FENTANYL TRANSDERMAL SYSTEM

Product NDC: 21695-975
11-digit product format: 216950975
Labeler code: 21695
Product ID: 21695-975_67cb9ea4-5adb-4a3a-9568-266b6f472078
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: fentanyl transdermal system
Dosage form: PATCH, EXTENDED RELEASE
Route: TRANSDERMAL
Labeler: Rebel Distributors Corp
Application: ANDA077154
Marketing category: ANDA
Marketing start: 2011-02-09
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	21695-975		I	Inactivated by FDA		2026-10-15
excluded package	package	21695-975	21695-975-05	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 · 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	21695-975-05	`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	21695-975-05	`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	21695-975-05	`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	21695-975-05	`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	21695-975-05	`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	21695-975-05	`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	21695-975-05	`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	21695-975-05	`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	21695-975-05	`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	21695-975-05	`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	21695-975-05	`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	21695-975-05	`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	21695-975-05	`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	21695-975-05	`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	21695-975-05	`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	21695-975-05	`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	21695-975-05	`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	21695-975-05	`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	21695-975-05	`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	21695-975-05	`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	21695-975-05	`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	21695-975-05	`110d247fa046…`	`a55b01930146…`

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	TE codes	RLD / RS	Approval date
A077154-001	FENTANYL-25	FENTANYL	25MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RS	2011-02-09
A077154-002	FENTANYL-50	FENTANYL	50MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB		2011-02-09
A077154-003	FENTANYL-75	FENTANYL	75MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB		2011-02-09
A077154-004	FENTANYL-100	FENTANYL	100MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB		2011-02-09
A077154-005	FENTANYL-12	FENTANYL	12.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB		2015-06-11
A077154-006	FENTANYL-37	FENTANYL	37.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB		2020-01-14
A077154-007	FENTANYL-62	FENTANYL	62.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB		2020-01-14

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 7 matching rows.

Application-product, TE code table
Application-product	TE code
A077154-001	AB
A077154-002	AB
A077154-003	AB
A077154-004	AB
A077154-005	AB
A077154-006	AB
A077154-007	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 8 · 300 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A077154-001	FENTANYL-25	25MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RS	2011-02-09	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A077154-002	FENTANYL-50	50MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB		2011-02-09	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A077154-003	FENTANYL-75	75MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB		2011-02-09	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A077154-004	FENTANYL-100	100MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB		2011-02-09	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A077154-005	FENTANYL-12	12.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB		2015-06-11	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A077154-006	FENTANYL-37	37.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB		2020-01-14	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A077154-007	FENTANYL-62	62.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB		2020-01-14	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A077154-001	FENTANYL-25	25MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RS	2011-02-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077154-002	FENTANYL-50	50MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB		2011-02-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077154-003	FENTANYL-75	75MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB		2011-02-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077154-004	FENTANYL-100	100MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB		2011-02-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077154-005	FENTANYL-12	12.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB		2015-06-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077154-006	FENTANYL-37	37.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB		2020-01-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077154-007	FENTANYL-62	62.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB		2020-01-14	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077154-001	FENTANYL-25	25MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RS	2011-02-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077154-002	FENTANYL-50	50MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB		2011-02-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077154-003	FENTANYL-75	75MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB		2011-02-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077154-004	FENTANYL-100	100MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB		2011-02-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077154-005	FENTANYL-12	12.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB		2015-06-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077154-006	FENTANYL-37	37.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB		2020-01-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077154-007	FENTANYL-62	62.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB		2020-01-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077154-001	FENTANYL-25	25MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RS	2011-02-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077154-002	FENTANYL-50	50MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB		2011-02-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077154-003	FENTANYL-75	75MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB		2011-02-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077154-004	FENTANYL-100	100MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB		2011-02-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077154-005	FENTANYL-12	12.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB		2015-06-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077154-006	FENTANYL-37	37.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB		2020-01-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077154-007	FENTANYL-62	62.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB		2020-01-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077154-001	FENTANYL-25	25MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RS	2011-02-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077154-002	FENTANYL-50	50MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB		2011-02-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077154-003	FENTANYL-75	75MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB		2011-02-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077154-004	FENTANYL-100	100MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB		2011-02-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077154-005	FENTANYL-12	12.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB		2015-06-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077154-006	FENTANYL-37	37.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB		2020-01-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077154-007	FENTANYL-62	62.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB		2020-01-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077154-001	FENTANYL-25	25MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RS	2011-02-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077154-002	FENTANYL-50	50MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB		2011-02-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077154-003	FENTANYL-75	75MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB		2011-02-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077154-004	FENTANYL-100	100MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB		2011-02-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077154-005	FENTANYL-12	12.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB		2015-06-11	`6a471c1ec25d…`

