Fentanyl

Product NDC: 63629-4765
11-digit product format: 636294765
Labeler code: 63629
Product ID: 63629-4765_725a1c40-6fcb-4483-9aef-3dbac0d174f3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fentanyl
Dosage form: PATCH
Route: TRANSDERMAL
Labeler: Bryant Ranch Prepack
Application: NDA019813
Marketing category: NDA
Marketing start: 2004-10-01
Marketing end: 0000-00-00
Substance: FENTANYL
Active strength: 13 ug/h
Pharmacologic classes: Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule: CII
NDC exclude flag: No
Listing certified through: 2019-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	63629-4765		D	Discontinued by firm	2026-10-05
excluded package	package	63629-4765	63629-4765-1	D	Discontinued by firm	2026-10-05
excluded package	package	63629-4765	63629-4765-2	D	Discontinued by firm	2026-10-05
excluded package	package	63629-4765	63629-4765-3	D	Discontinued by firm	2026-10-05

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 · 56 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-4765-3	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-4765-1	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-4765-2	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-4765-3	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-4765-1	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-4765-2	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-4765-3	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-4765-1	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-4765-2	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-4765-3	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-4765-1	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-4765-2	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-4765-3	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-4765-1	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-4765-2	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63629-4765-3	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63629-4765-1	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63629-4765-2	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63629-4765-3	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63629-4765-1	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63629-4765-2	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63629-4765-3	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63629-4765-1	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63629-4765-2	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63629-4765-3	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63629-4765-1	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63629-4765-2	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63629-4765-3	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63629-4765-1	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63629-4765-2	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	63629-4765-3	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	63629-4765-1	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	63629-4765-2	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	63629-4765-3	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	63629-4765-1	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	63629-4765-2	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	63629-4765-1	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	63629-4765-2	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	63629-4765-3	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	63629-4765-1	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	63629-4765-2	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	63629-4765-3	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`

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

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N019813-001	DURAGESIC-100	FENTANYL	100MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1990-08-07
N019813-002	DURAGESIC-75	FENTANYL	75MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1990-08-07
N019813-003	DURAGESIC-50	FENTANYL	50MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1990-08-07
N019813-004	DURAGESIC-25	FENTANYL	25MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1990-08-07
N019813-005	DURAGESIC-12	FENTANYL	12.5MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	2005-02-04
N019813-006	DURAGESIC-37	FENTANYL	37.5MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	2018-01-24

