IONSYS

Product NDC: 65293-011
11-digit product format: 652930011
Labeler code: 65293
Product ID: 65293-011_45eac440-fb43-3509-e054-00144ff8d46c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: fentanyl iontophoretic transdermal system
Dosage form: PATCH
Route: TRANSDERMAL
Labeler: The Medicines Company
Application: NDA021338
Marketing category: NDA
Marketing start: 2015-06-01
Marketing end: 0000-00-00
Substance: FENTANYL HYDROCHLORIDE
Active strength: 40 ug/1
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	65293-011		D	Discontinued by firm		2026-10-05
excluded package	package	65293-011	65293-011-06	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	65293-011-06	`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	65293-011-06	`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	65293-011-06	`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	65293-011-06	`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	65293-011-06	`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	65293-011-06	`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	65293-011-06	`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	65293-011-06	`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	65293-011-06	`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	65293-011-06	`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	65293-011-06	`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	65293-011-06	`557ba5c1ecfa…`	`9c80585c8c6e…`

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021338-001	IONSYS	FENTANYL HYDROCHLORIDE	EQ 40MCG BASE/ACTIVATION	SYSTEM / IONTOPHORESIS, TRANSDERMAL		RLD	2006-05-22

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N021338-001	8301238	2031-09-30		Drug product
N021338-001	9364656	2031-09-30	U-736		2016-06-21
N021338-001	9731121	2031-10-17		Drug product	2017-09-12
N021338-001	8781571	2032-03-31	U-736	Drug product	2015-05-28
N021338-001	8428708	2032-05-21	U-736
N021338-001	8428709	2032-06-11	U-736	Drug product	2015-05-28
N021338-001	9095706	2033-02-03		Drug product	2015-08-06

