FDA.reportPublic FDA data

Zenpep

Product NDC
73562-115
11-digit product format
735620115
Labeler code
73562
Product ID
73562-115_6b24ef38-2c65-4b1d-804a-a8301db084e6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
pancrelipase lipase, pancrelipase protease, pancrelipase amylase
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Aimmune Therapeutics, Inc.
Application
BLA022210
Marketing category
BLA
Marketing start
2021-01-01
Substance
PANCRELIPASE AMYLASE; PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE
Active strength
24000; 5000; 17000 [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
Zenpep
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PANCRELIPASE AMYLASE24000 [USP'U]/1
PANCRELIPASE LIPASE5000 [USP'U]/1
PANCRELIPASE PROTEASE17000 [USP'U]/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8MYC33932O, 3560D81V50, YOJ58O116E
Rxcui1594671, 1594673, 1595290, 1595292, 1595455, 1595457, 1595460, 1595462, 1595471, 1595473, 1595476, 1595478, 1995477, 1995479, 2669470, 2669472

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9e37788c-b1bf-42ae-aac9-b60601606144Product name820260122
1527ac37-808d-43be-a63e-74e1258dbe46Product name920250219
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
9fcb7a91-de07-4f00-aabf-e4d6fda403d5Product name820230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
0ec3537a-6c9b-432a-896c-b9ea8723049aProduct name920200701
0b1603b8-969e-b082-f6f5-ad66d8a6ea8aProduct name220200325
19041f15-771b-3d3a-88fc-f5e2d079cd6dProduct name220200325
1987d950-08e4-4b70-adeb-fb67a71142abProduct name220200325
8825ddf7-1520-4680-b0ee-684e2fa73672Product name220200325
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
7916de40-e296-41f0-b811-6d0df1a33e2cProduct name920180627
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
267a6f34-90b4-2f48-3063-4f505d06a7beProduct name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73562-115-01Zenpep100 in 1 BOTTLECAPSULE, DELAYED RELEASE1008
73562-115-10Zenpep100 in 1 BOTTLECAPSULE, DELAYED RELEASE1008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
73562-115-01EA - Each73562-1159b6b658f-6b40-4b60-a03d-1343d48d33a812021-07-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73562-115ZENPEP (PANCRELIPASE LIPASE, PANCRELIPASE PROTEASE, PANCRELIPASE AMYLASE) CAPSULE, DELAYED RELEASE [AIMMUNE THERAPEUTICS, INC.]7Current NDC, Legacy NDC, 2 package rows20250124_7f16f2d4-8df6-4bd7-ac10-56994fa257b0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1595460lipase 10,000 UNT / amylase 42,000 UNT / protease 32,000 UNT Delayed Release Oral CapsulePSN7f16f2d4-8df6-4bd7-ac10-56994fa257b08
1595471lipase 15,000 UNT / amylase 63,000 UNT / protease 47,000 UNT Delayed Release Oral CapsulePSN7f16f2d4-8df6-4bd7-ac10-56994fa257b08
1595476lipase 20,000 UNT / amylase 84,000 UNT / protease 63,000 UNT Delayed Release Oral CapsulePSN7f16f2d4-8df6-4bd7-ac10-56994fa257b08
