{
"NDC": [
{
"NDCCode": "60000-491-32",
"PackageDescription": "907 g in 1 CARTON (60000-491-32)",
"NDC11Code": "60000-0491-32",
"ProductNDC": "60000-491",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Pure Baking Soda",
"NonProprietaryName": "Baking Soda",
"DosageFormName": "POWDER, FOR SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20100601",
"EndMarketingDate": "20150115",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part331",
"LabelerName": "Ahold U.S.A., Inc.",
"SubstanceName": "SODIUM BICARBONATE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2015-01-16"
},
{
"NDCCode": "60000-491-16",
"PackageDescription": "454 g in 1 CARTON (60000-491-16)",
"NDC11Code": "60000-0491-16",
"ProductNDC": "60000-491",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Pure Baking Soda",
"NonProprietaryName": "Baking Soda",
"DosageFormName": "POWDER, FOR SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20100601",
"EndMarketingDate": "20150115",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part331",
"LabelerName": "Ahold U.S.A., Inc.",
"SubstanceName": "SODIUM BICARBONATE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2015-01-16"
},
{
"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": "60687-491-01",
"PackageDescription": "100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-491-01) / 1 TABLET in 1 BLISTER PACK (60687-491-11) ",
"NDC11Code": "60687-0491-01",
"ProductNDC": "60687-491",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Naproxen",
"NonProprietaryName": "Naproxen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200218",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078250",
"LabelerName": "American Health Packaging",
"SubstanceName": "NAPROXEN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200218",
"SamplePackage": "N",
"IndicationAndUsage": "Naproxen tablets and naproxen sodium tablets are indicated for: the relief of the signs and symptoms of: : 1 rheumatoid arthritis, 2 osteoarthritis, 3 ankylosing spondylitis, 4 Polyarticular Juvenile Idiopathic Arthritis.",
"Description": "Naproxen Tablets, USP and Naproxen Sodium Tablets, USP are nonsteroidal anti-inflammatory drugs available as follows. Naproxen Tablets, USP are available as follows for oral administration: 250 mg: circular, light orange colored, flat, uncoated tablets, engraved with ‘G’ and ‘32’ on either side of a break line on one side and ‘250’ on the other side. 375 mg: oval, light orange colored, biconvex, uncoated tablets, engraved with ‘G 32’ on one side and ‘375’ on the other side. 500 mg: capsule shaped, light orange colored, uncoated tablets, debossed with ‘G’ and ‘32’ on either side of a break line on one side and ‘500’ on the other side. The inactive ingredients are croscarmellose sodium, iron oxide red, iron oxide yellow, magnesium stearate, microcrystalline cellulose and povidone. Naproxen Sodium Tablets, USP are available as follows for oral administration: 275 mg: blue, oval, film-coated tablets with ‘G 0’ engraved on one side and ‘275’ engraved on the other side. 550 mg: blue colored, modified capsule shaped, biconvex, film-coated tablets, engraved with ‘G’ and ‘0’ on either side of a break line and a break line on the other side. The inactive ingredients are colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, povidone and talc. The coating suspension for the naproxen sodium 275 mg and 550 mg tablet contains FD&C blue#2, iron oxide red, hypromellose, polyethylene glycol and titanium dioxide. Naproxen, USP is a propionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical names for naproxen, USP and naproxen sodium, USP are (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid and (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid, sodium salt, respectively. Naproxen, USP has a molecular weight of 230.26 g/mol and a molecular formula of C 14H 14O 3. Naproxen sodium, USP has a molecular weight of 252.24 g/mol and a molecular formula of C 14H 13NaO 3. Naproxen, USP and naproxen sodium, USP have the following structures, respectively:. Naproxen, USP is a white to off-white crystalline powder. It is soluble in chloroform, dehydrated alcohol and alcohol; sparingly soluble in ether, insoluble in water. Naproxen sodium, USP is a white to almost white crystalline powder, soluble in water and methanol; sparingly soluble in ethanol."
},
{
"NDCCode": "65649-400-01",
"PackageDescription": "1 KIT in 1 CARTON (65649-400-01) * 46.26 POWDER, FOR SOLUTION in 1 POUCH * 55.65 POWDER, FOR SOLUTION in 1 POUCH * 115.96 POWDER, FOR SOLUTION in 1 POUCH",
"NDC11Code": "65649-0400-01",
"ProductNDC": "65649-400",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Plenvu",
"NonProprietaryName": "Polyethylene Glycol 3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Ascorbic Acid, Sodium Ascorbate",
"DosageFormName": "KIT",
"StartMarketingDate": "20180504",
"EndMarketingDate": "20270930",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA209381",
"LabelerName": "Salix Pharmaceuticals, Inc",
"Status": "Active",
"LastUpdate": "2026-08-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20180504",
"EndMarketingDatePackage": "20270930",
"SamplePackage": "N",
"IndicationAndUsage": "PLENVU® is indicated for cleansing of the colon in preparation for colonoscopy in adults.",
"Description": "The active ingredients contained in PLENVU are provided in Table 3. PLENVU (polyethylene glycol 3350, sodium ascorbate, sodium sulfate, ascorbic acid, sodium chloride and potassium chloride for oral solution) is an osmotic laxative consisting of three pouches (one for Dose 1, one for Dose 2 Pouch A and one for Dose 2 Pouch B) containing white to yellow powder for reconstitution. Dose 1 contains 100 grams of PEG 3350, 9 grams of sodium sulfate, 2 grams of sodium chloride, and 1 gram of potassium chloride, and the following excipients: sucralose, encapsulated citric acid and mango flavoring. When Dose 1 is dissolved in water to a volume of 16 fluid ounces, PLENVU Dose 1 (PEG 3350, sodium sulfate, sodium chloride and potassium chloride) is an oral solution having a mango flavor. Each Dose 2 Pouch A contains 40 grams of PEG 3350, 3.2 grams of sodium chloride, and 1.2 grams of potassium chloride, and the following excipients: aspartame and fruit punch flavoring. Each Dose 2 Pouch B contains 48.11 grams of sodium ascorbate and 7.54 grams of ascorbic acid. When Dose 2 Pouch A and Dose 2 Pouch B are dissolved together in water to a volume of 16 fluid ounces, PLENVU Dose 2 (sodium ascorbate, PEG 3350, ascorbic acid, sodium chloride and potassium chloride) is an oral solution having a fruit punch flavor. The entire reconstituted 32 fluid ounces of PLENVU bowel preparation contains 140 grams of PEG 3350, 48.11 grams of sodium ascorbate, 9 grams of sodium sulfate, 7.54 grams of ascorbic acid, 5.2 grams of sodium chloride and 2.2 grams of potassium chloride and the following excipients: aspartame, sucralose, encapsulated citric acid, mango and fruit punch flavorings. A mixing container for reconstitution is enclosed. Phenylketonurics: Contains Phenylalanine 491 mg per treatment. Contains no ingredient made from a gluten-containing grain (wheat, barley, or rye)."
},
{
"NDCCode": "65649-400-02",
"PackageDescription": "1 KIT in 1 CARTON (65649-400-02) * 46.26 POWDER, FOR SOLUTION in 1 POUCH * 55.65 POWDER, FOR SOLUTION in 1 POUCH * 115.96 POWDER, FOR SOLUTION in 1 POUCH",
"NDC11Code": "65649-0400-02",
"ProductNDC": "65649-400",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Plenvu",
"NonProprietaryName": "Polyethylene Glycol 3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Ascorbic Acid, Sodium Ascorbate",
"DosageFormName": "KIT",
"StartMarketingDate": "20180504",
"EndMarketingDate": "20270930",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA209381",
"LabelerName": "Salix Pharmaceuticals, Inc",
"Status": "Active",
"LastUpdate": "2026-08-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20180504",
"EndMarketingDatePackage": "20270930",
"SamplePackage": "Y",
"IndicationAndUsage": "PLENVU® is indicated for cleansing of the colon in preparation for colonoscopy in adults.",
"Description": "The active ingredients contained in PLENVU are provided in Table 3. PLENVU (polyethylene glycol 3350, sodium ascorbate, sodium sulfate, ascorbic acid, sodium chloride and potassium chloride for oral solution) is an osmotic laxative consisting of three pouches (one for Dose 1, one for Dose 2 Pouch A and one for Dose 2 Pouch B) containing white to yellow powder for reconstitution. Dose 1 contains 100 grams of PEG 3350, 9 grams of sodium sulfate, 2 grams of sodium chloride, and 1 gram of potassium chloride, and the following excipients: sucralose, encapsulated citric acid and mango flavoring. When Dose 1 is dissolved in water to a volume of 16 fluid ounces, PLENVU Dose 1 (PEG 3350, sodium sulfate, sodium chloride and potassium chloride) is an oral solution having a mango flavor. Each Dose 2 Pouch A contains 40 grams of PEG 3350, 3.2 grams of sodium chloride, and 1.2 grams of potassium chloride, and the following excipients: aspartame and fruit punch flavoring. Each Dose 2 Pouch B contains 48.11 grams of sodium ascorbate and 7.54 grams of ascorbic acid. When Dose 2 Pouch A and Dose 2 Pouch B are dissolved together in water to a volume of 16 fluid ounces, PLENVU Dose 2 (sodium ascorbate, PEG 3350, ascorbic acid, sodium chloride and potassium chloride) is an oral solution having a fruit punch flavor. The entire reconstituted 32 fluid ounces of PLENVU bowel preparation contains 140 grams of PEG 3350, 48.11 grams of sodium ascorbate, 9 grams of sodium sulfate, 7.54 grams of ascorbic acid, 5.2 grams of sodium chloride and 2.2 grams of potassium chloride and the following excipients: aspartame, sucralose, encapsulated citric acid, mango and fruit punch flavorings. A mixing container for reconstitution is enclosed. Phenylketonurics: Contains Phenylalanine 491 mg per treatment. Contains no ingredient made from a gluten-containing grain (wheat, barley, or rye)."
