NDC 67296-1210

Lomotil

Lomotil

Lomotil is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Redpharm Drug, Inc.. The primary component is Atropine Sulfate; Diphenoxylate Hydrochloride.

• Product ID: 67296-1210_4f1bbc1d-9586-20b2-e054-00144ff88e88
• NDC: 67296-1210
• Product Type: Human Prescription Drug
• Proprietary Name: Lomotil
• Generic Name: Lomotil
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 1960-09-15
• Marketing Category: NDA / NDA
• Application Number: NDA012462
• Labeler Name: RedPharm Drug, Inc.
• Substance Name: ATROPINE SULFATE; DIPHENOXYLATE 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: CV
• NDC Exclude Flag: E
• Listing Certified Through: 2018-12-31

Packaging

NDC 67296-1210-1

15 TABLET in 1 BOTTLE (67296-1210-1)

• Marketing Start Date: 1960-09-15
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 67296-1210-1 [67296121001]

Lomotil TABLET

• Marketing Category: NDA
• Application Number: NDA012462
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 1960-09-15

Drug Details

Active Ingredients

Ingredient	Strength
ATROPINE SULFATE	.025 mg/1

OpenFDA Data

• SPL SET ID: 4f1bbc1d-9585-20b2-e054-00144ff88e88
• Manufacturer:
  • RedPharm Drug, Inc.
• UNII:
  • 03J5ZE7KA5
  • W24OD7YW48
• RxNorm Concept Unique ID - RxCUI:
  • 1190572
• UPC Code:
  • 0367296121018

Pharmacological Class

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

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

NDC	Brand Name	Generic Name
0025-0061	Lomotil	diphenoxylate hydrochloride and atropine sulfate
67296-1210	Lomotil	Lomotil