1594671lipase 25,000 UNT / amylase 105,000 UNT / protease 79,000 UNT Delayed Release Oral CapsulePSN7f16f2d4-8df6-4bd7-ac10-56994fa257b08
1595290lipase 3000 UNT / amylase 14,000 UNT / protease 10,000 UNT Delayed Release Oral CapsulePSN7f16f2d4-8df6-4bd7-ac10-56994fa257b08
1995477lipase 40,000 UNT / amylase 168,000 UNT / protease 126,000 UNT Delayed Release Oral CapsulePSN7f16f2d4-8df6-4bd7-ac10-56994fa257b08
1595455lipase 5000 UNT / amylase 24,000 UNT / protease 17,000 UNT Delayed Release Oral CapsulePSN7f16f2d4-8df6-4bd7-ac10-56994fa257b08
2669470lipase 60,000 UNT / amylase 252,600 UNT / protease 189,600 UNT Delayed Release Oral CapsulePSN7f16f2d4-8df6-4bd7-ac10-56994fa257b08
1595462Zenpep 10,000 UNT / 42,000 UNT / 32,000 UNT Delayed Release Oral CapsulePSN7f16f2d4-8df6-4bd7-ac10-56994fa257b08
1595473Zenpep 15,000 UNT / 63,000 UNT / 47,000 UNT Delayed Release Oral CapsulePSN7f16f2d4-8df6-4bd7-ac10-56994fa257b08
1595478Zenpep 20,000 UNT / 84,000 UNT / 63,000 UNT Delayed Release Oral CapsulePSN7f16f2d4-8df6-4bd7-ac10-56994fa257b08
1594673Zenpep 25,000 UNT / 105,000 UNT / 79,000 UNT Delayed Release Oral CapsulePSN7f16f2d4-8df6-4bd7-ac10-56994fa257b08
1595292Zenpep 3000 UNT / 14,000 UNT / 10,000 UNT Delayed Release Oral CapsulePSN7f16f2d4-8df6-4bd7-ac10-56994fa257b08
1995479Zenpep 40,000 UNT / 168,000 UNT / 126,000 UNT Delayed Release Oral CapsulePSN7f16f2d4-8df6-4bd7-ac10-56994fa257b08
1595457Zenpep 5000 UNT / 24,000 UNT / 17,000 UNT Delayed Release Oral CapsulePSN7f16f2d4-8df6-4bd7-ac10-56994fa257b08
2669472Zenpep 60,000 UNT / 252,600 UNT / 189,600 UNT Delayed Release Oral CapsulePSN7f16f2d4-8df6-4bd7-ac10-56994fa257b08
1594673amylase 105000 UNT / lipase 25000 UNT / protease 79000 UNT Delayed Release Oral Capsule [Zenpep]SBD7f16f2d4-8df6-4bd7-ac10-56994fa257b08
1595292amylase 14000 UNT / lipase 3000 UNT / protease 10000 UNT Delayed Release Oral Capsule [Zenpep]SBD7f16f2d4-8df6-4bd7-ac10-56994fa257b08
1995479amylase 168000 UNT / lipase 40000 UNT / protease 126000 UNT Delayed Release Oral Capsule [Zenpep]SBD7f16f2d4-8df6-4bd7-ac10-56994fa257b08
1595457amylase 24000 UNT / lipase 5000 UNT / protease 17000 UNT Delayed Release Oral Capsule [Zenpep]SBD7f16f2d4-8df6-4bd7-ac10-56994fa257b08
2669472amylase 252600 UNT / lipase 60000 UNT / protease 189600 UNT Delayed Release Oral Capsule [Zenpep]SBD7f16f2d4-8df6-4bd7-ac10-56994fa257b08
1595462amylase 42000 UNT / lipase 10000 UNT / protease 32000 UNT Delayed Release Oral Capsule [Zenpep]SBD7f16f2d4-8df6-4bd7-ac10-56994fa257b08
1595473amylase 63000 UNT / lipase 15000 UNT / protease 47000 UNT Delayed Release Oral Capsule [Zenpep]SBD7f16f2d4-8df6-4bd7-ac10-56994fa257b08
1595478amylase 84000 UNT / lipase 20000 UNT / protease 63000 UNT Delayed Release Oral Capsule [Zenpep]SBD7f16f2d4-8df6-4bd7-ac10-56994fa257b08
1594671amylase 105000 UNT / lipase 25000 UNT / protease 79000 UNT Delayed Release Oral CapsuleSCD7f16f2d4-8df6-4bd7-ac10-56994fa257b08
