National Council for Prescription Drug Programs indexing - billing unit

Manufacturer: National Council for Prescription Drug Programs
Effective date: 2012-07-24
Label type: Indexing - Billing Unit
Version: 1
Source: full-release
Hydrated at: 2026-06-05 02:43:24

Label at a glance#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51772-314-01	EA - Each	51772-314	cef58cba-54dd-4ef6-ba59-6f33ffb98d94	1	2012-07-24

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
51772-314	51772-314-01

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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N022569-001	LAZANDA	FENTANYL CITRATE	EQ 0.1MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL	RLD	2011-06-30
N022569-002	LAZANDA	FENTANYL CITRATE	EQ 0.4MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL	RLD	2011-06-30
N022569-003	LAZANDA	FENTANYL CITRATE	EQ 0.3MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL	RLD	2015-12-21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 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	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	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	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	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	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	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	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	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	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	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	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	`caaa826d4ba7…`
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…`

Observed Orange Book patent history#

Patent history page 1 of 12 · 444 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N022569-001	9731869	2032-01-26		Drug product	2017-09-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022569-002	9731869	2032-01-26		Drug product	2017-09-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022569-003	9731869	2032-01-26		Drug product	2017-09-01	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022569-001	9731869	2032-01-26		Drug product	2017-09-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022569-002	9731869	2032-01-26		Drug product	2017-09-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022569-003	9731869	2032-01-26		Drug product	2017-09-01	`caaa826d4ba7…`
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…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.