LAZANDA
- Product NDC
- 71500-110
- 11-digit product format
- 715000110
- Labeler code
- 71500
- Product ID
- 71500-110_be24d79a-2287-2b3a-e053-2a95a90a8243
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- fentanyl
- Dosage form
- SPRAY
- Route
- NASAL
- Labeler
- West Therapeutic Development LLC
- Application
- NDA022569
- Marketing category
- NDA
- Marketing start
- 2018-08-25
- Marketing end
- 0000-00-00
- Substance
- FENTANYL CITRATE
- Active strength
- 100 ug/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 product | product | 71500-110 | I | Inactivated by FDA | 2026-08-11 | ||
| excluded package | package | 71500-110 | 71500-110-01 | 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 | 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 | 71500-110-01 | 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 | 71500-110-01 | 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 | 71500-110-01 | 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 | 71500-110-01 | 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 | 71500-110-01 | 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 | 71500-110-01 | 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 | 71500-110-01 | 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 | 71500-110-01 | 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 | 71500-110-01 | 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 | 71500-110-01 | 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 | 71500-110-01 | 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 | 71500-110-01 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded product | product | 8af77b9d5b6f… | d9bbb34c5368… | |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 71500-110-01 | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded product | product | 834df4deac94… | adcc014656a3… | |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 71500-110-01 | 834df4deac94… | adcc014656a3… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded product | product | 1332a3947898… | d4bfe170f9cd… | |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 71500-110-01 | 1332a3947898… | d4bfe170f9cd… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N022569-001 | LAZANDA | FENTANYL CITRATE | EQ 0.1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY, METERED / NASAL | RLD | 2011-06-30 | |
| N022569-002 | LAZANDA | FENTANYL CITRATE | EQ 0.4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY, METERED / NASAL | RLD | 2011-06-30 | |
| N022569-003 | LAZANDA | FENTANYL CITRATE | EQ 0.3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY, METERED / NASAL | RLD | 2015-12-21 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N022569-001 | 9731869 | 2032-01-26 | Drug product | 2017-09-01 | |
| N022569-002 | 9731869 | 2032-01-26 | Drug product | 2017-09-01 | |
| N022569-003 | 9731869 | 2032-01-26 | Drug product | 2017-09-01 |
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 | N022569-001 | LAZANDA | EQ 0.1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY, METERED / NASAL | RLD | 2011-06-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022569-002 | LAZANDA | EQ 0.4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY, METERED / NASAL | RLD | 2011-06-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022569-003 | LAZANDA | EQ 0.3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY, METERED / NASAL | RLD | 2015-12-21 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022569-001 | LAZANDA | EQ 0.1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY, METERED / NASAL | RLD | 2011-06-30 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022569-002 | LAZANDA | EQ 0.4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY, METERED / NASAL | RLD | 2011-06-30 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022569-003 | LAZANDA | EQ 0.3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY, METERED / NASAL | RLD | 2015-12-21 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022569-001 | LAZANDA | EQ 0.1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY, METERED / NASAL | RLD | 2011-06-30 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022569-002 | LAZANDA | EQ 0.4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY, METERED / NASAL | RLD | 2011-06-30 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022569-003 | LAZANDA | EQ 0.3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY, METERED / NASAL | RLD | 2015-12-21 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022569-001 | LAZANDA | EQ 0.1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY, METERED / NASAL | RLD | 2011-06-30 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022569-002 | LAZANDA | EQ 0.4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY, METERED / NASAL | RLD | 2011-06-30 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022569-003 | LAZANDA | EQ 0.3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY, METERED / NASAL | RLD | 2015-12-21 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022569-001 | LAZANDA | EQ 0.1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY, METERED / NASAL | RLD | 2011-06-30 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022569-002 | LAZANDA | EQ 0.4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY, METERED / NASAL | RLD | 2011-06-30 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022569-003 | LAZANDA | EQ 0.3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY, METERED / NASAL | RLD | 2015-12-21 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022569-001 | LAZANDA | EQ 0.1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY, METERED / NASAL | RLD | 2011-06-30 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022569-002 | LAZANDA | EQ 0.4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY, METERED / NASAL | RLD | 2011-06-30 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022569-003 | LAZANDA | EQ 0.3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY, METERED / NASAL | RLD | 2015-12-21 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022569-001 | LAZANDA | EQ 0.1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY, METERED / NASAL | RLD | 2011-06-30 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022569-002 | LAZANDA | EQ 0.4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY, METERED / NASAL | RLD | 2011-06-30 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022569-003 | LAZANDA | EQ 0.3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY, METERED / NASAL | RLD | 2015-12-21 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022569-001 | LAZANDA | EQ 0.1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY, METERED / NASAL | RLD | 2011-06-30 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022569-002 | LAZANDA | EQ 0.4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY, METERED / NASAL | RLD | 2011-06-30 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022569-003 | LAZANDA | EQ 0.3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY, METERED / NASAL | RLD | 2015-12-21 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022569-001 | LAZANDA | EQ 0.1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY, METERED / NASAL | RLD | 2011-06-30 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022569-002 | LAZANDA | EQ 0.4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY, METERED / NASAL | RLD | 2011-06-30 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022569-003 | LAZANDA | EQ 0.3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY, METERED / NASAL | RLD | 2015-12-21 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N022569-001 | LAZANDA | EQ 0.1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY, METERED / NASAL | RLD | 2011-06-30 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N022569-002 | LAZANDA | EQ 0.4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY, METERED / NASAL | RLD | 2011-06-30 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N022569-003 | LAZANDA | EQ 0.3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY, METERED / NASAL | RLD | 2015-12-21 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N022569-001 | LAZANDA | EQ 0.1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY, METERED / NASAL | RLD | 2011-06-30 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N022569-002 | LAZANDA | EQ 0.4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY, METERED / NASAL | RLD | 2011-06-30 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N022569-003 | LAZANDA | EQ 0.3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY, METERED / NASAL | RLD | 2015-12-21 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N022569-001 | LAZANDA | EQ 0.1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY, METERED / NASAL | RLD | 2011-06-30 