FDA.reportPublic FDA data

Transderm Scop

Product NDC
10019-553
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

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10019-553-032021-06-17C16284748780-1ba0f9c33-1b1a-a910-e053-dadaa90a0b85These 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
10019-553-042021-06-17C16284748780-1ba0f9c33-1b1a-a910-e053-dadaa90a0b85These 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
10019-553-902021-06-17C16284748780-1ba0f9c33-1b1a-a910-e053-dadaa90a0b85These 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
10019-553-032021-01-29C16284748780-1ba0f9c33-1b1a-a910-e053-dadaa90a0b85These 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
10019-553-042021-01-29C16284748780-1ba0f9c33-1b1a-a910-e053-dadaa90a0b85These 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
10019-553-902021-01-29C16284748780-1ba0f9c33-1b1a-a910-e053-dadaa90a0b85These 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

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
10019-553-031001905530310 POUCH in 1 BOX (10019-553-03) > 1 PATCH in 1 POUCH > 3 d in 1 PATCH10 pouch2016-12-010000-00-00NoNoCurrent
10019-553-041001905530424 POUCH in 1 BOX (10019-553-04) > 1 PATCH in 1 POUCH > 3 d in 1 PATCH24 pouch2016-12-010000-00-00NoNoCurrent
10019-553-06100190553061 in 1 POUCHHistorical
10019-553-90100190553901 PATCH in 1 POUCH (10019-553-90) > 3 d in 1 PATCH1 patch2016-12-010000-00-00NoNoCurrent