SUBSYS

Product NDC: 71500-004
Requested package NDC: 71500-004-30
11-digit product format: 715000004
Labeler code: 71500
Product ID: 71500-004_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.

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

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	71500-004	71500-004-30	I	Inactivated by FDA		2026-10-15

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 1 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
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…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 7 matching rows.

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

Current patent rows page 1 of 1 · 68 matching rows.

Application-product, Patent, Expiration table
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.

Product history page 1 of 8 · 308 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	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	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	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	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	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	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	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	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	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	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	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	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	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	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	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	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	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	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	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	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	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	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	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	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	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	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	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	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	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	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	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	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	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	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	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	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	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	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	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	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	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	`caaa826d4ba7…`
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…`

Observed Orange Book patent history#

Patent history page 1 of 75 · 2,969 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-10-15 13:18:30	2026-09	N202788-001	10016403	2027-01-25		Drug product	2018-08-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N202788-001	10610523	2027-01-25		Drug product	2020-04-22	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N202788-001	8835459	2027-01-25		Drug product	2014-09-24	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N202788-001	8835460	2027-01-25	U-55	Drug product	2014-09-24	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N202788-001	9241935	2027-01-25		Drug product	2016-02-18	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N202788-001	9289387	2027-01-25	U-55	Drug product	2017-05-15	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N202788-001	9642797	2027-01-25	U-55	Drug product	2017-05-15	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N202788-001	9642844	2027-01-25		Drug product	2017-05-15	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N202788-001	8486972	2030-04-27		Drug product	2013-07-30	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N202788-001	8486973	2030-04-27	U-55		2013-07-30	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N202788-002	10016403	2027-01-25		Drug product	2018-08-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N202788-002	10610523	2027-01-25		Drug product	2020-04-22	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N202788-002	8835460	2027-01-25	U-55	Drug product	2014-09-29	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N202788-002	9241935	2027-01-25		Drug product	2016-02-18	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N202788-002	9289387	2027-01-25	U-55	Drug product	2017-05-15	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N202788-002	9642797	2027-01-25	U-55	Drug product	2017-05-15	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N202788-002	9642844	2027-01-25		Drug product	2017-05-15	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N202788-002	8486972	2030-04-27		Drug product	2013-07-30	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N202788-002	8486973	2030-04-27	U-55		2013-07-30	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N202788-003	10016403	2027-01-25		Drug product	2018-08-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N202788-003	10610523	2027-01-25		Drug product	2020-04-22	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N202788-003	8835459	2027-01-25		Drug product	2014-09-24	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N202788-003	8835460	2027-01-25	U-55	Drug product	2014-09-24	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N202788-003	9241935	2027-01-25		Drug product	2016-02-18	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N202788-003	9289387	2027-01-25	U-55	Drug product	2017-05-15	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N202788-003	9642797	2027-01-25	U-55	Drug product	2017-05-15	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N202788-003	9642844	2027-01-25		Drug product	2017-05-15	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N202788-003	8486972	2030-04-27		Drug product	2013-07-30	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N202788-003	8486973	2030-04-27	U-55		2013-07-30	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N202788-004	10016403	2027-01-25		Drug product	2018-08-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N202788-004	10610523	2027-01-25		Drug product	2020-04-22	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N202788-004	8835459	2027-01-25		Drug product	2014-09-24	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N202788-004	8835460	2027-01-25	U-55	Drug product	2014-09-24	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N202788-004	9241935	2027-01-25		Drug product	2016-02-18	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N202788-004	9289387	2027-01-25	U-55	Drug product	2017-05-15	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N202788-004	9642797	2027-01-25	U-55	Drug product	2017-05-15	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N202788-004	9642844	2027-01-25		Drug product	2017-05-15	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N202788-004	8486972	2030-04-27		Drug product	2013-07-30	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N202788-004	8486973	2030-04-27	U-55		2013-07-30	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N202788-005	10016403	2027-01-25		Drug product	2018-08-10	`c2088c7a36db…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
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 table
NDC	Effective	Action	Document	Indexing SPL	Related label
71500-004-30	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 table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
71500-004-30	SUBSYS	30 in 1 CARTON	SPRAY	30		23
71500-004-30	SUBSYS	1 in 1 BLISTER PACK	SPRAY	1		23

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71500-004-30	EA - Each	71500-004	c829848c-606b-4564-a339-9fec667bdb52	1	2021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71500-004	SUBSYS (FENTANYL) SPRAY [WEST THERAPEUTICS DEVELOPMENT, LLC]	23	Legacy NDC, 2 package rows	20210429_be7670d5-b88a-13bd-e053-2995a90a2f78.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
UF599785JZ	FENTANYL	437-38-7	FENTANYL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
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 table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71500-004-30	71500000430	30 BLISTER PACK in 1 CARTON (71500-004-30) > 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