Transderm Scop

Product NDC
10019-553
Requested package NDC
10019-553-90
11-digit product format
100190553
Labeler code
10019
Product ID
10019-553_a123951d-5b0b-4b7a-9ae5-15dcaf902c0b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Scopalamine
Dosage form
PATCH, EXTENDED RELEASE
Route
TRANSDERMAL
Labeler
Baxter Healthcare Corporation
Application
NDA017874
Marketing category
NDA
Marketing start
2016-12-01
Marketing end
2025-02-28
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage10019-55310019-553-90DDiscontinued by firm2026-08-11

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 · 6 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N017874-001TRANSDERM SCOPSCOPOLAMINE1MG/72HRSYSTEM / TRANSDERMALABRLD, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N017874-001AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N017874-001TRANSDERM SCOP1MG/72HRSYSTEM / TRANSDERMALABRLD, Approved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017874-001TRANSDERM SCOP1MG/72HRSYSTEM / TRANSDERMALABRLD, Approved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08N017874-001TRANSDERM SCOP1MG/72HRSYSTEM / TRANSDERMALABRLD, Approved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N017874-001TRANSDERM SCOP1MG/72HRSYSTEM / TRANSDERMALABRLD, RS, Approved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N017874-001TRANSDERM SCOP1MG/72HRSYSTEM / TRANSDERMALABRLD, RS, Approved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N017874-001TRANSDERM SCOP1MG/72HRSYSTEM / TRANSDERMALABRLD, RS, Approved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N017874-001TRANSDERM SCOP1MG/72HRSYSTEM / TRANSDERMALABRLD, RS, Approved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N017874-001TRANSDERM SCOP1MG/72HRSYSTEM / TRANSDERMALABRLD, RS, Approved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N017874-001TRANSDERM SCOP1MG/72HRSYSTEM / TRANSDERMALABRLD, RS, Approved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N017874-001TRANSDERM SCOP1MG/72HRSYSTEM / TRANSDERMALABRLD, RS, Approved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N017874-001TRANSDERM SCOP1MG/72HRSYSTEM / TRANSDERMALABRLD, RS, Approved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N017874-001TRANSDERM SCOP1MG/72HRSYSTEM / TRANSDERMALABRLD, RS, Approved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N017874-001TRANSDERM SCOP1MG/72HRSYSTEM / TRANSDERMALABRLD, RS, Approved before 19821e350fbaab3a…
2024-05-31 18:47 UTC2024-05N017874-001TRANSDERM SCOP1MG/72HRSYSTEM / TRANSDERMALABRLD, RS, Approved before 19828072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N017874-001TRANSDERM SCOP1MG/72HRSYSTEM / TRANSDERMALABRLD, RS, Approved before 19825c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N017874-001TRANSDERM SCOP1MG/72HRSYSTEM / TRANSDERMALABRLD, RS, Approved before 19825d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N017874-001TRANSDERM SCOP1MG/72HRSYSTEM / TRANSDERMALABRLD, RS, Approved before 19824b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N017874-001TRANSDERM SCOP1MG/72HRFILM, EXTENDED RELEASE / TRANSDERMALABRLD, RS, Approved before 198274a2ff9319b5…
2022-03-09 01:35 UTC2022-03N017874-001TRANSDERM SCOP1MG/72HRSYSTEM / TRANSDERMALABRLD, RS, Approved before 1982bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N017874-001TRANSDERM SCOP1MG/72HRSYSTEM / TRANSDERMALABRLD, RS, Approved before 1982782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N017874-001TRANSDERM SCOP1MG/72HRSYSTEM / TRANSDERMALABRLD, RS, Approved before 198287673890dc5c…
2021-03-12 10:30 UTC2021-03N017874-001TRANSDERM SCOP1MG/72HRSYSTEM / TRANSDERMALABRLD, RS, Approved before 19825aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N017874-001TRANSDERM SCOP1MG/72HRFILM, EXTENDED RELEASE / TRANSDERMALABRLD, RS, Approved before 19828869cabd3fbd…
2020-11-12 02:37 UTC2020-11N017874-001TRANSDERM SCOP1MG/72HRFILM, EXTENDED RELEASE / TRANSDERMALABRLD, RS, Approved before 1982c0c555d07b60…
2019-12-14 00:12 UTC2019-12N017874-001TRANSDERM SCOP1MG/72HRFILM, EXTENDED RELEASE / TRANSDERMALABRLD, RS, Approved before 19823f01610625f2…
2019-09-15 20:21 UTC2019-09N017874-001TRANSDERM SCOP1MG/72HRFILM, EXTENDED RELEASE / TRANSDERMALABRLD, RS, Approved before 1982b00525d2431f…
2019-07-19 19:46 UTC2019-07N017874-001TRANSDERM SCOP1MG/72HRFILM, EXTENDED RELEASE / TRANSDERMALABRLD, RS, Approved before 1982ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N017874-001TRANSDERM SCOP1MG/72HRSYSTEM / TRANSDERMALABRLD, RS, Approved before 19826a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N017874-001TRANSDERM SCOP1MG/72HRSYSTEM / TRANSDERMALABRLD, RS, Approved before 19821c564ffb4f44…
2023-12-20 04:57 UTC2023-12N017874-001TRANSDERM SCOP1MG/72HRSYSTEM / TRANSDERMALABRLD, RS, Approved before 1982ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N017874-001TRANSDERM SCOP1MG/72HRSYSTEM / TRANSDERMALABRLD, RS, Approved before 1982a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N017874-001TRANSDERM SCOP1MG/72HRSYSTEM / TRANSDERMALABRLD, RS, Approved before 19829b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N017874-001TRANSDERM SCOP1MG/72HRSYSTEM / TRANSDERMALABRLD, RS, Approved before 1982a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N017874-001TRANSDERM SCOP1MG/72HRSYSTEM / TRANSDERMALABRLD, RS, Approved before 19823f0d92c62455…
2023-05-13 08:27 UTC2023-05N017874-001TRANSDERM SCOP1MG/72HRSYSTEM / TRANSDERMALABRLD, RS, Approved before 1982053a50430f4f…
2023-01-26 05:58 UTC2023-01N017874-001TRANSDERM SCOP1MG/72HRSYSTEM / TRANSDERMALABRLD, RS, Approved before 19823bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N017874-001TRANSDERM SCOP1MG/72HRSYSTEM / TRANSDERMALABRLD, RS, Approved before 19823a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N017874-001TRANSDERM SCOP1MG/72HRSYSTEM / TRANSDERMALABRLD, RS, Approved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N017874-001TRANSDERM SCOP1MG/72HRSYSTEM / TRANSDERMALABRLD, RS, Approved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N017874-001TRANSDERM SCOP1MG/72HRSYSTEM / TRANSDERMALABRLD, RS, Approved before 1982cb3db0bc1861…

