NDC 0378-6470

Scopolamine

Scopolamine

Scopolamine is a Transdermal Patch in the Human Prescription Drug category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is Scopolamine.

Product ID0378-6470_163accb7-45e6-4d97-844d-72b606677008
NDC0378-6470
Product TypeHuman Prescription Drug
Proprietary NameScopolamine
Generic NameScopolamine
Dosage FormPatch
Route of AdministrationTRANSDERMAL
Marketing Start Date2019-06-19
Marketing CategoryANDA / ANDA
Application NumberANDA203753
Labeler NameMylan Pharmaceuticals Inc.
Substance NameSCOPOLAMINE
Active Ingredient Strength1 mg/3d
Pharm ClassesAnticholinergic [EPC],Cholinergic Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0378-6470-44

24 POUCH in 1 CARTON (0378-6470-44) > 1 PATCH in 1 POUCH > 3 d in 1 PATCH
Marketing Start Date2019-06-19
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-6470-99 [00378647099]

Scopolamine PATCH
Marketing CategoryANDA
Application NumberANDA203753
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-06-19

NDC 0378-6470-97 [00378647097]

Scopolamine PATCH
Marketing CategoryANDA
Application NumberANDA203753
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-06-19

NDC 0378-6470-16 [00378647016]

Scopolamine PATCH
Marketing CategoryANDA
Application NumberANDA203753
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-06-19

NDC 0378-6470-44 [00378647044]

Scopolamine PATCH
Marketing CategoryANDA
Application NumberANDA203753
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-06-19

Drug Details

Active Ingredients

IngredientStrength
SCOPOLAMINE1 mg/3d

OpenFDA Data

SPL SET ID:163accb7-45e6-4d97-844d-72b606677008
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 226552

    • Pharmacological Class

    • Anticholinergic [EPC]
    • Cholinergic Antagonists [MoA]
    • Anticholinergic [EPC]
    • Cholinergic Antagonists [MoA]

    NDC Crossover Matching brand name "Scopolamine" or generic name "Scopolamine"

    NDCBrand NameGeneric Name
    0378-6470Scopolaminescopolamine
    0591-2258scopolaminescopolamine
    50090-5349Scopolaminescopolamine
    50742-505ScopolamineScopolamine
    72689-0023KIMITEScopolamine
    0067-4345Transderm Scopscopolamine
    0067-4346Transderm Scopscopolamine
    66758-208Transderm Scopscopolamine
    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.