RESTful Lookup — Test-Drive (2007 – 2026)

{
  "NDC": [
    {
      "NDCCode": "11673-168-84",
      "PackageDescription": "4 TUBE in 1 PACKAGE (11673-168-84)  / 17 g in 1 TUBE (11673-168-56) ",
      "NDC11Code": "11673-0168-84",
      "ProductNDC": "11673-168",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Target Up And Up Spf50 Sport Sunscreen Lip Balm Reef-conscious Formula",
      "NonProprietaryName": "Avobenzone, Homosalate, Octocrylene",
      "DosageFormName": "STICK",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20181221",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M020",
      "LabelerName": "TARGET CORPORATION",
      "SubstanceName": "HOMOSALATE; OCTOCRYLENE; AVOBENZONE",
      "StrengthNumber": "80; 100; 30",
      "StrengthUnit": "mg/g; mg/g; mg/g",
      "Status": "Active",
      "LastUpdate": "2024-10-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20181221",
      "SamplePackage": "N",
      "IndicationAndUsage": " helps prevent sunburn  if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun."
    },
    {
      "NDCCode": "11673-168-91",
      "PackageDescription": "2 TUBE in 1 PACKAGE (11673-168-91)  / 4.25 g in 1 TUBE (11673-168-58) ",
      "NDC11Code": "11673-0168-91",
      "ProductNDC": "11673-168",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Target Up And Up Spf50 Sport Sunscreen Lip Balm Reef-conscious Formula",
      "NonProprietaryName": "Avobenzone, Homosalate, Octocrylene",
      "DosageFormName": "STICK",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20181221",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M020",
      "LabelerName": "TARGET CORPORATION",
      "SubstanceName": "HOMOSALATE; OCTOCRYLENE; AVOBENZONE",
      "StrengthNumber": "80; 100; 30",
      "StrengthUnit": "mg/g; mg/g; mg/g",
      "Status": "Active",
      "LastUpdate": "2024-10-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20181221",
      "SamplePackage": "N",
      "IndicationAndUsage": " helps prevent sunburn  if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun."
    },
    {
      "NDCCode": "62932-168-20",
      "PackageDescription": "84 g in 1 TUBE (62932-168-20) ",
      "NDC11Code": "62932-0168-20",
      "ProductNDC": "62932-168",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Sunscreen",
      "NonProprietaryName": "Zinc Oxide Sunscreen",
      "DosageFormName": "OINTMENT",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20181231",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Private Label Select Ltd CO",
      "SubstanceName": "ZINC OXIDE",
      "StrengthNumber": "20",
      "StrengthUnit": "g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "StartMarketingDatePackage": "20181231",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "11673-135-36",
      "PackageDescription": "84 TUBE in 1 PACKAGE (11673-135-36)  / 42 g in 1 TUBE (11673-135-28) ",
      "NDC11Code": "11673-0135-36",
      "ProductNDC": "11673-135",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Target Up And Up Spf55 Sunscreen Reef-conscious Formula",
      "NonProprietaryName": "Avobenzone, Homosalate, Octisalate, Octocrylene",
      "DosageFormName": "STICK",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20190115",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M020",
      "LabelerName": "TARGET CORPORATION",
      "SubstanceName": "OCTISALATE; HOMOSALATE; OCTOCRYLENE; AVOBENZONE",
      "StrengthNumber": "50; 150; 100; 30",
      "StrengthUnit": "mg/g; mg/g; mg/g; mg/g",
      "Status": "Active",
      "LastUpdate": "2024-10-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20190424",
      "SamplePackage": "N",
      "IndicationAndUsage": " helps prevent sunburn  if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun."
