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"Description": "ERGOCALCIFEROL CAPSULES, USP, is a synthetic calcium regulator for oral administration. Ergocalciferol is a white, colorless crystal, insoluble in water, soluble in organic solvents, and slightly soluble in vegetable oils. It is affected by air and by light. Ergosterol or provitamin D 2is found in plants and yeast and has no antirachitic activity. There are more than 10 substances belonging to a group of steroid compounds, classified as having vitamin D or antirachitic activity. One USP Unit of vitamin D 2is equivalent to one International Unit (IU), and 1 mcg of vitamin D 2is equal to 40 IU. Each softgel, for oral administration, contains Ergocalciferol, USP 1,250 mcg (equivalent to 50,000 USP units of Vitamin D), in an edible vegetable oil. Ergocalciferol, also called vitamin D 2, is 9,10-secoergosta-5,7,10(19),22-tetraen-3-ol,(3 β,5 Z,7 E,22 E)-; (C 28H 44O) with a molecular weight of 396.65, and has the following structural formula:. Inactive Ingredients:Refined soybean oil, gelatin, glycerin, purified water, D&C Yellow #10, and FD&C Blue #1."
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"Description": "ERGOCALCIFEROL CAPSULES, USP, is a synthetic calcium regulator for oral administration. Ergocalciferol is a white, colorless crystal, insoluble in water, soluble in organic solvents, and slightly soluble in vegetable oils. It is affected by air and by light. Ergosterol or provitamin D 2is found in plants and yeast and has no antirachitic activity. There are more than 10 substances belonging to a group of steroid compounds, classified as having vitamin D or antirachitic activity. One USP Unit of vitamin D 2is equivalent to one International Unit (IU), and 1 mcg of vitamin D 2is equal to 40 IU. Each softgel, for oral administration, contains Ergocalciferol, USP 1,250 mcg (equivalent to 50,000 USP units of Vitamin D), in an edible vegetable oil. Ergocalciferol, also called vitamin D 2, is 9,10-secoergosta-5,7,10(19),22-tetraen-3-ol,(3 β,5 Z,7 E,22 E)-; (C 28H 44O) with a molecular weight of 396.65, and has the following structural formula:. Inactive Ingredients:Refined soybean oil, gelatin, glycerin, purified water, D&C Yellow #10, and FD&C Blue #1."
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"Description": "ERGOCALCIFEROL CAPSULES, USP, is a synthetic calcium regulator for oral administration. Ergocalciferol is a white, colorless crystal, insoluble in water, soluble in organic solvents, and slightly soluble in vegetable oils. It is affected by air and by light. Ergosterol or provitamin D 2is found in plants and yeast and has no antirachitic activity. There are more than 10 substances belonging to a group of steroid compounds, classified as having vitamin D or antirachitic activity. One USP Unit of vitamin D 2is equivalent to one International Unit (IU), and 1 mcg of vitamin D 2is equal to 40 IU. Each softgel, for oral administration, contains Ergocalciferol, USP 1,250 mcg (equivalent to 50,000 USP units of Vitamin D), in an edible vegetable oil. Ergocalciferol, also called vitamin D 2, is 9,10-secoergosta-5,7,10(19),22-tetraen-3-ol,(3 β,5 Z,7 E,22 E)-; (C 28H 44O) with a molecular weight of 396.65, and has the following structural formula:. Inactive Ingredients:Refined soybean oil, gelatin, glycerin, purified water, D&C Yellow #10, and FD&C Blue #1."
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"IndicationAndUsage": "Ergocalciferol is indicated for use in the treatment of hypoparathyroidism, refractory rickets, also known as vitamin D resistant rickets, and familial hypophosphatemia.",
"Description": "ERGOCALCIFEROL CAPSULES, USP, is a synthetic calcium regulator for oral administration. Ergocalciferol is a white, colorless crystal, insoluble in water, soluble in organic solvents, and slightly soluble in vegetable oils. It is affected by air and by light. Ergosterol or provitamin D 2is found in plants and yeast and has no antirachitic activity. There are more than 10 substances belonging to a group of steroid compounds, classified as having vitamin D or antirachitic activity. One USP Unit of vitamin D 2is equivalent to one International Unit (IU), and 1 mcg of vitamin D 2is equal to 40 IU. Each softgel, for oral administration, contains Ergocalciferol, USP 1,250 mcg (equivalent to 50,000 USP units of Vitamin D), in an edible vegetable oil. Ergocalciferol, also called vitamin D 2, is 9,10-secoergosta-5,7,10(19),22-tetraen-3-ol,(3 β,5 Z,7 E,22 E)-; (C 28H 44O) with a molecular weight of 396.65, and has the following structural formula:. Inactive Ingredients:Refined soybean oil, gelatin, glycerin, purified water, D&C Yellow #10, and FD&C Blue #1."
