NDC 54766-200

Motofen

Difenoxin And Atropine Sulfate

Motofen is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Sebela Pharmaceuticals Inc.. The primary component is Atropine Sulfate; Difenoxin Hydrochloride.

• Product ID: 54766-200_7cfe62d8-961c-5023-e053-2a91aa0a3575
• NDC: 54766-200
• Product Type: Human Prescription Drug
• Proprietary Name: Motofen
• Generic Name: Difenoxin And Atropine Sulfate
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2017-04-11
• Marketing Category: NDA / NDA
• Application Number: NDA017744
• Labeler Name: Sebela Pharmaceuticals Inc.
• Substance Name: ATROPINE SULFATE; DIFENOXIN HYDROCHLORIDE
• Active Ingredient Strength: 0 mg/1; mg/1
• Pharm Classes: Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA],Antidiarrheal [EPC]
• DEA Schedule: CIV
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 54766-200-04

4 TABLET in 1 BLISTER PACK (54766-200-04)

• Marketing Start Date: 2017-04-11
• NDC Exclude Flag: N
• Sample Package?: Y

NDC SPL Data Element Entries

NDC 54766-200-10 [54766020010]

Motofen TABLET

• Marketing Category: NDA
• Application Number: NDA017744
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-04-11

NDC 54766-200-04 [54766020004]

Motofen TABLET

• Marketing Category: NDA
• Application Number: NDA017744
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-04-11

Drug Details

Active Ingredients

Ingredient	Strength
ATROPINE SULFATE	.025 mg/1

OpenFDA Data

• SPL SET ID: 4cd3f029-a5e3-5812-e054-00144ff8d46c
• Manufacturer:
  • Sebela Pharmaceuticals Inc.
• UNII:
  • 03J5ZE7KA5
  • VQZ63K01IW
• RxNorm Concept Unique ID - RxCUI:
  • 1190740
  • 1190738
• UPC Code:
  • 0354766200106

Pharmacological Class

• Anticholinergic [EPC]
• Cholinergic Antagonists [MoA]
• Cholinergic Muscarinic Antagonist [EPC]
• Cholinergic Muscarinic Antagonists [MoA]
• Antidiarrheal [EPC]
• Anticholinergic [EPC]
• Cholinergic Antagonists [MoA]
• Cholinergic Muscarinic Antagonist [EPC]
• Cholinergic Muscarinic Antagonists [MoA]
• Antidiarrheal [EPC]