},
{
"NDCCode": "0032-0047-30",
"PackageDescription": "100 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (0032-0047-30) ",
"NDC11Code": "00032-0047-30",
"ProductNDC": "0032-0047",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Creon",
"NonProprietaryName": "Pancrelipase",
"DosageFormName": "CAPSULE, DELAYED RELEASE PELLETS",
"RouteName": "ORAL",
"StartMarketingDate": "20231012",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA020725",
"LabelerName": "AbbVie Inc.",
"SubstanceName": "PANCRELIPASE AMYLASE; PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE",
"StrengthNumber": "60000; 12000; 38000",
"StrengthUnit": "[USP'U]/1; [USP'U]/1; [USP'U]/1",
"Status": "Active",
"LastUpdate": "2026-07-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20231012",
"SamplePackage": "Y",
"IndicationAndUsage": "CREON® 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 spheres in CREON are formulated to release pancreatic enzymes at an approximate pH of 5.5 or greater. CREON (pancrelipase) delayed-release capsules are for oral administration, include a two-piece shell containing tan-colored enteric-coated spheres (0.71 mm to 1.60 mm in diameter), and are available as follows:. 3,000 USP units of lipase; 9,500 USP units of protease; and 15,000 USP units of amylase; delayed-release capsules with shells that contain hypromellose and titanium dioxide, and that also may contain carrageenan and potassium chloride. 6,000 USP units of lipase; 19,000 USP units of protease; and 30,000 USP units of amylase; delayed-release capsules with shells that may contain gelatin, hypromellose, carrageenan, potassium chloride, sodium lauryl sulfate, titanium dioxide, FD&C Blue No. 1, and FD&C Blue No. 2, red iron oxide, and yellow iron oxide. 12,000 USP units of lipase; 38,000 USP units of protease; and 60,000 USP units of amylase; delayed-release capsules with shells that may contain gelatin, hypromellose, carrageenan, potassium chloride, sodium lauryl sulfate, titanium dioxide, black iron oxide, red iron oxide, and yellow iron oxide. 24,000 USP units of lipase; 76,000 USP units of protease; and 120,000 USP units of amylase; delayed-release capsules with shells that may contain gelatin, hypromellose, carrageenan, potassium chloride, sodium lauryl sulfate, titanium dioxide, red iron oxide, and yellow iron oxide. 36,000 USP units of lipase; 114,000 USP units of protease; and 180,000 USP units of amylase; delayed-release capsules with shells that may contain gelatin, hypromellose, carrageenan, potassium chloride, sodium lauryl sulfate, titanium dioxide, FD&C Blue No. 1, and FD&C Blue No. 2. CREON (pancrelipase) delayed-release capsules include the following inactive ingredients: cetyl alcohol, dimethicone, hypromellose phthalate, polyethylene glycol, and triethyl citrate."
},
{
"NDCCode": "0032-0047-70",
"PackageDescription": "100 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (0032-0047-70) ",
"NDC11Code": "00032-0047-70",
"ProductNDC": "0032-0047",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Creon",
"NonProprietaryName": "Pancrelipase",
"DosageFormName": "CAPSULE, DELAYED RELEASE PELLETS",
"RouteName": "ORAL",
"StartMarketingDate": "20231012",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA020725",
"LabelerName": "AbbVie Inc.",
"SubstanceName": "PANCRELIPASE AMYLASE; PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE",
"StrengthNumber": "60000; 12000; 38000",
"StrengthUnit": "[USP'U]/1; [USP'U]/1; [USP'U]/1",
"Status": "Active",
"LastUpdate": "2026-07-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20231012",
"SamplePackage": "N",
"IndicationAndUsage": "CREON® 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 spheres in CREON are formulated to release pancreatic enzymes at an approximate pH of 5.5 or greater. CREON (pancrelipase) delayed-release capsules are for oral administration, include a two-piece shell containing tan-colored enteric-coated spheres (0.71 mm to 1.60 mm in diameter), and are available as follows:. 3,000 USP units of lipase; 9,500 USP units of protease; and 15,000 USP units of amylase; delayed-release capsules with shells that contain hypromellose and titanium dioxide, and that also may contain carrageenan and potassium chloride. 6,000 USP units of lipase; 19,000 USP units of protease; and 30,000 USP units of amylase; delayed-release capsules with shells that may contain gelatin, hypromellose, carrageenan, potassium chloride, sodium lauryl sulfate, titanium dioxide, FD&C Blue No. 1, and FD&C Blue No. 2, red iron oxide, and yellow iron oxide. 12,000 USP units of lipase; 38,000 USP units of protease; and 60,000 USP units of amylase; delayed-release capsules with shells that may contain gelatin, hypromellose, carrageenan, potassium chloride, sodium lauryl sulfate, titanium dioxide, black iron oxide, red iron oxide, and yellow iron oxide. 24,000 USP units of lipase; 76,000 USP units of protease; and 120,000 USP units of amylase; delayed-release capsules with shells that may contain gelatin, hypromellose, carrageenan, potassium chloride, sodium lauryl sulfate, titanium dioxide, red iron oxide, and yellow iron oxide. 36,000 USP units of lipase; 114,000 USP units of protease; and 180,000 USP units of amylase; delayed-release capsules with shells that may contain gelatin, hypromellose, carrageenan, potassium chloride, sodium lauryl sulfate, titanium dioxide, FD&C Blue No. 1, and FD&C Blue No. 2. CREON (pancrelipase) delayed-release capsules include the following inactive ingredients: cetyl alcohol, dimethicone, hypromellose phthalate, polyethylene glycol, and triethyl citrate."
},
{
"NDCCode": "0032-1212-01",
"PackageDescription": "100 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (0032-1212-01) ",
"NDC11Code": "00032-1212-01",
"ProductNDC": "0032-1212",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Creon",
"NonProprietaryName": "Pancrelipase",
"DosageFormName": "CAPSULE, DELAYED RELEASE PELLETS",
"RouteName": "ORAL",
"StartMarketingDate": "20090430",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA020725",
"LabelerName": "AbbVie Inc.",
"SubstanceName": "PANCRELIPASE AMYLASE; PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE",
"StrengthNumber": "60000; 12000; 38000",
"StrengthUnit": "[USP'U]/1; [USP'U]/1; [USP'U]/1",
"Status": "Active",
"LastUpdate": "2026-07-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20090430",
"SamplePackage": "N",
"IndicationAndUsage": "CREON® 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 spheres in CREON are formulated to release pancreatic enzymes at an approximate pH of 5.5 or greater. CREON (pancrelipase) delayed-release capsules are for oral administration, include a two-piece shell containing tan-colored enteric-coated spheres (0.71 mm to 1.60 mm in diameter), and are available as follows:. 3,000 USP units of lipase; 9,500 USP units of protease; and 15,000 USP units of amylase; delayed-release capsules with shells that contain hypromellose and titanium dioxide, and that also may contain carrageenan and potassium chloride. 6,000 USP units of lipase; 19,000 USP units of protease; and 30,000 USP units of amylase; delayed-release capsules with shells that may contain gelatin, hypromellose, carrageenan, potassium chloride, sodium lauryl sulfate, titanium dioxide, FD&C Blue No. 1, and FD&C Blue No. 2, red iron oxide, and yellow iron oxide. 12,000 USP units of lipase; 38,000 USP units of protease; and 60,000 USP units of amylase; delayed-release capsules with shells that may contain gelatin, hypromellose, carrageenan, potassium chloride, sodium lauryl sulfate, titanium dioxide, black iron oxide, red iron oxide, and yellow iron oxide. 24,000 USP units of lipase; 76,000 USP units of protease; and 120,000 USP units of amylase; delayed-release capsules with shells that may contain gelatin, hypromellose, carrageenan, potassium chloride, sodium lauryl sulfate, titanium dioxide, red iron oxide, and yellow iron oxide. 36,000 USP units of lipase; 114,000 USP units of protease; and 180,000 USP units of amylase; delayed-release capsules with shells that may contain gelatin, hypromellose, carrageenan, potassium chloride, sodium lauryl sulfate, titanium dioxide, FD&C Blue No. 1, and FD&C Blue No. 2. CREON (pancrelipase) delayed-release capsules include the following inactive ingredients: cetyl alcohol, dimethicone, hypromellose phthalate, polyethylene glycol, and triethyl citrate."
