LAZANDA

Product NDC: 51772-311
11-digit product format: 517720311
Labeler code: 51772
Product ID: 51772-311_ec21fe5a-b1f8-405e-9d75-6c01a24c9e51
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fentanyl Citrate
Dosage form: SPRAY
Route: NASAL
Labeler: Archimedes Pharma US Inc.
Application: NDA022569
Marketing category: NDA
Marketing start: 2011-10-17
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: 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.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	51772-311		I	Inactivated by FDA	2026-08-11
excluded package	package	51772-311	51772-311-01	I	Inactivated by FDA	2026-08-11
excluded package	package	51772-311	51772-311-04	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.

Historic NDC status page 1 of 2 · 66 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
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	51772-311-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	51772-311-04	`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	51772-311-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	51772-311-04	`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	51772-311-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	51772-311-04	`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	51772-311-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	51772-311-04	`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	51772-311-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	51772-311-04	`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	51772-311-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	51772-311-04	`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	51772-311-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	51772-311-04	`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	51772-311-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	51772-311-04	`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	51772-311-01	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	51772-311-04	`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	51772-311-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	51772-311-04	`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	51772-311-01	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	51772-311-04	`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	51772-311-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	51772-311-04	`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	51772-311-01	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	51772-311-04	`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	51772-311-01	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	51772-311-04	`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	51772-311-01	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	51772-311-04	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	51772-311-01	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	51772-311-04	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	51772-311-01	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	51772-311-04	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	51772-311-01	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	51772-311-04	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	51772-311-01	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	51772-311-04	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	51772-311-01	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	51772-311-04	`e2bbac7714bc…`	`27bdfed8d636…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	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#

Current patent rows page 1 of 1 · 3 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	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.

Product history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	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#

Patent history page 1 of 11 · 438 observed states.

Captured, Edition, Application-product table
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 table
Product concept	Relation	Version	Effective
77d14d2b-b9bf-4254-8dd6-c60dedb281d3	Product name	1	20231002
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
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
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508
d9ff6610-5d2e-d5c8-8a19-867d4a1efb77	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
51772-311-01	2020-01-31	C162847	48780-1	9d75b9cf-d793-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use LAZANDA safely and effectively. See full prescribing information for LAZANDA Lazanda ® (Fentanyl) Nasal Spray CII Initial U.S. Approval: 1968
51772-311-04	2020-01-31	C162847	48780-1	9d75b9cf-d793-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use LAZANDA safely and effectively. See full prescribing information for LAZANDA Lazanda ® (Fentanyl) Nasal Spray CII Initial U.S. Approval: 1968

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
51772-311-01	LAZANDA	1 in 1 CARTON	SPRAY	1	5
51772-311-01	LAZANDA	8 in 1 BOTTLE, SPRAY	SPRAY	8	5
51772-311-04	LAZANDA	8 in 1 BOTTLE, SPRAY	SPRAY	8	5
51772-311-04	LAZANDA	4 in 1 CARTON	SPRAY	4	5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51772-311-01	EA - Each	51772-311	4a60ae6a-f585-457d-8743-7be6ebd925b3	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Fentanyl Citrate	ACTIVE INGREDIENT	MUN5LYG46H	LAZANDA (FENTANYL CITRATE) SPRAY [ARCHIMEDES PHARMA US INC.]	5
Fentanyl	ACTIVE MOIETY	UF599785JZ	LAZANDA (FENTANYL CITRATE) SPRAY [ARCHIMEDES PHARMA US INC.]	5
Mannitol	INACTIVE INGREDIENT	3OWL53L36A	LAZANDA (FENTANYL CITRATE) SPRAY [ARCHIMEDES PHARMA US INC.]	5
Pectin	INACTIVE INGREDIENT	89NA02M4RX	LAZANDA (FENTANYL CITRATE) SPRAY [ARCHIMEDES PHARMA US INC.]	5
Phenylethyl alcohol	INACTIVE INGREDIENT	ML9LGA7468	LAZANDA (FENTANYL CITRATE) SPRAY [ARCHIMEDES PHARMA US INC.]	5
Propylparaben	INACTIVE INGREDIENT	Z8IX2SC1OH	LAZANDA (FENTANYL CITRATE) SPRAY [ARCHIMEDES PHARMA US INC.]	5
Sucrose	INACTIVE INGREDIENT	C151H8M554	LAZANDA (FENTANYL CITRATE) SPRAY [ARCHIMEDES PHARMA US INC.]	5
Water	INACTIVE INGREDIENT	059QF0KO0R	LAZANDA (FENTANYL CITRATE) SPRAY [ARCHIMEDES PHARMA US INC.]	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51772-311	LAZANDA (FENTANYL CITRATE) SPRAY [ARCHIMEDES PHARMA US INC.]	5	Legacy NDC, 4 package rows	20120801_39531d0c-db12-4627-81c9-6563076b637b.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
MUN5LYG46H	FENTANYL CITRATE	990-73-8	FENTANYL CITRATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1115573	fentaNYL 100 MCG/ACTUAT Metered Dose Nasal Spray	PSN	39531d0c-db12-4627-81c9-6563076b637b	5
1115577	fentaNYL 400 MCG/ACTUAT Metered Dose Nasal Spray	PSN	39531d0c-db12-4627-81c9-6563076b637b	5
1115575	Lazanda 100 MCG/ACTUAT Metered Dose Nasal Spray	PSN	39531d0c-db12-4627-81c9-6563076b637b	5
1115579	Lazanda 400 MCG/ACTUAT Metered Dose Nasal Spray	PSN	39531d0c-db12-4627-81c9-6563076b637b	5
1115575	fentanyl 0.1 MG/ACTUAT Metered Dose Nasal Spray [Lazanda]	SBD	39531d0c-db12-4627-81c9-6563076b637b	5
1115579	fentanyl 0.4 MG/ACTUAT Metered Dose Nasal Spray [Lazanda]	SBD	39531d0c-db12-4627-81c9-6563076b637b	5
1115573	fentanyl 0.1 MG/ACTUAT Metered Dose Nasal Spray	SCD	39531d0c-db12-4627-81c9-6563076b637b	5
1115577	fentanyl 0.4 MG/ACTUAT Metered Dose Nasal Spray	SCD	39531d0c-db12-4627-81c9-6563076b637b	5
1115573	fentanyl (as fentanyl citrate) 100 MCG/ACTUAT Metered Dose Nasal Spray	SY	39531d0c-db12-4627-81c9-6563076b637b	5
1115577	fentanyl (as fentanyl citrate) 400 MCG/ACTUAT Metered Dose Nasal Spray	SY	39531d0c-db12-4627-81c9-6563076b637b	5
1115575	Lazanda 0.1 MG/ACTUAT Metered Dose Nasal Spray	SY	39531d0c-db12-4627-81c9-6563076b637b	5
1115579	Lazanda 0.4 MG/ACTUAT Metered Dose Nasal Spray	SY	39531d0c-db12-4627-81c9-6563076b637b	5
1115575	Lazanda 100 MCG/ACTUAT Metered Dose Nasal Spray	SY	39531d0c-db12-4627-81c9-6563076b637b	5
1115579	Lazanda 400 MCG/ACTUAT Metered Dose Nasal Spray	SY	39531d0c-db12-4627-81c9-6563076b637b	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
51772-311-01	51772031101	1 in 1 CARTON	Historical
51772-311-04	51772031104	8 in 1 BOTTLE, SPRAY	Historical