FDA.reportPublic FDA data

Transderm Scop

Product NDC
0067-4345
11-digit product format
000674345
Labeler code
0067
Product ID
0067-4345_99ea3737-e82b-44eb-b125-b20e43e5044d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
scopolamine
Dosage form
PATCH, EXTENDED RELEASE
Route
TRANSDERMAL
Labeler
Novatris Consumer Health, Inc.
Application
NDA017874
Marketing category
NDA
Marketing start
2007-10-02
Marketing end
0000-00-00
Substance
SCOPOLAMINE
Active strength
1 mg/3d
Pharmacologic classes
Anticholinergic [EPC],Cholinergic Antagonists [MoA]
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fe8ea78e-e1a4-44bf-a6b2-42eed76976bbProduct name520250218

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0067-4345-042020-10-20C16284748780-19d75b9d0-ea91-f424-e053-dadaa90a57ce4d705c57-fa98-46e0-97f3-38e1b0ada76b
0067-4345-092020-10-20C16284748780-19d75b9d0-ea91-f424-e053-dadaa90a57ce4d705c57-fa98-46e0-97f3-38e1b0ada76b
0067-4345-042020-01-31C16284748780-19d75b9d0-ea91-f424-e053-dadaa90a57ce4d705c57-fa98-46e0-97f3-38e1b0ada76b
0067-4345-092020-01-31C16284748780-19d75b9d0-ea91-f424-e053-dadaa90a57ce4d705c57-fa98-46e0-97f3-38e1b0ada76b

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0067-4345-04EA - Each0067-43453ec99ef9-9916-4022-8cb9-25f09e0615e712013-02-13
0067-4345-09EA - Each0067-4345be7394c0-eaf2-4939-832b-e3287261292012016-02-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SCOPOLAMINEACTIVE INGREDIENTDL48G20X8XTRANSDERM SCOP (SCOPOLAMINE) PATCH, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
scopolamineACTIVE MOIETYDL48G20X8XTRANSDERM SCOP (SCOPOLAMINE) PATCH, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
CHLOROFORMINACTIVE INGREDIENT7V31YC746XTRANSDERM SCOP (SCOPOLAMINE) PATCH, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
LIGHT MINERAL OILINACTIVE INGREDIENTN6K5787QVPTRANSDERM SCOP (SCOPOLAMINE) PATCH, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
POLYISOBUTYLENE (1100000 MW)INACTIVE INGREDIENTFLT10CH37XTRANSDERM SCOP (SCOPOLAMINE) PATCH, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
POLYISOBUTYLENE (35000 MW)INACTIVE INGREDIENT98553S1MHQTRANSDERM SCOP (SCOPOLAMINE) PATCH, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
226552scopolamine 1 MG 3 Day Transdermal SystemPSNf6fdc88b-ea00-4694-8f21-b8d15dbb339e1
351875TRANSDERM SCOP 1 MG 3 Day Transdermal SystemPSNf6fdc88b-ea00-4694-8f21-b8d15dbb339e1
35187572 HR scopolamine 0.0139 MG/HR Transdermal System [Transderm Scop]SBDf6fdc88b-ea00-4694-8f21-b8d15dbb339e1
22655272 HR scopolamine 0.0139 MG/HR Transdermal SystemSCDf6fdc88b-ea00-4694-8f21-b8d15dbb339e1
35187572 HR Transderm Scop 0.0139 MG/HR Transdermal SystemSYf6fdc88b-ea00-4694-8f21-b8d15dbb339e1
226552scopolamine 0.0139 MG/HR 72 HR Transdermal PatchSYf6fdc88b-ea00-4694-8f21-b8d15dbb339e1
226552scopolamine 0.3336 MG/Day 72 HR Transdermal PatchSYf6fdc88b-ea00-4694-8f21-b8d15dbb339e1
226552scopolamine 1.3 MG 3 Day Transdermal SystemSYf6fdc88b-ea00-4694-8f21-b8d15dbb339e1
351875Transderm Scop 0.0139 MG/HR 72 HR Transdermal PatchSYf6fdc88b-ea00-4694-8f21-b8d15dbb339e1
351875Transderm Scop 0.33 MG/Day 72 HR Transdermal PatchSYf6fdc88b-ea00-4694-8f21-b8d15dbb339e1
351875Transderm Scop 1.3 MG 3 Day Transdermal SystemSYf6fdc88b-ea00-4694-8f21-b8d15dbb339e1