    },
    {
      "NDCCode": "27241-168-01",
      "PackageDescription": "100 CAPSULE in 1 BOTTLE (27241-168-01) ",
      "NDC11Code": "27241-0168-01",
      "ProductNDC": "27241-168",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Doxepin Hydrochloride",
      "NonProprietaryName": "Doxepin Hydrochloride",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20191220",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA212624",
      "LabelerName": "Ajanta Pharma USA Inc.",
      "SubstanceName": "DOXEPIN HYDROCHLORIDE",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Tricyclic Antidepressant [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-07-21",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20191220",
      "SamplePackage": "N",
      "IndicationAndUsage": "Doxepin hydrochloride capsules are indicated for the treatment of major depressive disorder (MDD) in adults.",
      "Description": "Doxepin is a tricyclic antidepressant. The molecular formula of doxepin hydrochloride, USP is C19H21NOHCl with a molecular weight of 315.84. It is a white or almost white crystalline powder freely soluble in water, in alcohol and methylene chloride. Doxepin is a dibenzoxepin derivative. Specifically, it is an isomeric mixture of: 1-Propanamine, 3-dibenz[b,e]oxepin-11(6H)ylidene-N,N-dimethyl-, hydrochloride. The structural formula of doxepin is shown below.    Doxepin hydrochloride, USP. Doxepin hydrochloride capsules, USP is for oral administration. Active ingredients for the capsules include: 10 mg, 25, mg, 50 mg, 75 mg, 100 mg, and 150 mg of doxepin (equivalent to 11.31 mg, 28.26 mg, 56.53 mg, 84.79 mg, 113.05 mg, and 169.58 mg of doxepin hydrochloride, respectively). Capsule inactive ingredients: microcrystalline cellulose, pregelatinized starch, sodium lauryl sulfate and magnesium stearate. The hard gelatin capsule shell contains titanium dioxide, gelatin, sodium lauryl sulfate, FD & C Yellow 6, D & C Yellow 10 and FD & C Green 3. The imprinting ink contains shellac, propylene glycol, black iron oxide and potassium hydroxide. Doxepin hydrochloride capsules meet USP Dissolution Test 3."
    },
    {
      "NDCCode": "27241-168-10",
      "PackageDescription": "1000 CAPSULE in 1 BOTTLE (27241-168-10) ",
      "NDC11Code": "27241-0168-10",
      "ProductNDC": "27241-168",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Doxepin Hydrochloride",
      "NonProprietaryName": "Doxepin Hydrochloride",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20191220",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA212624",
      "LabelerName": "Ajanta Pharma USA Inc.",
      "SubstanceName": "DOXEPIN HYDROCHLORIDE",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Tricyclic Antidepressant [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-07-21",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20200220",
      "SamplePackage": "N",
      "IndicationAndUsage": "Doxepin hydrochloride capsules are indicated for the treatment of major depressive disorder (MDD) in adults.",
      "Description": "Doxepin is a tricyclic antidepressant. The molecular formula of doxepin hydrochloride, USP is C19H21NOHCl with a molecular weight of 315.84. It is a white or almost white crystalline powder freely soluble in water, in alcohol and methylene chloride. Doxepin is a dibenzoxepin derivative. Specifically, it is an isomeric mixture of: 1-Propanamine, 3-dibenz[b,e]oxepin-11(6H)ylidene-N,N-dimethyl-, hydrochloride. The structural formula of doxepin is shown below.    Doxepin hydrochloride, USP. Doxepin hydrochloride capsules, USP is for oral administration. Active ingredients for the capsules include: 10 mg, 25, mg, 50 mg, 75 mg, 100 mg, and 150 mg of doxepin (equivalent to 11.31 mg, 28.26 mg, 56.53 mg, 84.79 mg, 113.05 mg, and 169.58 mg of doxepin hydrochloride, respectively). Capsule inactive ingredients: microcrystalline cellulose, pregelatinized starch, sodium lauryl sulfate and magnesium stearate. The hard gelatin capsule shell contains titanium dioxide, gelatin, sodium lauryl sulfate, FD & C Yellow 6, D & C Yellow 10 and FD & C Green 3. The imprinting ink contains shellac, propylene glycol, black iron oxide and potassium hydroxide. Doxepin hydrochloride capsules meet USP Dissolution Test 3."
