RESTful Lookup — Test-Drive (2007 – 2026)

{
  "NDC": [
    {
      "NDCCode": "87069-126-63",
      "PackageDescription": "6 POUCH in 1 CARTON (87069-126-63)  / 3 BAG in 1 POUCH / 70 mL in 1 BAG",
      "NDC11Code": "87069-0126-63",
      "ProductNDC": "87069-126",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Leukotrap Wb System - Cp2d",
      "NonProprietaryName": "Cp2d/as-3 - Anticoagulant And Additive System",
      "DosageFormName": "SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20251128",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "BN820915",
      "LabelerName": "GVS TM INC",
      "SubstanceName": "DEXTROSE, UNSPECIFIED FORM",
      "StrengthNumber": "3.57",
      "StrengthUnit": "g/70mL",
      "Status": "Active",
      "LastUpdate": "2026-08-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20251128",
      "SamplePackage": "N",
      "Description": "Leukotrap WB system."
    },
    {
      "NDCCode": "87069-126-62",
      "PackageDescription": "6 POUCH in 1 CARTON (87069-126-62)  / 3 BAG in 1 POUCH / 70 mL in 1 BAG",
      "NDC11Code": "87069-0126-62",
      "ProductNDC": "87069-126",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Leukotrap Wb System - Cp2d",
      "NonProprietaryName": "Cp2d/as-3 - Anticoagulant And Additive System",
      "DosageFormName": "SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20260623",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "BN820915",
      "LabelerName": "GVS TM INC",
      "SubstanceName": "DEXTROSE, UNSPECIFIED FORM",
      "StrengthNumber": "3.57",
      "StrengthUnit": "g/70mL",
      "Status": "Active",
      "LastUpdate": "2026-08-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260623",
      "SamplePackage": "N",
      "Description": "Leukotrap WB system."
    },
    {
      "NDCCode": "43744-126-63",
      "PackageDescription": "3000 g in 1 DRUM (43744-126-63)",
      "NDC11Code": "43744-0126-63",
      "ProductNDC": "43744-126",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Carbimazole",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20110707",
      "EndMarketingDate": "20130624",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "CBSCHEM LIMITED",
      "SubstanceName": "CARBIMAZOLE",
      "StrengthNumber": "1",
      "StrengthUnit": "g/g",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20130624"
    },
    {
      "NDCCode": "53157-126-63",
      "PackageDescription": "18 POUCH in 1 BOX (53157-126-63)  / 3 BAG in 1 POUCH / 70 mL in 1 BAG",
      "NDC11Code": "53157-0126-63",
      "ProductNDC": "53157-126",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Leukotrap Wb System - Cp2d",
      "NonProprietaryName": "Cp2d/as-3 Anticoagulant And Additive System",
      "DosageFormName": "SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20151007",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "BN820915",
      "LabelerName": "Haemonetics Manufacturing Inc",
      "SubstanceName": "DEXTROSE, UNSPECIFIED FORM",
      "StrengthNumber": "3.57",
      "StrengthUnit": "g/70mL",
      "Status": "Deprecated",
      "LastUpdate": "2025-07-30",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20151007",
      "SamplePackage": "N",
      "IndicationAndUsage": "For collection of blood and preparation of red blood cells and plasma with pre-storage leukocyte reduction.",
      "Description": "CP2D/AS-3 Blood Bag Unit with In-Line WBF Filter and Sampling System. Instruction for Use for Systems Containing a Y Sampling Site (YSS) or Sample Diversion Pouch (with or without a pre-attached Samp Lok Vacuum Tube Holder). Refer to unit foil package label for specific product description being used. Sterile, nonpyrogenic fluid path. Sterilized by steam. Rx only. This product is free of natural rubber latex."
    },
    {
      "NDCCode": "87069-121-63",
      "PackageDescription": "8 POUCH in 1 CARTON (87069-121-63)  / 3 BAG in 1 POUCH / 70 mL in 1 BAG",
      "NDC11Code": "87069-0121-63",
      "ProductNDC": "87069-121",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Blood Collection System",
      "NonProprietaryName": "Cp2d/as-3 Triple With Sampling System",
      "DosageFormName": "SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20260623",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "BN820915",
      "LabelerName": "GVS TM INC",
      "SubstanceName": "DEXTROSE, UNSPECIFIED FORM",
      "StrengthNumber": "3.57",
      "StrengthUnit": "g/70mL",
      "Status": "Active",
      "LastUpdate": "2026-06-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260623",
      "SamplePackage": "N",
      "Description": "Blood Collection System with Nutricel Additive Solution. CPD2/AS-3 Triple with Sampling System."
    },
    {
      "NDCCode": "87069-123-63",
      "PackageDescription": "6 POUCH in 1 CARTON (87069-123-63)  / 3 BAG in 1 POUCH / 70 mL in 1 BAG",
      "NDC11Code": "87069-0123-63",
      "ProductNDC": "87069-123",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Leukotrap Rc Pl System",
      "NonProprietaryName": "Cp2d/as-3 Anticoagulant And Additive System",
      "DosageFormName": "SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20260623",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "BN820915",
      "LabelerName": "GVS TM INC",
      "SubstanceName": "DEXTROSE, UNSPECIFIED FORM",
      "StrengthNumber": "3.57",
      "StrengthUnit": "g/70mL",
      "Status": "Active",
      "LastUpdate": "2026-08-15",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260623",
      "SamplePackage": "N",
      "Description": "Leukotrap RC PL system."
    },
    {
      "NDCCode": "87069-129-63",
      "PackageDescription": "6 POUCH in 1 CARTON (87069-129-63)  / 3 BAG in 1 POUCH / 70 mL in 1 BAG",
      "NDC11Code": "87069-0129-63",
      "ProductNDC": "87069-129",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Leukotrap Rc System",
      "NonProprietaryName": "Cp2d/as-3 Anticoagulant And Additive System",
      "DosageFormName": "SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20260302",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "BN820915",
      "LabelerName": "GVS TM INC",
      "SubstanceName": "DEXTROSE, UNSPECIFIED FORM",
      "StrengthNumber": "3.57",
      "StrengthUnit": "g/70mL",
      "Status": "Active",
      "LastUpdate": "2026-08-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260302",
      "SamplePackage": "N",
      "Description": "Leukotrap RC System CP2D/AS-3 - Triple blood bag unit with In-Line RC2D filter and sampling system."
    },
    {
      "NDCCode": "87069-726-62",
      "PackageDescription": "6 POUCH in 1 CARTON (87069-726-62)  / 3 BAG in 1 POUCH / 63 mL in 1 BAG",
      "NDC11Code": "87069-0726-62",
      "ProductNDC": "87069-726",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Leukotrap Wb System - Cp2d",
      "NonProprietaryName": "Cp2d/as-3 Anticoagulant And Additive System",
      "DosageFormName": "SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20260602",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "BN820915",
      "LabelerName": "GVS TM INC",
      "SubstanceName": "DEXTROSE, UNSPECIFIED FORM",
      "StrengthNumber": "3.21",
      "StrengthUnit": "g/63mL",
      "Status": "Active",
      "LastUpdate": "2026-07-13",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260602",
      "SamplePackage": "N",
      "Description": "CP2D/AS-3 Blood Bag Unit with In-Line WBF Filter (WBF2) and Sampling System."
    },
    {
      "NDCCode": "87069-726-63",
      "PackageDescription": "6 POUCH in 1 CARTON (87069-726-63)  / 3 BAG in 1 POUCH / 63 mL in 1 BAG",
      "NDC11Code": "87069-0726-63",
      "ProductNDC": "87069-726",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Leukotrap Wb System - Cp2d",
      "NonProprietaryName": "Cp2d/as-3 Anticoagulant And Additive System",
      "DosageFormName": "SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20260624",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "BN820915",
      "LabelerName": "GVS TM INC",
      "SubstanceName": "DEXTROSE, UNSPECIFIED FORM",
      "StrengthNumber": "3.21",
      "StrengthUnit": "g/63mL",
      "Status": "Active",
      "LastUpdate": "2026-08-17",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260624",
      "SamplePackage": "N",
      "Description": "CP2D/AS-3 Triple Blood Bag Unit with In-Line WBF Filter (WBF2) and sampling system."
    },
    {
      "NDCCode": "87069-736-62",
      "PackageDescription": "6 POUCH in 1 CARTON (87069-736-62)  / 3 BAG in 1 POUCH / 63 mL in 1 BAG",
      "NDC11Code": "87069-0736-62",
      "ProductNDC": "87069-736",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Leukotrap Wb System",
      "NonProprietaryName": "Cpda-1 Blood Bag Collection System",
      "DosageFormName": "SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20260624",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "BN800077",
      "LabelerName": "GVS TM INC",
      "SubstanceName": "DEXTROSE MONOHYDRATE; ADENINE; SODIUM CITRATE; CITRIC ACID MONOHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE",
      "StrengthNumber": "2.01; .017; 1.66; .206; .14",
      "StrengthUnit": "g/63mL; g/63mL; g/63mL; g/63mL; g/63mL",
      "Pharm_Classes": "Acidifying Activity [MoA], Acidifying Activity [MoA], Anti-coagulant [EPC], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE], Decreased Coagulation Factor Activity [PE]",
      "Status": "Active",
      "LastUpdate": "2026-08-17",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260624",
      "SamplePackage": "N",
      "Description": "CPDA-1 Blood Bag Unit with in-line WBF Filter (WBF2) and sampling System."
    },
    {
      "NDCCode": "50563-126-01",
      "PackageDescription": "29 mL in 1 BOTTLE (50563-126-01)",
      "NDC11Code": "50563-0126-01",
      "ProductNDC": "50563-126",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Body Luxuries French Lavender Antibacterial Hand Sanitizer",
      "NonProprietaryName": "Alcohol",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20121218",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333E",
      "LabelerName": "ENCHANTE ACCESSORIES INC.",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "63",
      "StrengthUnit": "mL/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Uses. To decrease bacteria on the skin that could cause diseases."
    },
    {
      "NDCCode": "70934-126-14",
      "PackageDescription": "14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70934-126-14) ",
      "NDC11Code": "70934-0126-14",
      "ProductNDC": "70934-126",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Amoxicillin And Clavulanate Potassium",
      "NonProprietaryName": "Amoxicillin And Clavulanate Potassium",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20190827",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA205707",
      "LabelerName": "Denton Pharma, Inc. DBA Northwind Pharmaceuticals",
      "SubstanceName": "AMOXICILLIN; CLAVULANATE POTASSIUM",
      "StrengthNumber": "500; 125",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2023-01-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20190827",
      "SamplePackage": "N",
      "IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium tablets USP, and other antibacterial drugs, amoxicillin and clavulanate potassium should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Amoxicillin and clavulanate potassium tablets USP is a combination penicillin-class antibacterial and beta-lactamase inhibitor indicated in the treatment of infections due to susceptible isolates of the designated bacteria in the conditions listed below*.",
      "Description": "Amoxicillin and clavulanate potassium tablets, USP is an oral antibacterial combination consisting of amoxicillin and the β-lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin, USP is an analog of ampicillin, derived from the basic penicillin nucleus, 6-aminopenicillanic acid. Chemically, amoxicillin, USP is ( 2S, 5R, 6R)-6-[( R)-(-)-2-Amino-2-( p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate and may be represented structurally as:. C 16H 19N 3O 5S3H 2O                M.W. 419.45 Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus. It is a beta-lactam structurally related to the penicillins and possesses the ability to inactivate some beta-lactamases by blocking the active sites of these enzymes. The clavulanate potassium molecular formula is C 8H 8KNO 5, and the molecular weight is 237.25. Chemically, clavulanate potassium, USP is potassium ( Z)-(2 R,5 R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate, and may be represented structurally as:. C  8H  8KNO  5                             M.W. 237.25  Each tablet contains 250 mg, 500 mg or 875 mg amoxicillin, USP as the trihydrate and 125 mg clavulanic acid as the potassium salt. Each Amoxicillin and Clavulanate Potassium Tablet USP contains 0.63 mEq potassium.  Inactive Ingredients: colloidal silicon dioxide, ethylcellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, talc and titanium dioxide.  Meets USP Dissolution Test 1."
