Transderm Scop

Product NDC: 66758-208
11-digit product format: 667580208
Labeler code: 66758
Product ID: 66758-208_b7418b93-fe24-45f4-a46c-326ab2c29d07
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: scopolamine
Dosage form: PATCH, EXTENDED RELEASE
Route: TRANSDERMAL
Labeler: Sandoz Inc
Application: NDA017874
Marketing category: NDA
Marketing start: 2016-12-01
Marketing end: 2021-11-30
Substance: SCOPOLAMINE
Active strength: 1 mg/3d
Pharmacologic classes: Anticholinergic [EPC],Cholinergic Antagonists [MoA]
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	66758-208		D	Discontinued by firm	2026-08-11
excluded package	package	66758-208	66758-208-54	D	Discontinued by firm	2026-08-11
excluded package	package	66758-208	66758-208-58	D	Discontinued by firm	2026-08-11

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 · 36 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	66758-208-58	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	66758-208-54	`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	66758-208-58	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	66758-208-54	`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	66758-208-58	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	66758-208-54	`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	66758-208-58	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	66758-208-54	`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	66758-208-58	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	66758-208-54	`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	66758-208-58	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	66758-208-54	`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	66758-208-58	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	66758-208-54	`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	66758-208-58	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	66758-208-54	`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	66758-208-58	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	66758-208-54	`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	66758-208-58	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	66758-208-54	`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	66758-208-58	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	66758-208-54	`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	66758-208-58	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	66758-208-54	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N017874-001	TRANSDERM SCOP	SCOPOLAMINE	1MG/72HR	SYSTEM / TRANSDERMAL	AB	RLD, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N017874-001	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 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N017874-001	TRANSDERM SCOP	1MG/72HR	SYSTEM / TRANSDERMAL	AB	RLD, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017874-001	TRANSDERM SCOP	1MG/72HR	SYSTEM / TRANSDERMAL	AB	RLD, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017874-001	TRANSDERM SCOP	1MG/72HR	SYSTEM / TRANSDERMAL	AB	RLD, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017874-001	TRANSDERM SCOP	1MG/72HR	SYSTEM / TRANSDERMAL	AB	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017874-001	TRANSDERM SCOP	1MG/72HR	SYSTEM / TRANSDERMAL	AB	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017874-001	TRANSDERM SCOP	1MG/72HR	SYSTEM / TRANSDERMAL	AB	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017874-001	TRANSDERM SCOP	1MG/72HR	SYSTEM / TRANSDERMAL	AB	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017874-001	TRANSDERM SCOP	1MG/72HR	SYSTEM / TRANSDERMAL	AB	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017874-001	TRANSDERM SCOP	1MG/72HR	SYSTEM / TRANSDERMAL	AB	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N017874-001	TRANSDERM SCOP	1MG/72HR	SYSTEM / TRANSDERMAL	AB	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017874-001	TRANSDERM SCOP	1MG/72HR	SYSTEM / TRANSDERMAL	AB	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017874-001	TRANSDERM SCOP	1MG/72HR	SYSTEM / TRANSDERMAL	AB	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017874-001	TRANSDERM SCOP	1MG/72HR	SYSTEM / TRANSDERMAL	AB	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N017874-001	TRANSDERM SCOP	1MG/72HR	SYSTEM / TRANSDERMAL	AB	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N017874-001	TRANSDERM SCOP	1MG/72HR	SYSTEM / TRANSDERMAL	AB	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N017874-001	TRANSDERM SCOP	1MG/72HR	SYSTEM / TRANSDERMAL	AB	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N017874-001	TRANSDERM SCOP	1MG/72HR	SYSTEM / TRANSDERMAL	AB	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N017874-001	TRANSDERM SCOP	1MG/72HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD, RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N017874-001	TRANSDERM SCOP	1MG/72HR	SYSTEM / TRANSDERMAL	AB	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N017874-001	TRANSDERM SCOP	1MG/72HR	SYSTEM / TRANSDERMAL	AB	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N017874-001	TRANSDERM SCOP	1MG/72HR	SYSTEM / TRANSDERMAL	AB	RLD, RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N017874-001	TRANSDERM SCOP	1MG/72HR	SYSTEM / TRANSDERMAL	AB	RLD, RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N017874-001	TRANSDERM SCOP	1MG/72HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD, RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N017874-001	