    },
    {
      "NDCCode": "33261-389-98",
      "PackageDescription": "168 TABLET in 1 BOTTLE (33261-389-98)",
      "NDC11Code": "33261-0389-98",
      "ProductNDC": "33261-389",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Tramadol Hydrochloride And Acetaminophen",
      "NonProprietaryName": "Tramadol Hydrochloride And Acetaminophen",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20091217",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090485",
      "LabelerName": "Aidarex Pharmaceuticals LLC",
      "SubstanceName": "TRAMADOL HYDROCHLORIDE; ACETAMINOPHEN",
      "StrengthNumber": "37.5; 325",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
      "DEASchedule": "CIV",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "IndicationAndUsage": "Tramadol hydrochloride and acetaminophen tablets, USP are indicated for the short-term (five days or less) management of acute pain.",
      "Description": "Tramadol hydrochloride and acetaminophen tablets, USP combine two analgesics, tramadol, USP 37.5 mg and acetaminophen, USP 325 mg. The chemical name for tramadol hydrochloride, USP is (±)cis-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. Its structural formula is. The molecular weight of tramadol hydrochloride, USP is 299.84. Tramadol hydrochloride, USP is a white, bitter, crystalline and odorless powder. The chemical name for acetaminophen, USP is N-acetyl-p-aminophenol. Its structural formula is. The molecular weight of acetaminophen, USP is 151.17. Acetaminophen, USP is an analgesic and antipyretic agent which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. Tramadol hydrochloride and acetaminophen tablets, USP contain 37.5 mg tramadol hydrochloride, USP and 325 mg acetaminophen, USP and are beige in color. Inactive ingredients in the tablets are carnauba wax, crospovidone, iron oxide black, iron oxide red, iron oxide yellow, microcrystalline cellulose, pregelatinized starch, polyethylene glycol, polyvinyl alcohol, povidone, sodium starch glycolate, stearic acid, talc and titanium dioxide. Dissolution Method: Test 2."
    },
    {
      "NDCCode": "53217-040-98",
      "PackageDescription": "168 TABLET in 1 BOTTLE (53217-040-98)",
      "NDC11Code": "53217-0040-98",
      "ProductNDC": "53217-040",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Tramadol Hydrochloride And Acetaminophen",
      "NonProprietaryName": "Tramadol Hydrochloride And Acetaminophen",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20091217",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090485",
      "LabelerName": "Aidarex Pharmaceuticals LLC",
      "SubstanceName": "TRAMADOL HYDROCHLORIDE; ACETAMINOPHEN",
      "StrengthNumber": "37.5; 325",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
      "DEASchedule": "CIV",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "IndicationAndUsage": "Tramadol hydrochloride and acetaminophen tablets, USP are indicated for the short-term (five days or less) management of acute pain.",
      "Description": "Tramadol hydrochloride and acetaminophen tablets, USP combine two analgesics, tramadol, USP 37.5 mg and acetaminophen, USP 325 mg. The chemical name for tramadol hydrochloride, USP is (±)cis-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. Its structural formula is. The molecular weight of tramadol hydrochloride, USP is 299.84. Tramadol hydrochloride, USP is a white, bitter, crystalline and odorless powder. The chemical name for acetaminophen, USP is N-acetyl-p-aminophenol. Its structural formula is. The molecular weight of acetaminophen, USP is 151.17. Acetaminophen, USP is an analgesic and antipyretic agent which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. Tramadol hydrochloride and acetaminophen tablets, USP contain 37.5 mg tramadol hydrochloride, USP and 325 mg acetaminophen, USP and are beige in color. Inactive ingredients in the tablets are carnauba wax, crospovidone, iron oxide black, iron oxide red, iron oxide yellow, microcrystalline cellulose, pregelatinized starch, polyethylene glycol, polyvinyl alcohol, povidone, sodium starch glycolate, stearic acid, talc and titanium dioxide. Dissolution Method: Test 2."
