NDC 0067-4346

Transderm Scop

Scopolamine

Transderm Scop is a Transdermal Patch, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Glaxosmithkline Consumer Healthcare Holdings (us) Llc. The primary component is Scopolamine.

• Product ID: 0067-4346_0d49b3bb-3c9e-4f4d-b928-f532c981b0fe
• NDC: 0067-4346
• Product Type: Human Prescription Drug
• Proprietary Name: Transderm Scop
• Generic Name: Scopolamine
• Dosage Form: Patch, Extended Release
• Route of Administration: TRANSDERMAL
• Marketing Start Date: 2019-03-01
• Marketing Category: NDA / NDA
• Application Number: NDA017874
• Labeler Name: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
• Substance Name: SCOPOLAMINE
• Active Ingredient Strength: 1 mg/3d
• Pharm Classes: Anticholinergic [EPC],Cholinergic Antagonists [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0067-4346-01

1 PATCH in 1 POUCH (0067-4346-01) > 3 d in 1 PATCH

• Marketing Start Date: 2019-03-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0067-4346-04 [00067434604]

Transderm Scop PATCH, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA017874
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2019-03-01

NDC 0067-4346-01 [00067434601]

Transderm Scop PATCH, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA017874
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-03-01

Drug Details

Active Ingredients

Ingredient	Strength
SCOPOLAMINE	1 mg/3d

OpenFDA Data

• SPL SET ID: 7192d89d-ea4b-42b0-b8c1-e7fd41be8a0a
• Manufacturer:
  • GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
• UNII:
  • DL48G20X8X
• RxNorm Concept Unique ID - RxCUI:
  • 226552
  • 351875

Pharmacological Class

• Anticholinergic [EPC]
• Cholinergic Antagonists [MoA]

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

NDC	Brand Name	Generic Name
0067-4345	Transderm Scop	scopolamine
0067-4346	Transderm Scop	scopolamine
10019-553	Transderm Scop	Scopalamine
66758-208	Transderm Scop	scopolamine
72689-0023	KIMITE	Scopolamine
0378-6470	Scopolamine	scopolamine
0591-2258	scopolamine	scopolamine
50090-5349	Scopolamine	scopolamine
50742-505	Scopolamine	Scopolamine