FDA.reportPublic FDA data

Scopolamine

Product NDC
0378-6470
11-digit product format
003786470
Labeler code
0378
Product ID
0378-6470_79930eea-4bac-4412-871f-5cd0933bef05
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
scopolamine
Dosage form
PATCH
Route
TRANSDERMAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA203753
Marketing category
ANDA
Marketing start
2019-06-19
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
0378-6470-16Scopolamine3 d in 1 PATCHPATCH37
0378-6470-16Scopolamine1 in 1 POUCHPATCH17
0378-6470-44Scopolamine1 in 1 POUCHPATCH17
0378-6470-44Scopolamine24 in 1 CARTONPATCH247
0378-6470-97Scopolamine10 in 1 CARTONPATCH107
0378-6470-97Scopolamine1 in 1 POUCHPATCH17
0378-6470-99Scopolamine4 in 1 CARTONPATCH47

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-6470-16EA - Each0378-647051a44ff4-9f40-4684-9d50-3220b44be76912019-07-02
0378-6470-44EA - Each0378-6470f743f108-b546-4a91-9d15-25ad00b934ae12019-07-02
0378-6470-97EA - Each0378-64708fa83f65-4df1-44de-ba6a-40ece23a136012019-07-02
0378-6470-99EA - Each0378-6470ad908584-6357-45f6-8b39-33066a341cc912019-07-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-6470SCOPOLAMINE PATCH [MYLAN PHARMACEUTICALS INC.]4Current NDC, Legacy NDC, 7 package rows20250523_163accb7-45e6-4d97-844d-72b606677008.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
226552scopolamine 1 MG 3 Day Transdermal SystemPSN163accb7-45e6-4d97-844d-72b6066770087
22655272 HR scopolamine 0.0139 MG/HR Transdermal SystemSCD163accb7-45e6-4d97-844d-72b6066770087
226552scopolamine 0.0139 MG/HR 72 HR Transdermal PatchSY163accb7-45e6-4d97-844d-72b6066770087
226552scopolamine 0.3336 MG/Day 72 HR Transdermal PatchSY163accb7-45e6-4d97-844d-72b6066770087
226552scopolamine 1.3 MG 3 Day Transdermal SystemSY163accb7-45e6-4d97-844d-72b6066770087
226552scopolamine 1 MG 3 Day Transdermal SystemPSNb24c2315-c947-4ad2-89fe-8dc0c45e221b6
22655272 HR scopolamine 0.0139 MG/HR Transdermal SystemSCDb24c2315-c947-4ad2-89fe-8dc0c45e221b6
226552scopolamine 0.0139 MG/HR 72 HR Transdermal PatchSYb24c2315-c947-4ad2-89fe-8dc0c45e221b6
226552scopolamine 0.3336 MG/Day 72 HR Transdermal PatchSYb24c2315-c947-4ad2-89fe-8dc0c45e221b6
226552scopolamine 1.3 MG 3 Day Transdermal SystemSYb24c2315-c947-4ad2-89fe-8dc0c45e221b6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0378-6470-16003786470163 d in 1 PATCH3 dHistorical
0378-6470-440037864704424 POUCH in 1 CARTON (0378-6470-44) / 1 PATCH in 1 POUCH / 3 d in 1 PATCH24 pouch2019-06-190000-00-00NoNoCurrent
0378-6470-970037864709710 POUCH in 1 CARTON (0378-6470-97) / 1 PATCH in 1 POUCH / 3 d in 1 PATCH10 pouch2019-06-190000-00-00NoNoCurrent
0378-6470-99003786470994 POUCH in 1 CARTON (0378-6470-99) / 1 PATCH in 1 POUCH (0378-6470-16) / 3 d in 1 PATCH4 pouch2019-06-190000-00-00NoNoCurrent