FDA.reportPublic FDA data

Scopolamine

Product NDC
70710-1846
11-digit product format
707101846
Labeler code
70710
Product ID
70710-1846_12f01688-9740-4229-b196-f51cff21a122
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Scopolamine
Dosage form
PATCH, EXTENDED RELEASE
Route
TRANSDERMAL
Labeler
Zydus Pharmaceuticals USA Inc.
Application
ANDA217893
Marketing category
ANDA
Marketing start
2024-09-05
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
Scopolamine
Listing expiration
2026-12-31

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
70710-1846-1Scopolamine3 d in 1 PATCHPATCH, EXTENDED RELEASE34
70710-1846-1Scopolamine1 in 1 POUCHPATCH, EXTENDED RELEASE14
70710-1846-2Scopolamine1 in 1 POUCHPATCH, EXTENDED RELEASE14
70710-1846-2Scopolamine10 in 1 CARTONPATCH, EXTENDED RELEASE104
70710-1846-4Scopolamine4 in 1 CARTONPATCH, EXTENDED RELEASE44
70710-1846-7Scopolamine1 in 1 POUCHPATCH, EXTENDED RELEASE14
70710-1846-7Scopolamine24 in 1 CARTONPATCH, EXTENDED RELEASE244

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70710-1846-1EA - Each70710-1846f2234b6b-42fb-4198-af17-5239f6e314c312024-11-05
70710-1846-2EA - Each70710-1846879f0785-07ac-49fe-b08a-e8c8ede0e1e112024-11-05
70710-1846-4EA - Each70710-1846c49c094e-1cd6-4b0c-9a45-5bb2f937232b12024-11-05
70710-1846-7EA - Each70710-1846d2f6723d-8eb0-4d8a-9441-ec3e33e17b9e12024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70710-1846SCOPOLAMINE PATCH, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS USA INC.]2Current NDC, 7 package rows20241013_62d8332e-b8d2-4d13-8071-978d57e51928.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
226552scopolamine 1 MG 3 Day Transdermal SystemPSN62d8332e-b8d2-4d13-8071-978d57e519284
22655272 HR scopolamine 0.0139 MG/HR Transdermal SystemSCD62d8332e-b8d2-4d13-8071-978d57e519284
226552scopolamine 0.0139 MG/HR 72 HR Transdermal PatchSY62d8332e-b8d2-4d13-8071-978d57e519284
226552scopolamine 0.3336 MG/Day 72 HR Transdermal PatchSY62d8332e-b8d2-4d13-8071-978d57e519284
226552scopolamine 1.3 MG 3 Day Transdermal SystemSY62d8332e-b8d2-4d13-8071-978d57e519284

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70710-1846-1707101846013 d in 1 PATCH3 dHistorical
70710-1846-27071018460210 POUCH in 1 CARTON (70710-1846-2) / 1 PATCH in 1 POUCH / 3 d in 1 PATCH10 pouch2024-09-05NoNoCurrent
70710-1846-4707101846044 POUCH in 1 CARTON (70710-1846-4) / 1 PATCH in 1 POUCH (70710-1846-1) / 3 d in 1 PATCH4 pouch2024-09-05NoNoCurrent
70710-1846-77071018460724 POUCH in 1 CARTON (70710-1846-7) / 1 PATCH in 1 POUCH / 3 d in 1 PATCH24 pouch2024-09-05NoNoCurrent