202788-005 | 10016403 | 2027-01-25 | Drug product | 2018-08-10 | 011fe1cb6892… |
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 |
|---|---|---|---|---|---|
| 71500-002-30 | 2023-01-30 | C162847 | 48780-1 | f386c649-9e81-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use SUBSYS safely and effectively. See full prescribing information for SUBSYS. SUBSYS®(fentanyl sublingual spray), CII Initial U.S. Approval: 1968 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 71500-002-30 | SUBSYS | 30 in 1 CARTON | SPRAY | 30 | 23 | |
| 71500-002-30 | SUBSYS | 1 in 1 BLISTER PACK | SPRAY | 1 | 23 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 71500-002-30 | EA - Each | 71500-002 | a6098e95-8ed9-4959-8345-38b4c14c34ac | 1 | 2021-05-05 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1740008 | {2 (fentanyl 0.6 MG/ACTUAT Mucosal Spray [Subsys]) } Pack [Subsys 1200 MCG] | BPCK | be7670d5-b88a-13bd-e053-2995a90a2f78 | 23 |
| 1740010 | {2 (fentanyl 0.8 MG/ACTUAT Mucosal Spray [Subsys]) } Pack [Subsys 1600 MCG] | BPCK | be7670d5-b88a-13bd-e053-2995a90a2f78 | 23 |
| 1740007 | {2 (fentanyl 0.6 MG/ACTUAT Mucosal Spray) } Pack | GPCK | be7670d5-b88a-13bd-e053-2995a90a2f78 | 23 |
| 1740009 | {2 (fentanyl 0.8 MG/ACTUAT Mucosal Spray) } Pack | GPCK | be7670d5-b88a-13bd-e053-2995a90a2f78 | 23 |
| 1237050 | fentaNYL 100 MCG/ACTUAT Mucosal Spray | PSN | be7670d5-b88a-13bd-e053-2995a90a2f78 | 23 |
| 1740007 | fentaNYL 1200 MCG (2 x 600 MCG/ACTUAT) Mucosal Spray | PSN | be7670d5-b88a-13bd-e053-2995a90a2f78 | 23 |
| 1740009 | fentaNYL 1600 MCG (2 x 800 MCG/ACTUAT) Mucosal Spray | PSN | be7670d5-b88a-13bd-e053-2995a90a2f78 | 23 |
| 1237057 | fentaNYL 200 MCG/ACTUAT Mucosal Spray | PSN | be7670d5-b88a-13bd-e053-2995a90a2f78 | 23 |
| 1237060 | fentaNYL 400 MCG/ACTUAT Mucosal Spray | PSN | be7670d5-b88a-13bd-e053-2995a90a2f78 | 23 |
| 1237064 | fentaNYL 600 MCG/ACTUAT Mucosal Spray | PSN | be7670d5-b88a-13bd-e053-2995a90a2f78 | 23 |
| 1237068 | fentaNYL 800 MCG/ACTUAT Mucosal Spray | PSN | be7670d5-b88a-13bd-e053-2995a90a2f78 | 23 |
| 1237055 | Subsys 100 MCG/ACTUAT Mucosal Spray | PSN | be7670d5-b88a-13bd-e053-2995a90a2f78 | 23 |
| 1740008 | Subsys 1200 MCG (2 x 600 MCG/ACTUAT) Mucosal Spray | PSN | be7670d5-b88a-13bd-e053-2995a90a2f78 | 23 |
| 1740010 | Subsys 1600 MCG (2 x 800 MCG/ACTUAT) Mucosal Spray | PSN | be7670d5-b88a-13bd-e053-2995a90a2f78 | 23 |
| 1237059 | Subsys 200 MCG/ACTUAT Sublingual Spray | PSN | be7670d5-b88a-13bd-e053-2995a90a2f78 | 23 |
| 1237062 | Subsys 400 MCG/ACTUAT Mucosal Spray | PSN | be7670d5-b88a-13bd-e053-2995a90a2f78 | 23 |
| 1237066 | Subsys 600 MCG/ACTUAT Mucosal Spray | PSN | be7670d5-b88a-13bd-e053-2995a90a2f78 | 23 |
| 1237070 | Subsys 800 MCG/ACTUAT Mucosal Spray | PSN | be7670d5-b88a-13bd-e053-2995a90a2f78 | 23 |
| 1237055 | fentanyl 0.1 MG/ACTUAT Mucosal Spray [Subsys] | SBD | be7670d5-b88a-13bd-e053-2995a90a2f78 | 23 |
| 1237059 | fentanyl 0.2 MG/ACTUAT Mucosal Spray [Subsys] | SBD | be7670d5-b88a-13bd-e053-2995a90a2f78 | 23 |
| 1237062 | fentanyl 0.4 MG/ACTUAT Mucosal Spray [Subsys] | SBD | be7670d5-b88a-13bd-e053-2995a90a2f78 | 23 |
| 1237066 | fentanyl 0.6 MG/ACTUAT Mucosal Spray [Subsys] | SBD | be7670d5-b88a-13bd-e053-2995a90a2f78 | 23 |
| 1237070 | fentanyl 0.8 MG/ACTUAT Mucosal Spray [Subsys] | SBD | be7670d5-b88a-13bd-e053-2995a90a2f78 | 23 |