},
{
"NDCCode": "0032-1212-07",
"PackageDescription": "250 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (0032-1212-07) ",
"NDC11Code": "00032-1212-07",
"ProductNDC": "0032-1212",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Creon",
"NonProprietaryName": "Pancrelipase",
"DosageFormName": "CAPSULE, DELAYED RELEASE PELLETS",
"RouteName": "ORAL",
"StartMarketingDate": "20090430",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA020725",
"LabelerName": "AbbVie Inc.",
"SubstanceName": "PANCRELIPASE AMYLASE; PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE",
"StrengthNumber": "60000; 12000; 38000",
"StrengthUnit": "[USP'U]/1; [USP'U]/1; [USP'U]/1",
"Status": "Active",
"LastUpdate": "2026-07-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20090430",
"SamplePackage": "N",
"IndicationAndUsage": "CREON® 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 spheres in CREON are formulated to release pancreatic enzymes at an approximate pH of 5.5 or greater. CREON (pancrelipase) delayed-release capsules are for oral administration, include a two-piece shell containing tan-colored enteric-coated spheres (0.71 mm to 1.60 mm in diameter), and are available as follows:. 3,000 USP units of lipase; 9,500 USP units of protease; and 15,000 USP units of amylase; delayed-release capsules with shells that contain hypromellose and titanium dioxide, and that also may contain carrageenan and potassium chloride. 6,000 USP units of lipase; 19,000 USP units of protease; and 30,000 USP units of amylase; delayed-release capsules with shells that may contain gelatin, hypromellose, carrageenan, potassium chloride, sodium lauryl sulfate, titanium dioxide, FD&C Blue No. 1, and FD&C Blue No. 2, red iron oxide, and yellow iron oxide. 12,000 USP units of lipase; 38,000 USP units of protease; and 60,000 USP units of amylase; delayed-release capsules with shells that may contain gelatin, hypromellose, carrageenan, potassium chloride, sodium lauryl sulfate, titanium dioxide, black iron oxide, red iron oxide, and yellow iron oxide. 24,000 USP units of lipase; 76,000 USP units of protease; and 120,000 USP units of amylase; delayed-release capsules with shells that may contain gelatin, hypromellose, carrageenan, potassium chloride, sodium lauryl sulfate, titanium dioxide, red iron oxide, and yellow iron oxide. 36,000 USP units of lipase; 114,000 USP units of protease; and 180,000 USP units of amylase; delayed-release capsules with shells that may contain gelatin, hypromellose, carrageenan, potassium chloride, sodium lauryl sulfate, titanium dioxide, FD&C Blue No. 1, and FD&C Blue No. 2. CREON (pancrelipase) delayed-release capsules include the following inactive ingredients: cetyl alcohol, dimethicone, hypromellose phthalate, polyethylene glycol, and triethyl citrate."
},
{
"NDCCode": "0032-1212-13",
"PackageDescription": "1 BOTTLE in 1 CARTON (0032-1212-13) / 100 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE",
"NDC11Code": "00032-1212-13",
"ProductNDC": "0032-1212",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Creon",
"NonProprietaryName": "Pancrelipase",
"DosageFormName": "CAPSULE, DELAYED RELEASE PELLETS",
"RouteName": "ORAL",
"StartMarketingDate": "20090430",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA020725",
"LabelerName": "AbbVie Inc.",
"SubstanceName": "PANCRELIPASE AMYLASE; PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE",
"StrengthNumber": "60000; 12000; 38000",
"StrengthUnit": "[USP'U]/1; [USP'U]/1; [USP'U]/1",
"Status": "Active",
"LastUpdate": "2026-07-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20181120",
"SamplePackage": "Y",
"IndicationAndUsage": "CREON® 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 spheres in CREON are formulated to release pancreatic enzymes at an approximate pH of 5.5 or greater. CREON (pancrelipase) delayed-release capsules are for oral administration, include a two-piece shell containing tan-colored enteric-coated spheres (0.71 mm to 1.60 mm in diameter), and are available as follows:. 3,000 USP units of lipase; 9,500 USP units of protease; and 15,000 USP units of amylase; delayed-release capsules with shells that contain hypromellose and titanium dioxide, and that also may contain carrageenan and potassium chloride. 6,000 USP units of lipase; 19,000 USP units of protease; and 30,000 USP units of amylase; delayed-release capsules with shells that may contain gelatin, hypromellose, carrageenan, potassium chloride, sodium lauryl sulfate, titanium dioxide, FD&C Blue No. 1, and FD&C Blue No. 2, red iron oxide, and yellow iron oxide. 12,000 USP units of lipase; 38,000 USP units of protease; and 60,000 USP units of amylase; delayed-release capsules with shells that may contain gelatin, hypromellose, carrageenan, potassium chloride, sodium lauryl sulfate, titanium dioxide, black iron oxide, red iron oxide, and yellow iron oxide. 24,000 USP units of lipase; 76,000 USP units of protease; and 120,000 USP units of amylase; delayed-release capsules with shells that may contain gelatin, hypromellose, carrageenan, potassium chloride, sodium lauryl sulfate, titanium dioxide, red iron oxide, and yellow iron oxide. 36,000 USP units of lipase; 114,000 USP units of protease; and 180,000 USP units of amylase; delayed-release capsules with shells that may contain gelatin, hypromellose, carrageenan, potassium chloride, sodium lauryl sulfate, titanium dioxide, FD&C Blue No. 1, and FD&C Blue No. 2. CREON (pancrelipase) delayed-release capsules include the following inactive ingredients: cetyl alcohol, dimethicone, hypromellose phthalate, polyethylene glycol, and triethyl citrate."