    },
    {
      "NDCCode": "70934-126-30",
      "PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70934-126-30) ",
      "NDC11Code": "70934-0126-30",
      "ProductNDC": "70934-126",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Amoxicillin And Clavulanate Potassium",
      "NonProprietaryName": "Amoxicillin And Clavulanate Potassium",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20190827",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA205707",
      "LabelerName": "Denton Pharma, Inc. DBA Northwind Pharmaceuticals",
      "SubstanceName": "AMOXICILLIN; CLAVULANATE POTASSIUM",
      "StrengthNumber": "500; 125",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2023-01-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20191209",
      "SamplePackage": "N",
      "IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium tablets USP, and other antibacterial drugs, amoxicillin and clavulanate potassium should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Amoxicillin and clavulanate potassium tablets USP is a combination penicillin-class antibacterial and beta-lactamase inhibitor indicated in the treatment of infections due to susceptible isolates of the designated bacteria in the conditions listed below*.",
      "Description": "Amoxicillin and clavulanate potassium tablets, USP is an oral antibacterial combination consisting of amoxicillin and the β-lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin, USP is an analog of ampicillin, derived from the basic penicillin nucleus, 6-aminopenicillanic acid. Chemically, amoxicillin, USP is ( 2S, 5R, 6R)-6-[( R)-(-)-2-Amino-2-( p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate and may be represented structurally as:. C 16H 19N 3O 5S3H 2O                M.W. 419.45 Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus. It is a beta-lactam structurally related to the penicillins and possesses the ability to inactivate some beta-lactamases by blocking the active sites of these enzymes. The clavulanate potassium molecular formula is C 8H 8KNO 5, and the molecular weight is 237.25. Chemically, clavulanate potassium, USP is potassium ( Z)-(2 R,5 R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate, and may be represented structurally as:. C  8H  8KNO  5                             M.W. 237.25  Each tablet contains 250 mg, 500 mg or 875 mg amoxicillin, USP as the trihydrate and 125 mg clavulanic acid as the potassium salt. Each Amoxicillin and Clavulanate Potassium Tablet USP contains 0.63 mEq potassium.  Inactive Ingredients: colloidal silicon dioxide, ethylcellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, talc and titanium dioxide.  Meets USP Dissolution Test 1."
    },
    {
      "NDCCode": "73562-110-01",
      "PackageDescription": "100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (73562-110-01) ",
      "NDC11Code": "73562-0110-01",
      "ProductNDC": "73562-110",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Zenpep",
      "NonProprietaryName": "Pancrelipase Lipase, Pancrelipase Protease, Pancrelipase Amylase",
      "DosageFormName": "CAPSULE, DELAYED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20210101",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA022210",
      "LabelerName": "Aimmune Therapeutics, Inc.",
      "SubstanceName": "PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE; PANCRELIPASE AMYLASE",
      "StrengthNumber": "10000; 32000; 42000",
      "StrengthUnit": "[USP'U]/1; [USP'U]/1; [USP'U]/1",
      "Status": "Active",
      "LastUpdate": "2025-11-21",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20210101",
      "SamplePackage": "N",
      "IndicationAndUsage": "ZENPEP® is indicated for the treatment of exocrine pancreatic insufficiency in adult and pediatric patients.",
      "Description": "Pancrelipase is a pancreatic enzyme product consisting of a mixture of enzymes including lipases, proteases, and amylases, and is an extract derived from porcine pancreatic glands. The enteric-coated pellets in ZENPEP are formulated to release pancreatic enzymes at an approximate pH of 5.5 or greater. ZENPEP (pancrelipase) delayed-release capsule for oral administration, include a two-piece shell containing light brown-colored enteric-coated pellets (1.8 to 1.9mm for 3,000 and 5,000 USP units of lipase, 2.2 to 2.5 mm for 10,000, 15,000, 20,000, 25,000, 40,000 and 60,000 USP units of lipase) and are available as follows. 3,000 USP units of lipase; 10,000 USP units of protease; and 14,000 USP units of amylase; delayed-release capsules have a white opaque cap and a white opaque body with imprint \"APTALIS 3\". The shells contain carnauba wax or talc, carrageenan, hypromellose, potassium chloride, titanium oxide, and water. The colorant of the printed ink is red iron oxide. 5,000 USP units of lipase; 17,000 USP units of protease; and 24,000 USP units of amylase; delayed-release capsules have a white opaque cap and a white opaque body with imprint \"APTALIS 5\". The shells contain carnauba wax or talc, carrageenan, hypromellose, potassium chloride, titanium oxide, and water. The colorant of the printed ink is FD&C Blue 2. 10,000 USP units of lipase; 32,000 USP units of protease; and 42,000 USP units of amylase; delayed-release capsules have a yellow opaque cap and a white opaque body with imprint \"APTALIS 10\". The shells contain carnauba wax or talc, carrageenan, hypromellose, potassium chloride, titanium oxide, water and yellow ferric oxide. The colorant of the printed ink is FD&C Blue 2. 15,000 USP units of lipase; 47,000 USP units of protease; and 63,000 USP units of amylase; delayed-release capsules have a red opaque cap and a white opaque body with imprint \"APTALIS 15\". The shells contain carnauba wax or talc, carrageenan, hypromellose, potassium chloride, red ferric oxide, titanium oxide, and water. The colorant of the printed ink is FD&C Blue 2. 20,000 USP units of lipase; 63,000 USP units of protease; and 84,000 USP units of amylase; delayed-release capsules have a green opaque cap and a white opaque body with imprint \"APTALIS 20\". The shells contain carnauba wax or talc, carrageenan, FD&C Blue #2, hypromellose, potassium chloride, titanium oxide, water, and yellow ferric oxide. The colorant of the printed ink is FD&C Blue 2. 25,000 USP units of lipase; 79,000 USP units of protease; and 105,000 USP units of amylase; delayed-release capsules have a blue opaque cap and a white opaque body with imprint \"APTALIS 25\". The shells contain carnauba wax or talc, carrageenan, FD&C Blue #2, hypromellose, potassium chloride, titanium oxide, and water. The colorant of the printed ink is FD&C Blue 2. 40,000 USP units of lipase; 126,000 USP units of protease; and 168,000 USP units of amylase; delayed-release capsules have an orange opaque cap and white opaque body, printed with \"APTALIS 40\". The shells contain FD&C Yellow #6, hypromellose, and titanium oxide. The colorant of the printed ink is FD&C Blue 2. 60,000 USP units of lipase; 189,600 USP units of protease; 252,600 USP units of amylase. Capsules have a powder blue opaque cap with two black stripes and white opaque body, printed with \"APTALIS 60\" The shells contain FD&C Blue #1, hypromellose, and titanium oxide. The colorant of the printed ink is black iron oxide. ZENPEP (pancrelipase) delayed-release capsules include the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hydrogenated castor oil, hypromellose phthalate, magnesium stearate, microcrystalline cellulose, talc, and triethyl citrate."
    },
    {
      "NDCCode": "73562-110-10",
      "PackageDescription": "100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (73562-110-10) ",
      "NDC11Code": "73562-0110-10",
      "ProductNDC": "73562-110",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Zenpep",
      "NonProprietaryName": "Pancrelipase Lipase, Pancrelipase Protease, Pancrelipase Amylase",
      "DosageFormName": "CAPSULE, DELAYED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20210101",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA022210",
      "LabelerName": "Aimmune Therapeutics, Inc.",
      "SubstanceName": "PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE; PANCRELIPASE AMYLASE",
      "StrengthNumber": "10000; 32000; 42000",
      "StrengthUnit": "[USP'U]/1; [USP'U]/1; [USP'U]/1",
      "Status": "Active",
      "LastUpdate": "2025-11-21",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20210201",
      "SamplePackage": "Y",
      "IndicationAndUsage": "ZENPEP® is indicated for the treatment of exocrine pancreatic insufficiency in adult and pediatric patients.",
      "Description": "Pancrelipase is a pancreatic enzyme product consisting of a mixture of enzymes including lipases, proteases, and amylases, and is an extract derived from porcine pancreatic glands. The enteric-coated pellets in ZENPEP are formulated to release pancreatic enzymes at an approximate pH of 5.5 or greater. ZENPEP (pancrelipase) delayed-release capsule for oral administration, include a two-piece shell containing light brown-colored enteric-coated pellets (1.8 to 1.9mm for 3,000 and 5,000 USP units of lipase, 2.2 to 2.5 mm for 10,000, 15,000, 20,000, 25,000, 40,000 and 60,000 USP units of lipase) and are available as follows. 3,000 USP units of lipase; 10,000 USP units of protease; and 14,000 USP units of amylase; delayed-release capsules have a white opaque cap and a white opaque body with imprint \"APTALIS 3\". The shells contain carnauba wax or talc, carrageenan, hypromellose, potassium chloride, titanium oxide, and water. The colorant of the printed ink is red iron oxide. 5,000 USP units of lipase; 17,000 USP units of protease; and 24,000 USP units of amylase; delayed-release capsules have a white opaque cap and a white opaque body with imprint \"APTALIS 5\". The shells contain carnauba wax or talc, carrageenan, hypromellose, potassium chloride, titanium oxide, and water. The colorant of the printed ink is FD&C Blue 2. 10,000 USP units of lipase; 32,000 USP units of protease; and 42,000 USP units of amylase; delayed-release capsules have a yellow opaque cap and a white opaque body with imprint \"APTALIS 10\". The shells contain carnauba wax or talc, carrageenan, hypromellose, potassium chloride, titanium oxide, water and yellow ferric oxide. The colorant of the printed ink is FD&C Blue 2. 15,000 USP units of lipase; 47,000 USP units of protease; and 63,000 USP units of amylase; delayed-release capsules have a red opaque cap and a white opaque body with imprint \"APTALIS 15\". The shells contain carnauba wax or talc, carrageenan, hypromellose, potassium chloride, red ferric oxide, titanium oxide, and water. The colorant of the printed ink is FD&C Blue 2. 20,000 USP units of lipase; 63,000 USP units of protease; and 84,000 USP units of amylase; delayed-release capsules have a green opaque cap and a white opaque body with imprint \"APTALIS 20\". The shells contain carnauba wax or talc, carrageenan, FD&C Blue #2, hypromellose, potassium chloride, titanium oxide, water, and yellow ferric oxide. The colorant of the printed ink is FD&C Blue 2. 25,000 USP units of lipase; 79,000 USP units of protease; and 105,000 USP units of amylase; delayed-release capsules have a blue opaque cap and a white opaque body with imprint \"APTALIS 25\". The shells contain carnauba wax or talc, carrageenan, FD&C Blue #2, hypromellose, potassium chloride, titanium oxide, and water. The colorant of the printed ink is FD&C Blue 2. 40,000 USP units of lipase; 126,000 USP units of protease; and 168,000 USP units of amylase; delayed-release capsules have an orange opaque cap and white opaque body, printed with \"APTALIS 40\". The shells contain FD&C Yellow #6, hypromellose, and titanium oxide. The colorant of the printed ink is FD&C Blue 2. 60,000 USP units of lipase; 189,600 USP units of protease; 252,600 USP units of amylase. Capsules have a powder blue opaque cap with two black stripes and white opaque body, printed with \"APTALIS 60\" The shells contain FD&C Blue #1, hypromellose, and titanium oxide. The colorant of the printed ink is black iron oxide. ZENPEP (pancrelipase) delayed-release capsules include the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hydrogenated castor oil, hypromellose phthalate, magnesium stearate, microcrystalline cellulose, talc, and triethyl citrate."