1595290amylase 14000 UNT / lipase 3000 UNT / protease 10000 UNT Delayed Release Oral CapsuleSCD7f16f2d4-8df6-4bd7-ac10-56994fa257b08
1995477amylase 168000 UNT / lipase 40000 UNT / protease 126000 UNT Delayed Release Oral CapsuleSCD7f16f2d4-8df6-4bd7-ac10-56994fa257b08
1595455amylase 24000 UNT / lipase 5000 UNT / protease 17000 UNT Delayed Release Oral CapsuleSCD7f16f2d4-8df6-4bd7-ac10-56994fa257b08
2669470amylase 252600 UNT / lipase 60000 UNT / protease 189600 UNT Delayed Release Oral CapsuleSCD7f16f2d4-8df6-4bd7-ac10-56994fa257b08
1595460amylase 42000 UNT / lipase 10000 UNT / protease 32000 UNT Delayed Release Oral CapsuleSCD7f16f2d4-8df6-4bd7-ac10-56994fa257b08
1595471amylase 63000 UNT / lipase 15000 UNT / protease 47000 UNT Delayed Release Oral CapsuleSCD7f16f2d4-8df6-4bd7-ac10-56994fa257b08
1595476amylase 84000 UNT / lipase 20000 UNT / protease 63000 UNT Delayed Release Oral CapsuleSCD7f16f2d4-8df6-4bd7-ac10-56994fa257b08
1594671amylase 105,000 UNT / lipase 25,000 UNT / protease 79,000 UNT Delayed Release Oral CapsuleSY7f16f2d4-8df6-4bd7-ac10-56994fa257b08
1595290amylase 14,000 UNT / protease 10,000 UNT / lipase 3000 UNT Delayed Release Oral CapsuleSY7f16f2d4-8df6-4bd7-ac10-56994fa257b08
1594671amylases 105,000 UNT / endopeptidases 79,000 UNT / lipase 25,000 UNT Delayed Release Oral CapsuleSY7f16f2d4-8df6-4bd7-ac10-56994fa257b08
1595290amylases 14,000 UNT / endopeptidases 10,000 UNT / lipase 3000 UNT Delayed Release Oral CapsuleSY7f16f2d4-8df6-4bd7-ac10-56994fa257b08
1995477amylases 168,000 UNT / endopeptidases 126,000 UNT / lipase 40,000 UNT Delayed Release Oral CapsuleSY7f16f2d4-8df6-4bd7-ac10-56994fa257b08
1595455amylases 24,000 UNT / endopeptidases 17,000 UNT / lipase 5000 UNT Delayed Release Oral CapsuleSY7f16f2d4-8df6-4bd7-ac10-56994fa257b08
2669470amylases 252,600 UNT / endopeptidases 189,600 UNT / lipase 60,000 UNT Delayed Release Oral CapsuleSY7f16f2d4-8df6-4bd7-ac10-56994fa257b08
1595460amylases 42,000 UNT / endopeptidases 32,000 UNT / lipase 10,000 UNT Delayed Release Oral CapsuleSY7f16f2d4-8df6-4bd7-ac10-56994fa257b08
1595471amylases 63,000 UNT / endopeptidases 47,000 UNT / lipase 15,000 UNT Delayed Release Oral CapsuleSY7f16f2d4-8df6-4bd7-ac10-56994fa257b08
1595476amylases 84,000 UNT / endopeptidases 63,000 UNT / lipase 20,000 UNT Delayed Release Oral CapsuleSY7f16f2d4-8df6-4bd7-ac10-56994fa257b08
1595460lipase 10,000 UNT / amylase 42,000 UNT / protease 32,000 UNT Delayed Release Oral CapsuleSY7f16f2d4-8df6-4bd7-ac10-56994fa257b08
1595471lipase 15,000 UNT / amylase 63,000 UNT / protease 47,000 UNT Delayed Release Oral CapsuleSY7f16f2d4-8df6-4bd7-ac10-56994fa257b08
1595476lipase 20,000 UNT / amylase 84,000 UNT / protease 63,000 UNT Delayed Release Oral CapsuleSY7f16f2d4-8df6-4bd7-ac10-56994fa257b08
1995477lipase 40,000 UNT / amylase 168,000 UNT / protease 126,000 UNT Delayed Release Oral Capsule Category : CapsuleSY7f16f2d4-8df6-4bd7-ac10-56994fa257b08