},
{
"NDCCode": "0032-1212-46",
"PackageDescription": "1 BOTTLE in 1 CARTON (0032-1212-46) > 12 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE",
"NDC11Code": "00032-1212-46",
"ProductNDC": "0032-1212",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Creon",
"NonProprietaryName": "Pancrelipase",
"DosageFormName": "CAPSULE, DELAYED RELEASE PELLETS",
"RouteName": "ORAL",
"StartMarketingDate": "20090430",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020725",
"LabelerName": "AbbVie Inc.",
"SubstanceName": "PANCRELIPASE AMYLASE; PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE",
"StrengthNumber": "60000; 12000; 38000",
"StrengthUnit": "[USP'U]/1; [USP'U]/1; [USP'U]/1",
"Status": "Deprecated",
"LastUpdate": "2018-12-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20090430",
"SamplePackage": "N"
},
{
"NDCCode": "0067-6286-98",
"PackageDescription": "60000 CAPSULE, DELAYED RELEASE in 1 DRUM (0067-6286-98)",
"NDC11Code": "00067-6286-98",
"ProductNDC": "0067-6286",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Prevacid",
"ProprietaryNameSuffix": "24 Hr",
"NonProprietaryName": "Lansoprazole",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20091012",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022327",
"LabelerName": "Novartis Consumer Health, Inc.",
"SubstanceName": "LANSOPRAZOLE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "0078-1504-01",
"PackageDescription": "60000 TABLET, FILM COATED in 1 DRUM (0078-1504-01) ",
"NDC11Code": "00078-1504-01",
"ProductNDC": "0078-1504",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"NonProprietaryName": "Amlodipine Valsartan And Hydrochlorothiazide",
"DosageFormName": "TABLET, FILM COATED",
"StartMarketingDate": "20090404",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Novartis Pharmaceuticals Corporation",
"SubstanceName": "AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN",
"StrengthNumber": "10; 25; 160",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "04-APR-09"
},
{
"NDCCode": "0078-1518-01",
"PackageDescription": "60000 TABLET, FILM COATED in 1 DRUM (0078-1518-01) ",
"NDC11Code": "00078-1518-01",
"ProductNDC": "0078-1518",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"NonProprietaryName": "Amlodipine Valsartan And Hydrochlorothiazide",
"DosageFormName": "TABLET, FILM COATED",
"StartMarketingDate": "20090404",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Novartis Pharmaceuticals Corporation",
"SubstanceName": "AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN",
"StrengthNumber": "10; 12.5; 160",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Status": "Unfinished",
"LastUpdate": "2026-03-19",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "04-APR-09"
},
{
"NDCCode": "0110-6120-10",
"PackageDescription": "60000 TABLET, COATED in 1 DRUM (0110-6120-10) ",
"NDC11Code": "00110-6120-10",
"ProductNDC": "0110-6120",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Selpercatinib",
"DosageFormName": "TABLET, COATED",
"StartMarketingDate": "20240410",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Eli Lilly and Company",
"SubstanceName": "SELPERCATINIB",
"StrengthNumber": "120",
"StrengthUnit": "mg/1",
"Status": "Unfinished",
"LastUpdate": "2026-07-27",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "10-APR-24"
},
{
"NDCCode": "0268-1156-50",
"PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (0268-1156-50) ",
"NDC11Code": "00268-1156-50",
"ProductNDC": "0268-1156",
"ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
"ProprietaryName": "Rumex Acetosella Pollen",
"NonProprietaryName": "Dock Sour Sheep Sorrel",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "19650101",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103753",
"LabelerName": "ALK-Abello, Inc.",
"SubstanceName": "RUMEX ACETOSELLA POLLEN",
"StrengthNumber": "60000",
"StrengthUnit": "[PNU]/mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS]",
"Status": "Deprecated",
"LastUpdate": "2023-06-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "19650101",
"SamplePackage": "N"
},
{
"NDCCode": "0456-1121-00",
"PackageDescription": "1 BAG in 1 DRUM (0456-1121-00) / 60000 TABLET in 1 BAG",
"NDC11Code": "00456-1121-00",
"ProductNDC": "0456-1121",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Vilazodone Hydrochloride",
"DosageFormName": "TABLET",
"StartMarketingDate": "20110429",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Allergan, Inc.",
"SubstanceName": "VILAZODONE HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Status": "Unfinished",
"LastUpdate": "2025-12-19",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "29-APR-11"
},
{
"NDCCode": "0456-1526-00",
"PackageDescription": "1 BAG in 1 DRUM (0456-1526-00) / 60000 TABLET, FILM COATED in 1 BAG",
"NDC11Code": "00456-1526-00",
"ProductNDC": "0456-1526",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Milnacipran Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"StartMarketingDate": "20090417",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Allergan, Inc.",
"SubstanceName": "MILNACIPRAN HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Status": "Unfinished",
"LastUpdate": "2024-11-26",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "17-APR-09"
},
{
"NDCCode": "0456-3422-00",
"PackageDescription": "1 BAG in 1 DRUM (0456-3422-00) / 60000 CAPSULE, EXTENDED RELEASE in 1 BAG",
"NDC11Code": "00456-3422-00",
"ProductNDC": "0456-3422",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Memantine Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"StartMarketingDate": "20111031",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Allergan, Inc.",
"SubstanceName": "MEMANTINE HYDROCHLORIDE",
"StrengthNumber": "21",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "31-OCT-11"
},
{
"NDCCode": "0555-0483-99",
"PackageDescription": "60000 TABLET in 1 PAIL (0555-0483-99) ",
"NDC11Code": "00555-0483-99",
"ProductNDC": "0555-0483",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Amiloride Hydrochloride And Hydrochlorothiazide",
"DosageFormName": "TABLET",
"StartMarketingDate": "20230524",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "AMILORIDE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE",
"StrengthNumber": "5; 50",
"StrengthUnit": "mg/1; mg/1",
"Status": "Unfinished",
"LastUpdate": "2023-05-26",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "24-MAY-23"
},
{
"NDCCode": "0591-5307-77",
"PackageDescription": "60000 TABLET in 1 CONTAINER (0591-5307-77) ",
"NDC11Code": "00591-5307-77",
"ProductNDC": "0591-5307",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Promethazine Hydrochloride",
"DosageFormName": "TABLET",
"StartMarketingDate": "19730919",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "PROMETHAZINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Status": "Unfinished",
"LastUpdate": "2024-09-20",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "19-SEP-24"
},
{
"NDCCode": "0924-0246-06",
"PackageDescription": "60000 PACKET in 1 CONTAINER (0924-0246-06) / 1.35 mL in 1 PACKET",
"NDC11Code": "00924-0246-06",
"ProductNDC": "0924-0246",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Med Nap Benzalkonium Chloride Antiseptic",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20220211",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "Acme United Corporation",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": ".0018",
"StrengthUnit": "mg/1.35mL",
"Status": "Deprecated",
"LastUpdate": "2024-11-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20230228",
"SamplePackage": "N",
"IndicationAndUsage": "First Aid antiseptic to help prevent infection in minor. cuts scrapes burns."
},
{
"NDCCode": "11014-0236-1",
"PackageDescription": "1 BAG in 1 DRUM (11014-0236-1) > 60000 g in 1 BAG",
"NDC11Code": "11014-0236-01",
"ProductNDC": "11014-0236",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Secnidazole",
"DosageFormName": "POWDER",
"StartMarketingDate": "20171030",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Catalent Pharma Solutions, LLC",
"SubstanceName": "SECNIDAZOLE",
"StrengthNumber": "2",
"StrengthUnit": "g/4.8g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "30-OCT-17"
},
{
"NDCCode": "11014-0550-1",
"PackageDescription": "1 BAG in 1 DRUM (11014-0550-1) / 60000 CAPSULE in 1 BAG",
"NDC11Code": "11014-0550-01",
"ProductNDC": "11014-0550",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Entrectinib",
"DosageFormName": "CAPSULE",
"StartMarketingDate": "20221003",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Catalent Pharma Solutions, LLC",
"SubstanceName": "ENTRECTINIB",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Status": "Unfinished",
"LastUpdate": "2025-09-24",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "03-OCT-22"
},
{
"NDCCode": "11014-0551-1",
"PackageDescription": "1 BAG in 1 DRUM (11014-0551-1) / 60000 CAPSULE in 1 BAG",
"NDC11Code": "11014-0551-01",
"ProductNDC": "11014-0551",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Entrectinib",
"DosageFormName": "CAPSULE",
"StartMarketingDate": "20221003",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Catalent Pharma Solutions, LLC",
"SubstanceName": "ENTRECTINIB",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Status": "Unfinished",
"LastUpdate": "2025-09-24",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "03-OCT-22"
},
{
"NDCCode": "11014-0562-2",
"PackageDescription": "1 BAG in 1 DRUM (11014-0562-2) / 60000 CAPSULE in 1 BAG",
"NDC11Code": "11014-0562-02",
"ProductNDC": "11014-0562",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Entrectinib",
"DosageFormName": "CAPSULE",
"StartMarketingDate": "20220310",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Catalent Pharma Solutions, LLC",
"SubstanceName": "ENTRECTINIB",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Status": "Unfinished",
"LastUpdate": "2025-09-24",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "10-MAR-22"
},
{
"NDCCode": "11014-0563-2",
"PackageDescription": "1 BAG in 1 DRUM (11014-0563-2) / 60000 CAPSULE in 1 BAG",
"NDC11Code": "11014-0563-02",
"ProductNDC": "11014-0563",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Entrectinib",
"DosageFormName": "CAPSULE",
