NDC 0168-0483

Methscopolamine Bromide

Methscopolamine Bromide

Methscopolamine Bromide is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by E. Fougera & Co. A Division Of Fougera Pharmaceuticals Inc.. The primary component is Methscopolamine Bromide.

• Product ID: 0168-0483_2f0c4bdf-185a-4e44-b7ea-ef3e763762b3
• NDC: 0168-0483
• Product Type: Human Prescription Drug
• Proprietary Name: Methscopolamine Bromide
• Generic Name: Methscopolamine Bromide
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2011-07-27
• Marketing Category: NDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
• Application Number: NDA008848
• Labeler Name: E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
• Substance Name: METHSCOPOLAMINE BROMIDE
• Active Ingredient Strength: 5 mg/1
• Pharm Classes: Anticholinergic [EPC],Cholinergic Antagonists [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 0168-0483-60

5 BLISTER PACK in 1 BOX (0168-0483-60) > 12 TABLET in 1 BLISTER PACK

• Marketing Start Date: 2011-07-27
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0168-0483-60 [00168048360]

Methscopolamine Bromide TABLET

• Marketing Category: NDA authorized generic
• Application Number: NDA008848
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2011-07-27
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
METHSCOPOLAMINE BROMIDE	5 mg/1

OpenFDA Data

• SPL SET ID: 9607b733-0f3a-4a2c-8057-41d0a5df070d
• Manufacturer:
  • E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
• UNII:
  • RTN51LK7WL
• RxNorm Concept Unique ID - RxCUI:
  • 314088
  • 403914
• UPC Code:
  • 0301680482996

Pharmacological Class

• Anticholinergic [EPC]
• Cholinergic Antagonists [MoA]

NDC Crossover Matching brand name "Methscopolamine Bromide" or generic name "Methscopolamine Bromide"

NDC	Brand Name	Generic Name
0168-0482	Methscopolamine Bromide	methscopolamine bromide
0168-0483	Methscopolamine Bromide	methscopolamine bromide
43063-740	METHSCOPOLAMINE BROMIDE	methscopolamine bromide
43063-741	METHSCOPOLAMINE BROMIDE	methscopolamine bromide
51991-191	Methscopolamine Bromide	methscopolamine bromide
51991-192	Methscopolamine Bromide	methscopolamine bromide
64376-603	Methscopolamine Bromide	Methscopolamine Bromide
64376-604	Methscopolamine Bromide	Methscopolamine Bromide
76385-100	METHSCOPOLAMINE BROMIDE	methscopolamine bromide
76385-101	METHSCOPOLAMINE BROMIDE	methscopolamine bromide
10337-061	Pamine	methscopolamine bromide
10337-062	Pamine Forte	methscopolamine bromide