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 7 · 258 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	N019813-001	DURAGESIC-100	100MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1990-08-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019813-002	DURAGESIC-75	75MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1990-08-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019813-003	DURAGESIC-50	50MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1990-08-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019813-004	DURAGESIC-25	25MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1990-08-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019813-005	DURAGESIC-12	12.5MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	2005-02-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019813-006	DURAGESIC-37	37.5MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	2018-01-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N019813-001	DURAGESIC-100	100MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1990-08-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019813-002	DURAGESIC-75	75MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1990-08-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019813-003	DURAGESIC-50	50MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1990-08-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019813-004	DURAGESIC-25	25MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1990-08-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019813-005	DURAGESIC-12	12.5MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	2005-02-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019813-006	DURAGESIC-37	37.5MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	2018-01-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019813-001	DURAGESIC-100	100MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1990-08-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019813-002	DURAGESIC-75	75MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1990-08-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019813-003	DURAGESIC-50	50MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1990-08-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019813-004	DURAGESIC-25	25MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1990-08-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019813-005	DURAGESIC-12	12.5MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	2005-02-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019813-006	DURAGESIC-37	37.5MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	2018-01-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019813-001	DURAGESIC-100	100MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1990-08-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019813-002	DURAGESIC-75	75MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1990-08-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019813-003	DURAGESIC-50	50MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1990-08-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019813-004	DURAGESIC-25	25MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1990-08-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019813-005	DURAGESIC-12	12.5MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	2005-02-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019813-006	DURAGESIC-37	37.5MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	2018-01-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019813-001	DURAGESIC-100	100MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1990-08-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019813-002	DURAGESIC-75	75MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1990-08-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019813-003	DURAGESIC-50	50MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1990-08-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019813-004	DURAGESIC-25	25MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1990-08-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019813-005	DURAGESIC-12	12.5MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	2005-02-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019813-006	DURAGESIC-37	37.5MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	2018-01-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019813-001	DURAGESIC-100	100MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1990-08-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019813-002	DURAGESIC-75	75MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1990-08-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019813-003	DURAGESIC-50	50MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1990-08-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019813-004	DURAGESIC-25	25MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1990-08-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019813-005	DURAGESIC-12	12.5MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	2005-02-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019813-006	DURAGESIC-37	37.5MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	2018-01-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019813-001	DURAGESIC-100	100MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1990-08-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019813-002	DURAGESIC-75	75MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1990-08-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019813-003	DURAGESIC-50	50MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1990-08-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019813-004	DURAGESIC-25	25MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1990-08-07	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 48 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N019813-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019813-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019813-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019813-004	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019813-005	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019813-006	AB	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019813-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019813-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019813-003	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019813-004	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019813-005	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019813-006	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019813-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N019813-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N019813-003	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N019813-004	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N019813-005	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N019813-006	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019813-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N019813-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N019813-003	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N019813-004	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N019813-005	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N019813-006	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019813-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N019813-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N019813-003	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N019813-004	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N019813-005	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N019813-006	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019813-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N019813-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N019813-003	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N019813-004	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N019813-005	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N019813-006	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019813-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N019813-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N019813-003	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N019813-004	AB	1	`b00525d2431f…`

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
63629-4765-1	2021-04-23	These highlights do not include all the information needed to use Fentanyl Transdermal System safely and effectively. See full prescribing information for Fentanyl Transdermal System. Fentanyl Transdermal System for transdermal administration, CII Initial U.S. Approval: 1968
63629-4765-2	2021-04-23	These highlights do not include all the information needed to use Fentanyl Transdermal System safely and effectively. See full prescribing information for Fentanyl Transdermal System. Fentanyl Transdermal System for transdermal administration, CII Initial U.S. Approval: 1968
63629-4765-3	2021-04-23	These highlights do not include all the information needed to use Fentanyl Transdermal System safely and effectively. See full prescribing information for Fentanyl Transdermal System. Fentanyl Transdermal System for transdermal administration, CII Initial U.S. Approval: 1968
63629-4765-1	2020-01-31	These highlights do not include all the information needed to use Fentanyl Transdermal System safely and effectively. See full prescribing information for Fentanyl Transdermal System. Fentanyl Transdermal System for transdermal administration, CII Initial U.S. Approval: 1968
63629-4765-2	2020-01-31	These highlights do not include all the information needed to use Fentanyl Transdermal System safely and effectively. See full prescribing information for Fentanyl Transdermal System. Fentanyl Transdermal System for transdermal administration, CII Initial U.S. Approval: 1968
63629-4765-3	2020-01-31	These highlights do not include all the information needed to use Fentanyl Transdermal System safely and effectively. See full prescribing information for Fentanyl Transdermal System. Fentanyl Transdermal System for transdermal administration, CII Initial U.S. Approval: 1968

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63629-4765-3	EA - Each	63629-4765	793cedec-2816-4e73-90ec-641c4f708da6	1	2017-11-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
FENTANYL	ACTIVE INGREDIENT	UF599785JZ	FENTANYL PATCH [BRYANT RANCH PREPACK]	1000
FENTANYL	ACTIVE MOIETY	UF599785JZ	FENTANYL PATCH [BRYANT RANCH PREPACK]	1000
COPOVIDONE K25-31	INACTIVE INGREDIENT	D9C330MD8B	FENTANYL PATCH [BRYANT RANCH PREPACK]	1000

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Fentanyl - Bryant Ranch Prepack	Bryant Ranch Prepack	2017-05-22	HUMAN PRESCRIPTION DRUG LABEL	1002