FDA.reportPublic FDA data

Scopolamine Transdermal System

Product NDC
45802-580
11-digit product format
458020580
Labeler code
45802
Product ID
45802-580_d334a21d-7546-477f-a66a-f95b2cf523ce
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
scopolamine transdermal system
Dosage form
PATCH, EXTENDED RELEASE
Route
TRANSDERMAL
Labeler
Padagis Israel Pharmaceuticals Ltd
Application
ANDA078830
Marketing category
ANDA
Marketing start
2017-06-13
Marketing end
2028-06-30
Substance
SCOPOLAMINE
Active strength
1 mg/1
Pharmacologic classes
Anticholinergic [EPC], Cholinergic Antagonists [MoA]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Scopolamine Transdermal System

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SCOPOLAMINE1 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiDL48G20X8X
Rxcui226552

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
45802-580-01Scopolamine Transdermal System1 in 1 POUCHPATCH, EXTENDED RELEASE112
45802-580-46Scopolamine Transdermal System1 in 1 POUCHPATCH, EXTENDED RELEASE112
45802-580-46Scopolamine Transdermal System10 in 1 CARTONPATCH, EXTENDED RELEASE1012
45802-580-62Scopolamine Transdermal System1 in 1 POUCHPATCH, EXTENDED RELEASE112
45802-580-62Scopolamine Transdermal System24 in 1 CARTONPATCH, EXTENDED RELEASE2412
45802-580-84Scopolamine Transdermal System1 in 1 POUCHPATCH, EXTENDED RELEASE112
45802-580-84Scopolamine Transdermal System4 in 1 CARTONPATCH, EXTENDED RELEASE412