| 1237050 | fentanyl 0.1 MG/ACTUAT Mucosal Spray | SCD | be7670d5-b88a-13bd-e053-2995a90a2f78 | 23 |
| 1237057 | fentanyl 0.2 MG/ACTUAT Mucosal Spray | SCD | be7670d5-b88a-13bd-e053-2995a90a2f78 | 23 |
| 1237060 | fentanyl 0.4 MG/ACTUAT Mucosal Spray | SCD | be7670d5-b88a-13bd-e053-2995a90a2f78 | 23 |
| 1237064 | fentanyl 0.6 MG/ACTUAT Mucosal Spray | SCD | be7670d5-b88a-13bd-e053-2995a90a2f78 | 23 |
| 1237068 | fentanyl 0.8 MG/ACTUAT Mucosal Spray | SCD | be7670d5-b88a-13bd-e053-2995a90a2f78 | 23 |
| 1237050 | fentanyl 0.1 MG/ACTUAT Sublingual Spray | SY | be7670d5-b88a-13bd-e053-2995a90a2f78 | 23 |
| 1237057 | fentanyl 0.2 MG/ACTUAT Sublingual Spray | SY | be7670d5-b88a-13bd-e053-2995a90a2f78 | 23 |
| 1237060 | fentanyl 0.4 MG/ACTUAT Sublingual Spray | SY | be7670d5-b88a-13bd-e053-2995a90a2f78 | 23 |
| 1237064 | fentanyl 0.6 MG/ACTUAT Sublingual Spray | SY | be7670d5-b88a-13bd-e053-2995a90a2f78 | 23 |
| 1237068 | fentanyl 0.8 MG/ACTUAT Sublingual Spray | SY | be7670d5-b88a-13bd-e053-2995a90a2f78 | 23 |
| 1237050 | fentanyl 100 MCG/ACTUAT Mucosal Spray | SY | be7670d5-b88a-13bd-e053-2995a90a2f78 | 23 |
| 1740007 | fentanyl 1200 MCG (2 x 600 MCG/ACTUAT) Mucosal Spray | SY | be7670d5-b88a-13bd-e053-2995a90a2f78 | 23 |
| 1740009 | fentaNYL 1600 MCG (2 x 800 MCG/ACTUAT) Mucosal Spray | SY | be7670d5-b88a-13bd-e053-2995a90a2f78 | 23 |
| 1237057 | fentanyl 200 MCG/ACTUAT Mucosal Spray | SY | be7670d5-b88a-13bd-e053-2995a90a2f78 | 23 |
| 1237060 | fentanyl 400 MCG/ACTUAT Mucosal Spray | SY | be7670d5-b88a-13bd-e053-2995a90a2f78 | 23 |
| 1237064 | fentanyl 600 MCG/ACTUAT Sublingual Spray | SY | be7670d5-b88a-13bd-e053-2995a90a2f78 | 23 |
| 1237068 | fentanyl 800 MCG/ACTUAT Mucosal Spray | SY | be7670d5-b88a-13bd-e053-2995a90a2f78 | 23 |
| 1237055 | Subsys 0.1 MG/ACTUAT Mucosal Spray | SY | be7670d5-b88a-13bd-e053-2995a90a2f78 | 23 |
| 1237059 | Subsys 0.2 MG/ACTUAT Mucosal Spray | SY | be7670d5-b88a-13bd-e053-2995a90a2f78 | 23 |
| 1237062 | Subsys 0.4 MG/ACTUAT Mucosal Spray | SY | be7670d5-b88a-13bd-e053-2995a90a2f78 | 23 |
| 1237066 | Subsys 0.6 MG/ACTUAT Mucosal Spray | SY | be7670d5-b88a-13bd-e053-2995a90a2f78 | 23 |
| 1237070 | Subsys 0.8 MG/ACTUAT Mucosal Spray | SY | be7670d5-b88a-13bd-e053-2995a90a2f78 | 23 |
| 1237055 | Subsys 100 MCG/ACTUAT Sublingual Spray | SY | be7670d5-b88a-13bd-e053-2995a90a2f78 | 23 |
| 1740008 | Subsys 1200 MCG (2 x 600 MCG/ACTUAT) Mucosal Spray | SY | be7670d5-b88a-13bd-e053-2995a90a2f78 | 23 |
| 1740010 | Subsys 1600 MCG (2 x 800 MCG/ACTUAT) Mucosal Spray | SY | be7670d5-b88a-13bd-e053-2995a90a2f78 | 23 |
| 1237059 | Subsys 200 MCG/ACTUAT Sublingual Spray | SY | be7670d5-b88a-13bd-e053-2995a90a2f78 | 23 |
| 1237062 | Subsys 400 MCG/ACTUAT Sublingual Spray | SY | be7670d5-b88a-13bd-e053-2995a90a2f78 | 23 |
| 1237066 | Subsys 600 MCG/ACTUAT Sublingual Spray | SY | be7670d5-b88a-13bd-e053-2995a90a2f78 | 23 |
| 1237070 | Subsys 800 MCG/ACTUAT Sublingual Spray | SY | be7670d5-b88a-13bd-e053-2995a90a2f78 | 23 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 71500-002-30 | 71500000230 | 30 BLISTER PACK in 1 CARTON (71500-002-30) > 1 BOTTLE, SPRAY in 1 BLISTER PACK > 1 SPRAY in 1 BOTTLE, SPRAY | 30 blister pack | 2021-03-10 | 0000-00-00 | No | No | Current |