Fentanyl

Product NDC: 68258-3023
11-digit product format: 682583023
Labeler code: 68258
Product ID: 68258-3023_0cd9cc40-f972-4d65-8d4a-cff05c03ad07
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fentanyl
Dosage form: PATCH, EXTENDED RELEASE
Route: TRANSDERMAL
Labeler: Dispensing Solutions Inc.
Application: ANDA077449
Marketing category: ANDA
Marketing start: 2006-11-06
Marketing end: 0000-00-00
Substance: FENTANYL
Active strength: 25 ug/h
Pharmacologic classes: Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule: CII
NDC exclude flag: E
Listing certified through: 2017-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	68258-3023		I	Inactivated by FDA		2026-10-05
excluded package	package	68258-3023	68258-3023-1	I	Inactivated by FDA		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 · 44 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	68258-3023-1	`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	68258-3023-1	`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	68258-3023-1	`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	68258-3023-1	`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	68258-3023-1	`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	68258-3023-1	`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	68258-3023-1	`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	68258-3023-1	`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	68258-3023-1	`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	68258-3023-1	`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	68258-3023-1	`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	68258-3023-1	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	68258-3023-1	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	68258-3023-1	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	68258-3023-1	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	68258-3023-1	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	68258-3023-1	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	68258-3023-1	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	68258-3023-1	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	68258-3023-1	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	68258-3023-1	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	68258-3023-1	`110d247fa046…`	`a55b01930146…`

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

Orange Book products#

Current product rows page 1 of 1 · 8 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A077449-001	FENTANYL-25	FENTANYL	25MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2008-10-20
A077449-002	FENTANYL-50	FENTANYL	50MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2008-10-20
A077449-003	FENTANYL-75	FENTANYL	75MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2008-10-20
A077449-004	FENTANYL-100	FENTANYL	100MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2008-10-20
A077449-005	FENTANYL-12	FENTANYL	12.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2015-09-11
A077449-006	FENTANYL-37	FENTANYL	37.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2017-12-06
A077449-007	FENTANYL-62	FENTANYL	62.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2017-12-06
A077449-008	FENTANYL-87	FENTANYL	87.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2017-12-06

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 8 matching rows.

Application-product, TE code table
Application-product	TE code
A077449-001	AB
A077449-002	AB
A077449-003	AB
A077449-004	AB
A077449-005	AB
A077449-006	AB
A077449-007	AB
A077449-008	AB

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 9 · 344 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A077449-001	FENTANYL-25	25MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2008-10-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077449-002	FENTANYL-50	50MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2008-10-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077449-003	FENTANYL-75	75MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2008-10-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077449-004	FENTANYL-100	100MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2008-10-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077449-005	FENTANYL-12	12.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2015-09-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077449-006	FENTANYL-37	37.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2017-12-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077449-007	FENTANYL-62	62.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2017-12-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077449-008	FENTANYL-87	87.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2017-12-06	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077449-001	FENTANYL-25	25MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2008-10-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077449-002	FENTANYL-50	50MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2008-10-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077449-003	FENTANYL-75	75MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2008-10-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077449-004	FENTANYL-100	100MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2008-10-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077449-005	FENTANYL-12	12.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2015-09-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077449-006	FENTANYL-37	37.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2017-12-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077449-007	FENTANYL-62	62.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2017-12-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077449-008	FENTANYL-87	87.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2017-12-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077449-001	FENTANYL-25	25MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2008-10-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077449-002	FENTANYL-50	50MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2008-10-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077449-003	FENTANYL-75	75MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2008-10-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077449-004	FENTANYL-100	100MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2008-10-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077449-005	FENTANYL-12	12.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2015-09-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077449-006	FENTANYL-37	37.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2017-12-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077449-007	FENTANYL-62	62.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2017-12-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077449-008	FENTANYL-87	87.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2017-12-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077449-001	FENTANYL-25	25MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2008-10-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077449-002	FENTANYL-50	50MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2008-10-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077449-003	FENTANYL-75	75MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2008-10-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077449-004	FENTANYL-100	100MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2008-10-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077449-005	FENTANYL-12	12.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2015-09-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077449-006	FENTANYL-37	37.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2017-12-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077449-007	FENTANYL-62	62.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2017-12-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077449-008	FENTANYL-87	87.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2017-12-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077449-001	FENTANYL-25	25MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2008-10-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077449-002	FENTANYL-50	50MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2008-10-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077449-003	FENTANYL-75	75MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2008-10-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077449-004	FENTANYL-100	100MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2008-10-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077449-005	FENTANYL-12	12.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2015-09-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077449-006	FENTANYL-37	37.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2017-12-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077449-007	FENTANYL-62	62.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2017-12-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077449-008	FENTANYL-87	87.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2017-12-06	`6a471c1ec25d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 8 · 304 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A077449-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077449-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077449-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077449-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077449-005	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077449-006	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077449-007	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077449-008	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077449-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077449-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077449-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077449-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077449-005	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077449-006	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077449-007	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077449-008	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077449-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077449-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077449-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077449-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077449-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077449-006	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077449-007	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077449-008	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077449-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077449-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077449-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077449-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077449-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077449-006	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077449-007	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077449-008	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077449-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077449-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077449-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077449-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077449-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077449-006	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077449-007	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077449-008	AB	1	`6a471c1ec25d…`