"StartMarketingDate": "20221003",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Catalent Pharma Solutions, LLC",
"SubstanceName": "ENTRECTINIB",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Status": "Unfinished",
"LastUpdate": "2025-09-24",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "03-OCT-22"
},
{
"NDCCode": "11071-841-01",
"PackageDescription": "60000 TABLET, FILM COATED in 1 DRUM (11071-841-01)",
"NDC11Code": "11071-0841-01",
"ProductNDC": "11071-841",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Donepezil Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"StartMarketingDate": "19961125",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Eisai Co., Ltd.",
"SubstanceName": "DONEPEZIL HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20201231"
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>60000-491-32</NDCCode>
<PackageDescription>907 g in 1 CARTON (60000-491-32)</PackageDescription>
<NDC11Code>60000-0491-32</NDC11Code>
<ProductNDC>60000-491</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Pure Baking Soda</ProprietaryName>
<NonProprietaryName>Baking Soda</NonProprietaryName>
<DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100601</StartMarketingDate>
<EndMarketingDate>20150115</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part331</ApplicationNumber>
<LabelerName>Ahold U.S.A., Inc.</LabelerName>
<SubstanceName>SODIUM BICARBONATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2015-01-16</LastUpdate>
</NDC>
<NDC>
<NDCCode>60000-491-16</NDCCode>
<PackageDescription>454 g in 1 CARTON (60000-491-16)</PackageDescription>
<NDC11Code>60000-0491-16</NDC11Code>
<ProductNDC>60000-491</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Pure Baking Soda</ProprietaryName>
<NonProprietaryName>Baking Soda</NonProprietaryName>
<DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100601</StartMarketingDate>
<EndMarketingDate>20150115</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part331</ApplicationNumber>
<LabelerName>Ahold U.S.A., Inc.</LabelerName>
<SubstanceName>SODIUM BICARBONATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2015-01-16</LastUpdate>
</NDC>
<NDC>
<NDCCode>73562-117-01</NDCCode>
<PackageDescription>100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (73562-117-01) </PackageDescription>
<NDC11Code>73562-0117-01</NDC11Code>
<ProductNDC>73562-117</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zenpep</ProprietaryName>
<NonProprietaryName>Pancrelipase Lipase, Pancrelipase Protease, Pancrelipase Amylase</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201101</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA022210</ApplicationNumber>
<LabelerName>Aimmune Therapeutics, Inc.</LabelerName>
<SubstanceName>PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE; PANCRELIPASE AMYLASE</SubstanceName>
<StrengthNumber>60000; 189600; 252600</StrengthNumber>
<StrengthUnit>[USP'U]/1; [USP'U]/1; [USP'U]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-11-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231027</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ZENPEP® is indicated for the treatment of exocrine pancreatic insufficiency in adult and pediatric patients.</IndicationAndUsage>
<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.</Description>
</NDC>
<NDC>
<NDCCode>73562-117-12</NDCCode>
<PackageDescription>12 CAPSULE, DELAYED RELEASE in 1 BOTTLE (73562-117-12) </PackageDescription>
<NDC11Code>73562-0117-12</NDC11Code>
<ProductNDC>73562-117</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zenpep</ProprietaryName>
<NonProprietaryName>Pancrelipase Lipase, Pancrelipase Protease, Pancrelipase Amylase</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201101</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA022210</ApplicationNumber>
<LabelerName>Aimmune Therapeutics, Inc.</LabelerName>
<SubstanceName>PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE; PANCRELIPASE AMYLASE</SubstanceName>
<StrengthNumber>60000; 189600; 252600</StrengthNumber>
<StrengthUnit>[USP'U]/1; [USP'U]/1; [USP'U]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-11-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231027</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>ZENPEP® is indicated for the treatment of exocrine pancreatic insufficiency in adult and pediatric patients.</IndicationAndUsage>
<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.</Description>
</NDC>
<NDC>
<NDCCode>60687-491-01</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-491-01) / 1 TABLET in 1 BLISTER PACK (60687-491-11) </PackageDescription>
<NDC11Code>60687-0491-01</NDC11Code>
<ProductNDC>60687-491</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Naproxen</ProprietaryName>
<NonProprietaryName>Naproxen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200218</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078250</ApplicationNumber>
<LabelerName>American Health Packaging</LabelerName>
<SubstanceName>NAPROXEN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200218</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Naproxen tablets and naproxen sodium tablets are indicated for: the relief of the signs and symptoms of: : 1 rheumatoid arthritis, 2 osteoarthritis, 3 ankylosing spondylitis, 4 Polyarticular Juvenile Idiopathic Arthritis.</IndicationAndUsage>
<Description>Naproxen Tablets, USP and Naproxen Sodium Tablets, USP are nonsteroidal anti-inflammatory drugs available as follows. Naproxen Tablets, USP are available as follows for oral administration: 250 mg: circular, light orange colored, flat, uncoated tablets, engraved with ‘G’ and ‘32’ on either side of a break line on one side and ‘250’ on the other side. 375 mg: oval, light orange colored, biconvex, uncoated tablets, engraved with ‘G 32’ on one side and ‘375’ on the other side. 500 mg: capsule shaped, light orange colored, uncoated tablets, debossed with ‘G’ and ‘32’ on either side of a break line on one side and ‘500’ on the other side. The inactive ingredients are croscarmellose sodium, iron oxide red, iron oxide yellow, magnesium stearate, microcrystalline cellulose and povidone. Naproxen Sodium Tablets, USP are available as follows for oral administration: 275 mg: blue, oval, film-coated tablets with ‘G 0’ engraved on one side and ‘275’ engraved on the other side. 550 mg: blue colored, modified capsule shaped, biconvex, film-coated tablets, engraved with ‘G’ and ‘0’ on either side of a break line and a break line on the other side. The inactive ingredients are colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, povidone and talc. The coating suspension for the naproxen sodium 275 mg and 550 mg tablet contains FD&C blue#2, iron oxide red, hypromellose, polyethylene glycol and titanium dioxide. Naproxen, USP is a propionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical names for naproxen, USP and naproxen sodium, USP are (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid and (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid, sodium salt, respectively. Naproxen, USP has a molecular weight of 230.26 g/mol and a molecular formula of C 14H 14O 3. Naproxen sodium, USP has a molecular weight of 252.24 g/mol and a molecular formula of C 14H 13NaO 3. Naproxen, USP and naproxen sodium, USP have the following structures, respectively:. Naproxen, USP is a white to off-white crystalline powder. It is soluble in chloroform, dehydrated alcohol and alcohol; sparingly soluble in ether, insoluble in water. Naproxen sodium, USP is a white to almost white crystalline powder, soluble in water and methanol; sparingly soluble in ethanol.</Description>
</NDC>
<NDC>
<NDCCode>65649-400-01</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (65649-400-01) * 46.26 POWDER, FOR SOLUTION in 1 POUCH * 55.65 POWDER, FOR SOLUTION in 1 POUCH * 115.96 POWDER, FOR SOLUTION in 1 POUCH</PackageDescription>
<NDC11Code>65649-0400-01</NDC11Code>
<ProductNDC>65649-400</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Plenvu</ProprietaryName>
<NonProprietaryName>Polyethylene Glycol 3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Ascorbic Acid, Sodium Ascorbate</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20180504</StartMarketingDate>
<EndMarketingDate>20270930</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA209381</ApplicationNumber>
<LabelerName>Salix Pharmaceuticals, Inc</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-08-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20180504</StartMarketingDatePackage>
<EndMarketingDatePackage>20270930</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PLENVU® is indicated for cleansing of the colon in preparation for colonoscopy in adults.</IndicationAndUsage>
<Description>The active ingredients contained in PLENVU are provided in Table 3. PLENVU (polyethylene glycol 3350, sodium ascorbate, sodium sulfate, ascorbic acid, sodium chloride and potassium chloride for oral solution) is an osmotic laxative consisting of three pouches (one for Dose 1, one for Dose 2 Pouch A and one for Dose 2 Pouch B) containing white to yellow powder for reconstitution. Dose 1 contains 100 grams of PEG 3350, 9 grams of sodium sulfate, 2 grams of sodium chloride, and 1 gram of potassium chloride, and the following excipients: sucralose, encapsulated citric acid and mango flavoring. When Dose 1 is dissolved in water to a volume of 16 fluid ounces, PLENVU Dose 1 (PEG 3350, sodium sulfate, sodium chloride and potassium chloride) is an oral solution having a mango flavor. Each Dose 2 Pouch A contains 40 grams of PEG 3350, 3.2 grams of sodium chloride, and 1.2 grams of potassium chloride, and the following excipients: aspartame and fruit punch flavoring. Each Dose 2 Pouch B contains 48.11 grams of sodium ascorbate and 7.54 grams of ascorbic acid. When Dose 2 Pouch A and Dose 2 Pouch B are dissolved together in water to a volume of 16 fluid ounces, PLENVU Dose 2 (sodium ascorbate, PEG 3350, ascorbic acid, sodium chloride and potassium chloride) is an oral solution having a fruit punch flavor. The entire reconstituted 32 fluid ounces of PLENVU bowel preparation contains 140 grams of PEG 3350, 48.11 grams of sodium ascorbate, 9 grams of sodium sulfate, 7.54 grams of ascorbic acid, 5.2 grams of sodium chloride and 2.2 grams of potassium chloride and the following excipients: aspartame, sucralose, encapsulated citric acid, mango and fruit punch flavorings. A mixing container for reconstitution is enclosed. Phenylketonurics: Contains Phenylalanine 491 mg per treatment. Contains no ingredient made from a gluten-containing grain (wheat, barley, or rye).</Description>