    },
    {
      "NDCCode": "69288-001-02",
      "PackageDescription": "1 CONTAINER in 1 CARTON (69288-001-02)  > 280 mL in 1 CONTAINER (69288-001-01)",
      "NDC11Code": "69288-0001-02",
      "ProductNDC": "69288-001",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Ndm Scalp",
      "NonProprietaryName": "Biotin, Nicotinamide, Dpanthenol, Pyrithione Zinc",
      "DosageFormName": "SHAMPOO",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20141027",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Damomedical Ltd.",
      "SubstanceName": "BIOTIN; PYRITHIONE ZINC; NIACINAMIDE; DEXPANTHENOL",
      "StrengthNumber": ".168; .168; .84; 1.4",
      "StrengthUnit": "g/280mL; g/280mL; g/280mL; g/280mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Immediately nourishes your skin, resulting in a noticeably brighter, softer, and smother complexion."
    },
    {
      "NDCCode": "71610-865-67",
      "PackageDescription": "168 TABLET, FILM COATED in 1 BOTTLE (71610-865-67) ",
      "NDC11Code": "71610-0865-67",
      "ProductNDC": "71610-865",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Tramadol Hydrochloride",
      "NonProprietaryName": "Tramadol Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20020619",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA075977",
      "LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
      "SubstanceName": "TRAMADOL HYDROCHLORIDE",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
      "DEASchedule": "CIV",
      "Status": "Active",
      "LastUpdate": "2024-11-20",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20241118",
      "SamplePackage": "N",
      "IndicationAndUsage": "Tramadol hydrochloride tablets are indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration [see Warnings and Precautions ( 5.1)] , reserve tramadol hydrochloride tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: : 1 Have not been tolerated or are not expected to be tolerated., 2 Have not provided adequate analgesia or are not expected to provide adequate analgesia.",
      "Description": "Tramadol hydrochloride tablets, USP, for oral use, are an opioid agonist. The chemical name for tramadol hydrochloride, USP is (±) cis-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl)cyclohexanol hydrochloride. Its structural formula is:. C 16H 25NO 2HCl        M.W. 299.84. Tramadol hydrochloride, USP is a white, bitter, crystalline and odorless powder. It is readily soluble in water and ethanol and has a pKa of 9.41. The n-octanol/water log partition coefficient (logP) is 1.35 at pH 7. Tramadol hydrochloride tablets, USP contain 50 mg of tramadol hydrochloride, USP (equivalent to 43.9 mg of tramadol) and are white in color. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol 4000, pregelatinized corn starch, sodium starch glycolate, and titanium dioxide."
    },
    {
      "NDCCode": "71939-003-01",
      "PackageDescription": "84 g in 1 BOX (71939-003-01) ",
      "NDC11Code": "71939-0003-01",
      "ProductNDC": "71939-003",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Yiganerjing Suifursoap",
      "NonProprietaryName": "Yiganerjing Suifursoap",
      "DosageFormName": "SOAP",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200622",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "TAIZHOU YOUPENG IMPORT AND EXPORT TRADING CO.,LTD.",
      "SubstanceName": "EDETIC ACID; SULFUR; TITANIUM DIOXIDE",
      "StrengthNumber": ".0672; .84; .168",
      "StrengthUnit": "g/84g; g/84g; g/84g",
      "Pharm_Classes": "Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Decreased Coagulation Factor Activity [PE], Lead Chelating Activity [MoA], Lead Chelator [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2023-08-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "20200622",
      "SamplePackage": "N",
      "IndicationAndUsage": "When using sulfur soap to clean the face, first rub the sulfur soap in the palm of the hand until it foams, then rub the face, this can reduce the irritation of the sulfur component on the skin."