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"IndicationAndUsage": "Ergocalciferol is indicated for use in the treatment of hypoparathyroidism, refractory rickets, also known as vitamin D resistant rickets, and familial hypophosphatemia.",
"Description": "ERGOCALCIFEROL CAPSULES, USP, is a synthetic calcium regulator for oral administration. Ergocalciferol is a white, colorless crystal, insoluble in water, soluble in organic solvents, and slightly soluble in vegetable oils. It is affected by air and by light. Ergosterol or provitamin D 2is found in plants and yeast and has no antirachitic activity. There are more than 10 substances belonging to a group of steroid compounds, classified as having vitamin D or antirachitic activity. One USP Unit of vitamin D 2is equivalent to one International Unit (IU), and 1 mcg of vitamin D 2is equal to 40 IU. Each softgel, for oral administration, contains Ergocalciferol, USP 1,250 mcg (equivalent to 50,000 USP units of Vitamin D), in an edible vegetable oil. Ergocalciferol, also called vitamin D 2, is 9,10-secoergosta-5,7,10(19),22-tetraen-3-ol,(3 β,5 Z,7 E,22 E)-; (C 28H 44O) with a molecular weight of 396.65, and has the following structural formula:. Inactive Ingredients:Refined soybean oil, gelatin, glycerin, purified water, D&C Yellow #10, and FD&C Blue #1."
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"IndicationAndUsage": "Ergocalciferol is indicated for use in the treatment of hypoparathyroidism, refractory rickets, also known as vitamin D resistant rickets, and familial hypophosphatemia.",
"Description": "ERGOCALCIFEROL CAPSULES, USP, is a synthetic calcium regulator for oral administration. Ergocalciferol is a white, colorless crystal, insoluble in water, soluble in organic solvents, and slightly soluble in vegetable oils. It is affected by air and by light. Ergosterol or provitamin D 2is found in plants and yeast and has no antirachitic activity. There are more than 10 substances belonging to a group of steroid compounds, classified as having vitamin D or antirachitic activity. One USP Unit of vitamin D 2is equivalent to one International Unit (IU), and 1 mcg of vitamin D 2is equal to 40 IU. Each softgel, for oral administration, contains Ergocalciferol, USP 1,250 mcg (equivalent to 50,000 USP units of Vitamin D), in an edible vegetable oil. Ergocalciferol, also called vitamin D 2, is 9,10-secoergosta-5,7,10(19),22-tetraen-3-ol,(3 β,5 Z,7 E,22 E)-; (C 28H 44O) with a molecular weight of 396.65, and has the following structural formula:. Inactive Ingredients:Refined soybean oil, gelatin, glycerin, purified water, D&C Yellow #10, and FD&C Blue #1."
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"IndicationAndUsage": "Ergocalciferol is indicated for use in the treatment of hypoparathyroidism, refractory rickets, also known as vitamin D resistant rickets, and familial hypophosphatemia.",
"Description": "ERGOCALCIFEROL CAPSULES, USP, is a synthetic calcium regulator for oral administration. Ergocalciferol is a white, colorless crystal, insoluble in water, soluble in organic solvents, and slightly soluble in vegetable oils. It is affected by air and by light. Ergosterol or provitamin D 2is found in plants and yeast and has no antirachitic activity. There are more than 10 substances belonging to a group of steroid compounds, classified as having vitamin D or antirachitic activity. One USP Unit of vitamin D 2is equivalent to one International Unit (IU), and 1 mcg of vitamin D 2is equal to 40 IU. Each softgel, for oral administration, contains Ergocalciferol, USP 1,250 mcg (equivalent to 50,000 USP units of Vitamin D), in an edible vegetable oil. Ergocalciferol, also called vitamin D 2, is 9,10-secoergosta-5,7,10(19),22-tetraen-3-ol,(3 β,5 Z,7 E,22 E)-; (C 28H 44O) with a molecular weight of 396.65, and has the following structural formula:. Inactive Ingredients:Refined soybean oil, gelatin, glycerin, purified water, D&C Yellow #10, and FD&C Blue #1."
