FDA.reportPublic FDA data

Scopolamine

Product NDC
50742-505
11-digit product format
507420505
Labeler code
50742
Product ID
50742-505_4c2816f0-78a7-476c-baa3-438d3873a92c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Scopolamine
Dosage form
PATCH, EXTENDED RELEASE
Route
TRANSDERMAL
Labeler
Ingenus Pharmaceuticals, LLC
Application
ANDA212342
Marketing category
ANDA
Marketing start
2020-11-24
Substance
SCOPOLAMINE
Active strength
1.5 mg/1
Pharmacologic classes
Anticholinergic [EPC], Cholinergic Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Scopolamine
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SCOPOLAMINE1.5 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
50742-505-04Scopolamine1 in 1 POUCHPATCH, EXTENDED RELEASE112
50742-505-04Scopolamine4 in 1 CARTONPATCH, EXTENDED RELEASE412
50742-505-10Scopolamine10 in 1 CARTONPATCH, EXTENDED RELEASE1012
50742-505-10Scopolamine1 in 1 POUCHPATCH, EXTENDED RELEASE112
50742-505-24Scopolamine1 in 1 POUCHPATCH, EXTENDED RELEASE112
50742-505-24Scopolamine24 in 1 CARTONPATCH, EXTENDED RELEASE2412

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50742-505SCOPOLAMINE PATCH, EXTENDED RELEASE [INGENUS PHARMACEUTICALS, LLC]8Current NDC, Legacy NDC, 6 package rows20241003_2a6f9aaf-a70a-481f-a82b-1dcaaadc185b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
226552scopolamine 1 MG 3 Day Transdermal SystemPSN2a6f9aaf-a70a-481f-a82b-1dcaaadc185b12
22655272 HR scopolamine 0.0139 MG/HR Transdermal SystemSCD2a6f9aaf-a70a-481f-a82b-1dcaaadc185b12
226552scopolamine 0.0139 MG/HR 72 HR Transdermal PatchSY2a6f9aaf-a70a-481f-a82b-1dcaaadc185b12
226552scopolamine 0.3336 MG/Day 72 HR Transdermal PatchSY2a6f9aaf-a70a-481f-a82b-1dcaaadc185b12
226552scopolamine 1.3 MG 3 Day Transdermal SystemSY2a6f9aaf-a70a-481f-a82b-1dcaaadc185b12
226552scopolamine 1 MG 3 Day Transdermal SystemPSN51289d8b-f7e3-a3e0-e063-6294a90add431
22655272 HR scopolamine 0.0139 MG/HR Transdermal SystemSCD51289d8b-f7e3-a3e0-e063-6294a90add431
226552scopolamine 0.0139 MG/HR 72 HR Transdermal PatchSY51289d8b-f7e3-a3e0-e063-6294a90add431
226552scopolamine 0.3336 MG/Day 72 HR Transdermal PatchSY51289d8b-f7e3-a3e0-e063-6294a90add431
226552scopolamine 1.3 MG 3 Day Transdermal SystemSY51289d8b-f7e3-a3e0-e063-6294a90add431

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50742-505-04507420505044 POUCH in 1 CARTON (50742-505-04) / 1 PATCH, EXTENDED RELEASE in 1 POUCH4 pouch2020-11-240000-00-00NoNoCurrent
50742-505-105074205051010 POUCH in 1 CARTON (50742-505-10) / 1 PATCH, EXTENDED RELEASE in 1 POUCH10 pouch2020-11-240000-00-00NoNoCurrent
50742-505-245074205052424 POUCH in 1 CARTON (50742-505-24) / 1 PATCH, EXTENDED RELEASE in 1 POUCH24 pouch2020-11-240000-00-00NoNoCurrent