    },
    {
      "NDCCode": "73362-100-01",
      "PackageDescription": "2 BOX in 1 CARTON (73362-100-01)  / 1 SYRINGE in 1 BOX (73362-100-02)  / 1 CARTRIDGE in 1 SYRINGE (73362-100-03)  / .56 mL in 1 CARTRIDGE",
      "NDC11Code": "73362-0100-01",
      "ProductNDC": "73362-100",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Yorvipath",
      "NonProprietaryName": "Palopegteriparatide",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "SUBCUTANEOUS",
      "StartMarketingDate": "20240809",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA216490",
      "LabelerName": "Ascendis Pharma, Endocrinology, Inc.",
      "SubstanceName": "PALOPEGTERIPARATIDE",
      "StrengthNumber": "168",
      "StrengthUnit": "ug/.56mL",
      "Pharm_Classes": "Parathyroid Hormone Analog [EPC], Parathyroid Hormone [CS]",
      "Status": "Active",
      "LastUpdate": "2026-08-15",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20240809",
      "SamplePackage": "N",
      "IndicationAndUsage": "YORVIPATH is indicated for the treatment of hypoparathyroidism in adults.",
      "Description": "YORVIPATH (palopegteriparatide injection) is a parathyroid hormone analog (PTH(1-34)). Palopegteriparatide is a prodrug of teriparatide (PTH(1-34)) consisting of PTH(1-34) transiently conjugated to an inert carrier via a proprietary TransCon Linker. PTH(1-34) is identical to the 34 N-terminal amino acids (the biologically active region) of the 84-amino acid human parathyroid hormone. The carrier is a branched 40 kDa (2×20 kDa) methoxypolyethylene glycol (mPEG) moiety. The average molecular weight of palopegteriparatide is approximately 47.4 kDa. The structure of palopegteriparatide drug substance is shown in Figure 2. The theoretical molecular formula is C209H340N60O59S3 + 2 × (C2H4O)n, where n is between approximately 450 and 500. Figure 2: Structure of Palopegteriparatide. YORVIPATH is a sterile, clear, and colorless solution in a glass cartridge which is pre-assembled in a single-patient-use prefilled pen for subcutaneous administration. The prefilled pen is co-packaged with disposable needles to administer 14 doses of YORVIPATH. YORVIPATH is available in three presentations containing 0.56 mL, 0.98 mL, or 1.4 mL of YORVIPATH solution, and each pen presentation can deliver one of three distinct doses for 14 days of therapy. Each mL of YORVIPATH solution contains 3456 mcg of palopegteriparatide, equivalent to 300 mcg of teriparatide (PTH(1-34)), and the following inactive ingredients: 41.7 mg mannitol, 2.5 mg metacresol, 0.13 mg sodium hydroxide, 1.18 mg succinic acid, and water for injection. YORVIPATH has a pH of 3.7 to 4.3. : 1 Each pen of 0.56 mL contains 168 mcg teriparatide equivalent to 1935 mcg palopegteriparatide., 2 Each pen of 0.98 mL contains 294 mcg teriparatide equivalent to 3387 mcg palopegteriparatide., 3 Each pen of 1.4 mL contains 420 mcg teriparatide equivalent to 4838 mcg palopegteriparatide."