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"IndicationAndUsage": "Ergocalciferol is indicated for use in the treatment of hypoparathyroidism, refractory rickets, also known as vitamin D resistant rickets, and familial hypophosphatemia.",
"Description": "ERGOCALCIFEROL CAPSULES, USP, is a synthetic calcium regulator for oral administration. Ergocalciferol is a white, colorless crystal, insoluble in water, soluble in organic solvents, and slightly soluble in vegetable oils. It is affected by air and by light. Ergosterol or provitamin D 2is found in plants and yeast and has no antirachitic activity. There are more than 10 substances belonging to a group of steroid compounds, classified as having vitamin D or antirachitic activity. One USP Unit of vitamin D 2is equivalent to one International Unit (IU), and 1 mcg of vitamin D 2is equal to 40 IU. Each softgel, for oral administration, contains Ergocalciferol, USP 1,250 mcg (equivalent to 50,000 USP units of Vitamin D), in an edible vegetable oil. Ergocalciferol, also called vitamin D 2, is 9,10-secoergosta-5,7,10(19),22-tetraen-3-ol,(3 β,5 Z,7 E,22 E)-; (C 28H 44O) with a molecular weight of 396.65, and has the following structural formula:. Inactive Ingredients:Refined soybean oil, gelatin, glycerin, purified water, D&C Yellow #10, and FD&C Blue #1."
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"SamplePackage": "N",
"IndicationAndUsage": "Ergocalciferol is indicated for use in the treatment of hypoparathyroidism, refractory rickets, also known as vitamin D resistant rickets, and familial hypophosphatemia.",
"Description": "ERGOCALCIFEROL CAPSULES, USP, is a synthetic calcium regulator for oral administration. Ergocalciferol is a white, colorless crystal, insoluble in water, soluble in organic solvents, and slightly soluble in vegetable oils. It is affected by air and by light. Ergosterol or provitamin D 2is found in plants and yeast and has no antirachitic activity. There are more than 10 substances belonging to a group of steroid compounds, classified as having vitamin D or antirachitic activity. One USP Unit of vitamin D 2is equivalent to one International Unit (IU), and 1 mcg of vitamin D 2is equal to 40 IU. Each softgel, for oral administration, contains Ergocalciferol, USP 1,250 mcg (equivalent to 50,000 USP units of Vitamin D), in an edible vegetable oil. Ergocalciferol, also called vitamin D 2, is 9,10-secoergosta-5,7,10(19),22-tetraen-3-ol,(3 β,5 Z,7 E,22 E)-; (C 28H 44O) with a molecular weight of 396.65, and has the following structural formula:. Inactive Ingredients:Refined soybean oil, gelatin, glycerin, purified water, D&C Yellow #10, and FD&C Blue #1."