TRANSDERM SCOP	1MG/72HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD, RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N017874-001	TRANSDERM SCOP	1MG/72HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD, RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N017874-001	TRANSDERM SCOP	1MG/72HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD, RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N017874-001	TRANSDERM SCOP	1MG/72HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD, RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N017874-001	TRANSDERM SCOP	1MG/72HR	SYSTEM / TRANSDERMAL	AB	RLD, RS, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N017874-001	TRANSDERM SCOP	1MG/72HR	SYSTEM / TRANSDERMAL	AB	RLD, RS, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N017874-001	TRANSDERM SCOP	1MG/72HR	SYSTEM / TRANSDERMAL	AB	RLD, RS, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N017874-001	TRANSDERM SCOP	1MG/72HR	SYSTEM / TRANSDERMAL	AB	RLD, RS, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N017874-001	TRANSDERM SCOP	1MG/72HR	SYSTEM / TRANSDERMAL	AB	RLD, RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N017874-001	TRANSDERM SCOP	1MG/72HR	SYSTEM / TRANSDERMAL	AB	RLD, RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N017874-001	TRANSDERM SCOP	1MG/72HR	SYSTEM / TRANSDERMAL	AB	RLD, RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N017874-001	TRANSDERM SCOP	1MG/72HR	SYSTEM / TRANSDERMAL	AB	RLD, RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N017874-001	TRANSDERM SCOP	1MG/72HR	SYSTEM / TRANSDERMAL	AB	RLD, RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N017874-001	TRANSDERM SCOP	1MG/72HR	SYSTEM / TRANSDERMAL	AB	RLD, RS, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N017874-001	TRANSDERM SCOP	1MG/72HR	SYSTEM / TRANSDERMAL	AB	RLD, RS, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N017874-001	TRANSDERM SCOP	1MG/72HR	SYSTEM / TRANSDERMAL	AB	RLD, RS, Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N017874-001	TRANSDERM SCOP	1MG/72HR	SYSTEM / TRANSDERMAL	AB	RLD, RS, Approved before 1982	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N017874-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017874-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017874-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017874-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017874-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017874-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017874-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017874-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017874-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N017874-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017874-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017874-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017874-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N017874-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N017874-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N017874-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N017874-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N017874-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N017874-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N017874-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N017874-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N017874-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N017874-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N017874-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N017874-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N017874-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N017874-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N017874-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N017874-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N017874-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N017874-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N017874-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N017874-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N017874-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N017874-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N017874-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N017874-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N017874-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N017874-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N017874-001	AB	1	`cb3db0bc1861…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
66758-208-54	EA - Each	66758-208	359c59d9-e762-4bed-9215-f85625196d55	1	2017-03-06

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
Transderm Scop	SCOPOLAMINE	Baxter Healthcare Corporation	b877a694-a1d0-4280-937a-a06820b12a88	2025-06-10	Warnings, Adverse reactions	Exact identifier application applno (NDA): 017874 application number: NDA017874

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
DL48G20X8X	SCOPOLAMINE	51-34-3	SCOPOLAMINE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
66758-208-54	66758020854	4 POUCH in 1 BOX (66758-208-54) > 1 PATCH in 1 POUCH > 3 d in 1 PATCH	4 pouch	2016-12-01	2021-11-30	No	No	Current
66758-208-58	66758020858	1 POUCH in 1 BOX (66758-208-58) > 1 PATCH in 1 POUCH > 3 d in 1 PATCH	1 pouch	2016-12-01	2021-11-30	No	No	Current