FDA.reportPublic FDA data

Scopolamine

Product NDC
69238-1662
11-digit product format
692381662
Labeler code
69238
Product ID
69238-1662_eef82f5e-a712-475a-9206-91891d462bee
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Scopolamine
Dosage form
PATCH, EXTENDED RELEASE
Route
TRANSDERMAL
Labeler
Amneal Pharmaceuticals NY LLC
Application
ANDA218384
Marketing category
ANDA
Marketing start
2025-06-11
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
69238-1662-2Scopolamine3 d in 1 PATCHPATCH, EXTENDED RELEASE311
69238-1662-2Scopolamine10 in 1 CARTONPATCH, EXTENDED RELEASE1011
69238-1662-4Scopolamine3 d in 1 PATCHPATCH, EXTENDED RELEASE311
69238-1662-4Scopolamine24 in 1 CARTONPATCH, EXTENDED RELEASE2411
69238-1662-9Scopolamine4 in 1 CARTONPATCH, EXTENDED RELEASE411
69238-1662-9Scopolamine3 d in 1 PATCHPATCH, EXTENDED RELEASE311

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69238-1662-2EA - Each69238-16629634add3-e98d-4067-98b7-18b9a918ab4e12026-02-05
69238-1662-4EA - Each69238-16625454bd10-863b-4dd9-9d42-55d9f6e739b712026-02-05
69238-1662-9EA - Each69238-166206df3951-b5c2-4334-92d5-800d0210ec8912026-02-05

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
226552scopolamine 1 MG 3 Day Transdermal SystemPSN48e6e53a-d904-475b-84dd-6068cc0cb36b11
22655272 HR scopolamine 0.0139 MG/HR Transdermal SystemSCD48e6e53a-d904-475b-84dd-6068cc0cb36b11
226552scopolamine 0.0139 MG/HR 72 HR Transdermal PatchSY48e6e53a-d904-475b-84dd-6068cc0cb36b11
226552scopolamine 0.3336 MG/Day 72 HR Transdermal PatchSY48e6e53a-d904-475b-84dd-6068cc0cb36b11
226552scopolamine 1.3 MG 3 Day Transdermal SystemSY48e6e53a-d904-475b-84dd-6068cc0cb36b11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69238-1662-26923816620210 PATCH in 1 CARTON (69238-1662-2) / 3 d in 1 PATCH10 patch2025-06-11NoNoCurrent
69238-1662-46923816620424 PATCH in 1 CARTON (69238-1662-4) / 3 d in 1 PATCH24 patch2025-06-11NoNoCurrent
69238-1662-9692381662094 PATCH in 1 CARTON (69238-1662-9) / 3 d in 1 PATCH4 patch2025-06-11NoNoCurrent