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
68258-3023-1	2019-10-21	C162847	48780-1	956f9ecf-c56d-621f-e053-dbdaa90a74ad	FENTANYL TRANSDERMAL SYSTEM CII Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68258-3023-1	Fentanyl	5 in 1 CARTON	PATCH, EXTENDED RELEASE	5		1
68258-3023-1	Fentanyl	72 h in 1 PATCH	PATCH, EXTENDED RELEASE	72		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68258-3023-1	EA - Each	68258-3023	11c1f4d3-415f-4c02-8d8b-33302a60b598	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
FENTANYL	ACTIVE INGREDIENT	UF599785JZ	FENTANYL PATCH, EXTENDED RELEASE [DISPENSING SOLUTIONS INC.]	1
FENTANYL	ACTIVE MOIETY	UF599785JZ	FENTANYL PATCH, EXTENDED RELEASE [DISPENSING SOLUTIONS INC.]	1
ISOPROPYL MYRISTATE	INACTIVE INGREDIENT	0RE8K4LNJS	FENTANYL PATCH, EXTENDED RELEASE [DISPENSING SOLUTIONS INC.]	1
OCTYLDODECANOL	INACTIVE INGREDIENT	461N1O614Y	FENTANYL PATCH, EXTENDED RELEASE [DISPENSING SOLUTIONS INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68258-3023	FENTANYL PATCH, EXTENDED RELEASE [DISPENSING SOLUTIONS INC.]	1	Legacy NDC, 2 package rows	20100315_0a639bb3-2883-47f7-b117-737df8bed33c.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
FENTANYL	FENTANYL	Aveva Drug Delivery Systems Inc.	73897c38-e4ec-40bc-9f41-3359ee23a5a8	2026-04-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077449 application number: ANDA077449
FENTANYL	FENTANYL	INGENUS PHARMACEUTICALS, LLC	bf02ffd0-cc5d-446b-b648-378f6885052f	2026-04-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077449 application number: ANDA077449

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
245136	fentaNYL 100 MCG/HR 72HR Transdermal System	PSN	0a639bb3-2883-47f7-b117-737df8bed33c	1
245134	fentaNYL 25 MCG/HR 72HR Transdermal System	PSN	0a639bb3-2883-47f7-b117-737df8bed33c	1
197696	fentaNYL 75 MCG/HR 72HR Transdermal System	PSN	0a639bb3-2883-47f7-b117-737df8bed33c	1
245134	72 HR fentanyl 0.025 MG/HR Transdermal System	SCD	0a639bb3-2883-47f7-b117-737df8bed33c	1
197696	72 HR fentanyl 0.075 MG/HR Transdermal System	SCD	0a639bb3-2883-47f7-b117-737df8bed33c	1
245136	72 HR fentanyl 0.1 MG/HR Transdermal System	SCD	0a639bb3-2883-47f7-b117-737df8bed33c	1
245136	fentanyl 100 MCG/HR 3 Day Transdermal Patch	SY	0a639bb3-2883-47f7-b117-737df8bed33c	1
245136	fentanyl 100 MCG/HR 72HR Transdermal System	SY	0a639bb3-2883-47f7-b117-737df8bed33c	1
245134	fentanyl 25 MCG/HR 3 Day Transdermal Patch	SY	0a639bb3-2883-47f7-b117-737df8bed33c	1
245134	fentanyl 25 MCG/HR 72HR Transdermal System	SY	0a639bb3-2883-47f7-b117-737df8bed33c	1
197696	fentanyl 75 MCG/HR 3 Day Transdermal Patch	SY	0a639bb3-2883-47f7-b117-737df8bed33c	1
197696	fentanyl 75 MCG/HR 72HR Transdermal System	SY	0a639bb3-2883-47f7-b117-737df8bed33c	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
68258-3023-1	68258302301	5 in 1 CARTON	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
FENTANYL TRANSDERMAL SYSTEM CII Rx only	Dispensing Solutions Inc.	2010-03-03	HUMAN PRESCRIPTION DRUG LABEL	1