    },
    {
      "NDCCode": "73562-111-01",
      "PackageDescription": "100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (73562-111-01) ",
      "NDC11Code": "73562-0111-01",
      "ProductNDC": "73562-111",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Zenpep",
      "NonProprietaryName": "Pancrelipase Lipase, Pancrelipase Protease, Pancrelipase Amylase",
      "DosageFormName": "CAPSULE, DELAYED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20201201",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA022210",
      "LabelerName": "Aimmune Therapeutics, Inc.",
      "SubstanceName": "PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE; PANCRELIPASE AMYLASE",
      "StrengthNumber": "15000; 47000; 63000",
      "StrengthUnit": "[USP'U]/1; [USP'U]/1; [USP'U]/1",
      "Status": "Active",
      "LastUpdate": "2025-11-21",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20201201",
      "SamplePackage": "N",
      "IndicationAndUsage": "ZENPEP® is indicated for the treatment of exocrine pancreatic insufficiency in adult and pediatric patients.",
      "Description": "Pancrelipase is a pancreatic enzyme product consisting of a mixture of enzymes including lipases, proteases, and amylases, and is an extract derived from porcine pancreatic glands. The enteric-coated pellets in ZENPEP are formulated to release pancreatic enzymes at an approximate pH of 5.5 or greater. ZENPEP (pancrelipase) delayed-release capsule for oral administration, include a two-piece shell containing light brown-colored enteric-coated pellets (1.8 to 1.9mm for 3,000 and 5,000 USP units of lipase, 2.2 to 2.5 mm for 10,000, 15,000, 20,000, 25,000, 40,000 and 60,000 USP units of lipase) and are available as follows. 3,000 USP units of lipase; 10,000 USP units of protease; and 14,000 USP units of amylase; delayed-release capsules have a white opaque cap and a white opaque body with imprint \"APTALIS 3\". The shells contain carnauba wax or talc, carrageenan, hypromellose, potassium chloride, titanium oxide, and water. The colorant of the printed ink is red iron oxide. 5,000 USP units of lipase; 17,000 USP units of protease; and 24,000 USP units of amylase; delayed-release capsules have a white opaque cap and a white opaque body with imprint \"APTALIS 5\". The shells contain carnauba wax or talc, carrageenan, hypromellose, potassium chloride, titanium oxide, and water. The colorant of the printed ink is FD&C Blue 2. 10,000 USP units of lipase; 32,000 USP units of protease; and 42,000 USP units of amylase; delayed-release capsules have a yellow opaque cap and a white opaque body with imprint \"APTALIS 10\". The shells contain carnauba wax or talc, carrageenan, hypromellose, potassium chloride, titanium oxide, water and yellow ferric oxide. The colorant of the printed ink is FD&C Blue 2. 15,000 USP units of lipase; 47,000 USP units of protease; and 63,000 USP units of amylase; delayed-release capsules have a red opaque cap and a white opaque body with imprint \"APTALIS 15\". The shells contain carnauba wax or talc, carrageenan, hypromellose, potassium chloride, red ferric oxide, titanium oxide, and water. The colorant of the printed ink is FD&C Blue 2. 20,000 USP units of lipase; 63,000 USP units of protease; and 84,000 USP units of amylase; delayed-release capsules have a green opaque cap and a white opaque body with imprint \"APTALIS 20\". The shells contain carnauba wax or talc, carrageenan, FD&C Blue #2, hypromellose, potassium chloride, titanium oxide, water, and yellow ferric oxide. The colorant of the printed ink is FD&C Blue 2. 25,000 USP units of lipase; 79,000 USP units of protease; and 105,000 USP units of amylase; delayed-release capsules have a blue opaque cap and a white opaque body with imprint \"APTALIS 25\". The shells contain carnauba wax or talc, carrageenan, FD&C Blue #2, hypromellose, potassium chloride, titanium oxide, and water. The colorant of the printed ink is FD&C Blue 2. 40,000 USP units of lipase; 126,000 USP units of protease; and 168,000 USP units of amylase; delayed-release capsules have an orange opaque cap and white opaque body, printed with \"APTALIS 40\". The shells contain FD&C Yellow #6, hypromellose, and titanium oxide. The colorant of the printed ink is FD&C Blue 2. 60,000 USP units of lipase; 189,600 USP units of protease; 252,600 USP units of amylase. Capsules have a powder blue opaque cap with two black stripes and white opaque body, printed with \"APTALIS 60\" The shells contain FD&C Blue #1, hypromellose, and titanium oxide. The colorant of the printed ink is black iron oxide. ZENPEP (pancrelipase) delayed-release capsules include the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hydrogenated castor oil, hypromellose phthalate, magnesium stearate, microcrystalline cellulose, talc, and triethyl citrate."
    },
    {
      "NDCCode": "73562-112-01",
      "PackageDescription": "100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (73562-112-01) ",
      "NDC11Code": "73562-0112-01",
      "ProductNDC": "73562-112",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Zenpep",
      "NonProprietaryName": "Pancrelipase Lipase, Pancrelipase Protease, Pancrelipase Amylase",
      "DosageFormName": "CAPSULE, DELAYED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20201201",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA022210",
      "LabelerName": "Aimmune Therapeutics, Inc.",
      "SubstanceName": "PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE; PANCRELIPASE AMYLASE",
      "StrengthNumber": "20000; 63000; 84000",
      "StrengthUnit": "[USP'U]/1; [USP'U]/1; [USP'U]/1",
      "Status": "Active",
      "LastUpdate": "2025-11-21",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20201201",
      "SamplePackage": "N",
      "IndicationAndUsage": "ZENPEP® is indicated for the treatment of exocrine pancreatic insufficiency in adult and pediatric patients.",
      "Description": "Pancrelipase is a pancreatic enzyme product consisting of a mixture of enzymes including lipases, proteases, and amylases, and is an extract derived from porcine pancreatic glands. The enteric-coated pellets in ZENPEP are formulated to release pancreatic enzymes at an approximate pH of 5.5 or greater. ZENPEP (pancrelipase) delayed-release capsule for oral administration, include a two-piece shell containing light brown-colored enteric-coated pellets (1.8 to 1.9mm for 3,000 and 5,000 USP units of lipase, 2.2 to 2.5 mm for 10,000, 15,000, 20,000, 25,000, 40,000 and 60,000 USP units of lipase) and are available as follows. 3,000 USP units of lipase; 10,000 USP units of protease; and 14,000 USP units of amylase; delayed-release capsules have a white opaque cap and a white opaque body with imprint \"APTALIS 3\". The shells contain carnauba wax or talc, carrageenan, hypromellose, potassium chloride, titanium oxide, and water. The colorant of the printed ink is red iron oxide. 5,000 USP units of lipase; 17,000 USP units of protease; and 24,000 USP units of amylase; delayed-release capsules have a white opaque cap and a white opaque body with imprint \"APTALIS 5\". The shells contain carnauba wax or talc, carrageenan, hypromellose, potassium chloride, titanium oxide, and water. The colorant of the printed ink is FD&C Blue 2. 10,000 USP units of lipase; 32,000 USP units of protease; and 42,000 USP units of amylase; delayed-release capsules have a yellow opaque cap and a white opaque body with imprint \"APTALIS 10\". The shells contain carnauba wax or talc, carrageenan, hypromellose, potassium chloride, titanium oxide, water and yellow ferric oxide. The colorant of the printed ink is FD&C Blue 2. 15,000 USP units of lipase; 47,000 USP units of protease; and 63,000 USP units of amylase; delayed-release capsules have a red opaque cap and a white opaque body with imprint \"APTALIS 15\". The shells contain carnauba wax or talc, carrageenan, hypromellose, potassium chloride, red ferric oxide, titanium oxide, and water. The colorant of the printed ink is FD&C Blue 2. 20,000 USP units of lipase; 63,000 USP units of protease; and 84,000 USP units of amylase; delayed-release capsules have a green opaque cap and a white opaque body with imprint \"APTALIS 20\". The shells contain carnauba wax or talc, carrageenan, FD&C Blue #2, hypromellose, potassium chloride, titanium oxide, water, and yellow ferric oxide. The colorant of the printed ink is FD&C Blue 2. 25,000 USP units of lipase; 79,000 USP units of protease; and 105,000 USP units of amylase; delayed-release capsules have a blue opaque cap and a white opaque body with imprint \"APTALIS 25\". The shells contain carnauba wax or talc, carrageenan, FD&C Blue #2, hypromellose, potassium chloride, titanium oxide, and water. The colorant of the printed ink is FD&C Blue 2. 40,000 USP units of lipase; 126,000 USP units of protease; and 168,000 USP units of amylase; delayed-release capsules have an orange opaque cap and white opaque body, printed with \"APTALIS 40\". The shells contain FD&C Yellow #6, hypromellose, and titanium oxide. The colorant of the printed ink is FD&C Blue 2. 60,000 USP units of lipase; 189,600 USP units of protease; 252,600 USP units of amylase. Capsules have a powder blue opaque cap with two black stripes and white opaque body, printed with \"APTALIS 60\" The shells contain FD&C Blue #1, hypromellose, and titanium oxide. The colorant of the printed ink is black iron oxide. ZENPEP (pancrelipase) delayed-release capsules include the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hydrogenated castor oil, hypromellose phthalate, magnesium stearate, microcrystalline cellulose, talc, and triethyl citrate."
