DURAGESIC

Product NDC: 50458-092
11-digit product format: 504580092
Labeler code: 50458
Product ID: 50458-092_4510e337-3d1f-4eab-907e-85e95dc7d5a0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: fentanyl
Dosage form: PATCH
Route: TRANSDERMAL
Labeler: Janssen Pharmaceuticals, Inc.
Application: NDA019813
Marketing category: NDA
Marketing start: 1990-08-07
Marketing end: 2020-03-31
Substance: FENTANYL
Active strength: 50 ug/h
Pharmacologic classes: Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule: CII
NDC exclude flag: No
Listing certified through: 0000-00-00
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	50458-092		D	Discontinued by firm		2026-10-05
excluded package	package	50458-092	50458-092-05	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 · 24 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	50458-092-05	`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	50458-092-05	`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	50458-092-05	`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	50458-092-05	`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	50458-092-05	`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	50458-092-05	`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	50458-092-05	`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	50458-092-05	`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	50458-092-05	`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	50458-092-05	`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	50458-092-05	`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	50458-092-05	`557ba5c1ecfa…`	`9c80585c8c6e…`

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.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50458-092-05	EA - Each	50458-092	5efd9e7c-195a-4f1b-8938-16629e8dc9c2	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
fentanyl	ACTIVE INGREDIENT	UF599785JZ	DURAGESIC (FENTANYL) PATCH [JANSSEN PHARMACEUTICALS, INC.]	8
fentanyl	ACTIVE MOIETY	UF599785JZ	DURAGESIC (FENTANYL) PATCH [JANSSEN PHARMACEUTICALS, INC.]	8
Copovidone K25-31	INACTIVE INGREDIENT	D9C330MD8B	DURAGESIC (FENTANYL) PATCH [JANSSEN PHARMACEUTICALS, INC.]	8

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
DURAGESIC	Janssen Pharmaceuticals, Inc. \| Alza Corporation \| Johnson Matthey Inc.	2019-10-15	HUMAN PRESCRIPTION DRUG LABEL	16