FDA.reportPublic FDA data

PANCREAZE

Product NDC
62541-404
11-digit product format
625410404
Labeler code
62541
Product ID
62541-404_36e934b1-3fbb-8f0c-e063-6294a90a968c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PANCRELIPASE LIPASE, PANCRELIPASE AMYLASE, and PANCRELIPASE PROTEASE
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
VIVUS LLC
Application
BLA022523
Marketing category
BLA
Marketing start
2010-04-12
Substance
PANCRELIPASE AMYLASE; PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE
Active strength
98400; 16800; 56800 [USP'U]/1; [USP'U]/1; [USP'U]/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
PANCREAZE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PANCRELIPASE AMYLASE98400 [USP'U]/1
PANCRELIPASE LIPASE16800 [USP'U]/1
PANCRELIPASE PROTEASE56800 [USP'U]/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3560D81V50, 8MYC33932O, YOJ58O116E
Rxcui1806919, 1806921, 1806924, 1806926, 1806929, 1806931, 1806964, 1806966, 2478453, 2478455, 2564410, 2564412

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0b1603b8-969e-b082-f6f5-ad66d8a6ea8aProduct name220200325
19041f15-771b-3d3a-88fc-f5e2d079cd6dProduct name220200325
1987d950-08e4-4b70-adeb-fb67a71142abProduct name220200325
8825ddf7-1520-4680-b0ee-684e2fa73672Product name220200325
267a6f34-90b4-2f48-3063-4f505d06a7beProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62541-404-10PANCREAZE100 in 1 BOTTLE, GLASSCAPSULE, DELAYED RELEASE10017
62541-404-10PANCREAZE1 in 1 CARTONCAPSULE, DELAYED RELEASE117