    },
    {
      "NDCCode": "73562-113-01",
      "PackageDescription": "100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (73562-113-01) ",
      "NDC11Code": "73562-0113-01",
      "ProductNDC": "73562-113",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Zenpep",
      "NonProprietaryName": "Pancrelipase Lipase, Pancrelipase Protease, Pancrelipase Amylase",
      "DosageFormName": "CAPSULE, DELAYED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20210101",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA022210",
      "LabelerName": "Aimmune Therapeutics, Inc.",
      "SubstanceName": "PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE; PANCRELIPASE AMYLASE",
      "StrengthNumber": "3000; 10000; 14000",
      "StrengthUnit": "[USP'U]/1; [USP'U]/1; [USP'U]/1",
      "Status": "Active",
      "LastUpdate": "2025-11-21",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20210401",
      "SamplePackage": "N",
      "IndicationAndUsage": "ZENPEP® is indicated for the treatment of exocrine pancreatic insufficiency in adult and pediatric patients.",
      "Description": "Pancrelipase is a pancreatic enzyme product consisting of a mixture of enzymes including lipases, proteases, and amylases, and is an extract derived from porcine pancreatic glands. The enteric-coated pellets in ZENPEP are formulated to release pancreatic enzymes at an approximate pH of 5.5 or greater. ZENPEP (pancrelipase) delayed-release capsule for oral administration, include a two-piece shell containing light brown-colored enteric-coated pellets (1.8 to 1.9mm for 3,000 and 5,000 USP units of lipase, 2.2 to 2.5 mm for 10,000, 15,000, 20,000, 25,000, 40,000 and 60,000 USP units of lipase) and are available as follows. 3,000 USP units of lipase; 10,000 USP units of protease; and 14,000 USP units of amylase; delayed-release capsules have a white opaque cap and a white opaque body with imprint \"APTALIS 3\". The shells contain carnauba wax or talc, carrageenan, hypromellose, potassium chloride, titanium oxide, and water. The colorant of the printed ink is red iron oxide. 5,000 USP units of lipase; 17,000 USP units of protease; and 24,000 USP units of amylase; delayed-release capsules have a white opaque cap and a white opaque body with imprint \"APTALIS 5\". The shells contain carnauba wax or talc, carrageenan, hypromellose, potassium chloride, titanium oxide, and water. The colorant of the printed ink is FD&C Blue 2. 10,000 USP units of lipase; 32,000 USP units of protease; and 42,000 USP units of amylase; delayed-release capsules have a yellow opaque cap and a white opaque body with imprint \"APTALIS 10\". The shells contain carnauba wax or talc, carrageenan, hypromellose, potassium chloride, titanium oxide, water and yellow ferric oxide. The colorant of the printed ink is FD&C Blue 2. 15,000 USP units of lipase; 47,000 USP units of protease; and 63,000 USP units of amylase; delayed-release capsules have a red opaque cap and a white opaque body with imprint \"APTALIS 15\". The shells contain carnauba wax or talc, carrageenan, hypromellose, potassium chloride, red ferric oxide, titanium oxide, and water. The colorant of the printed ink is FD&C Blue 2. 20,000 USP units of lipase; 63,000 USP units of protease; and 84,000 USP units of amylase; delayed-release capsules have a green opaque cap and a white opaque body with imprint \"APTALIS 20\". The shells contain carnauba wax or talc, carrageenan, FD&C Blue #2, hypromellose, potassium chloride, titanium oxide, water, and yellow ferric oxide. The colorant of the printed ink is FD&C Blue 2. 25,000 USP units of lipase; 79,000 USP units of protease; and 105,000 USP units of amylase; delayed-release capsules have a blue opaque cap and a white opaque body with imprint \"APTALIS 25\". The shells contain carnauba wax or talc, carrageenan, FD&C Blue #2, hypromellose, potassium chloride, titanium oxide, and water. The colorant of the printed ink is FD&C Blue 2. 40,000 USP units of lipase; 126,000 USP units of protease; and 168,000 USP units of amylase; delayed-release capsules have an orange opaque cap and white opaque body, printed with \"APTALIS 40\". The shells contain FD&C Yellow #6, hypromellose, and titanium oxide. The colorant of the printed ink is FD&C Blue 2. 60,000 USP units of lipase; 189,600 USP units of protease; 252,600 USP units of amylase. Capsules have a powder blue opaque cap with two black stripes and white opaque body, printed with \"APTALIS 60\" The shells contain FD&C Blue #1, hypromellose, and titanium oxide. The colorant of the printed ink is black iron oxide. ZENPEP (pancrelipase) delayed-release capsules include the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hydrogenated castor oil, hypromellose phthalate, magnesium stearate, microcrystalline cellulose, talc, and triethyl citrate."
    },
    {
      "NDCCode": "73562-113-10",
      "PackageDescription": "100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (73562-113-10) ",
      "NDC11Code": "73562-0113-10",
      "ProductNDC": "73562-113",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Zenpep",
      "NonProprietaryName": "Pancrelipase Lipase, Pancrelipase Protease, Pancrelipase Amylase",
      "DosageFormName": "CAPSULE, DELAYED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20210101",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA022210",
      "LabelerName": "Aimmune Therapeutics, Inc.",
      "SubstanceName": "PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE; PANCRELIPASE AMYLASE",
      "StrengthNumber": "3000; 10000; 14000",
      "StrengthUnit": "[USP'U]/1; [USP'U]/1; [USP'U]/1",
      "Status": "Active",
      "LastUpdate": "2025-11-21",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20210101",
      "SamplePackage": "Y",
      "IndicationAndUsage": "ZENPEP® is indicated for the treatment of exocrine pancreatic insufficiency in adult and pediatric patients.",
      "Description": "Pancrelipase is a pancreatic enzyme product consisting of a mixture of enzymes including lipases, proteases, and amylases, and is an extract derived from porcine pancreatic glands. The enteric-coated pellets in ZENPEP are formulated to release pancreatic enzymes at an approximate pH of 5.5 or greater. ZENPEP (pancrelipase) delayed-release capsule for oral administration, include a two-piece shell containing light brown-colored enteric-coated pellets (1.8 to 1.9mm for 3,000 and 5,000 USP units of lipase, 2.2 to 2.5 mm for 10,000, 15,000, 20,000, 25,000, 40,000 and 60,000 USP units of lipase) and are available as follows. 3,000 USP units of lipase; 10,000 USP units of protease; and 14,000 USP units of amylase; delayed-release capsules have a white opaque cap and a white opaque body with imprint \"APTALIS 3\". The shells contain carnauba wax or talc, carrageenan, hypromellose, potassium chloride, titanium oxide, and water. The colorant of the printed ink is red iron oxide. 5,000 USP units of lipase; 17,000 USP units of protease; and 24,000 USP units of amylase; delayed-release capsules have a white opaque cap and a white opaque body with imprint \"APTALIS 5\". The shells contain carnauba wax or talc, carrageenan, hypromellose, potassium chloride, titanium oxide, and water. The colorant of the printed ink is FD&C Blue 2. 10,000 USP units of lipase; 32,000 USP units of protease; and 42,000 USP units of amylase; delayed-release capsules have a yellow opaque cap and a white opaque body with imprint \"APTALIS 10\". The shells contain carnauba wax or talc, carrageenan, hypromellose, potassium chloride, titanium oxide, water and yellow ferric oxide. The colorant of the printed ink is FD&C Blue 2. 15,000 USP units of lipase; 47,000 USP units of protease; and 63,000 USP units of amylase; delayed-release capsules have a red opaque cap and a white opaque body with imprint \"APTALIS 15\". The shells contain carnauba wax or talc, carrageenan, hypromellose, potassium chloride, red ferric oxide, titanium oxide, and water. The colorant of the printed ink is FD&C Blue 2. 20,000 USP units of lipase; 63,000 USP units of protease; and 84,000 USP units of amylase; delayed-release capsules have a green opaque cap and a white opaque body with imprint \"APTALIS 20\". The shells contain carnauba wax or talc, carrageenan, FD&C Blue #2, hypromellose, potassium chloride, titanium oxide, water, and yellow ferric oxide. The colorant of the printed ink is FD&C Blue 2. 25,000 USP units of lipase; 79,000 USP units of protease; and 105,000 USP units of amylase; delayed-release capsules have a blue opaque cap and a white opaque body with imprint \"APTALIS 25\". The shells contain carnauba wax or talc, carrageenan, FD&C Blue #2, hypromellose, potassium chloride, titanium oxide, and water. The colorant of the printed ink is FD&C Blue 2. 40,000 USP units of lipase; 126,000 USP units of protease; and 168,000 USP units of amylase; delayed-release capsules have an orange opaque cap and white opaque body, printed with \"APTALIS 40\". The shells contain FD&C Yellow #6, hypromellose, and titanium oxide. The colorant of the printed ink is FD&C Blue 2. 60,000 USP units of lipase; 189,600 USP units of protease; 252,600 USP units of amylase. Capsules have a powder blue opaque cap with two black stripes and white opaque body, printed with \"APTALIS 60\" The shells contain FD&C Blue #1, hypromellose, and titanium oxide. The colorant of the printed ink is black iron oxide. ZENPEP (pancrelipase) delayed-release capsules include the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hydrogenated castor oil, hypromellose phthalate, magnesium stearate, microcrystalline cellulose, talc, and triethyl citrate."
    },
    {
      "NDCCode": "73562-114-01",
      "PackageDescription": "100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (73562-114-01) ",
      "NDC11Code": "73562-0114-01",
      "ProductNDC": "73562-114",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Zenpep",
      "NonProprietaryName": "Pancrelipase Lipase, Pancrelipase Protease, Pancrelipase Amylase",
      "DosageFormName": "CAPSULE, DELAYED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20201101",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA022210",
      "LabelerName": "Aimmune Therapeutics, Inc.",
      "SubstanceName": "PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE; PANCRELIPASE AMYLASE",
      "StrengthNumber": "40000; 126000; 168000",
      "StrengthUnit": "[USP'U]/1; [USP'U]/1; [USP'U]/1",
      "Status": "Active",
      "LastUpdate": "2025-11-21",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20201101",
      "SamplePackage": "N",
      "IndicationAndUsage": "ZENPEP® is indicated for the treatment of exocrine pancreatic insufficiency in adult and pediatric patients.",
      "Description": "Pancrelipase is a pancreatic enzyme product consisting of a mixture of enzymes including lipases, proteases, and amylases, and is an extract derived from porcine pancreatic glands. The enteric-coated pellets in ZENPEP are formulated to release pancreatic enzymes at an approximate pH of 5.5 or greater. ZENPEP (pancrelipase) delayed-release capsule for oral administration, include a two-piece shell containing light brown-colored enteric-coated pellets (1.8 to 1.9mm for 3,000 and 5,000 USP units of lipase, 2.2 to 2.5 mm for 10,000, 15,000, 20,000, 25,000, 40,000 and 60,000 USP units of lipase) and are available as follows. 3,000 USP units of lipase; 10,000 USP units of protease; and 14,000 USP units of amylase; delayed-release capsules have a white opaque cap and a white opaque body with imprint \"APTALIS 3\". The shells contain carnauba wax or talc, carrageenan, hypromellose, potassium chloride, titanium oxide, and water. The colorant of the printed ink is red iron oxide. 5,000 USP units of lipase; 17,000 USP units of protease; and 24,000 USP units of amylase; delayed-release capsules have a white opaque cap and a white opaque body with imprint \"APTALIS 5\". The shells contain carnauba wax or talc, carrageenan, hypromellose, potassium chloride, titanium oxide, and water. The colorant of the printed ink is FD&C Blue 2. 10,000 USP units of lipase; 32,000 USP units of protease; and 42,000 USP units of amylase; delayed-release capsules have a yellow opaque cap and a white opaque body with imprint \"APTALIS 10\". The shells contain carnauba wax or talc, carrageenan, hypromellose, potassium chloride, titanium oxide, water and yellow ferric oxide. The colorant of the printed ink is FD&C Blue 2. 15,000 USP units of lipase; 47,000 USP units of protease; and 63,000 USP units of amylase; delayed-release capsules have a red opaque cap and a white opaque body with imprint \"APTALIS 15\". The shells contain carnauba wax or talc, carrageenan, hypromellose, potassium chloride, red ferric oxide, titanium oxide, and water. The colorant of the printed ink is FD&C Blue 2. 20,000 USP units of lipase; 63,000 USP units of protease; and 84,000 USP units of amylase; delayed-release capsules have a green opaque cap and a white opaque body with imprint \"APTALIS 20\". The shells contain carnauba wax or talc, carrageenan, FD&C Blue #2, hypromellose, potassium chloride, titanium oxide, water, and yellow ferric oxide. The colorant of the printed ink is FD&C Blue 2. 25,000 USP units of lipase; 79,000 USP units of protease; and 105,000 USP units of amylase; delayed-release capsules have a blue opaque cap and a white opaque body with imprint \"APTALIS 25\". The shells contain carnauba wax or talc, carrageenan, FD&C Blue #2, hypromellose, potassium chloride, titanium oxide, and water. The colorant of the printed ink is FD&C Blue 2. 40,000 USP units of lipase; 126,000 USP units of protease; and 168,000 USP units of amylase; delayed-release capsules have an orange opaque cap and white opaque body, printed with \"APTALIS 40\". The shells contain FD&C Yellow #6, hypromellose, and titanium oxide. The colorant of the printed ink is FD&C Blue 2. 60,000 USP units of lipase; 189,600 USP units of protease; 252,600 USP units of amylase. Capsules have a powder blue opaque cap with two black stripes and white opaque body, printed with \"APTALIS 60\" The shells contain FD&C Blue #1, hypromellose, and titanium oxide. The colorant of the printed ink is black iron oxide. ZENPEP (pancrelipase) delayed-release capsules include the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hydrogenated castor oil, hypromellose phthalate, magnesium stearate, microcrystalline cellulose, talc, and triethyl citrate."