</NDC>
<NDC>
<NDCCode>65649-400-02</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (65649-400-02) * 46.26 POWDER, FOR SOLUTION in 1 POUCH * 55.65 POWDER, FOR SOLUTION in 1 POUCH * 115.96 POWDER, FOR SOLUTION in 1 POUCH</PackageDescription>
<NDC11Code>65649-0400-02</NDC11Code>
<ProductNDC>65649-400</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Plenvu</ProprietaryName>
<NonProprietaryName>Polyethylene Glycol 3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Ascorbic Acid, Sodium Ascorbate</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20180504</StartMarketingDate>
<EndMarketingDate>20270930</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA209381</ApplicationNumber>
<LabelerName>Salix Pharmaceuticals, Inc</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-08-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20180504</StartMarketingDatePackage>
<EndMarketingDatePackage>20270930</EndMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>PLENVU® is indicated for cleansing of the colon in preparation for colonoscopy in adults.</IndicationAndUsage>
<Description>The active ingredients contained in PLENVU are provided in Table 3. PLENVU (polyethylene glycol 3350, sodium ascorbate, sodium sulfate, ascorbic acid, sodium chloride and potassium chloride for oral solution) is an osmotic laxative consisting of three pouches (one for Dose 1, one for Dose 2 Pouch A and one for Dose 2 Pouch B) containing white to yellow powder for reconstitution. Dose 1 contains 100 grams of PEG 3350, 9 grams of sodium sulfate, 2 grams of sodium chloride, and 1 gram of potassium chloride, and the following excipients: sucralose, encapsulated citric acid and mango flavoring. When Dose 1 is dissolved in water to a volume of 16 fluid ounces, PLENVU Dose 1 (PEG 3350, sodium sulfate, sodium chloride and potassium chloride) is an oral solution having a mango flavor. Each Dose 2 Pouch A contains 40 grams of PEG 3350, 3.2 grams of sodium chloride, and 1.2 grams of potassium chloride, and the following excipients: aspartame and fruit punch flavoring. Each Dose 2 Pouch B contains 48.11 grams of sodium ascorbate and 7.54 grams of ascorbic acid. When Dose 2 Pouch A and Dose 2 Pouch B are dissolved together in water to a volume of 16 fluid ounces, PLENVU Dose 2 (sodium ascorbate, PEG 3350, ascorbic acid, sodium chloride and potassium chloride) is an oral solution having a fruit punch flavor. The entire reconstituted 32 fluid ounces of PLENVU bowel preparation contains 140 grams of PEG 3350, 48.11 grams of sodium ascorbate, 9 grams of sodium sulfate, 7.54 grams of ascorbic acid, 5.2 grams of sodium chloride and 2.2 grams of potassium chloride and the following excipients: aspartame, sucralose, encapsulated citric acid, mango and fruit punch flavorings. A mixing container for reconstitution is enclosed. Phenylketonurics: Contains Phenylalanine 491 mg per treatment. Contains no ingredient made from a gluten-containing grain (wheat, barley, or rye).</Description>
</NDC>
<NDC>
<NDCCode>0032-0047-30</NDCCode>
<PackageDescription>100 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (0032-0047-30) </PackageDescription>
<NDC11Code>00032-0047-30</NDC11Code>
<ProductNDC>0032-0047</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Creon</ProprietaryName>
<NonProprietaryName>Pancrelipase</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE PELLETS</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20231012</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA020725</ApplicationNumber>
<LabelerName>AbbVie Inc.</LabelerName>
<SubstanceName>PANCRELIPASE AMYLASE; PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE</SubstanceName>
<StrengthNumber>60000; 12000; 38000</StrengthNumber>
<StrengthUnit>[USP'U]/1; [USP'U]/1; [USP'U]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-07-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231012</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>CREON® is indicated for the treatment of exocrine pancreatic insufficiency in adult and pediatric patients.</IndicationAndUsage>
<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 spheres in CREON are formulated to release pancreatic enzymes at an approximate pH of 5.5 or greater. CREON (pancrelipase) delayed-release capsules are for oral administration, include a two-piece shell containing tan-colored enteric-coated spheres (0.71 mm to 1.60 mm in diameter), and are available as follows:. 3,000 USP units of lipase; 9,500 USP units of protease; and 15,000 USP units of amylase; delayed-release capsules with shells that contain hypromellose and titanium dioxide, and that also may contain carrageenan and potassium chloride. 6,000 USP units of lipase; 19,000 USP units of protease; and 30,000 USP units of amylase; delayed-release capsules with shells that may contain gelatin, hypromellose, carrageenan, potassium chloride, sodium lauryl sulfate, titanium dioxide, FD&C Blue No. 1, and FD&C Blue No. 2, red iron oxide, and yellow iron oxide. 12,000 USP units of lipase; 38,000 USP units of protease; and 60,000 USP units of amylase; delayed-release capsules with shells that may contain gelatin, hypromellose, carrageenan, potassium chloride, sodium lauryl sulfate, titanium dioxide, black iron oxide, red iron oxide, and yellow iron oxide. 24,000 USP units of lipase; 76,000 USP units of protease; and 120,000 USP units of amylase; delayed-release capsules with shells that may contain gelatin, hypromellose, carrageenan, potassium chloride, sodium lauryl sulfate, titanium dioxide, red iron oxide, and yellow iron oxide. 36,000 USP units of lipase; 114,000 USP units of protease; and 180,000 USP units of amylase; delayed-release capsules with shells that may contain gelatin, hypromellose, carrageenan, potassium chloride, sodium lauryl sulfate, titanium dioxide, FD&C Blue No. 1, and FD&C Blue No. 2. CREON (pancrelipase) delayed-release capsules include the following inactive ingredients: cetyl alcohol, dimethicone, hypromellose phthalate, polyethylene glycol, and triethyl citrate.</Description>
</NDC>
<NDC>
<NDCCode>0032-0047-70</NDCCode>
<PackageDescription>100 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (0032-0047-70) </PackageDescription>
<NDC11Code>00032-0047-70</NDC11Code>
<ProductNDC>0032-0047</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Creon</ProprietaryName>
<NonProprietaryName>Pancrelipase</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE PELLETS</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20231012</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA020725</ApplicationNumber>
<LabelerName>AbbVie Inc.</LabelerName>
<SubstanceName>PANCRELIPASE AMYLASE; PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE</SubstanceName>
<StrengthNumber>60000; 12000; 38000</StrengthNumber>
<StrengthUnit>[USP'U]/1; [USP'U]/1; [USP'U]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-07-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231012</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>CREON® is indicated for the treatment of exocrine pancreatic insufficiency in adult and pediatric patients.</IndicationAndUsage>
<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 spheres in CREON are formulated to release pancreatic enzymes at an approximate pH of 5.5 or greater. CREON (pancrelipase) delayed-release capsules are for oral administration, include a two-piece shell containing tan-colored enteric-coated spheres (0.71 mm to 1.60 mm in diameter), and are available as follows:. 3,000 USP units of lipase; 9,500 USP units of protease; and 15,000 USP units of amylase; delayed-release capsules with shells that contain hypromellose and titanium dioxide, and that also may contain carrageenan and potassium chloride. 6,000 USP units of lipase; 19,000 USP units of protease; and 30,000 USP units of amylase; delayed-release capsules with shells that may contain gelatin, hypromellose, carrageenan, potassium chloride, sodium lauryl sulfate, titanium dioxide, FD&C Blue No. 1, and FD&C Blue No. 2, red iron oxide, and yellow iron oxide. 12,000 USP units of lipase; 38,000 USP units of protease; and 60,000 USP units of amylase; delayed-release capsules with shells that may contain gelatin, hypromellose, carrageenan, potassium chloride, sodium lauryl sulfate, titanium dioxide, black iron oxide, red iron oxide, and yellow iron oxide. 24,000 USP units of lipase; 76,000 USP units of protease; and 120,000 USP units of amylase; delayed-release capsules with shells that may contain gelatin, hypromellose, carrageenan, potassium chloride, sodium lauryl sulfate, titanium dioxide, red iron oxide, and yellow iron oxide. 36,000 USP units of lipase; 114,000 USP units of protease; and 180,000 USP units of amylase; delayed-release capsules with shells that may contain gelatin, hypromellose, carrageenan, potassium chloride, sodium lauryl sulfate, titanium dioxide, FD&C Blue No. 1, and FD&C Blue No. 2. CREON (pancrelipase) delayed-release capsules include the following inactive ingredients: cetyl alcohol, dimethicone, hypromellose phthalate, polyethylene glycol, and triethyl citrate.</Description>
</NDC>
<NDC>
<NDCCode>0032-1212-01</NDCCode>
<PackageDescription>100 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (0032-1212-01) </PackageDescription>
<NDC11Code>00032-1212-01</NDC11Code>
<ProductNDC>0032-1212</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Creon</ProprietaryName>
<NonProprietaryName>Pancrelipase</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE PELLETS</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090430</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA020725</ApplicationNumber>
<LabelerName>AbbVie Inc.</LabelerName>
<SubstanceName>PANCRELIPASE AMYLASE; PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE</SubstanceName>
<StrengthNumber>60000; 12000; 38000</StrengthNumber>