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N017874-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017874-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N017874-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N017874-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N017874-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N017874-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N017874-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N017874-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N017874-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N017874-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N017874-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N017874-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N017874-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N017874-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N017874-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N017874-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N017874-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N017874-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N017874-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N017874-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N017874-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03N017874-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N017874-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N017874-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N017874-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09N017874-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07N017874-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N017874-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N017874-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N017874-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N017874-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N017874-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N017874-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N017874-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05N017874-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01N017874-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N017874-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N017874-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N017874-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N017874-001AB1cb3db0bc1861…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fe8ea78e-e1a4-44bf-a6b2-42eed76976bbProduct name520250218

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
10019-553-032021-06-17These highlights do not include all the information needed to use TRANSDERM SCŌP safely and effectively. See full prescribing information for TRANSDERM SCŌP. TRANSDERM SCŌP (scopolamine transdermal system) Initial U.S. Approval: 1979
10019-553-042021-06-17These highlights do not include all the information needed to use TRANSDERM SCŌP safely and effectively. See full prescribing information for TRANSDERM SCŌP. TRANSDERM SCŌP (scopolamine transdermal system) Initial U.S. Approval: 1979
10019-553-902021-06-17These highlights do not include all the information needed to use TRANSDERM SCŌP safely and effectively. See full prescribing information for TRANSDERM SCŌP. TRANSDERM SCŌP (scopolamine transdermal system) Initial U.S. Approval: 1979
10019-553-032021-01-29These highlights do not include all the information needed to use TRANSDERM SCŌP safely and effectively. See full prescribing information for TRANSDERM SCŌP. TRANSDERM SCŌP (scopolamine transdermal system) Initial U.S. Approval: 1979
10019-553-042021-01-29These highlights do not include all the information needed to use TRANSDERM SCŌP safely and effectively. See full prescribing information for TRANSDERM SCŌP. TRANSDERM SCŌP (scopolamine transdermal system) Initial U.S. Approval: 1979
10019-553-902021-01-29These highlights do not include all the information needed to use TRANSDERM SCŌP safely and effectively. See full prescribing information for TRANSDERM SCŌP. TRANSDERM SCŌP (scopolamine transdermal system) Initial U.S. Approval: 1979

