NDC 62541-404

PANCREAZE

Pancrelipase Lipase, Pancrelipase Amylase, And Pancrelipase Protease

PANCREAZE is a Oral Capsule, Delayed Release in the Human Prescription Drug category. It is labeled and distributed by Vivus, Inc.. The primary component is Pancrelipase Lipase; Pancrelipase Amylase; Pancrelipase Protease.

• Product ID: 62541-404_7ad0b87a-b79f-9800-e053-2991aa0a7bdc
• NDC: 62541-404
• Product Type: Human Prescription Drug
• Proprietary Name: PANCREAZE
• Generic Name: Pancrelipase Lipase, Pancrelipase Amylase, And Pancrelipase Protease
• Dosage Form: Capsule, Delayed Release
• Route of Administration: ORAL
• Marketing Start Date: 2010-04-12
• Marketing Category: NDA / NDA
• Application Number: NDA022523
• Labeler Name: VIVUS, Inc.
• Substance Name: PANCRELIPASE LIPASE; PANCRELIPASE AMYLASE; PANCRELIPASE PROTEASE
• Active Ingredient Strength: 16800 [USP'U]/1; [USP'U]/1; [USP'U]/1
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 62541-404-10

1 BOTTLE, GLASS in 1 CARTON (62541-404-10) > 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE, GLASS

• Marketing Start Date: 2010-04-12
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 62541-404-10 [62541040410]

PANCREAZE CAPSULE, DELAYED RELEASE

• Marketing Category: BLA
• Application Number: BLA022523
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2010-04-12

Drug Details

Active Ingredients

Ingredient	Strength
PANCRELIPASE LIPASE	16800 [USP'U]/1

OpenFDA Data

• SPL SET ID: e8f5d2fe-728d-42af-99a6-83dddc6539c5
• Manufacturer:
  • VIVUS, Inc.
• UNII:
  • 8MYC33932O
  • 3560D81V50
  • YOJ58O116E
• RxNorm Concept Unique ID - RxCUI:
  • 1806926
  • 1806924
  • 1806931
  • 1806921
  • 1806919
  • 1806966
  • 1806929
  • 1806964
  • 1806953
  • 1806955

NDC Crossover Matching brand name "PANCREAZE" or generic name "Pancrelipase Lipase, Pancrelipase Amylase, And Pancrelipase Protease"

NDC	Brand Name	Generic Name
50458-341	PANCREAZE	PANCRELIPASE
50458-342	PANCREAZE	PANCRELIPASE
50458-343	PANCREAZE	PANCRELIPASE
50458-346	PANCREAZE	PANCRELIPASE
50458-347	PANCREAZE	PANCRELIPASE
62541-401	PANCREAZE	PANCRELIPASE LIPASE, PANCRELIPASE AMYLASE, and PANCRELIPASE PROTEASE
62541-402	PANCREAZE	PANCRELIPASE LIPASE, PANCRELIPASE AMYLASE, and PANCRELIPASE PROTEASE
62541-403	PANCREAZE	PANCRELIPASE LIPASE, PANCRELIPASE AMYLASE, and PANCRELIPASE PROTEASE
62541-404	PANCREAZE	PANCRELIPASE LIPASE, PANCRELIPASE AMYLASE, and PANCRELIPASE PROTEASE
62541-405	PANCREAZE	PANCRELIPASE LIPASE, PANCRELIPASE AMYLASE, and PANCRELIPASE PROTEASE