    },
    {
      "NDCCode": "73562-114-12",
      "PackageDescription": "12 CAPSULE, DELAYED RELEASE in 1 BOTTLE (73562-114-12) ",
      "NDC11Code": "73562-0114-12",
      "ProductNDC": "73562-114",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Zenpep",
      "NonProprietaryName": "Pancrelipase Lipase, Pancrelipase Protease, Pancrelipase Amylase",
      "DosageFormName": "CAPSULE, DELAYED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20201101",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA022210",
      "LabelerName": "Aimmune Therapeutics, Inc.",
      "SubstanceName": "PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE; PANCRELIPASE AMYLASE",
      "StrengthNumber": "40000; 126000; 168000",
      "StrengthUnit": "[USP'U]/1; [USP'U]/1; [USP'U]/1",
      "Status": "Active",
      "LastUpdate": "2025-11-21",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20201101",
      "SamplePackage": "Y",
      "IndicationAndUsage": "ZENPEP® is indicated for the treatment of exocrine pancreatic insufficiency in adult and pediatric patients.",
      "Description": "Pancrelipase is a pancreatic enzyme product consisting of a mixture of enzymes including lipases, proteases, and amylases, and is an extract derived from porcine pancreatic glands. The enteric-coated pellets in ZENPEP are formulated to release pancreatic enzymes at an approximate pH of 5.5 or greater. ZENPEP (pancrelipase) delayed-release capsule for oral administration, include a two-piece shell containing light brown-colored enteric-coated pellets (1.8 to 1.9mm for 3,000 and 5,000 USP units of lipase, 2.2 to 2.5 mm for 10,000, 15,000, 20,000, 25,000, 40,000 and 60,000 USP units of lipase) and are available as follows. 3,000 USP units of lipase; 10,000 USP units of protease; and 14,000 USP units of amylase; delayed-release capsules have a white opaque cap and a white opaque body with imprint \"APTALIS 3\". The shells contain carnauba wax or talc, carrageenan, hypromellose, potassium chloride, titanium oxide, and water. The colorant of the printed ink is red iron oxide. 5,000 USP units of lipase; 17,000 USP units of protease; and 24,000 USP units of amylase; delayed-release capsules have a white opaque cap and a white opaque body with imprint \"APTALIS 5\". The shells contain carnauba wax or talc, carrageenan, hypromellose, potassium chloride, titanium oxide, and water. The colorant of the printed ink is FD&C Blue 2. 10,000 USP units of lipase; 32,000 USP units of protease; and 42,000 USP units of amylase; delayed-release capsules have a yellow opaque cap and a white opaque body with imprint \"APTALIS 10\". The shells contain carnauba wax or talc, carrageenan, hypromellose, potassium chloride, titanium oxide, water and yellow ferric oxide. The colorant of the printed ink is FD&C Blue 2. 15,000 USP units of lipase; 47,000 USP units of protease; and 63,000 USP units of amylase; delayed-release capsules have a red opaque cap and a white opaque body with imprint \"APTALIS 15\". The shells contain carnauba wax or talc, carrageenan, hypromellose, potassium chloride, red ferric oxide, titanium oxide, and water. The colorant of the printed ink is FD&C Blue 2. 20,000 USP units of lipase; 63,000 USP units of protease; and 84,000 USP units of amylase; delayed-release capsules have a green opaque cap and a white opaque body with imprint \"APTALIS 20\". The shells contain carnauba wax or talc, carrageenan, FD&C Blue #2, hypromellose, potassium chloride, titanium oxide, water, and yellow ferric oxide. The colorant of the printed ink is FD&C Blue 2. 25,000 USP units of lipase; 79,000 USP units of protease; and 105,000 USP units of amylase; delayed-release capsules have a blue opaque cap and a white opaque body with imprint \"APTALIS 25\". The shells contain carnauba wax or talc, carrageenan, FD&C Blue #2, hypromellose, potassium chloride, titanium oxide, and water. The colorant of the printed ink is FD&C Blue 2. 40,000 USP units of lipase; 126,000 USP units of protease; and 168,000 USP units of amylase; delayed-release capsules have an orange opaque cap and white opaque body, printed with \"APTALIS 40\". The shells contain FD&C Yellow #6, hypromellose, and titanium oxide. The colorant of the printed ink is FD&C Blue 2. 60,000 USP units of lipase; 189,600 USP units of protease; 252,600 USP units of amylase. Capsules have a powder blue opaque cap with two black stripes and white opaque body, printed with \"APTALIS 60\" The shells contain FD&C Blue #1, hypromellose, and titanium oxide. The colorant of the printed ink is black iron oxide. ZENPEP (pancrelipase) delayed-release capsules include the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hydrogenated castor oil, hypromellose phthalate, magnesium stearate, microcrystalline cellulose, talc, and triethyl citrate."
    },
    {
      "NDCCode": "73562-115-01",
      "PackageDescription": "100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (73562-115-01) ",
      "NDC11Code": "73562-0115-01",
      "ProductNDC": "73562-115",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Zenpep",
      "NonProprietaryName": "Pancrelipase Lipase, Pancrelipase Protease, Pancrelipase Amylase",
      "DosageFormName": "CAPSULE, DELAYED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20210101",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA022210",
      "LabelerName": "Aimmune Therapeutics, Inc.",
      "SubstanceName": "PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE; PANCRELIPASE AMYLASE",
      "StrengthNumber": "5000; 17000; 24000",
      "StrengthUnit": "[USP'U]/1; [USP'U]/1; [USP'U]/1",
      "Status": "Active",
      "LastUpdate": "2025-11-21",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20210101",
      "SamplePackage": "N",
      "IndicationAndUsage": "ZENPEP® is indicated for the treatment of exocrine pancreatic insufficiency in adult and pediatric patients.",
      "Description": "Pancrelipase is a pancreatic enzyme product consisting of a mixture of enzymes including lipases, proteases, and amylases, and is an extract derived from porcine pancreatic glands. The enteric-coated pellets in ZENPEP are formulated to release pancreatic enzymes at an approximate pH of 5.5 or greater. ZENPEP (pancrelipase) delayed-release capsule for oral administration, include a two-piece shell containing light brown-colored enteric-coated pellets (1.8 to 1.9mm for 3,000 and 5,000 USP units of lipase, 2.2 to 2.5 mm for 10,000, 15,000, 20,000, 25,000, 40,000 and 60,000 USP units of lipase) and are available as follows. 3,000 USP units of lipase; 10,000 USP units of protease; and 14,000 USP units of amylase; delayed-release capsules have a white opaque cap and a white opaque body with imprint \"APTALIS 3\". The shells contain carnauba wax or talc, carrageenan, hypromellose, potassium chloride, titanium oxide, and water. The colorant of the printed ink is red iron oxide. 5,000 USP units of lipase; 17,000 USP units of protease; and 24,000 USP units of amylase; delayed-release capsules have a white opaque cap and a white opaque body with imprint \"APTALIS 5\". The shells contain carnauba wax or talc, carrageenan, hypromellose, potassium chloride, titanium oxide, and water. The colorant of the printed ink is FD&C Blue 2. 10,000 USP units of lipase; 32,000 USP units of protease; and 42,000 USP units of amylase; delayed-release capsules have a yellow opaque cap and a white opaque body with imprint \"APTALIS 10\". The shells contain carnauba wax or talc, carrageenan, hypromellose, potassium chloride, titanium oxide, water and yellow ferric oxide. The colorant of the printed ink is FD&C Blue 2. 15,000 USP units of lipase; 47,000 USP units of protease; and 63,000 USP units of amylase; delayed-release capsules have a red opaque cap and a white opaque body with imprint \"APTALIS 15\". The shells contain carnauba wax or talc, carrageenan, hypromellose, potassium chloride, red ferric oxide, titanium oxide, and water. The colorant of the printed ink is FD&C Blue 2. 20,000 USP units of lipase; 63,000 USP units of protease; and 84,000 USP units of amylase; delayed-release capsules have a green opaque cap and a white opaque body with imprint \"APTALIS 20\". The shells contain carnauba wax or talc, carrageenan, FD&C Blue #2, hypromellose, potassium chloride, titanium oxide, water, and yellow ferric oxide. The colorant of the printed ink is FD&C Blue 2. 25,000 USP units of lipase; 79,000 USP units of protease; and 105,000 USP units of amylase; delayed-release capsules have a blue opaque cap and a white opaque body with imprint \"APTALIS 25\". The shells contain carnauba wax or talc, carrageenan, FD&C Blue #2, hypromellose, potassium chloride, titanium oxide, and water. The colorant of the printed ink is FD&C Blue 2. 40,000 USP units of lipase; 126,000 USP units of protease; and 168,000 USP units of amylase; delayed-release capsules have an orange opaque cap and white opaque body, printed with \"APTALIS 40\". The shells contain FD&C Yellow #6, hypromellose, and titanium oxide. The colorant of the printed ink is FD&C Blue 2. 60,000 USP units of lipase; 189,600 USP units of protease; 252,600 USP units of amylase. Capsules have a powder blue opaque cap with two black stripes and white opaque body, printed with \"APTALIS 60\" The shells contain FD&C Blue #1, hypromellose, and titanium oxide. The colorant of the printed ink is black iron oxide. ZENPEP (pancrelipase) delayed-release capsules include the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hydrogenated castor oil, hypromellose phthalate, magnesium stearate, microcrystalline cellulose, talc, and triethyl citrate."