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62541-404-10EA - Each62541-404075b6b93-272c-40d1-816b-e829d6ab6a7912019-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62541-404PANCREAZE (PANCRELIPASE LIPASE, PANCRELIPASE AMYLASE, AND PANCRELIPASE PROTEASE) CAPSULE, DELAYED RELEASE [VIVUS LLC]15Current NDC, Legacy NDC, 2 package rows20240321_e8f5d2fe-728d-42af-99a6-83dddc6539c5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2564410amylase 149,900 UNT / lipase 37,000 UNT / protease 97,300 UNT Delayed Release Oral CapsulePSNe8f5d2fe-728d-42af-99a6-83dddc6539c517
2478453amylase 15200 UNT / lipase 2600 UNT / protease 8800 UNT Delayed Release Oral CapsulePSNe8f5d2fe-728d-42af-99a6-83dddc6539c517
1806919lipase 10,500 UNT / amylase 61,500 UNT / protease 35,500 UNT Delayed Release Oral CapsulePSNe8f5d2fe-728d-42af-99a6-83dddc6539c517
1806924lipase 16,800 UNT / amylase 98,400 UNT / protease 56,800 UNT Delayed Release Oral CapsulePSNe8f5d2fe-728d-42af-99a6-83dddc6539c517
1806929lipase 21,000 UNT / amylase 83,900 UNT / protease 54,700 UNT Delayed Release Oral CapsulePSNe8f5d2fe-728d-42af-99a6-83dddc6539c517
1806964lipase 4200 UNT / amylase 24,600 UNT / protease 14,200 UNT Delayed Release Oral CapsulePSNe8f5d2fe-728d-42af-99a6-83dddc6539c517
1806921PANCREAZE 10,500 UNT / 61,500 UNT / 35,500 UNT Delayed Release Oral CapsulePSNe8f5d2fe-728d-42af-99a6-83dddc6539c517
1806926PANCREAZE 16,800 UNT / 98,400 UNT / 56,800 UNT Delayed Release Oral CapsulePSNe8f5d2fe-728d-42af-99a6-83dddc6539c517
2478455PANCREAZE 2,600 UNT / 15,200 UNT / 8,800 UNT Delayed Release Oral CapsulePSNe8f5d2fe-728d-42af-99a6-83dddc6539c517
1806931PANCREAZE 21,000 UNT / 83,900 UNT / 54,700 UNT Delayed Release Oral CapsulePSNe8f5d2fe-728d-42af-99a6-83dddc6539c517
2564412PANCREAZE 37,000 UNT / 149,900 UNT / 97,300 UNT Delayed Release Oral CapsulePSNe8f5d2fe-728d-42af-99a6-83dddc6539c517
1806966PANCREAZE 4200 UNT / 24,600 UNT / 14,200 UNT Delayed Release Oral CapsulePSNe8f5d2fe-728d-42af-99a6-83dddc6539c517
2564412amylase 149900 UNT / lipase 37000 UNT / protease 97300 UNT Delayed Release Oral Capsule [Pancreaze]SBDe8f5d2fe-728d-42af-99a6-83dddc6539c517
2478455amylase 15200 UNT / lipase 2600 UNT / protease 8800 UNT Delayed Release Oral Capsule [Pancreaze]SBDe8f5d2fe-728d-42af-99a6-83dddc6539c517
1806966amylase 24600 UNT / lipase 4200 UNT / protease 14200 UNT Delayed Release Oral Capsule [Pancreaze]SBDe8f5d2fe-728d-42af-99a6-83dddc6539c517
1806921amylase 61500 UNT / lipase 10500 UNT / protease 35500 UNT Delayed Release Oral Capsule [Pancreaze]SBDe8f5d2fe-728d-42af-99a6-83dddc6539c517
1806931amylase 83900 UNT / lipase 21000 UNT / protease 54700 UNT Delayed Release Oral Capsule [Pancreaze]SBDe8f5d2fe-728d-42af-99a6-83dddc6539c517
1806926amylase 98400 UNT / lipase 16800 UNT / protease 56800 UNT Delayed Release Oral Capsule [Pancreaze]SBDe8f5d2fe-728d-42af-99a6-83dddc6539c517
2564410amylase 149900 UNT / lipase 37000 UNT / protease 97300 UNT Delayed Release Oral CapsuleSCDe8f5d2fe-728d-42af-99a6-83dddc6539c517
2478453amylase 15200 UNT / lipase 2600 UNT / protease 8800 UNT Delayed Release Oral CapsuleSCDe8f5d2fe-728d-42af-99a6-83dddc6539c517
1806964amylase 24600 UNT / lipase 4200 UNT / protease 14200 UNT Delayed Release Oral CapsuleSCDe8f5d2fe-728d-42af-99a6-83dddc6539c517
1806919amylase 61500 UNT / lipase 10500 UNT / protease 35500 UNT Delayed Release Oral CapsuleSCDe8f5d2fe-728d-42af-99a6-83dddc6539c517
1806929amylase 83900 UNT / lipase 21000 UNT / protease 54700 UNT Delayed Release Oral CapsuleSCDe8f5d2fe-728d-42af-99a6-83dddc6539c517
1806924amylase 98400 UNT / lipase 16800 UNT / protease 56800 UNT Delayed Release Oral CapsuleSCDe8f5d2fe-728d-42af-99a6-83dddc6539c517
1806964amylase 24,600 UNT / lipase 4200 UNT / protease 14,200 UNT Delayed Release Oral CapsuleSYe8f5d2fe-728d-42af-99a6-83dddc6539c517
1806919amylase 61,500 UNT / lipase 10,500 UNT / protease 35,500 UNT Delayed Release Oral CapsuleSYe8f5d2fe-728d-42af-99a6-83dddc6539c517
1806929amylase 83,900 UNT / lipase 21,000 UNT / protease 54,700 UNT Delayed Release Oral CapsuleSYe8f5d2fe-728d-42af-99a6-83dddc6539c517
1806924amylase 98,400 UNT / lipase 16,800 UNT / protease 56,800 UNT Delayed Release Oral CapsuleSYe8f5d2fe-728d-42af-99a6-83dddc6539c517
1806964amylases 24,600 UNT / endopeptidases 14,200 UNT / lipase 4200 UNT Delayed Release Oral CapsuleSYe8f5d2fe-728d-42af-99a6-83dddc6539c517
1806919amylases 61,500 UNT / endopeptidases 35,500 UNT / lipase 10,500 UNT Delayed Release Oral CapsuleSYe8f5d2fe-728d-42af-99a6-83dddc6539c517
1806929amylases 83,900 UNT / endopeptidases 54,700 UNT / lipase 21,000 UNT Delayed Release Oral CapsuleSYe8f5d2fe-728d-42af-99a6-83dddc6539c517
1806924amylases 98,400 UNT / endopeptidases 56,800 UNT / lipase 16,800 UNT Delayed Release Oral CapsuleSYe8f5d2fe-728d-42af-99a6-83dddc6539c517
2564412Pancreaze (amylase 149,900 UNT / lipase 37,000 UNT / protease 97,300 UNT) Delayed Release Oral CapsuleSYe8f5d2fe-728d-42af-99a6-83dddc6539c517
1806966Pancreaze (amylase 24,600 UNT / lipase 4200 UNT / protease 14,200 UNT) Delayed Release Oral CapsuleSYe8f5d2fe-728d-42af-99a6-83dddc6539c517
1806931Pancreaze (amylase 83,900 UNT / lipase 21,000 UNT / protease 54,7000 UNT) Delayed Release Oral CapsuleSYe8f5d2fe-728d-42af-99a6-83dddc6539c517
1806926Pancreaze (amylase 98,400 UNT / lipase 16,800 UNT / protease 56,800 UNT) Delayed Release Oral CapsuleSYe8f5d2fe-728d-42af-99a6-83dddc6539c517
2478455Pancreaze (amylases 15,200 UNT / endopeptidases 8,800 UNT / lipase 2,600 UNT) Delayed Release Oral CapsuleSYe8f5d2fe-728d-42af-99a6-83dddc6539c517
1806966Pancreaze (amylases 24,600 UNT / endopeptidases 14,200 UNT / lipase 4200 UNT) Delayed Release Oral CapsuleSYe8f5d2fe-728d-42af-99a6-83dddc6539c517
1806921Pancreaze (amylases 61,500 UNT / endopeptidases 35,500 UNT / lipase 10,500 UNT) Delayed Release Oral CapsuleSYe8f5d2fe-728d-42af-99a6-83dddc6539c517
1806931Pancreaze (amylases 83,900 UNT / endopeptidases 54,700 UNT / lipase 21,000 UNT) Delayed Release Oral CapsuleSYe8f5d2fe-728d-42af-99a6-83dddc6539c517
1806926Pancreaze (amylases 98,400 UNT / endopeptidases 56,800 UNT / lipase 16,800 UNT) Delayed Release Oral CapsuleSYe8f5d2fe-728d-42af-99a6-83dddc6539c517
1806921Pancreaze 10 (amylase 61,500 UNT / lipase 10,500 UNT / protease 35,500 UNT) Delayed Release Oral CapsuleSYe8f5d2fe-728d-42af-99a6-83dddc6539c517

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
62541-404-10625410404101 BOTTLE, GLASS in 1 CARTON (62541-404-10) / 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE, GLASS2010-04-120000-00-00NoNoCurrent