    },
    {
      "NDCCode": "73362-101-01",
      "PackageDescription": "2 BOX in 1 CARTON (73362-101-01)  / 1 SYRINGE in 1 BOX (73362-101-02)  / 1 CARTRIDGE in 1 SYRINGE (73362-101-03)  / .98 mL in 1 CARTRIDGE",
      "NDC11Code": "73362-0101-01",
      "ProductNDC": "73362-101",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Yorvipath",
      "NonProprietaryName": "Palopegteriparatide",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "SUBCUTANEOUS",
      "StartMarketingDate": "20240809",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA216490",
      "LabelerName": "Ascendis Pharma, Endocrinology, Inc.",
      "SubstanceName": "PALOPEGTERIPARATIDE",
      "StrengthNumber": "294",
      "StrengthUnit": "ug/.98mL",
      "Pharm_Classes": "Parathyroid Hormone Analog [EPC], Parathyroid Hormone [CS]",
      "Status": "Active",
      "LastUpdate": "2026-08-15",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20240809",
      "SamplePackage": "N",
      "IndicationAndUsage": "YORVIPATH is indicated for the treatment of hypoparathyroidism in adults.",
      "Description": "YORVIPATH (palopegteriparatide injection) is a parathyroid hormone analog (PTH(1-34)). Palopegteriparatide is a prodrug of teriparatide (PTH(1-34)) consisting of PTH(1-34) transiently conjugated to an inert carrier via a proprietary TransCon Linker. PTH(1-34) is identical to the 34 N-terminal amino acids (the biologically active region) of the 84-amino acid human parathyroid hormone. The carrier is a branched 40 kDa (2×20 kDa) methoxypolyethylene glycol (mPEG) moiety. The average molecular weight of palopegteriparatide is approximately 47.4 kDa. The structure of palopegteriparatide drug substance is shown in Figure 2. The theoretical molecular formula is C209H340N60O59S3 + 2 × (C2H4O)n, where n is between approximately 450 and 500. Figure 2: Structure of Palopegteriparatide. YORVIPATH is a sterile, clear, and colorless solution in a glass cartridge which is pre-assembled in a single-patient-use prefilled pen for subcutaneous administration. The prefilled pen is co-packaged with disposable needles to administer 14 doses of YORVIPATH. YORVIPATH is available in three presentations containing 0.56 mL, 0.98 mL, or 1.4 mL of YORVIPATH solution, and each pen presentation can deliver one of three distinct doses for 14 days of therapy. Each mL of YORVIPATH solution contains 3456 mcg of palopegteriparatide, equivalent to 300 mcg of teriparatide (PTH(1-34)), and the following inactive ingredients: 41.7 mg mannitol, 2.5 mg metacresol, 0.13 mg sodium hydroxide, 1.18 mg succinic acid, and water for injection. YORVIPATH has a pH of 3.7 to 4.3. : 1 Each pen of 0.56 mL contains 168 mcg teriparatide equivalent to 1935 mcg palopegteriparatide., 2 Each pen of 0.98 mL contains 294 mcg teriparatide equivalent to 3387 mcg palopegteriparatide., 3 Each pen of 1.4 mL contains 420 mcg teriparatide equivalent to 4838 mcg palopegteriparatide."
    },
    {
      "NDCCode": "73362-102-01",
      "PackageDescription": "2 BOX in 1 CARTON (73362-102-01)  / 1 SYRINGE in 1 BOX (73362-102-02)  / 1 CARTRIDGE in 1 SYRINGE (73362-102-03)  / 1.4 mL in 1 CARTRIDGE",
      "NDC11Code": "73362-0102-01",
      "ProductNDC": "73362-102",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Yorvipath",
      "NonProprietaryName": "Palopegteriparatide",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "SUBCUTANEOUS",
      "StartMarketingDate": "20240809",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA216490",
      "LabelerName": "Ascendis Pharma, Endocrinology, Inc.",
      "SubstanceName": "PALOPEGTERIPARATIDE",
      "StrengthNumber": "420",
      "StrengthUnit": "ug/1.4mL",
      "Pharm_Classes": "Parathyroid Hormone Analog [EPC], Parathyroid Hormone [CS]",
      "Status": "Active",
      "LastUpdate": "2026-08-15",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20240809",
      "SamplePackage": "N",
      "IndicationAndUsage": "YORVIPATH is indicated for the treatment of hypoparathyroidism in adults.",