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45802-580-01EA - Each45802-58036538346-8445-40ce-88f8-85f6765f27fb12017-09-11
45802-580-46EA - Each45802-5808e23ad05-ae60-41ec-96ae-3c8ea7555c6812017-08-11
45802-580-62EA - Each45802-580c0827981-ceff-43c9-9627-7005144347a612017-08-11
45802-580-84EA - Each45802-58006c2c56b-451d-40c7-8a89-2194ebc83c1012017-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45802-580SCOPOLAMINE TRANSDERMAL SYSTEM (SCOLOPAMINE TRANSDERMAL SYSTEM) PATCH, EXTENDED RELEASE [PADAGIS ISRAEL PHARMACEUTICALS LTD]9Current NDC, Legacy NDC, 7 package rows20240405_cb93bfad-3e37-4a27-92f6-f21703ae7bdf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
226552scopolamine 1 MG 3 Day Transdermal SystemPSN1099a330-fcb8-4acd-9ef8-525024c6b9d6107
22655272 HR scopolamine 0.0139 MG/HR Transdermal SystemSCD1099a330-fcb8-4acd-9ef8-525024c6b9d6107
226552scopolamine 0.0139 MG/HR 72 HR Transdermal PatchSY1099a330-fcb8-4acd-9ef8-525024c6b9d6107
226552scopolamine 0.3336 MG/Day 72 HR Transdermal PatchSY1099a330-fcb8-4acd-9ef8-525024c6b9d6107
226552scopolamine 1.3 MG 3 Day Transdermal SystemSY1099a330-fcb8-4acd-9ef8-525024c6b9d6107
226552scopolamine 1 MG 3 Day Transdermal SystemPSN81c57d46-1617-4295-8a60-acb7e365551c106
226552scopolamine 1 MG 3 Day Transdermal SystemPSNc89cc74e-9506-48e5-bbb7-26b454b498aa106
22655272 HR scopolamine 0.0139 MG/HR Transdermal SystemSCDc89cc74e-9506-48e5-bbb7-26b454b498aa106
22655272 HR scopolamine 0.0139 MG/HR Transdermal SystemSCD81c57d46-1617-4295-8a60-acb7e365551c106
226552scopolamine 0.0139 MG/HR 72 HR Transdermal PatchSY81c57d46-1617-4295-8a60-acb7e365551c106
226552scopolamine 0.0139 MG/HR 72 HR Transdermal PatchSYc89cc74e-9506-48e5-bbb7-26b454b498aa106
226552scopolamine 0.3336 MG/Day 72 HR Transdermal PatchSY81c57d46-1617-4295-8a60-acb7e365551c106
226552scopolamine 0.3336 MG/Day 72 HR Transdermal PatchSYc89cc74e-9506-48e5-bbb7-26b454b498aa106
226552scopolamine 1.3 MG 3 Day Transdermal SystemSY81c57d46-1617-4295-8a60-acb7e365551c106
226552scopolamine 1.3 MG 3 Day Transdermal SystemSYc89cc74e-9506-48e5-bbb7-26b454b498aa106
226552scopolamine 1 MG 3 Day Transdermal SystemPSN69401d6f-3d18-48b0-b28c-a578c9834f32104
22655272 HR scopolamine 0.0139 MG/HR Transdermal SystemSCD69401d6f-3d18-48b0-b28c-a578c9834f32104
226552scopolamine 0.0139 MG/HR 72 HR Transdermal PatchSY69401d6f-3d18-48b0-b28c-a578c9834f32104
226552scopolamine 0.3336 MG/Day 72 HR Transdermal PatchSY69401d6f-3d18-48b0-b28c-a578c9834f32104
226552scopolamine 1.3 MG 3 Day Transdermal SystemSY69401d6f-3d18-48b0-b28c-a578c9834f32104
226552scopolamine 1 MG 3 Day Transdermal SystemPSN8455ce88-1270-440b-b62e-fe5fef1415ac101
22655272 HR scopolamine 0.0139 MG/HR Transdermal SystemSCD8455ce88-1270-440b-b62e-fe5fef1415ac101
226552scopolamine 0.0139 MG/HR 72 HR Transdermal PatchSY8455ce88-1270-440b-b62e-fe5fef1415ac101
226552scopolamine 0.3336 MG/Day 72 HR Transdermal PatchSY8455ce88-1270-440b-b62e-fe5fef1415ac101
226552scopolamine 1.3 MG 3 Day Transdermal SystemSY8455ce88-1270-440b-b62e-fe5fef1415ac101
226552scopolamine 1 MG 3 Day Transdermal SystemPSNcb93bfad-3e37-4a27-92f6-f21703ae7bdf12
22655272 HR scopolamine 0.0139 MG/HR Transdermal SystemSCDcb93bfad-3e37-4a27-92f6-f21703ae7bdf12
226552scopolamine 0.0139 MG/HR 72 HR Transdermal PatchSYcb93bfad-3e37-4a27-92f6-f21703ae7bdf12
226552scopolamine 0.3336 MG/Day 72 HR Transdermal PatchSYcb93bfad-3e37-4a27-92f6-f21703ae7bdf12
226552scopolamine 1.3 MG 3 Day Transdermal SystemSYcb93bfad-3e37-4a27-92f6-f21703ae7bdf12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45802-580-01458020580011 PATCH, EXTENDED RELEASE in 1 POUCH (45802-580-01) 2017-06-130000-00-00NoNoCurrent
45802-580-464580205804610 POUCH in 1 CARTON (45802-580-46) / 1 PATCH, EXTENDED RELEASE in 1 POUCH10 pouch2017-06-132028-06-30NoNoCurrent
45802-580-624580205806224 POUCH in 1 CARTON (45802-580-62) / 1 PATCH, EXTENDED RELEASE in 1 POUCH24 pouch2017-06-132028-06-30NoNoCurrent
45802-580-84458020580844 POUCH in 1 CARTON (45802-580-84) / 1 PATCH, EXTENDED RELEASE in 1 POUCH4 pouch2017-06-132028-06-30NoNoCurrent