    },
    {
      "NDCCode": "73562-115-10",
      "PackageDescription": "100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (73562-115-10) ",
      "NDC11Code": "73562-0115-10",
      "ProductNDC": "73562-115",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Zenpep",
      "NonProprietaryName": "Pancrelipase Lipase, Pancrelipase Protease, Pancrelipase Amylase",
      "DosageFormName": "CAPSULE, DELAYED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20210101",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA022210",
      "LabelerName": "Aimmune Therapeutics, Inc.",
      "SubstanceName": "PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE; PANCRELIPASE AMYLASE",
      "StrengthNumber": "5000; 17000; 24000",
      "StrengthUnit": "[USP'U]/1; [USP'U]/1; [USP'U]/1",
      "Status": "Active",
      "LastUpdate": "2025-11-21",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20210201",
      "SamplePackage": "Y",
      "IndicationAndUsage": "ZENPEP® is indicated for the treatment of exocrine pancreatic insufficiency in adult and pediatric patients.",
      "Description": "Pancrelipase is a pancreatic enzyme product consisting of a mixture of enzymes including lipases, proteases, and amylases, and is an extract derived from porcine pancreatic glands. The enteric-coated pellets in ZENPEP are formulated to release pancreatic enzymes at an approximate pH of 5.5 or greater. ZENPEP (pancrelipase) delayed-release capsule for oral administration, include a two-piece shell containing light brown-colored enteric-coated pellets (1.8 to 1.9mm for 3,000 and 5,000 USP units of lipase, 2.2 to 2.5 mm for 10,000, 15,000, 20,000, 25,000, 40,000 and 60,000 USP units of lipase) and are available as follows. 3,000 USP units of lipase; 10,000 USP units of protease; and 14,000 USP units of amylase; delayed-release capsules have a white opaque cap and a white opaque body with imprint \"APTALIS 3\". The shells contain carnauba wax or talc, carrageenan, hypromellose, potassium chloride, titanium oxide, and water. The colorant of the printed ink is red iron oxide. 5,000 USP units of lipase; 17,000 USP units of protease; and 24,000 USP units of amylase; delayed-release capsules have a white opaque cap and a white opaque body with imprint \"APTALIS 5\". The shells contain carnauba wax or talc, carrageenan, hypromellose, potassium chloride, titanium oxide, and water. The colorant of the printed ink is FD&C Blue 2. 10,000 USP units of lipase; 32,000 USP units of protease; and 42,000 USP units of amylase; delayed-release capsules have a yellow opaque cap and a white opaque body with imprint \"APTALIS 10\". The shells contain carnauba wax or talc, carrageenan, hypromellose, potassium chloride, titanium oxide, water and yellow ferric oxide. The colorant of the printed ink is FD&C Blue 2. 15,000 USP units of lipase; 47,000 USP units of protease; and 63,000 USP units of amylase; delayed-release capsules have a red opaque cap and a white opaque body with imprint \"APTALIS 15\". The shells contain carnauba wax or talc, carrageenan, hypromellose, potassium chloride, red ferric oxide, titanium oxide, and water. The colorant of the printed ink is FD&C Blue 2. 20,000 USP units of lipase; 63,000 USP units of protease; and 84,000 USP units of amylase; delayed-release capsules have a green opaque cap and a white opaque body with imprint \"APTALIS 20\". The shells contain carnauba wax or talc, carrageenan, FD&C Blue #2, hypromellose, potassium chloride, titanium oxide, water, and yellow ferric oxide. The colorant of the printed ink is FD&C Blue 2. 25,000 USP units of lipase; 79,000 USP units of protease; and 105,000 USP units of amylase; delayed-release capsules have a blue opaque cap and a white opaque body with imprint \"APTALIS 25\". The shells contain carnauba wax or talc, carrageenan, FD&C Blue #2, hypromellose, potassium chloride, titanium oxide, and water. The colorant of the printed ink is FD&C Blue 2. 40,000 USP units of lipase; 126,000 USP units of protease; and 168,000 USP units of amylase; delayed-release capsules have an orange opaque cap and white opaque body, printed with \"APTALIS 40\". The shells contain FD&C Yellow #6, hypromellose, and titanium oxide. The colorant of the printed ink is FD&C Blue 2. 60,000 USP units of lipase; 189,600 USP units of protease; 252,600 USP units of amylase. Capsules have a powder blue opaque cap with two black stripes and white opaque body, printed with \"APTALIS 60\" The shells contain FD&C Blue #1, hypromellose, and titanium oxide. The colorant of the printed ink is black iron oxide. ZENPEP (pancrelipase) delayed-release capsules include the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hydrogenated castor oil, hypromellose phthalate, magnesium stearate, microcrystalline cellulose, talc, and triethyl citrate."
    },
    {
      "NDCCode": "73562-116-01",
      "PackageDescription": "100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (73562-116-01) ",
      "NDC11Code": "73562-0116-01",
      "ProductNDC": "73562-116",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Zenpep",
      "NonProprietaryName": "Pancrelipase Lipase, Pancrelipase Protease, Pancrelipase Amylase",
      "DosageFormName": "CAPSULE, DELAYED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20201101",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA022210",
      "LabelerName": "Aimmune Therapeutics, Inc.",
      "SubstanceName": "PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE; PANCRELIPASE AMYLASE",
      "StrengthNumber": "25000; 79000; 105000",
      "StrengthUnit": "[USP'U]/1; [USP'U]/1; [USP'U]/1",
      "Status": "Active",
      "LastUpdate": "2025-11-21",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20201101",
      "SamplePackage": "N",
      "IndicationAndUsage": "ZENPEP® is indicated for the treatment of exocrine pancreatic insufficiency in adult and pediatric patients.",
      "Description": "Pancrelipase is a pancreatic enzyme product consisting of a mixture of enzymes including lipases, proteases, and amylases, and is an extract derived from porcine pancreatic glands. The enteric-coated pellets in ZENPEP are formulated to release pancreatic enzymes at an approximate pH of 5.5 or greater. ZENPEP (pancrelipase) delayed-release capsule for oral administration, include a two-piece shell containing light brown-colored enteric-coated pellets (1.8 to 1.9mm for 3,000 and 5,000 USP units of lipase, 2.2 to 2.5 mm for 10,000, 15,000, 20,000, 25,000, 40,000 and 60,000 USP units of lipase) and are available as follows. 3,000 USP units of lipase; 10,000 USP units of protease; and 14,000 USP units of amylase; delayed-release capsules have a white opaque cap and a white opaque body with imprint \"APTALIS 3\". The shells contain carnauba wax or talc, carrageenan, hypromellose, potassium chloride, titanium oxide, and water. The colorant of the printed ink is red iron oxide. 5,000 USP units of lipase; 17,000 USP units of protease; and 24,000 USP units of amylase; delayed-release capsules have a white opaque cap and a white opaque body with imprint \"APTALIS 5\". The shells contain carnauba wax or talc, carrageenan, hypromellose, potassium chloride, titanium oxide, and water. The colorant of the printed ink is FD&C Blue 2. 10,000 USP units of lipase; 32,000 USP units of protease; and 42,000 USP units of amylase; delayed-release capsules have a yellow opaque cap and a white opaque body with imprint \"APTALIS 10\". The shells contain carnauba wax or talc, carrageenan, hypromellose, potassium chloride, titanium oxide, water and yellow ferric oxide. The colorant of the printed ink is FD&C Blue 2. 15,000 USP units of lipase; 47,000 USP units of protease; and 63,000 USP units of amylase; delayed-release capsules have a red opaque cap and a white opaque body with imprint \"APTALIS 15\". The shells contain carnauba wax or talc, carrageenan, hypromellose, potassium chloride, red ferric oxide, titanium oxide, and water. The colorant of the printed ink is FD&C Blue 2. 20,000 USP units of lipase; 63,000 USP units of protease; and 84,000 USP units of amylase; delayed-release capsules have a green opaque cap and a white opaque body with imprint \"APTALIS 20\". The shells contain carnauba wax or talc, carrageenan, FD&C Blue #2, hypromellose, potassium chloride, titanium oxide, water, and yellow ferric oxide. The colorant of the printed ink is FD&C Blue 2. 25,000 USP units of lipase; 79,000 USP units of protease; and 105,000 USP units of amylase; delayed-release capsules have a blue opaque cap and a white opaque body with imprint \"APTALIS 25\". The shells contain carnauba wax or talc, carrageenan, FD&C Blue #2, hypromellose, potassium chloride, titanium oxide, and water. The colorant of the printed ink is FD&C Blue 2. 40,000 USP units of lipase; 126,000 USP units of protease; and 168,000 USP units of amylase; delayed-release capsules have an orange opaque cap and white opaque body, printed with \"APTALIS 40\". The shells contain FD&C Yellow #6, hypromellose, and titanium oxide. The colorant of the printed ink is FD&C Blue 2. 60,000 USP units of lipase; 189,600 USP units of protease; 252,600 USP units of amylase. Capsules have a powder blue opaque cap with two black stripes and white opaque body, printed with \"APTALIS 60\" The shells contain FD&C Blue #1, hypromellose, and titanium oxide. The colorant of the printed ink is black iron oxide. ZENPEP (pancrelipase) delayed-release capsules include the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hydrogenated castor oil, hypromellose phthalate, magnesium stearate, microcrystalline cellulose, talc, and triethyl citrate."
    },
    {
      "NDCCode": "73562-116-12",
      "PackageDescription": "12 CAPSULE, DELAYED RELEASE in 1 BOTTLE (73562-116-12) ",
      "NDC11Code": "73562-0116-12",
      "ProductNDC": "73562-116",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Zenpep",
      "NonProprietaryName": "Pancrelipase Lipase, Pancrelipase Protease, Pancrelipase Amylase",
      "DosageFormName": "CAPSULE, DELAYED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20201101",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA022210",
      "LabelerName": "Aimmune Therapeutics, Inc.",
      "SubstanceName": "PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE; PANCRELIPASE AMYLASE",
      "StrengthNumber": "25000; 79000; 105000",
      "StrengthUnit": "[USP'U]/1; [USP'U]/1; [USP'U]/1",
      "Status": "Active",
      "LastUpdate": "2025-11-21",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20210501",
      "SamplePackage": "Y",
      "IndicationAndUsage": "ZENPEP® is indicated for the treatment of exocrine pancreatic insufficiency in adult and pediatric patients.",
      "Description": "Pancrelipase is a pancreatic enzyme product consisting of a mixture of enzymes including lipases, proteases, and amylases, and is an extract derived from porcine pancreatic glands. The enteric-coated pellets in ZENPEP are formulated to release pancreatic enzymes at an approximate pH of 5.5 or greater. ZENPEP (pancrelipase) delayed-release capsule for oral administration, include a two-piece shell containing light brown-colored enteric-coated pellets (1.8 to 1.9mm for 3,000 and 5,000 USP units of lipase, 2.2 to 2.5 mm for 10,000, 15,000, 20,000, 25,000, 40,000 and 60,000 USP units of lipase) and are available as follows. 3,000 USP units of lipase; 10,000 USP units of protease; and 14,000 USP units of amylase; delayed-release capsules have a white opaque cap and a white opaque body with imprint \"APTALIS 3\". The shells contain carnauba wax or talc, carrageenan, hypromellose, potassium chloride, titanium oxide, and water. The colorant of the printed ink is red iron oxide. 5,000 USP units of lipase; 17,000 USP units of protease; and 24,000 USP units of amylase; delayed-release capsules have a white opaque cap and a white opaque body with imprint \"APTALIS 5\". The shells contain carnauba wax or talc, carrageenan, hypromellose, potassium chloride, titanium oxide, and water. The colorant of the printed ink is FD&C Blue 2. 10,000 USP units of lipase; 32,000 USP units of protease; and 42,000 USP units of amylase; delayed-release capsules have a yellow opaque cap and a white opaque body with imprint \"APTALIS 10\". The shells contain carnauba wax or talc, carrageenan, hypromellose, potassium chloride, titanium oxide, water and yellow ferric oxide. The colorant of the printed ink is FD&C Blue 2. 15,000 USP units of lipase; 47,000 USP units of protease; and 63,000 USP units of amylase; delayed-release capsules have a red opaque cap and a white opaque body with imprint \"APTALIS 15\". The shells contain carnauba wax or talc, carrageenan, hypromellose, potassium chloride, red ferric oxide, titanium oxide, and water. The colorant of the printed ink is FD&C Blue 2. 20,000 USP units of lipase; 63,000 USP units of protease; and 84,000 USP units of amylase; delayed-release capsules have a green opaque cap and a white opaque body with imprint \"APTALIS 20\". The shells contain carnauba wax or talc, carrageenan, FD&C Blue #2, hypromellose, potassium chloride, titanium oxide, water, and yellow ferric oxide. The colorant of the printed ink is FD&C Blue 2. 25,000 USP units of lipase; 79,000 USP units of protease; and 105,000 USP units of amylase; delayed-release capsules have a blue opaque cap and a white opaque body with imprint \"APTALIS 25\". The shells contain carnauba wax or talc, carrageenan, FD&C Blue #2, hypromellose, potassium chloride, titanium oxide, and water. The colorant of the printed ink is FD&C Blue 2. 40,000 USP units of lipase; 126,000 USP units of protease; and 168,000 USP units of amylase; delayed-release capsules have an orange opaque cap and white opaque body, printed with \"APTALIS 40\". The shells contain FD&C Yellow #6, hypromellose, and titanium oxide. The colorant of the printed ink is FD&C Blue 2. 60,000 USP units of lipase; 189,600 USP units of protease; 252,600 USP units of amylase. Capsules have a powder blue opaque cap with two black stripes and white opaque body, printed with \"APTALIS 60\" The shells contain FD&C Blue #1, hypromellose, and titanium oxide. The colorant of the printed ink is black iron oxide. ZENPEP (pancrelipase) delayed-release capsules include the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hydrogenated castor oil, hypromellose phthalate, magnesium stearate, microcrystalline cellulose, talc, and triethyl citrate."