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10019-553-03Transderm Scop10 in 1 BOXPATCH, EXTENDED RELEASE1020
10019-553-03Transderm Scop1 in 1 POUCHPATCH, EXTENDED RELEASE120
10019-553-04Transderm Scop1 in 1 POUCHPATCH, EXTENDED RELEASE120
10019-553-04Transderm Scop24 in 1 BOXPATCH, EXTENDED RELEASE2420
10019-553-06Transderm Scop1 in 1 POUCHPATCH, EXTENDED RELEASE120
10019-553-06Transderm Scop4 in 1 BOXPATCH, EXTENDED RELEASE420
10019-553-90Transderm Scop1 in 1 POUCHPATCH, EXTENDED RELEASE120
10019-553-90Transderm Scop3 d in 1 PATCHPATCH, EXTENDED RELEASE320

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10019-553-01EA - Each10019-55397fd38ad-276b-4f13-b8bc-8cc22e41668912013-02-13
10019-553-02EA - Each10019-5534956f03f-355f-4cb8-bd65-f2a9b41e72d412013-02-13
10019-553-03EA - Each10019-553b8be484d-1657-4025-94a1-6551bfed7ca612017-03-06
10019-553-04EA - Each10019-55367b5ab75-a1d8-459e-9664-bf7c8908185912017-03-06
10019-553-88EA - Each10019-5538ae9ce8f-097c-4765-ba3f-d4898706d19a12013-02-13
10019-553-90EA - Each10019-553311824e6-6526-4b73-8156-eb816ff8406612017-03-06

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Transderm ScopSCOPOLAMINEBaxter Healthcare Corporationb877a694-a1d0-4280-937a-a06820b12a882025-06-10Warnings, Adverse reactionsExact identifier
application applno (NDA): 017874
application number: NDA017874
ndc (package): 10019-553-90
ndc (product): 10019-553
ndc11 (package): 10019055390

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
226552scopolamine 1 MG 3 Day Transdermal SystemPSNb877a694-a1d0-4280-937a-a06820b12a8820
351875TRANSDERM SCOP 1 MG 3 Day Transdermal SystemPSNb877a694-a1d0-4280-937a-a06820b12a8820
35187572 HR scopolamine 0.0139 MG/HR Transdermal System [Transderm Scop]SBDb877a694-a1d0-4280-937a-a06820b12a8820
22655272 HR scopolamine 0.0139 MG/HR Transdermal SystemSCDb877a694-a1d0-4280-937a-a06820b12a8820
35187572 HR Transderm Scop 0.0139 MG/HR Transdermal SystemSYb877a694-a1d0-4280-937a-a06820b12a8820
226552scopolamine 0.0139 MG/HR 72 HR Transdermal PatchSYb877a694-a1d0-4280-937a-a06820b12a8820
226552scopolamine 0.3336 MG/Day 72 HR Transdermal PatchSYb877a694-a1d0-4280-937a-a06820b12a8820
226552scopolamine 1.3 MG 3 Day Transdermal SystemSYb877a694-a1d0-4280-937a-a06820b12a8820
351875Transderm Scop 0.0139 MG/HR 72 HR Transdermal PatchSYb877a694-a1d0-4280-937a-a06820b12a8820
351875Transderm Scop 0.33 MG/Day 72 HR Transdermal PatchSYb877a694-a1d0-4280-937a-a06820b12a8820
351875Transderm Scop 1.3 MG 3 Day Transdermal SystemSYb877a694-a1d0-4280-937a-a06820b12a8820

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10019-553-90100190553901 PATCH in 1 POUCH (10019-553-90) > 3 d in 1 PATCH1 patch2016-12-012025-02-28NoNoCurrent