      "Description": "YORVIPATH (palopegteriparatide injection) is a parathyroid hormone analog (PTH(1-34)). Palopegteriparatide is a prodrug of teriparatide (PTH(1-34)) consisting of PTH(1-34) transiently conjugated to an inert carrier via a proprietary TransCon Linker. PTH(1-34) is identical to the 34 N-terminal amino acids (the biologically active region) of the 84-amino acid human parathyroid hormone. The carrier is a branched 40 kDa (2×20 kDa) methoxypolyethylene glycol (mPEG) moiety. The average molecular weight of palopegteriparatide is approximately 47.4 kDa. The structure of palopegteriparatide drug substance is shown in Figure 2. The theoretical molecular formula is C209H340N60O59S3 + 2 × (C2H4O)n, where n is between approximately 450 and 500. Figure 2: Structure of Palopegteriparatide. YORVIPATH is a sterile, clear, and colorless solution in a glass cartridge which is pre-assembled in a single-patient-use prefilled pen for subcutaneous administration. The prefilled pen is co-packaged with disposable needles to administer 14 doses of YORVIPATH. YORVIPATH is available in three presentations containing 0.56 mL, 0.98 mL, or 1.4 mL of YORVIPATH solution, and each pen presentation can deliver one of three distinct doses for 14 days of therapy. Each mL of YORVIPATH solution contains 3456 mcg of palopegteriparatide, equivalent to 300 mcg of teriparatide (PTH(1-34)), and the following inactive ingredients: 41.7 mg mannitol, 2.5 mg metacresol, 0.13 mg sodium hydroxide, 1.18 mg succinic acid, and water for injection. YORVIPATH has a pH of 3.7 to 4.3. : 1 Each pen of 0.56 mL contains 168 mcg teriparatide equivalent to 1935 mcg palopegteriparatide., 2 Each pen of 0.98 mL contains 294 mcg teriparatide equivalent to 3387 mcg palopegteriparatide., 3 Each pen of 1.4 mL contains 420 mcg teriparatide equivalent to 4838 mcg palopegteriparatide."
    },
    {
      "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": "0004-0086-94",
      "PackageDescription": "168 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0004-0086-94) ",
      "NDC11Code": "00004-0086-94",
      "ProductNDC": "0004-0086",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Copegus",
      "NonProprietaryName": "Ribavirin",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20021203",
      "EndMarketingDate": "20180131",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA021511",
      "LabelerName": "Genentech, Inc.",
      "SubstanceName": "RIBAVIRIN",
      "StrengthNumber": "200",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2018-02-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20181231"
    },
    {
      "NDCCode": "0006-3083-01",
      "PackageDescription": "1 VIAL in 1 CARTON (0006-3083-01)  / 2.4 mL in 1 VIAL (0006-3083-99) ",
      "NDC11Code": "00006-3083-01",
      "ProductNDC": "0006-3083",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Keytruda Qlex",
      "NonProprietaryName": "Pembrolizumab And Berahyaluronidase Alfa-pmph",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "SUBCUTANEOUS",
      "StartMarketingDate": "20250919",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA761467",
      "LabelerName": "Merck Sharp & Dohme LLC",
      "SubstanceName": "PEMBROLIZUMAB; BERAHYALURONIDASE ALFA",
      "StrengthNumber": "165; 2000",
      "StrengthUnit": "mg/mL; U/mL",
      "Pharm_Classes": "Endoglycosidase [EPC], Glycoside Hydrolases [CS], Programmed Death Receptor-1 Blocking Antibody [EPC], Programmed Death Receptor-1-directed Antibody Interactions [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-08-12",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20250919",
      "SamplePackage": "N",
      "IndicationAndUsage": "KEYTRUDA QLEX is a combination of pembrolizumab, a programmed death receptor-1 (PD-1)-blocking antibody, and berahyaluronidase alfa, an endoglycosidase, indicated:. Melanoma: 1 for the treatment of adult patients with unresectable or metastatic melanoma. (1.1), 2 for the adjuvant treatment of adult and pediatric patients 12 years and older with Stage IIB, IIC, or III melanoma following complete resection. (1.1).",