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 2 · 43 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	N021338-001	IONSYS	EQ 40MCG BASE/ACTIVATION	SYSTEM / IONTOPHORESIS, TRANSDERMAL	RLD	2006-05-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021338-001	IONSYS	EQ 40MCG BASE/ACTIVATION	SYSTEM / IONTOPHORESIS, TRANSDERMAL	RLD	2006-05-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021338-001	IONSYS	EQ 40MCG BASE/ACTIVATION	SYSTEM / IONTOPHORESIS, TRANSDERMAL	RLD	2006-05-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021338-001	IONSYS	EQ 40MCG BASE/ACTIVATION	SYSTEM / IONTOPHORESIS, TRANSDERMAL	RLD	2006-05-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021338-001	IONSYS	EQ 40MCG BASE/ACTIVATION	SYSTEM / IONTOPHORESIS, TRANSDERMAL	RLD	2006-05-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021338-001	IONSYS	EQ 40MCG BASE/ACTIVATION	SYSTEM / IONTOPHORESIS, TRANSDERMAL	RLD	2006-05-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021338-001	IONSYS	EQ 40MCG BASE/ACTIVATION	SYSTEM / IONTOPHORESIS, TRANSDERMAL	RLD	2006-05-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021338-001	IONSYS	EQ 40MCG BASE/ACTIVATION	SYSTEM / IONTOPHORESIS, TRANSDERMAL	RLD	2006-05-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021338-001	IONSYS	EQ 40MCG BASE/ACTIVATION	SYSTEM / IONTOPHORESIS, TRANSDERMAL	RLD	2006-05-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021338-001	IONSYS	EQ 40MCG BASE/ACTIVATION	SYSTEM / IONTOPHORESIS, TRANSDERMAL	RLD	2006-05-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021338-001	IONSYS	EQ 40MCG BASE/ACTIVATION	SYSTEM / IONTOPHORESIS, TRANSDERMAL	RLD	2006-05-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021338-001	IONSYS	EQ 40MCG BASE/ACTIVATION	SYSTEM / IONTOPHORESIS, TRANSDERMAL	RLD	2006-05-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021338-001	IONSYS	EQ 40MCG BASE/ACTIVATION	SYSTEM / IONTOPHORESIS, TRANSDERMAL	RLD	2006-05-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021338-001	IONSYS	EQ 40MCG BASE/ACTIVATION	SYSTEM / IONTOPHORESIS, TRANSDERMAL	RLD	2006-05-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021338-001	IONSYS	EQ 40MCG BASE/ACTIVATION	SYSTEM / IONTOPHORESIS, TRANSDERMAL	RLD	2006-05-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021338-001	IONSYS	EQ 40MCG BASE/ACTIVATION	SYSTEM / IONTOPHORESIS, TRANSDERMAL	RLD	2006-05-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021338-001	IONSYS	EQ 40MCG BASE/ACTIVATION	SYSTEM / IONTOPHORESIS, TRANSDERMAL	RLD	2006-05-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021338-001	IONSYS	EQ 40MCG BASE/ACTIVATION	SYSTEM / IONTOPHORESIS, TRANSDERMAL	RLD	2006-05-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021338-001	IONSYS	EQ 40MCG BASE/ACTIVATION	SYSTEM / IONTOPHORESIS, TRANSDERMAL	RLD	2006-05-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021338-001	IONSYS	EQ 40MCG BASE/ACTIVATION	SYSTEM / IONTOPHORESIS, TRANSDERMAL	RLD	2006-05-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021338-001	IONSYS	EQ 40MCG BASE/ACTIVATION	SYSTEM / IONTOPHORESIS, TRANSDERMAL	RLD	2006-05-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021338-001	IONSYS	EQ 40MCG BASE/ACTIVATION	SYSTEM / IONTOPHORESIS, TRANSDERMAL	RLD	2006-05-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021338-001	IONSYS	EQ 40MCG BASE/ACTIVATION	SYSTEM / IONTOPHORESIS, TRANSDERMAL	RLD	2006-05-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021338-001	IONSYS	EQ 40MCG BASE/ACTIVATION	SYSTEM / IONTOPHORESIS, TRANSDERMAL	RLD	2006-05-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021338-001	IONSYS	EQ 40MCG BASE/ACTIVATION	SYSTEM / IONTOPHORESIS, TRANSDERMAL	RLD	2006-05-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021338-001	IONSYS	EQ 40MCG BASE/ACTIVATION	SYSTEM / IONTOPHORESIS, TRANSDERMAL	RLD	2006-05-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021338-001	IONSYS	EQ 40MCG BASE/ACTIVATION	SYSTEM / IONTOPHORESIS, TRANSDERMAL	RLD	2006-05-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021338-001	IONSYS	EQ 40MCG BASE/ACTIVATION	SYSTEM / IONTOPHORESIS, TRANSDERMAL	RLD	2006-05-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021338-001	IONSYS	EQ 40MCG BASE/ACTIVATION	SYSTEM / IONTOPHORESIS, TRANSDERMAL	RLD	2006-05-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021338-001	IONSYS	EQ 40MCG BASE/ACTIVATION	SYSTEM / IONTOPHORESIS, TRANSDERMAL	RLD	2006-05-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021338-001	IONSYS	EQ 40MCG BASE/ACTIVATION	SYSTEM / IONTOPHORESIS, TRANSDERMAL	RLD	2006-05-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021338-001	IONSYS	EQ 40MCG BASE/ACTIVATION	SYSTEM / IONTOPHORESIS, TRANSDERMAL	RLD	2006-05-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021338-001	IONSYS	EQ 40MCG BASE/ACTIVATION	SYSTEM / IONTOPHORESIS, TRANSDERMAL	RLD	2006-05-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021338-001	IONSYS	EQ 40MCG BASE/ACTIVATION	SYSTEM / IONTOPHORESIS, TRANSDERMAL	RLD	2006-05-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021338-001	IONSYS	EQ 40MCG BASE/ACTIVATION	SYSTEM / IONTOPHORESIS, TRANSDERMAL	RLD	2006-05-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021338-001	IONSYS	EQ 40MCG BASE/ACTIVATION	SYSTEM / IONTOPHORESIS, TRANSDERMAL	RLD	2006-05-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021338-001	IONSYS	EQ 40MCG BASE/ACTIVATION	SYSTEM / IONTOPHORESIS, TRANSDERMAL	RLD	2006-05-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021338-001	IONSYS	EQ 40MCG BASE/ACTIVATION	SYSTEM / IONTOPHORESIS, TRANSDERMAL	RLD	2006-05-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021338-001	IONSYS	EQ 40MCG BASE/ACTIVATION	SYSTEM / IONTOPHORESIS, TRANSDERMAL	RLD	2006-05-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021338-001	IONSYS	EQ 40MCG BASE/ACTIVATION	SYSTEM / IONTOPHORESIS, TRANSDERMAL	RLD	2006-05-22	`f41ea6bd6efb…`