    },
    {
      "NDCCode": "73562-117-01",
      "PackageDescription": "100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (73562-117-01) ",
      "NDC11Code": "73562-0117-01",
      "ProductNDC": "73562-117",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Zenpep",
      "NonProprietaryName": "Pancrelipase Lipase, Pancrelipase Protease, Pancrelipase Amylase",
      "DosageFormName": "CAPSULE, DELAYED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20201101",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA022210",
      "LabelerName": "Aimmune Therapeutics, Inc.",
      "SubstanceName": "PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE; PANCRELIPASE AMYLASE",
      "StrengthNumber": "60000; 189600; 252600",
      "StrengthUnit": "[USP'U]/1; [USP'U]/1; [USP'U]/1",
      "Status": "Active",
      "LastUpdate": "2025-11-21",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20231027",
      "SamplePackage": "N",
      "IndicationAndUsage": "ZENPEP® is indicated for the treatment of exocrine pancreatic insufficiency in adult and pediatric patients.",
      "Description": "Pancrelipase is a pancreatic enzyme product consisting of a mixture of enzymes including lipases, proteases, and amylases, and is an extract derived from porcine pancreatic glands. The enteric-coated pellets in ZENPEP are formulated to release pancreatic enzymes at an approximate pH of 5.5 or greater. ZENPEP (pancrelipase) delayed-release capsule for oral administration, include a two-piece shell containing light brown-colored enteric-coated pellets (1.8 to 1.9mm for 3,000 and 5,000 USP units of lipase, 2.2 to 2.5 mm for 10,000, 15,000, 20,000, 25,000, 40,000 and 60,000 USP units of lipase) and are available as follows. 3,000 USP units of lipase; 10,000 USP units of protease; and 14,000 USP units of amylase; delayed-release capsules have a white opaque cap and a white opaque body with imprint \"APTALIS 3\". The shells contain carnauba wax or talc, carrageenan, hypromellose, potassium chloride, titanium oxide, and water. The colorant of the printed ink is red iron oxide. 5,000 USP units of lipase; 17,000 USP units of protease; and 24,000 USP units of amylase; delayed-release capsules have a white opaque cap and a white opaque body with imprint \"APTALIS 5\". The shells contain carnauba wax or talc, carrageenan, hypromellose, potassium chloride, titanium oxide, and water. The colorant of the printed ink is FD&C Blue 2. 10,000 USP units of lipase; 32,000 USP units of protease; and 42,000 USP units of amylase; delayed-release capsules have a yellow opaque cap and a white opaque body with imprint \"APTALIS 10\". The shells contain carnauba wax or talc, carrageenan, hypromellose, potassium chloride, titanium oxide, water and yellow ferric oxide. The colorant of the printed ink is FD&C Blue 2. 15,000 USP units of lipase; 47,000 USP units of protease; and 63,000 USP units of amylase; delayed-release capsules have a red opaque cap and a white opaque body with imprint \"APTALIS 15\". The shells contain carnauba wax or talc, carrageenan, hypromellose, potassium chloride, red ferric oxide, titanium oxide, and water. The colorant of the printed ink is FD&C Blue 2. 20,000 USP units of lipase; 63,000 USP units of protease; and 84,000 USP units of amylase; delayed-release capsules have a green opaque cap and a white opaque body with imprint \"APTALIS 20\". The shells contain carnauba wax or talc, carrageenan, FD&C Blue #2, hypromellose, potassium chloride, titanium oxide, water, and yellow ferric oxide. The colorant of the printed ink is FD&C Blue 2. 25,000 USP units of lipase; 79,000 USP units of protease; and 105,000 USP units of amylase; delayed-release capsules have a blue opaque cap and a white opaque body with imprint \"APTALIS 25\". The shells contain carnauba wax or talc, carrageenan, FD&C Blue #2, hypromellose, potassium chloride, titanium oxide, and water. The colorant of the printed ink is FD&C Blue 2. 40,000 USP units of lipase; 126,000 USP units of protease; and 168,000 USP units of amylase; delayed-release capsules have an orange opaque cap and white opaque body, printed with \"APTALIS 40\". The shells contain FD&C Yellow #6, hypromellose, and titanium oxide. The colorant of the printed ink is FD&C Blue 2. 60,000 USP units of lipase; 189,600 USP units of protease; 252,600 USP units of amylase. Capsules have a powder blue opaque cap with two black stripes and white opaque body, printed with \"APTALIS 60\" The shells contain FD&C Blue #1, hypromellose, and titanium oxide. The colorant of the printed ink is black iron oxide. ZENPEP (pancrelipase) delayed-release capsules include the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hydrogenated castor oil, hypromellose phthalate, magnesium stearate, microcrystalline cellulose, talc, and triethyl citrate."
    },
    {
      "NDCCode": "73562-117-12",
      "PackageDescription": "12 CAPSULE, DELAYED RELEASE in 1 BOTTLE (73562-117-12) ",
      "NDC11Code": "73562-0117-12",
      "ProductNDC": "73562-117",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Zenpep",
      "NonProprietaryName": "Pancrelipase Lipase, Pancrelipase Protease, Pancrelipase Amylase",
      "DosageFormName": "CAPSULE, DELAYED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20201101",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA022210",
      "LabelerName": "Aimmune Therapeutics, Inc.",
      "SubstanceName": "PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE; PANCRELIPASE AMYLASE",
      "StrengthNumber": "60000; 189600; 252600",
      "StrengthUnit": "[USP'U]/1; [USP'U]/1; [USP'U]/1",
      "Status": "Active",
      "LastUpdate": "2025-11-21",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20231027",
      "SamplePackage": "Y",
      "IndicationAndUsage": "ZENPEP® is indicated for the treatment of exocrine pancreatic insufficiency in adult and pediatric patients.",
      "Description": "Pancrelipase is a pancreatic enzyme product consisting of a mixture of enzymes including lipases, proteases, and amylases, and is an extract derived from porcine pancreatic glands. The enteric-coated pellets in ZENPEP are formulated to release pancreatic enzymes at an approximate pH of 5.5 or greater. ZENPEP (pancrelipase) delayed-release capsule for oral administration, include a two-piece shell containing light brown-colored enteric-coated pellets (1.8 to 1.9mm for 3,000 and 5,000 USP units of lipase, 2.2 to 2.5 mm for 10,000, 15,000, 20,000, 25,000, 40,000 and 60,000 USP units of lipase) and are available as follows. 3,000 USP units of lipase; 10,000 USP units of protease; and 14,000 USP units of amylase; delayed-release capsules have a white opaque cap and a white opaque body with imprint \"APTALIS 3\". The shells contain carnauba wax or talc, carrageenan, hypromellose, potassium chloride, titanium oxide, and water. The colorant of the printed ink is red iron oxide. 5,000 USP units of lipase; 17,000 USP units of protease; and 24,000 USP units of amylase; delayed-release capsules have a white opaque cap and a white opaque body with imprint \"APTALIS 5\". The shells contain carnauba wax or talc, carrageenan, hypromellose, potassium chloride, titanium oxide, and water. The colorant of the printed ink is FD&C Blue 2. 10,000 USP units of lipase; 32,000 USP units of protease; and 42,000 USP units of amylase; delayed-release capsules have a yellow opaque cap and a white opaque body with imprint \"APTALIS 10\". The shells contain carnauba wax or talc, carrageenan, hypromellose, potassium chloride, titanium oxide, water and yellow ferric oxide. The colorant of the printed ink is FD&C Blue 2. 15,000 USP units of lipase; 47,000 USP units of protease; and 63,000 USP units of amylase; delayed-release capsules have a red opaque cap and a white opaque body with imprint \"APTALIS 15\". The shells contain carnauba wax or talc, carrageenan, hypromellose, potassium chloride, red ferric oxide, titanium oxide, and water. The colorant of the printed ink is FD&C Blue 2. 20,000 USP units of lipase; 63,000 USP units of protease; and 84,000 USP units of amylase; delayed-release capsules have a green opaque cap and a white opaque body with imprint \"APTALIS 20\". The shells contain carnauba wax or talc, carrageenan, FD&C Blue #2, hypromellose, potassium chloride, titanium oxide, water, and yellow ferric oxide. The colorant of the printed ink is FD&C Blue 2. 25,000 USP units of lipase; 79,000 USP units of protease; and 105,000 USP units of amylase; delayed-release capsules have a blue opaque cap and a white opaque body with imprint \"APTALIS 25\". The shells contain carnauba wax or talc, carrageenan, FD&C Blue #2, hypromellose, potassium chloride, titanium oxide, and water. The colorant of the printed ink is FD&C Blue 2. 40,000 USP units of lipase; 126,000 USP units of protease; and 168,000 USP units of amylase; delayed-release capsules have an orange opaque cap and white opaque body, printed with \"APTALIS 40\". The shells contain FD&C Yellow #6, hypromellose, and titanium oxide. The colorant of the printed ink is FD&C Blue 2. 60,000 USP units of lipase; 189,600 USP units of protease; 252,600 USP units of amylase. Capsules have a powder blue opaque cap with two black stripes and white opaque body, printed with \"APTALIS 60\" The shells contain FD&C Blue #1, hypromellose, and titanium oxide. The colorant of the printed ink is black iron oxide. ZENPEP (pancrelipase) delayed-release capsules include the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hydrogenated castor oil, hypromellose phthalate, magnesium stearate, microcrystalline cellulose, talc, and triethyl citrate."
    },
    {
      "NDCCode": "87069-123-64",
      "PackageDescription": "6 POUCH in 1 CARTON (87069-123-64)  / 3 BAG in 1 POUCH / 70 mL in 1 BAG",
      "NDC11Code": "87069-0123-64",
      "ProductNDC": "87069-123",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Leukotrap Rc Pl System",
      "NonProprietaryName": "Cp2d/as-3 Anticoagulant And Additive System",
      "DosageFormName": "SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20260623",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "BN820915",
      "LabelerName": "GVS TM INC",
      "SubstanceName": "DEXTROSE, UNSPECIFIED FORM",
      "StrengthNumber": "3.57",
      "StrengthUnit": "g/70mL",
      "Status": "Active",
      "LastUpdate": "2026-08-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260623",
      "SamplePackage": "N",
      "Description": "Leukotrap RC PL System."
    },
    {
      "NDCCode": "87069-123-93",
      "PackageDescription": "6 POUCH in 1 CARTON (87069-123-93)  / 3 BAG in 1 POUCH / 70 mL in 1 BAG",
      "NDC11Code": "87069-0123-93",
      "ProductNDC": "87069-123",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Leukotrap Rc Pl System",
      "NonProprietaryName": "Cp2d/as-3 Anticoagulant And Additive System",
      "DosageFormName": "SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20260623",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "BN820915",
      "LabelerName": "GVS TM INC",
      "SubstanceName": "DEXTROSE, UNSPECIFIED FORM",
      "StrengthNumber": "3.57",
      "StrengthUnit": "g/70mL",
      "Status": "Active",
      "LastUpdate": "2026-08-08",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260623",
      "SamplePackage": "N",
      "Description": "Leukotrap RC PL System."