1595455lipase 5000 UNT / amylase 24,000 UNT / protease 17,000 UNT Delayed Release Oral CapsuleSY7f16f2d4-8df6-4bd7-ac10-56994fa257b08
1594673Zenpep (amylase 105,000 UNT / lipase 25,000 UNT / protease 79,000 UNT) Delayed Release Oral CapsuleSY7f16f2d4-8df6-4bd7-ac10-56994fa257b08
1595292Zenpep (amylase 14,000 UNT / protease 10,000 UNT / lipase 3000 UNT) Delayed Release Oral CapsuleSY7f16f2d4-8df6-4bd7-ac10-56994fa257b08
1995479Zenpep (amylase 168,000 UNT / lipase 40,000 UNT / protease 126,000 UNT) Delayed Release Oral CapsuleSY7f16f2d4-8df6-4bd7-ac10-56994fa257b08
1594673Zenpep (amylases 105,000 UNT / endopeptidases 79,000 UNT / lipase 25,000 UNT) Delayed Release Oral CapsuleSY7f16f2d4-8df6-4bd7-ac10-56994fa257b08
1595292Zenpep (amylases 14,000 UNT / endopeptidases 10,000 UNT / lipase 3000 UNT) Delayed Release Oral CapsuleSY7f16f2d4-8df6-4bd7-ac10-56994fa257b08
1995479Zenpep (amylases 168,000 UNT / endopeptidases 126,000 UNT / lipase 40,000 UNT) Delayed Release Oral CapsuleSY7f16f2d4-8df6-4bd7-ac10-56994fa257b08
1595457Zenpep (amylases 24,000 UNT / endopeptidases 17,000 UNT / lipase 5000 UNT) Delayed Release Oral CapsuleSY7f16f2d4-8df6-4bd7-ac10-56994fa257b08
2669472Zenpep (amylases 252,600 UNT / endopeptidases 189,600 UNT / lipase 60,000 UNT) Delayed Release Oral CapsuleSY7f16f2d4-8df6-4bd7-ac10-56994fa257b08
1595462Zenpep (amylases 42,000 UNT / endopeptidases 32,000 UNT / lipase 10,000 UNT) Delayed Release Oral CapsuleSY7f16f2d4-8df6-4bd7-ac10-56994fa257b08
1595473Zenpep (amylases 63,000 UNT / endopeptidases 47,000 UNT / lipase 15,000 UNT) Delayed Release Oral CapsuleSY7f16f2d4-8df6-4bd7-ac10-56994fa257b08
1595478Zenpep (amylases 84,000 UNT / endopeptidases 63,000 UNT / lipase 20,000 UNT) Delayed Release Oral CapsuleSY7f16f2d4-8df6-4bd7-ac10-56994fa257b08
1595462Zenpep (lipase 10,000 UNT / amylase 42,000 UNT / protease 32,000 UNT) Delayed Release Oral CapsuleSY7f16f2d4-8df6-4bd7-ac10-56994fa257b08
1595473Zenpep (lipase 15,000 UNT / amylase 63,000 UNT / protease 47,000 UNT) Delayed Release Oral CapsuleSY7f16f2d4-8df6-4bd7-ac10-56994fa257b08
1595478Zenpep (lipase 20,000 UNT / amylase 84,000 UNT / protease 63,000 UNT) Delayed Release Oral CapsuleSY7f16f2d4-8df6-4bd7-ac10-56994fa257b08
1595457Zenpep (lipase 5000 UNT / amylase 24,000 UNT / protease 17,000 UNT) Delayed Release Oral CapsuleSY7f16f2d4-8df6-4bd7-ac10-56994fa257b08
1995479Zenpep 40,000 UNT / 168,000 UNT / 126,000 UNT Delayed Release Oral CapsuleSY7f16f2d4-8df6-4bd7-ac10-56994fa257b08
2669472Zenpep 60,000 UNT / 252,600 UNT / 189,600 UNT Delayed Release Oral CapsuleSY7f16f2d4-8df6-4bd7-ac10-56994fa257b08

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
73562-115-0173562011501100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (73562-115-01) 2021-01-010000-00-00NoNoCurrent
73562-115-1073562011510100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (73562-115-10) 2021-02-010000-00-00YesNoCurrent