NDC 50458-347

PANCREAZE

Pancrelipase

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

• Product ID: 50458-347_84df27aa-7ea7-11e8-b709-c19a9d46d017
• NDC: 50458-347
• Product Type: Human Prescription Drug
• Proprietary Name: PANCREAZE
• Generic Name: Pancrelipase
• Dosage Form: Capsule, Delayed Release
• Route of Administration: ORAL
• Marketing Start Date: 2016-08-01
• Marketing End Date: 2020-05-31
• Marketing Category: NDA / NDA
• Application Number: NDA022523
• Labeler Name: Janssen Pharmaceuticals, Inc.
• Substance Name: PANCRELIPASE LIPASE; PANCRELIPASE AMYLASE; PANCRELIPASE PROTEASE
• Active Ingredient Strength: 2600 [USP'U]/1; [USP'U]/1; [USP'U]/1
• NDC Exclude Flag: N

Packaging

NDC 50458-347-60

1 BOTTLE, GLASS in 1 CARTON (50458-347-60) > 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE, GLASS

• Marketing Start Date: 2016-08-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50458-347-60 [50458034760]

PANCREAZE CAPSULE, DELAYED RELEASE

• Marketing Category: NDA
• Application Number: NDA022523
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2016-08-01
• Marketing End Date: 2020-05-31

Drug Details

Active Ingredients

Ingredient	Strength
PANCRELIPASE LIPASE	2600 [USP'U]/1

OpenFDA Data

• SPL SET ID: e1431edd-0fc5-4ebc-8c10-53deb0db0d23
• Manufacturer:
  • Janssen Pharmaceuticals, Inc.
• UNII:
  • 8MYC33932O
  • 3560D81V50
  • YOJ58O116E
• RxNorm Concept Unique ID - RxCUI:
  • 1806926
  • 1806924
  • 1806931
  • 1806921
  • 1806919
  • 1806966
  • 1806929
  • 1806964
  • 1806953
  • 1806955
• UPC Code:
  • 0350458341607

NDC Crossover Matching brand name "PANCREAZE" or generic name "Pancrelipase"

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
62541-405	PANCREAZE	PANCREAZE
62541-404	PANCREAZE	PANCREAZE
62541-401	PANCREAZE	PANCREAZE
62541-402	PANCREAZE	PANCREAZE
62541-403	PANCREAZE	PANCREAZE
0032-1203	Creon	Pancrelipase
0032-1206	Creon	Pancrelipase
0032-1212	Creon	Pancrelipase
0032-1224	Creon	Pancrelipase
0032-3016	Creon	Pancrelipase
17856-1206	Creon	Pancrelipase
17856-1212	Creon	Pancrelipase
17856-1224	Creon	Pancrelipase
58914-112	Viokace	Pancrelipase
58914-117	Viokace	Pancrelipase
42865-300	ZENPEP	pancrelipase
42865-302	ZENPEP	pancrelipase
42865-303	ZENPEP	pancrelipase
42865-304	ZENPEP	pancrelipase
42865-305	ZENPEP	pancrelipase
42865-306	ZENPEP	pancrelipase
42865-307	ZENPEP	pancrelipase