Observed Orange Book patent history#

Patent history page 1 of 10 · 362 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N021338-001	8301238	2031-09-30		Drug product		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021338-001	9364656	2031-09-30	U-736		2016-06-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021338-001	9731121	2031-10-17		Drug product	2017-09-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021338-001	8781571	2032-03-31	U-736	Drug product	2015-05-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021338-001	8428708	2032-05-21	U-736			`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021338-001	8428709	2032-06-11	U-736	Drug product	2015-05-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021338-001	9095706	2033-02-03		Drug product	2015-08-06	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021338-001	8301238	2031-09-30		Drug product		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021338-001	9364656	2031-09-30	U-736		2016-06-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021338-001	9731121	2031-10-17		Drug product	2017-09-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021338-001	8781571	2032-03-31	U-736	Drug product	2015-05-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021338-001	8428708	2032-05-21	U-736			`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021338-001	8428709	2032-06-11	U-736	Drug product	2015-05-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021338-001	9095706	2033-02-03		Drug product	2015-08-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021338-001	8301238	2031-09-30		Drug product		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021338-001	9364656	2031-09-30	U-736		2016-06-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021338-001	9731121	2031-10-17		Drug product	2017-09-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021338-001	8781571	2032-03-31	U-736	Drug product	2015-05-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021338-001	8428708	2032-05-21	U-736			`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021338-001	8428709	2032-06-11	U-736	Drug product	2015-05-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021338-001	9095706	2033-02-03		Drug product	2015-08-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021338-001	8301238	2031-09-30		Drug product		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021338-001	9364656	2031-09-30	U-736		2016-06-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021338-001	9731121	2031-10-17		Drug product	2017-09-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021338-001	8781571	2032-03-31	U-736	Drug product	2015-05-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021338-001	8428708	2032-05-21	U-736			`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021338-001	8428709	2032-06-11	U-736	Drug product	2015-05-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021338-001	9095706	2033-02-03		Drug product	2015-08-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021338-001	8301238	2031-09-30		Drug product		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021338-001	9364656	2031-09-30	U-736		2016-06-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021338-001	9731121	2031-10-17		Drug product	2017-09-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021338-001	8781571	2032-03-31	U-736	Drug product	2015-05-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021338-001	8428708	2032-05-21	U-736			`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021338-001	8428709	2032-06-11	U-736	Drug product	2015-05-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021338-001	9095706	2033-02-03		Drug product	2015-08-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021338-001	8301238	2031-09-30		Drug product		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021338-001	9364656	2031-09-30	U-736		2016-06-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021338-001	9731121	2031-10-17		Drug product	2017-09-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021338-001	8781571	2032-03-31	U-736	Drug product	2015-05-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021338-001	8428708	2032-05-21	U-736			`fd3edfee7708…`

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
65293-011-06	2020-02-11	C162847	48780-1	9d75b9cf-ecf3-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use IONSYS safely and effectively. See full prescribing information for IONSYS. IONSYS ® (fentanyl iontophoretic transdermal system), CII Initial U.S. Approval: 1968
65293-011-06	2020-01-31	C162847	48780-1	9d75b9cf-ecf3-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use IONSYS safely and effectively. See full prescribing information for IONSYS. IONSYS ® (fentanyl iontophoretic transdermal system), 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
65293-011-01	EA - Each	65293-011	628fc235-06c2-4678-99ec-ac5e7338a727	1	2015-06-09
65293-011-06	EA - Each	65293-011	10c5f707-33f8-42f9-9644-133d431193d6	1	2015-06-09

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
FENTANYL HYDROCHLORIDE	ACTIVE INGREDIENT	59H156XY46	IONSYS (FENTANYL IONTOPHORETIC TRANSDERMAL SYSTEM) PATCH [THE MEDICINES COMPANY]	3
FENTANYL	ACTIVE MOIETY	UF599785JZ	IONSYS (FENTANYL IONTOPHORETIC TRANSDERMAL SYSTEM) PATCH [THE MEDICINES COMPANY]	3
CETYLPYRIDINIUM CHLORIDE	INACTIVE INGREDIENT	D9OM4SK49P	IONSYS (FENTANYL IONTOPHORETIC TRANSDERMAL SYSTEM) PATCH [THE MEDICINES COMPANY]	3
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	IONSYS (FENTANYL IONTOPHORETIC TRANSDERMAL SYSTEM) PATCH [THE MEDICINES COMPANY]	3
POLACRILIN	INACTIVE INGREDIENT	RCZ785HI7S	IONSYS (FENTANYL IONTOPHORETIC TRANSDERMAL SYSTEM) PATCH [THE MEDICINES COMPANY]	3
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	IONSYS (FENTANYL IONTOPHORETIC TRANSDERMAL SYSTEM) PATCH [THE MEDICINES COMPANY]	3
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	IONSYS (FENTANYL IONTOPHORETIC TRANSDERMAL SYSTEM) PATCH [THE MEDICINES COMPANY]	3
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	IONSYS (FENTANYL IONTOPHORETIC TRANSDERMAL SYSTEM) PATCH [THE MEDICINES COMPANY]	3
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	IONSYS (FENTANYL IONTOPHORETIC TRANSDERMAL SYSTEM) PATCH [THE MEDICINES COMPANY]	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	IONSYS (FENTANYL IONTOPHORETIC TRANSDERMAL SYSTEM) PATCH [THE MEDICINES COMPANY]	3

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
59H156XY46	FENTANYL HYDROCHLORIDE	1443-54-5	FENTANYL HYDROCHLORIDE

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
IONSYS	The Medicines Company \| DPT Lakewood LLC \| Intertek USA Inc. \| Johnson Matthey Pharmaceutical Materials	2017-01-12	HUMAN PRESCRIPTION DRUG LABEL	10