Observed Orange Book normalized TE history#

Normalized TE history page 5 of 8 · 300 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077154-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077154-003	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077154-004	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077154-005	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077154-006	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077154-007	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077154-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A077154-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A077154-003	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A077154-004	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A077154-005	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A077154-006	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A077154-007	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077154-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A077154-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A077154-003	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A077154-004	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A077154-005	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A077154-006	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A077154-007	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077154-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A077154-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A077154-003	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A077154-004	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A077154-005	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A077154-006	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A077154-007	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077154-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077154-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077154-003	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077154-004	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077154-005	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077154-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077154-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077154-003	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077154-004	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077154-005	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077154-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A077154-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A077154-003	AB	1	`ea99ee380514…`

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
21695-975-05	2019-09-24	C162847	48780-1	934fe258-4884-48b1-e053-8cdaa90a720a	FENTANYL TRANSDERMAL SYSTEM 25 mcg/hr, 50 mcg/hr, 75 mcg/hr, 100 mcg/hr CII Full Prescribing Information Rx only FOR USE IN OPIOID-TOLERANT PATIENTS ONLY

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
21695-975-05	FENTANYL TRANSDERMAL SYSTEM	5 in 1 CARTON	PATCH, EXTENDED RELEASE	5		1
21695-975-05	FENTANYL TRANSDERMAL SYSTEM	1 in 1 POUCH	PATCH, EXTENDED RELEASE	1		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
21695-975-05	EA - Each	21695-975	870e0f78-1e6b-4b53-8434-fab3c3b4755f	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
FENTANYL	ACTIVE INGREDIENT	UF599785JZ	FENTANYL TRANSDERMAL SYSTEM PATCH, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1
FENTANYL	ACTIVE MOIETY	UF599785JZ	FENTANYL TRANSDERMAL SYSTEM PATCH, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	FENTANYL TRANSDERMAL SYSTEM PATCH, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1
DIMETHICONE 350	INACTIVE INGREDIENT	2Y53S6ATLU	FENTANYL TRANSDERMAL SYSTEM PATCH, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1
DIPROPYLENE GLYCOL	INACTIVE INGREDIENT	E107L85C40	FENTANYL TRANSDERMAL SYSTEM PATCH, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1
ETHYLENE-VINYL ACETATE COPOLYMER (19% VINYLACETATE)	INACTIVE INGREDIENT	JK6142KK4O	FENTANYL TRANSDERMAL SYSTEM PATCH, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1
HEPTANE	INACTIVE INGREDIENT	456148SDMJ	FENTANYL TRANSDERMAL SYSTEM PATCH, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	FENTANYL TRANSDERMAL SYSTEM PATCH, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
21695-975	FENTANYL TRANSDERMAL SYSTEM PATCH, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1	Legacy NDC, 2 package rows	20111021_67cb9ea4-5adb-4a3a-9568-266b6f472078.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
FENTANYL TRANSDERMAL	FENTANYL TRANSDERMAL	SpecGx LLC	e15a7e9b-8025-49dd-9a6d-bafcccf1959f	2026-04-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077154 application number: ANDA077154

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
245134	fentaNYL 25 MCG/HR 72HR Transdermal System	PSN	67cb9ea4-5adb-4a3a-9568-266b6f472078	1
245134	72 HR fentanyl 0.025 MG/HR Transdermal System	SCD	67cb9ea4-5adb-4a3a-9568-266b6f472078	1
245134	fentanyl 25 MCG/HR 3 Day Transdermal Patch	SY	67cb9ea4-5adb-4a3a-9568-266b6f472078	1
245134	fentanyl 25 MCG/HR 72HR Transdermal System	SY	67cb9ea4-5adb-4a3a-9568-266b6f472078	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
21695-975-05	21695097505	5 in 1 CARTON	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
FENTANYL TRANSDERMAL SYSTEM - Rebel Distributors Corp	Rebel Distributors Corp	2011-09-07	HUMAN PRESCRIPTION DRUG LABEL	1