FDA.reportPublic FDA data

Scopolamine

Product NDC
42858-150
11-digit product format
428580150
Labeler code
42858
Product ID
42858-150_1aa687d4-9052-41b4-baaa-cc69c444e623
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Scopolamine
Dosage form
PATCH, EXTENDED RELEASE
Route
TRANSDERMAL
Labeler
Rhodes Pharmaceuticals LLC
Application
ANDA215329
Marketing category
ANDA
Marketing start
2024-11-01
Substance
SCOPOLAMINE
Active strength
1 mg/3d
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 mg/3d

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
42858-150-14Scopolamine10 in 1 BOXPATCH, EXTENDED RELEASE106
42858-150-14Scopolamine1 in 1 POUCHPATCH, EXTENDED RELEASE16
42858-150-40Scopolamine4 in 1 BOXPATCH, EXTENDED RELEASE46
42858-150-40Scopolamine1 in 1 POUCHPATCH, EXTENDED RELEASE16
42858-150-70Scopolamine1 in 1 POUCHPATCH, EXTENDED RELEASE16
42858-150-70Scopolamine24 in 1 BOXPATCH, EXTENDED RELEASE246

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42858-150-14EA - Each42858-15066b42d79-1447-40f9-ac99-4f3a046a386512025-01-14
42858-150-40EA - Each42858-150429a925f-153c-4ec2-918c-429cd82e1e5312025-01-14
42858-150-70EA - Each42858-150d54ebbbc-467a-4e3e-8853-02c4075a9f4812025-01-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42858-150SCOPOLAMINE PATCH, EXTENDED RELEASE [RHODES PHARMACEUTICALS L.P.]3Current NDC, 6 package rows20241102_ba5a1237-4d23-441a-808e-96b97045fbe2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
226552scopolamine 1 MG 3 Day Transdermal SystemPSNa472ee74-76a7-470f-8564-9018940a82e8102
22655272 HR scopolamine 0.0139 MG/HR Transdermal SystemSCDa472ee74-76a7-470f-8564-9018940a82e8102
226552scopolamine 0.0139 MG/HR 72 HR Transdermal PatchSYa472ee74-76a7-470f-8564-9018940a82e8102
226552scopolamine 0.3336 MG/Day 72 HR Transdermal PatchSYa472ee74-76a7-470f-8564-9018940a82e8102
226552scopolamine 1.3 MG 3 Day Transdermal SystemSYa472ee74-76a7-470f-8564-9018940a82e8102
226552scopolamine 1 MG 3 Day Transdermal SystemPSNdd031a59-6b8c-49b1-9b4d-e7a7b75e3801101
226552scopolamine 1 MG 3 Day Transdermal SystemPSN5aa64f85-ae52-4a86-a894-a4e536fbe4ad101
226552scopolamine 1 MG 3 Day Transdermal SystemPSN8d53ee59-e0ef-4332-a6d6-0ac5a6c21b55101
22655272 HR scopolamine 0.0139 MG/HR Transdermal SystemSCD5aa64f85-ae52-4a86-a894-a4e536fbe4ad101
22655272 HR scopolamine 0.0139 MG/HR Transdermal SystemSCD8d53ee59-e0ef-4332-a6d6-0ac5a6c21b55101
22655272 HR scopolamine 0.0139 MG/HR Transdermal SystemSCDdd031a59-6b8c-49b1-9b4d-e7a7b75e3801101
226552scopolamine 0.0139 MG/HR 72 HR Transdermal PatchSY5aa64f85-ae52-4a86-a894-a4e536fbe4ad101
226552scopolamine 0.0139 MG/HR 72 HR Transdermal PatchSYdd031a59-6b8c-49b1-9b4d-e7a7b75e3801101
226552scopolamine 0.0139 MG/HR 72 HR Transdermal PatchSY8d53ee59-e0ef-4332-a6d6-0ac5a6c21b55101
226552scopolamine 0.3336 MG/Day 72 HR Transdermal PatchSY8d53ee59-e0ef-4332-a6d6-0ac5a6c21b55101
226552scopolamine 0.3336 MG/Day 72 HR Transdermal PatchSYdd031a59-6b8c-49b1-9b4d-e7a7b75e3801101
226552scopolamine 0.3336 MG/Day 72 HR Transdermal PatchSY5aa64f85-ae52-4a86-a894-a4e536fbe4ad101
226552scopolamine 1.3 MG 3 Day Transdermal SystemSY8d53ee59-e0ef-4332-a6d6-0ac5a6c21b55101
226552scopolamine 1.3 MG 3 Day Transdermal SystemSY5aa64f85-ae52-4a86-a894-a4e536fbe4ad101
226552scopolamine 1.3 MG 3 Day Transdermal SystemSYdd031a59-6b8c-49b1-9b4d-e7a7b75e3801101
226552scopolamine 1 MG 3 Day Transdermal SystemPSNba5a1237-4d23-441a-808e-96b97045fbe26
22655272 HR scopolamine 0.0139 MG/HR Transdermal SystemSCDba5a1237-4d23-441a-808e-96b97045fbe26
226552scopolamine 0.0139 MG/HR 72 HR Transdermal PatchSYba5a1237-4d23-441a-808e-96b97045fbe26
226552scopolamine 0.3336 MG/Day 72 HR Transdermal PatchSYba5a1237-4d23-441a-808e-96b97045fbe26
226552scopolamine 1.3 MG 3 Day Transdermal SystemSYba5a1237-4d23-441a-808e-96b97045fbe26

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
42858-150-144285801501410 POUCH in 1 BOX (42858-150-14) / 1 PATCH in 1 POUCH / 3 d in 1 PATCH10 pouch2024-11-01NoNoCurrent
42858-150-40428580150404 POUCH in 1 BOX (42858-150-40) / 1 PATCH in 1 POUCH / 3 d in 1 PATCH4 pouch2024-11-01NoNoCurrent
42858-150-704285801507024 POUCH in 1 BOX (42858-150-70) / 1 PATCH in 1 POUCH / 3 d in 1 PATCH24 pouch2024-11-01NoNoCurrent