<StrengthUnit>[USP'U]/1; [USP'U]/1; [USP'U]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-07-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090430</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>CREON® is indicated for the treatment of exocrine pancreatic insufficiency in adult and pediatric patients.</IndicationAndUsage>
<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 spheres in CREON are formulated to release pancreatic enzymes at an approximate pH of 5.5 or greater. CREON (pancrelipase) delayed-release capsules are for oral administration, include a two-piece shell containing tan-colored enteric-coated spheres (0.71 mm to 1.60 mm in diameter), and are available as follows:. 3,000 USP units of lipase; 9,500 USP units of protease; and 15,000 USP units of amylase; delayed-release capsules with shells that contain hypromellose and titanium dioxide, and that also may contain carrageenan and potassium chloride. 6,000 USP units of lipase; 19,000 USP units of protease; and 30,000 USP units of amylase; delayed-release capsules with shells that may contain gelatin, hypromellose, carrageenan, potassium chloride, sodium lauryl sulfate, titanium dioxide, FD&C Blue No. 1, and FD&C Blue No. 2, red iron oxide, and yellow iron oxide. 12,000 USP units of lipase; 38,000 USP units of protease; and 60,000 USP units of amylase; delayed-release capsules with shells that may contain gelatin, hypromellose, carrageenan, potassium chloride, sodium lauryl sulfate, titanium dioxide, black iron oxide, red iron oxide, and yellow iron oxide. 24,000 USP units of lipase; 76,000 USP units of protease; and 120,000 USP units of amylase; delayed-release capsules with shells that may contain gelatin, hypromellose, carrageenan, potassium chloride, sodium lauryl sulfate, titanium dioxide, red iron oxide, and yellow iron oxide. 36,000 USP units of lipase; 114,000 USP units of protease; and 180,000 USP units of amylase; delayed-release capsules with shells that may contain gelatin, hypromellose, carrageenan, potassium chloride, sodium lauryl sulfate, titanium dioxide, FD&C Blue No. 1, and FD&C Blue No. 2. CREON (pancrelipase) delayed-release capsules include the following inactive ingredients: cetyl alcohol, dimethicone, hypromellose phthalate, polyethylene glycol, and triethyl citrate.</Description>
</NDC>
<NDC>
<NDCCode>0032-1212-07</NDCCode>
<PackageDescription>250 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (0032-1212-07) </PackageDescription>
<NDC11Code>00032-1212-07</NDC11Code>
<ProductNDC>0032-1212</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Creon</ProprietaryName>
<NonProprietaryName>Pancrelipase</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE PELLETS</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090430</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA020725</ApplicationNumber>
<LabelerName>AbbVie Inc.</LabelerName>
<SubstanceName>PANCRELIPASE AMYLASE; PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE</SubstanceName>
<StrengthNumber>60000; 12000; 38000</StrengthNumber>
<StrengthUnit>[USP'U]/1; [USP'U]/1; [USP'U]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-07-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090430</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>CREON® is indicated for the treatment of exocrine pancreatic insufficiency in adult and pediatric patients.</IndicationAndUsage>
<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 spheres in CREON are formulated to release pancreatic enzymes at an approximate pH of 5.5 or greater. CREON (pancrelipase) delayed-release capsules are for oral administration, include a two-piece shell containing tan-colored enteric-coated spheres (0.71 mm to 1.60 mm in diameter), and are available as follows:. 3,000 USP units of lipase; 9,500 USP units of protease; and 15,000 USP units of amylase; delayed-release capsules with shells that contain hypromellose and titanium dioxide, and that also may contain carrageenan and potassium chloride. 6,000 USP units of lipase; 19,000 USP units of protease; and 30,000 USP units of amylase; delayed-release capsules with shells that may contain gelatin, hypromellose, carrageenan, potassium chloride, sodium lauryl sulfate, titanium dioxide, FD&C Blue No. 1, and FD&C Blue No. 2, red iron oxide, and yellow iron oxide. 12,000 USP units of lipase; 38,000 USP units of protease; and 60,000 USP units of amylase; delayed-release capsules with shells that may contain gelatin, hypromellose, carrageenan, potassium chloride, sodium lauryl sulfate, titanium dioxide, black iron oxide, red iron oxide, and yellow iron oxide. 24,000 USP units of lipase; 76,000 USP units of protease; and 120,000 USP units of amylase; delayed-release capsules with shells that may contain gelatin, hypromellose, carrageenan, potassium chloride, sodium lauryl sulfate, titanium dioxide, red iron oxide, and yellow iron oxide. 36,000 USP units of lipase; 114,000 USP units of protease; and 180,000 USP units of amylase; delayed-release capsules with shells that may contain gelatin, hypromellose, carrageenan, potassium chloride, sodium lauryl sulfate, titanium dioxide, FD&C Blue No. 1, and FD&C Blue No. 2. CREON (pancrelipase) delayed-release capsules include the following inactive ingredients: cetyl alcohol, dimethicone, hypromellose phthalate, polyethylene glycol, and triethyl citrate.</Description>
</NDC>
<NDC>
<NDCCode>0032-1212-13</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (0032-1212-13) / 100 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE</PackageDescription>
<NDC11Code>00032-1212-13</NDC11Code>
<ProductNDC>0032-1212</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Creon</ProprietaryName>
<NonProprietaryName>Pancrelipase</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE PELLETS</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090430</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA020725</ApplicationNumber>
<LabelerName>AbbVie Inc.</LabelerName>
<SubstanceName>PANCRELIPASE AMYLASE; PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE</SubstanceName>
<StrengthNumber>60000; 12000; 38000</StrengthNumber>
<StrengthUnit>[USP'U]/1; [USP'U]/1; [USP'U]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-07-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181120</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>CREON® is indicated for the treatment of exocrine pancreatic insufficiency in adult and pediatric patients.</IndicationAndUsage>
<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 spheres in CREON are formulated to release pancreatic enzymes at an approximate pH of 5.5 or greater. CREON (pancrelipase) delayed-release capsules are for oral administration, include a two-piece shell containing tan-colored enteric-coated spheres (0.71 mm to 1.60 mm in diameter), and are available as follows:. 3,000 USP units of lipase; 9,500 USP units of protease; and 15,000 USP units of amylase; delayed-release capsules with shells that contain hypromellose and titanium dioxide, and that also may contain carrageenan and potassium chloride. 6,000 USP units of lipase; 19,000 USP units of protease; and 30,000 USP units of amylase; delayed-release capsules with shells that may contain gelatin, hypromellose, carrageenan, potassium chloride, sodium lauryl sulfate, titanium dioxide, FD&C Blue No. 1, and FD&C Blue No. 2, red iron oxide, and yellow iron oxide. 12,000 USP units of lipase; 38,000 USP units of protease; and 60,000 USP units of amylase; delayed-release capsules with shells that may contain gelatin, hypromellose, carrageenan, potassium chloride, sodium lauryl sulfate, titanium dioxide, black iron oxide, red iron oxide, and yellow iron oxide. 24,000 USP units of lipase; 76,000 USP units of protease; and 120,000 USP units of amylase; delayed-release capsules with shells that may contain gelatin, hypromellose, carrageenan, potassium chloride, sodium lauryl sulfate, titanium dioxide, red iron oxide, and yellow iron oxide. 36,000 USP units of lipase; 114,000 USP units of protease; and 180,000 USP units of amylase; delayed-release capsules with shells that may contain gelatin, hypromellose, carrageenan, potassium chloride, sodium lauryl sulfate, titanium dioxide, FD&C Blue No. 1, and FD&C Blue No. 2. CREON (pancrelipase) delayed-release capsules include the following inactive ingredients: cetyl alcohol, dimethicone, hypromellose phthalate, polyethylene glycol, and triethyl citrate.</Description>
</NDC>
<NDC>
<NDCCode>0032-1212-46</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (0032-1212-46) > 12 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE</PackageDescription>
<NDC11Code>00032-1212-46</NDC11Code>
<ProductNDC>0032-1212</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Creon</ProprietaryName>
<NonProprietaryName>Pancrelipase</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE PELLETS</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090430</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020725</ApplicationNumber>
<LabelerName>AbbVie Inc.</LabelerName>
<SubstanceName>PANCRELIPASE AMYLASE; PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE</SubstanceName>
<StrengthNumber>60000; 12000; 38000</StrengthNumber>
<StrengthUnit>[USP'U]/1; [USP'U]/1; [USP'U]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-12-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090430</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0067-6286-98</NDCCode>
<PackageDescription>60000 CAPSULE, DELAYED RELEASE in 1 DRUM (0067-6286-98)</PackageDescription>
<NDC11Code>00067-6286-98</NDC11Code>
<ProductNDC>0067-6286</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Prevacid</ProprietaryName>
<ProprietaryNameSuffix>24 Hr</ProprietaryNameSuffix>
<NonProprietaryName>Lansoprazole</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091012</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022327</ApplicationNumber>
<LabelerName>Novartis Consumer Health, Inc.</LabelerName>
<SubstanceName>LANSOPRAZOLE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>0078-1504-01</NDCCode>
<PackageDescription>60000 TABLET, FILM COATED in 1 DRUM (0078-1504-01) </PackageDescription>