      "Description": "KEYTRUDA QLEX is a fixed-combination drug product containing pembrolizumab and berahyaluronidase alfa. Pembrolizumab is a programmed death receptor-1 (PD 1)-blocking antibody. Pembrolizumab is a humanized monoclonal IgG4 kappa antibody with an approximate molecular weight of 149 kDa. Pembrolizumab is produced in recombinant Chinese hamster ovary (CHO) cells. Berahyaluronidase alfa is an endoglycosidase used to enhance dispersion and permeation, which facilitates delivery of increased volume of pembrolizumab that is co-administered subcutaneously. It is produced by mammalian CHO (Chinese Hamster Ovary) cells containing a DNA plasmid encoding a variant of human hyaluronidase PH20. It is a glycosylated protein with an approximate molecular weight of 49 kDa under nonreducing, deglycosylated conditions. KEYTRUDA QLEX (pembrolizumab and berahyaluronidase alfa-pmph) injection is a sterile, preservative-free, clear to slightly opalescent, colorless to slightly yellow solution supplied in single-dose vials for subcutaneous administration. KEYTRUDA QLEX is supplied as two different configurations: : 1 Each KEYTRUDA QLEX 2.4 mL single-dose vial contains 395 mg of pembrolizumab and 4,800 units of berahyaluronidase alfa, and histidine (0.7 mg), histidine hydrochloride monohydrate (4.1 mg), methionine (3.6 mg), polysorbate 80 (0.5 mg), sucrose (168 mg), and Water for Injection, USP. The pH is 5.3-5.9. , 2 Each KEYTRUDA QLEX 4.8 mL single-dose vial contains 790 mg of pembrolizumab and 9,600 units of berahyaluronidase alfa, and histidine (1.4 mg), histidine hydrochloride monohydrate (8.2 mg), methionine (7.2 mg), polysorbate 80 (1 mg), sucrose (336 mg), and Water for Injection, USP. The pH is 5.3-5.9."
    }
  ]
}
                    

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Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>27241-168-10</NDCCode><ProprietaryName>Doxepin Hydrochloride</ProprietaryName><NonProprietaryName>Doxepin Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>33261-389-98</NDCCode><ProprietaryName>Tramadol Hydrochloride And Acetaminophen</ProprietaryName><NonProprietaryName>Tramadol Hydrochloride And Acetaminophen</NonProprietaryName></NDC><NDC><NDCCode>53217-040-98</NDCCode><ProprietaryName>Tramadol Hydrochloride And Acetaminophen</ProprietaryName><NonProprietaryName>Tramadol Hydrochloride And Acetaminophen</NonProprietaryName></NDC><NDC><NDCCode>69288-001-02</NDCCode><ProprietaryName>Ndm Scalp</ProprietaryName><NonProprietaryName>Biotin, Nicotinamide, Dpanthenol, Pyrithione Zinc</NonProprietaryName></NDC><NDC><NDCCode>71610-865-67</NDCCode><ProprietaryName>Tramadol Hydrochloride</ProprietaryName><NonProprietaryName>Tramadol Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>71939-003-01</NDCCode><ProprietaryName>Yiganerjing Suifursoap</ProprietaryName><NonProprietaryName>Yiganerjing Suifursoap</NonProprietaryName></NDC><NDC><NDCCode>73362-100-01</NDCCode><ProprietaryName>Yorvipath</ProprietaryName><NonProprietaryName>Palopegteriparatide</NonProprietaryName></NDC><NDC><NDCCode>73362-101-01</NDCCode><ProprietaryName>Yorvipath</ProprietaryName><NonProprietaryName>Palopegteriparatide</NonProprietaryName></NDC><NDC><NDCCode>73362-102-01</NDCCode><ProprietaryName>Yorvipath</ProprietaryName><NonProprietaryName>Palopegteriparatide</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 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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>0004-0086-94</NDCCode><ProprietaryName>Copegus</ProprietaryName><NonProprietaryName>Ribavirin</NonProprietaryName></NDC><NDC><NDCCode>0006-3083-01</NDCCode><ProprietaryName>Keytruda Qlex</ProprietaryName><NonProprietaryName>Pembrolizumab And Berahyaluronidase Alfa-pmph</NonProprietaryName></NDC></NDCList>