FDA.reportPublic FDA data

Transderm Scop

Product NDC
10019-008
11-digit product format
100190008
Labeler code
10019
Product ID
10019-008_b29f6fe1-c232-49ac-914b-29c31ab8c73d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Scopolamine
Dosage form
PATCH, EXTENDED RELEASE
Route
TRANSDERMAL
Labeler
Baxter Healthcare Corporation
Application
NDA017874
Marketing category
NDA
Marketing start
2016-12-01
Substance
SCOPOLAMINE
Active strength
1 mg/3d
Pharmacologic classes
Anticholinergic [EPC], Cholinergic Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Transderm Scop
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SCOPOLAMINE1 mg/3d

Harmonized Identifiers#

Field, Values table
FieldValues
UniiDL48G20X8X
Rxcui226552, 351875

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10019-008-01Transderm Scop1 in 1 POUCHPATCH, EXTENDED RELEASE120
10019-008-01Transderm Scop3 d in 1 PATCHPATCH, EXTENDED RELEASE320
10019-008-04Transderm Scop4 in 1 BOXPATCH, EXTENDED RELEASE420
10019-008-04Transderm Scop1 in 1 POUCHPATCH, EXTENDED RELEASE120
10019-008-10Transderm Scop1 in 1 POUCHPATCH, EXTENDED RELEASE120
10019-008-10Transderm Scop10 in 1 BOXPATCH, EXTENDED RELEASE1020
10019-008-24Transderm Scop24 in 1 BOXPATCH, EXTENDED RELEASE2420
10019-008-24Transderm Scop1 in 1 POUCHPATCH, EXTENDED RELEASE120

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10019-008-01EA - Each10019-008fc779afa-4394-47ef-b86b-7b23b0c823d712025-11-13
10019-008-04EA - Each10019-0087114352c-bdf8-4b6c-a61f-a1e6894bc7b112025-11-13
10019-008-10EA - Each10019-0084e455ac4-ef69-4286-87b8-2ea647a337c112025-11-13
10019-008-24EA - Each10019-008f918f7a4-b59a-408f-8ec4-6eb4e1dba3a512025-11-13

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 startSampleExclude flagStatus
10019-008-01100190008011 PATCH in 1 POUCH (10019-008-01) / 3 d in 1 PATCH1 patch2026-06-100Current
10019-008-04100190008044 POUCH in 1 BOX (10019-008-04) / 1 PATCH in 1 POUCH / 3 d in 1 PATCH4 pouch2025-06-10NoNoCurrent
10019-008-101001900081010 POUCH in 1 BOX (10019-008-10) / 1 PATCH in 1 POUCH / 3 d in 1 PATCH10 pouch2025-06-10NoNoCurrent
10019-008-241001900082424 POUCH in 1 BOX (10019-008-24) / 1 PATCH in 1 POUCH / 3 d in 1 PATCH24 pouch2025-06-10NoNoCurrent