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N022569-002 | LAZANDA | EQ 0.4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY, METERED / NASAL | RLD | 2011-06-30 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N022569-003 | LAZANDA | EQ 0.3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY, METERED / NASAL | RLD | 2015-12-21 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N022569-001 | LAZANDA | EQ 0.1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY, METERED / NASAL | RLD | 2011-06-30 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N022569-002 | LAZANDA | EQ 0.4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY, METERED / NASAL | RLD | 2011-06-30 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N022569-003 | LAZANDA | EQ 0.3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY, METERED / NASAL | RLD | 2015-12-21 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N022569-001 | LAZANDA | EQ 0.1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY, METERED / NASAL | RLD | 2011-06-30 | 8072bd15b7f6… |
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 | N022569-001 | 9731869 | 2032-01-26 | Drug product | 2017-09-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022569-002 | 9731869 | 2032-01-26 | Drug product | 2017-09-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022569-003 | 9731869 | 2032-01-26 | Drug product | 2017-09-01 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022569-001 | 9731869 | 2032-01-26 | Drug product | 2017-09-01 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022569-002 | 9731869 | 2032-01-26 | Drug product | 2017-09-01 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022569-003 | 9731869 | 2032-01-26 | Drug product | 2017-09-01 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022569-001 | 9731869 | 2032-01-26 | Drug product | 2017-09-01 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022569-002 | 9731869 | 2032-01-26 | Drug product | 2017-09-01 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022569-003 | 9731869 | 2032-01-26 | Drug product | 2017-09-01 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022569-001 | 9731869 | 2032-01-26 | Drug product | 2017-09-01 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022569-002 | 9731869 | 2032-01-26 | Drug product | 2017-09-01 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022569-003 | 9731869 | 2032-01-26 | Drug product | 2017-09-01 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022569-001 | 9731869 | 2032-01-26 | Drug product | 2017-09-01 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022569-002 | 9731869 | 2032-01-26 | Drug product | 2017-09-01 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022569-003 | 9731869 | 2032-01-26 | Drug product | 2017-09-01 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022569-001 | 9078814 | 2024-01-08 | Drug product | 2015-08-11 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022569-001 | 9814705 | 2024-01-08 | Drug product | 2017-12-13 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022569-001 | 8889176 | 2024-01-16 | U-767 | 2014-12-12 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022569-001 | 8216604 | 2024-10-03 | U-767 | 2012-07-19 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022569-001 | 9731869 | 2032-01-26 | Drug product | 2017-09-01 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022569-002 | 9078814 | 2024-01-08 | Drug product | 2015-08-11 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022569-002 | 9814705 | 2024-01-08 | Drug product | 2017-12-13 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022569-002 | 8889176 | 2024-01-16 | U-767 | 2014-12-12 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022569-002 | 8216604 | 2024-10-03 | U-767 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022569-002 | 9731869 | 2032-01-26 | Drug product | 2017-09-01 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022569-003 | 9814705 | 2024-01-08 | Drug product | 2017-12-13 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022569-003 | 9731869 | 2032-01-26 | Drug product | 2017-09-01 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022569-001 | 9078814 | 2024-01-08 | Drug product | 2015-08-11 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022569-001 | 9814705 | 2024-01-08 | Drug product | 2017-12-13 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022569-001 | 8889176 | 2024-01-16 | U-767 | 2014-12-12 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022569-001 | 8216604 | 2024-10-03 | U-767 | 2012-07-19 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022569-001 | 9731869 | 2032-01-26 | Drug product | 2017-09-01 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022569-002 | 9078814 | 2024-01-08 | Drug product | 2015-08-11 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022569-002 | 9814705 | 2024-01-08 | Drug product | 2017-12-13 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022569-002 | 8889176 | 2024-01-16 | U-767 | 2014-12-12 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022569-002 | 8216604 | 2024-10-03 | U-767 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022569-002 | 9731869 | 2032-01-26 | Drug product | 2017-09-01 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022569-003 | 9814705 | 2024-01-08 | Drug product | 2017-12-13 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022569-003 | 9731869 | 2032-01-26 | Drug product | 2017-09-01 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022569-001 | 9078814 | 2024-01-08 | Drug product | 2015-08-11 | 5bbf6a4d5a75… |
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 |
|---|---|---|---|---|---|
| 71500-110-01 | 2023-01-30 | C162847 | 48780-1 | f386c649-fcb9-0266-e053-dadaa90a7c1a | Lazanda (fentanyl citrate) Nasal Spray, 100 mcg, 300 mcg, 400 mcg |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 71500-110-01 | LAZANDA | 8 in 1 BOTTLE, SPRAY | SPRAY | 8 | 4 | |
| 71500-110-01 | LAZANDA | 1 in 1 CARTON | SPRAY | 1 | 4 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 71500-110-01 | EA - Each | 71500-110 | ca10f6ca-d43c-4605-8362-a3a6a2bb5e08 | 1 | 2020-01-03 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1115573 | fentaNYL 100 MCG/ACTUAT Metered Dose Nasal Spray | PSN | 73f38bde-2132-2b5a-e053-2a91aa0a6efb | 4 |
| 1729320 | fentaNYL 300 MCG/ACTUAT Metered Dose Nasal Spray | PSN | 73f38bde-2132-2b5a-e053-2a91aa0a6efb | 4 |
| 1115577 | fentaNYL 400 MCG/ACTUAT Metered Dose Nasal Spray | PSN | 73f38bde-2132-2b5a-e053-2a91aa0a6efb | 4 |
| 1115575 | Lazanda 100 MCG/ACTUAT Metered Dose Nasal Spray | PSN | 73f38bde-2132-2b5a-e053-2a91aa0a6efb | 4 |
| 1729322 | Lazanda 300 MCG/ACTUAT Metered Dose Nasal Spray | PSN | 73f38bde-2132-2b5a-e053-2a91aa0a6efb | 4 |
| 1115579 | Lazanda 400 MCG/ACTUAT Metered Dose Nasal Spray | PSN | 73f38bde-2132-2b5a-e053-2a91aa0a6efb | 4 |
| 1115575 | fentanyl 0.1 MG/ACTUAT Metered Dose Nasal Spray [Lazanda] | SBD | 73f38bde-2132-2b5a-e053-2a91aa0a6efb | 4 |
| 1729322 | fentanyl 0.3 MG/ACTUAT Metered Dose Nasal Spray [Lazanda] | SBD | 73f38bde-2132-2b5a-e053-2a91aa0a6efb | 4 |
| 1115579 | fentanyl 0.4 MG/ACTUAT Metered Dose Nasal Spray [Lazanda] | SBD | 73f38bde-2132-2b5a-e053-2a91aa0a6efb | 4 |
| 1115573 | fentanyl 0.1 MG/ACTUAT Metered Dose Nasal Spray | SCD | 73f38bde-2132-2b5a-e053-2a91aa0a6efb | 4 |
| 1729320 | fentanyl 0.3 MG/ACTUAT Metered Dose Nasal Spray | SCD | 73f38bde-2132-2b5a-e053-2a91aa0a6efb | 4 |
| 1115577 | fentanyl 0.4 MG/ACTUAT Metered Dose Nasal Spray | SCD | 73f38bde-2132-2b5a-e053-2a91aa0a6efb | 4 |
| 1115573 | fentanyl (as fentanyl citrate) 100 MCG/ACTUAT Metered Dose Nasal Spray | SY | 73f38bde-2132-2b5a-e053-2a91aa0a6efb | 4 |
| 1115577 | fentanyl (as fentanyl citrate) 400 MCG/ACTUAT Metered Dose Nasal Spray | SY | 73f38bde-2132-2b5a-e053-2a91aa0a6efb | 4 |
| 1729320 | fentanyl 300 MCG/ACTUAT Metered Dose Nasal Spray | SY | 73f38bde-2132-2b5a-e053-2a91aa0a6efb | 4 |
| 1115575 | Lazanda 0.1 MG/ACTUAT Metered Dose Nasal Spray | SY | 73f38bde-2132-2b5a-e053-2a91aa0a6efb | 4 |
| 1729322 | Lazanda 0.3 MG/ACTUAT Metered Dose Nasal Spray | SY | 73f38bde-2132-2b5a-e053-2a91aa0a6efb | 4 |
| 1115579 | Lazanda 0.4 MG/ACTUAT Metered Dose Nasal Spray | SY | 73f38bde-2132-2b5a-e053-2a91aa0a6efb | 4 |
| 1115575 | Lazanda 100 MCG/ACTUAT Metered Dose Nasal Spray | SY | 73f38bde-2132-2b5a-e053-2a91aa0a6efb | 4 |
| 1729322 | Lazanda 300 MCG/ACTUAT Metered Dose Nasal Spray | SY | 73f38bde-2132-2b5a-e053-2a91aa0a6efb | 4 |
| 1115579 | Lazanda 400 MCG/ACTUAT Metered Dose Nasal Spray | SY | 73f38bde-2132-2b5a-e053-2a91aa0a6efb | 4 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 71500-110-01 | 71500011001 | 1 BOTTLE, SPRAY in 1 CARTON (71500-110-01) > 8 SPRAY in 1 BOTTLE, SPRAY | 2018-08-25 | 0000-00-00 | No | No | Current |