<NDC11Code>00078-1504-01</NDC11Code>
<ProductNDC>0078-1504</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<NonProprietaryName>Amlodipine Valsartan And Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<StartMarketingDate>20090404</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN</SubstanceName>
<StrengthNumber>10; 25; 160</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>04-APR-09</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>0078-1518-01</NDCCode>
<PackageDescription>60000 TABLET, FILM COATED in 1 DRUM (0078-1518-01) </PackageDescription>
<NDC11Code>00078-1518-01</NDC11Code>
<ProductNDC>0078-1518</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<NonProprietaryName>Amlodipine Valsartan And Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<StartMarketingDate>20090404</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN</SubstanceName>
<StrengthNumber>10; 12.5; 160</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2026-03-19</LastUpdate>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>04-APR-09</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>0110-6120-10</NDCCode>
<PackageDescription>60000 TABLET, COATED in 1 DRUM (0110-6120-10) </PackageDescription>
<NDC11Code>00110-6120-10</NDC11Code>
<ProductNDC>0110-6120</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Selpercatinib</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<StartMarketingDate>20240410</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Eli Lilly and Company</LabelerName>
<SubstanceName>SELPERCATINIB</SubstanceName>
<StrengthNumber>120</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2026-07-27</LastUpdate>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>10-APR-24</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>0268-1156-50</NDCCode>
<PackageDescription>50 mL in 1 VIAL, MULTI-DOSE (0268-1156-50) </PackageDescription>
<NDC11Code>00268-1156-50</NDC11Code>
<ProductNDC>0268-1156</ProductNDC>
<ProductTypeName>NON-STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>Rumex Acetosella Pollen</ProprietaryName>
<NonProprietaryName>Dock Sour Sheep Sorrel</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>19650101</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103753</ApplicationNumber>
<LabelerName>ALK-Abello, Inc.</LabelerName>
<SubstanceName>RUMEX ACETOSELLA POLLEN</SubstanceName>
<StrengthNumber>60000</StrengthNumber>
<StrengthUnit>[PNU]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-06-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19650101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0456-1121-00</NDCCode>
<PackageDescription>1 BAG in 1 DRUM (0456-1121-00) / 60000 TABLET in 1 BAG</PackageDescription>
<NDC11Code>00456-1121-00</NDC11Code>
<ProductNDC>0456-1121</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Vilazodone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<StartMarketingDate>20110429</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Allergan, Inc.</LabelerName>
<SubstanceName>VILAZODONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-12-19</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>29-APR-11</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>0456-1526-00</NDCCode>
<PackageDescription>1 BAG in 1 DRUM (0456-1526-00) / 60000 TABLET, FILM COATED in 1 BAG</PackageDescription>
<NDC11Code>00456-1526-00</NDC11Code>
<ProductNDC>0456-1526</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Milnacipran Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<StartMarketingDate>20090417</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Allergan, Inc.</LabelerName>
<SubstanceName>MILNACIPRAN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2024-11-26</LastUpdate>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>17-APR-09</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>0456-3422-00</NDCCode>
<PackageDescription>1 BAG in 1 DRUM (0456-3422-00) / 60000 CAPSULE, EXTENDED RELEASE in 1 BAG</PackageDescription>
<NDC11Code>00456-3422-00</NDC11Code>
<ProductNDC>0456-3422</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Memantine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<StartMarketingDate>20111031</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Allergan, Inc.</LabelerName>
<SubstanceName>MEMANTINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>21</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>31-OCT-11</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>0555-0483-99</NDCCode>
<PackageDescription>60000 TABLET in 1 PAIL (0555-0483-99) </PackageDescription>
<NDC11Code>00555-0483-99</NDC11Code>
<ProductNDC>0555-0483</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Amiloride Hydrochloride And Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<StartMarketingDate>20230524</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>AMILORIDE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE</SubstanceName>
<StrengthNumber>5; 50</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2023-05-26</LastUpdate>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>24-MAY-23</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>0591-5307-77</NDCCode>
<PackageDescription>60000 TABLET in 1 CONTAINER (0591-5307-77) </PackageDescription>
<NDC11Code>00591-5307-77</NDC11Code>
<ProductNDC>0591-5307</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Promethazine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<StartMarketingDate>19730919</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Actavis Pharma, Inc.</LabelerName>
<SubstanceName>PROMETHAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2024-09-20</LastUpdate>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19-SEP-24</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>0924-0246-06</NDCCode>
<PackageDescription>60000 PACKET in 1 CONTAINER (0924-0246-06) / 1.35 mL in 1 PACKET</PackageDescription>
<NDC11Code>00924-0246-06</NDC11Code>
<ProductNDC>0924-0246</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Med Nap Benzalkonium Chloride Antiseptic</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20220211</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>Acme United Corporation</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>.0018</StrengthNumber>
<StrengthUnit>mg/1.35mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-11-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230228</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>First Aid antiseptic to help prevent infection in minor. cuts scrapes burns.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>11014-0236-1</NDCCode>
<PackageDescription>1 BAG in 1 DRUM (11014-0236-1) > 60000 g in 1 BAG</PackageDescription>
<NDC11Code>11014-0236-01</NDC11Code>
<ProductNDC>11014-0236</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Secnidazole</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20171030</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Catalent Pharma Solutions, LLC</LabelerName>
<SubstanceName>SECNIDAZOLE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>g/4.8g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>30-OCT-17</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>11014-0550-1</NDCCode>
<PackageDescription>1 BAG in 1 DRUM (11014-0550-1) / 60000 CAPSULE in 1 BAG</PackageDescription>
<NDC11Code>11014-0550-01</NDC11Code>
<ProductNDC>11014-0550</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Entrectinib</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<StartMarketingDate>20221003</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Catalent Pharma Solutions, LLC</LabelerName>
<SubstanceName>ENTRECTINIB</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-09-24</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>03-OCT-22</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>11014-0551-1</NDCCode>
<PackageDescription>1 BAG in 1 DRUM (11014-0551-1) / 60000 CAPSULE in 1 BAG</PackageDescription>
<NDC11Code>11014-0551-01</NDC11Code>
<ProductNDC>11014-0551</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Entrectinib</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<StartMarketingDate>20221003</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Catalent Pharma Solutions, LLC</LabelerName>
<SubstanceName>ENTRECTINIB</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-09-24</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>03-OCT-22</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>11014-0562-2</NDCCode>
<PackageDescription>1 BAG in 1 DRUM (11014-0562-2) / 60000 CAPSULE in 1 BAG</PackageDescription>
<NDC11Code>11014-0562-02</NDC11Code>
<ProductNDC>11014-0562</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Entrectinib</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<StartMarketingDate>20220310</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Catalent Pharma Solutions, LLC</LabelerName>
<SubstanceName>ENTRECTINIB</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-09-24</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>10-MAR-22</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>11014-0563-2</NDCCode>
<PackageDescription>1 BAG in 1 DRUM (11014-0563-2) / 60000 CAPSULE in 1 BAG</PackageDescription>
<NDC11Code>11014-0563-02</NDC11Code>
<ProductNDC>11014-0563</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Entrectinib</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<StartMarketingDate>20221003</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Catalent Pharma Solutions, LLC</LabelerName>
<SubstanceName>ENTRECTINIB</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-09-24</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>03-OCT-22</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>11071-841-01</NDCCode>
<PackageDescription>60000 TABLET, FILM COATED in 1 DRUM (11071-841-01)</PackageDescription>
<NDC11Code>11071-0841-01</NDC11Code>
<ProductNDC>11071-841</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Donepezil Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<StartMarketingDate>19961125</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Eisai Co., Ltd.</LabelerName>
<SubstanceName>DONEPEZIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
</NDC>
</NDCList>