    },
    {
      "NDCCode": "87069-129-62",
      "PackageDescription": "6 POUCH in 1 CARTON (87069-129-62)  / 3 BAG in 1 POUCH / 70 mL in 1 BAG",
      "NDC11Code": "87069-0129-62",
      "ProductNDC": "87069-129",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Leukotrap Rc System",
      "NonProprietaryName": "Cp2d/as-3 Anticoagulant And Additive System",
      "DosageFormName": "SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20260623",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "BN820915",
      "LabelerName": "GVS TM INC",
      "SubstanceName": "DEXTROSE, UNSPECIFIED FORM",
      "StrengthNumber": "3.57",
      "StrengthUnit": "g/70mL",
      "Status": "Active",
      "LastUpdate": "2026-08-08",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260623",
      "SamplePackage": "N",
      "Description": "Leukotrap RC System."
    }
  ]
}
                    

{"NDC":[{"NDCCode":"87069-126-63","ProprietaryName":"Leukotrap Wb System - Cp2d","NonProprietaryName":"Cp2d/as-3 - Anticoagulant And Additive System"},{"NDCCode":"87069-126-62","ProprietaryName":"Leukotrap Wb System - Cp2d","NonProprietaryName":"Cp2d/as-3 - Anticoagulant And Additive System"},{"NDCCode":"43744-126-63","NonProprietaryName":"Carbimazole"},{"NDCCode":"53157-126-63","ProprietaryName":"Leukotrap Wb System - Cp2d","NonProprietaryName":"Cp2d/as-3 Anticoagulant And Additive System"},{"NDCCode":"87069-121-63","ProprietaryName":"Blood Collection System","NonProprietaryName":"Cp2d/as-3 Triple With Sampling System"},{"NDCCode":"87069-123-63","ProprietaryName":"Leukotrap Rc Pl System","NonProprietaryName":"Cp2d/as-3 Anticoagulant And Additive System"},{"NDCCode":"87069-129-63","ProprietaryName":"Leukotrap Rc System","NonProprietaryName":"Cp2d/as-3 Anticoagulant And Additive System"},{"NDCCode":"87069-726-62","ProprietaryName":"Leukotrap Wb System - Cp2d","NonProprietaryName":"Cp2d/as-3 Anticoagulant And Additive System"},{"NDCCode":"87069-726-63","ProprietaryName":"Leukotrap Wb System - Cp2d","NonProprietaryName":"Cp2d/as-3 Anticoagulant And Additive System"},{"NDCCode":"87069-736-62","ProprietaryName":"Leukotrap Wb System","NonProprietaryName":"Cpda-1 Blood Bag Collection System"},{"NDCCode":"50563-126-01","ProprietaryName":"Body Luxuries French Lavender Antibacterial Hand Sanitizer","NonProprietaryName":"Alcohol"},{"NDCCode":"70934-126-14","ProprietaryName":"Amoxicillin And Clavulanate Potassium","NonProprietaryName":"Amoxicillin And Clavulanate Potassium"},{"NDCCode":"70934-126-30","ProprietaryName":"Amoxicillin And Clavulanate Potassium","NonProprietaryName":"Amoxicillin And Clavulanate Potassium"},{"NDCCode":"73562-110-01","ProprietaryName":"Zenpep","NonProprietaryName":"Pancrelipase Lipase, Pancrelipase Protease, Pancrelipase Amylase"},{"NDCCode":"73562-110-10","ProprietaryName":"Zenpep","NonProprietaryName":"Pancrelipase Lipase, Pancrelipase Protease, Pancrelipase Amylase"},{"NDCCode":"73562-111-01","ProprietaryName":"Zenpep","NonProprietaryName":"Pancrelipase Lipase, Pancrelipase Protease, Pancrelipase Amylase"},{"NDCCode":"73562-112-01","ProprietaryName":"Zenpep","NonProprietaryName":"Pancrelipase Lipase, Pancrelipase Protease, Pancrelipase Amylase"},{"NDCCode":"73562-113-01","ProprietaryName":"Zenpep","NonProprietaryName":"Pancrelipase Lipase, Pancrelipase Protease, Pancrelipase Amylase"},{"NDCCode":"73562-113-10","ProprietaryName":"Zenpep","NonProprietaryName":"Pancrelipase Lipase, Pancrelipase Protease, Pancrelipase Amylase"},{"NDCCode":"73562-114-01","ProprietaryName":"Zenpep","NonProprietaryName":"Pancrelipase Lipase, Pancrelipase Protease, Pancrelipase Amylase"},{"NDCCode":"73562-114-12","ProprietaryName":"Zenpep","NonProprietaryName":"Pancrelipase Lipase, Pancrelipase Protease, Pancrelipase Amylase"},{"NDCCode":"73562-115-01","ProprietaryName":"Zenpep","NonProprietaryName":"Pancrelipase Lipase, Pancrelipase Protease, Pancrelipase Amylase"},{"NDCCode":"73562-115-10","ProprietaryName":"Zenpep","NonProprietaryName":"Pancrelipase Lipase, Pancrelipase Protease, Pancrelipase Amylase"},{"NDCCode":"73562-116-01","ProprietaryName":"Zenpep","NonProprietaryName":"Pancrelipase Lipase, Pancrelipase Protease, Pancrelipase Amylase"},{"NDCCode":"73562-116-12","ProprietaryName":"Zenpep","NonProprietaryName":"Pancrelipase Lipase, Pancrelipase Protease, Pancrelipase Amylase"},{"NDCCode":"73562-117-01","ProprietaryName":"Zenpep","NonProprietaryName":"Pancrelipase Lipase, Pancrelipase Protease, Pancrelipase Amylase"},{"NDCCode":"73562-117-12","ProprietaryName":"Zenpep","NonProprietaryName":"Pancrelipase Lipase, Pancrelipase Protease, Pancrelipase Amylase"},{"NDCCode":"87069-123-64","ProprietaryName":"Leukotrap Rc Pl System","NonProprietaryName":"Cp2d/as-3 Anticoagulant And Additive System"},{"NDCCode":"87069-123-93","ProprietaryName":"Leukotrap Rc Pl System","NonProprietaryName":"Cp2d/as-3 Anticoagulant And Additive System"},{"NDCCode":"87069-129-62","ProprietaryName":"Leukotrap Rc System","NonProprietaryName":"Cp2d/as-3 Anticoagulant And Additive System"}]}
                    

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Cp2d</ProprietaryName><NonProprietaryName>Cp2d/as-3 Anticoagulant And Additive System</NonProprietaryName></NDC><NDC><NDCCode>87069-726-63</NDCCode><ProprietaryName>Leukotrap Wb System - Cp2d</ProprietaryName><NonProprietaryName>Cp2d/as-3 Anticoagulant And Additive System</NonProprietaryName></NDC><NDC><NDCCode>87069-736-62</NDCCode><ProprietaryName>Leukotrap Wb System</ProprietaryName><NonProprietaryName>Cpda-1 Blood Bag Collection System</NonProprietaryName></NDC><NDC><NDCCode>50563-126-01</NDCCode><ProprietaryName>Body Luxuries French Lavender Antibacterial Hand Sanitizer</ProprietaryName><NonProprietaryName>Alcohol</NonProprietaryName></NDC><NDC><NDCCode>70934-126-14</NDCCode><ProprietaryName>Amoxicillin And Clavulanate Potassium</ProprietaryName><NonProprietaryName>Amoxicillin And Clavulanate Potassium</NonProprietaryName></NDC><NDC><NDCCode>70934-126-30</NDCCode><ProprietaryName>Amoxicillin And Clavulanate Potassium</ProprietaryName><NonProprietaryName>Amoxicillin And Clavulanate Potassium</NonProprietaryName></NDC><NDC><NDCCode>73562-110-01</NDCCode><ProprietaryName>Zenpep</ProprietaryName><NonProprietaryName>Pancrelipase Lipase, Pancrelipase Protease, Pancrelipase Amylase</NonProprietaryName></NDC><NDC><NDCCode>73562-110-10</NDCCode><ProprietaryName>Zenpep</ProprietaryName><NonProprietaryName>Pancrelipase Lipase, Pancrelipase Protease, Pancrelipase Amylase</NonProprietaryName></NDC><NDC><NDCCode>73562-111-01</NDCCode><ProprietaryName>Zenpep</ProprietaryName><NonProprietaryName>Pancrelipase Lipase, Pancrelipase Protease, Pancrelipase Amylase</NonProprietaryName></NDC><NDC><NDCCode>73562-112-01</NDCCode><ProprietaryName>Zenpep</ProprietaryName><NonProprietaryName>Pancrelipase Lipase, Pancrelipase Protease, Pancrelipase Amylase</NonProprietaryName></NDC><NDC><NDCCode>73562-113-01</NDCCode><ProprietaryName>Zenpep</ProprietaryName><NonProprietaryName>Pancrelipase Lipase, Pancrelipase Protease, Pancrelipase Amylase</NonProprietaryName></NDC><NDC><NDCCode>73562-113-10</NDCCode><ProprietaryName>Zenpep</ProprietaryName><NonProprietaryName>Pancrelipase Lipase, Pancrelipase Protease, Pancrelipase Amylase</NonProprietaryName></NDC><NDC><NDCCode>73562-114-01</NDCCode><ProprietaryName>Zenpep</ProprietaryName><NonProprietaryName>Pancrelipase Lipase, Pancrelipase Protease, Pancrelipase Amylase</NonProprietaryName></NDC><NDC><NDCCode>73562-114-12</NDCCode><ProprietaryName>Zenpep</ProprietaryName><NonProprietaryName>Pancrelipase Lipase, Pancrelipase Protease, Pancrelipase Amylase</NonProprietaryName></NDC><NDC><NDCCode>73562-115-01</NDCCode><ProprietaryName>Zenpep</ProprietaryName><NonProprietaryName>Pancrelipase Lipase, Pancrelipase Protease, Pancrelipase Amylase</NonProprietaryName></NDC><NDC><NDCCode>73562-115-10</NDCCode><ProprietaryName>Zenpep</ProprietaryName><NonProprietaryName>Pancrelipase Lipase, Pancrelipase Protease, Pancrelipase Amylase</NonProprietaryName></NDC><NDC><NDCCode>73562-116-01</NDCCode><ProprietaryName>Zenpep</ProprietaryName><NonProprietaryName>Pancrelipase Lipase, Pancrelipase Protease, Pancrelipase Amylase</NonProprietaryName></NDC><NDC><NDCCode>73562-116-12</NDCCode><ProprietaryName>Zenpep</ProprietaryName><NonProprietaryName>Pancrelipase Lipase, Pancrelipase Protease, Pancrelipase Amylase</NonProprietaryName></NDC><NDC><NDCCode>73562-117-01</NDCCode><ProprietaryName>Zenpep</ProprietaryName><NonProprietaryName>Pancrelipase Lipase, Pancrelipase Protease, Pancrelipase Amylase</NonProprietaryName></NDC><NDC><NDCCode>73562-117-12</NDCCode><ProprietaryName>Zenpep</ProprietaryName><NonProprietaryName>Pancrelipase Lipase, Pancrelipase Protease, Pancrelipase Amylase</NonProprietaryName></NDC><NDC><NDCCode>87069-123-64</NDCCode><ProprietaryName>Leukotrap Rc Pl System</ProprietaryName><NonProprietaryName>Cp2d/as-3 Anticoagulant And Additive System</NonProprietaryName></NDC><NDC><NDCCode>87069-123-93</NDCCode><ProprietaryName>Leukotrap Rc Pl System</ProprietaryName><NonProprietaryName>Cp2d/as-3 Anticoagulant And Additive System</NonProprietaryName></NDC><NDC><NDCCode>87069-129-62</NDCCode><ProprietaryName>Leukotrap Rc System</ProprietaryName><NonProprietaryName>Cp2d/as-3 Anticoagulant And Additive System</NonProprietaryName></NDC></NDCList>