},
{
"NDCCode": "0054-0062-58",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (0054-0062-58) / 240 mL in 1 BOTTLE, PLASTIC",
"NDC11Code": "00054-0062-58",
"ProductNDC": "0054-0062",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Citalopram",
"NonProprietaryName": "Citalopram",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20040525",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077043",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "CITALOPRAM HYDROBROMIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2023-08-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20040525",
"SamplePackage": "N",
"IndicationAndUsage": "Citalopram oral solution is indicated for the treatment of depression. The efficacy of citalopram oral solution in the treatment of depression was established in 4 to 6 week, controlled trials of outpatients whose diagnosis corresponded most closely to the DSM-III and DSM-III-R category of major depressive disorder (see CLINICAL PHARMACOLOGY). A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least five of the following nine symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation. The antidepressant action of citalopram oral solution in hospitalized depressed patients has not been adequately studied. The efficacy of citalopram oral solution in maintaining an antidepressant response for up to 24 weeks following 6 to 8 weeks of acute treatment was demonstrated in two placebo-controlled trials (see CLINICAL PHARMACOLOGY). Nevertheless, the physician who elects to use citalopram oral solution for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.",
"Description": "Citalopram Oral Solution, USP is an orally administered selective serotonin reuptake inhibitor (SSRI) with a chemical structure unrelated to that of other SSRI's or of tricyclic, tetracyclic, or other available antidepressant agents. Citalopram hydrobromide is a racemic bicyclic phthalane derivative designated (±)-1-(3-dimethylaminopropyl)-1-(4-fluorophenyl)-1,3-dihydroisobenzofuran-5-carbonitrile, HBr with the following structural formula. The molecular formula is C20H22BrFN2O and its molecular weight is 405.30. Citalopram hydrobromide, USP occurs as a fine, white to off-white powder. Citalopram hydrobromide is sparingly soluble in water and soluble in ethanol. Citalopram is available as an oral solution. Citalopram Oral Solution, USP contains citalopram hydrobromide, USP equivalent to 2 mg/mL citalopram base. It also contains the following inactive ingredients: methylparaben, peppermint stick, propylene glycol, propylparaben, purified water, and sorbitol solution."
},
{
"NDCCode": "0062-5356-01",
"PackageDescription": "20 g in 1 TUBE, WITH APPLICATOR (0062-5356-01)",
"NDC11Code": "00062-5356-01",
"ProductNDC": "0062-5356",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Terazol 3",
"NonProprietaryName": "Terconazole",
"DosageFormName": "CREAM",
"RouteName": "VAGINAL",
"StartMarketingDate": "19910221",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019964",
"LabelerName": "Ortho-McNeil-Janssen Pharmaceutical",
"SubstanceName": "TERCONAZOLE",
"StrengthNumber": "8",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Azole Antifungal [EPC],Azoles [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "13630-0062-4",
"PackageDescription": "177 mL in 1 CAN (13630-0062-4) ",
"NDC11Code": "13630-0062-04",
"ProductNDC": "13630-0062",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Australian Gold",
"ProprietaryNameSuffix": "Broad Spectrum Spf 30",
"NonProprietaryName": "Avobenzone, Homosalate, Octisalate, Octocrylene And Octobenzone",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20131215",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Prime Packaging, Inc.",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE",
"StrengthNumber": "24.8; 62.1; 41.4; 22.8; 16.6",
"StrengthUnit": "mg/mL; mg/mL; mg/mL; mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2022-04-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20131215",
"SamplePackage": "N"
},
{
"NDCCode": "17856-0062-1",
"PackageDescription": "72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0062-1) > 10 mL in 1 CUP, UNIT-DOSE",
"NDC11Code": "17856-0062-01",
"ProductNDC": "17856-0062",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sucralfate",
"NonProprietaryName": "Sucralfate Oral",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20191202",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209356",
"LabelerName": "ATLANTIC BIOLOGICALS CORP.",
"SubstanceName": "SUCRALFATE",
"StrengthNumber": "1",
"StrengthUnit": "g/10mL",
"Pharm_Classes": "Aluminum Complex [EPC], Organometallic Compounds [CS]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20210111",
"SamplePackage": "N",
"IndicationAndUsage": "Sucralfate Oral Suspension is indicated in the short-term (up to 8 weeks) treatment of active duodenal ulcer.",
"Description": "Sucralfate Oral Suspension contains sucralfate, USP and sucralfate is an α-D-glucopyranoside, β-D-fructofuranosyl-, octakis-(hydrogen sulfate), aluminum complex. Sucralfate Oral Suspension for oral administration contains 1 g of sucralfate, USP per 10 mL. Sucralfate Oral Suspension also contains: cherry flavor, colloidal silicon dioxide, FD&C Red #40, glycerin, methylcellulose, methylparaben, microcrystalline cellulose, purified water, simethicone emulsion, and sorbitol solution. Therapeutic category: antiulcer."
},
{
"NDCCode": "20151-062-02",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 BOTTLE, PLASTIC (20151-062-02) > 50 mL in 1 BOTTLE, PLASTIC (20151-062-01)",
"NDC11Code": "20151-0062-02",
"ProductNDC": "20151-062",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hydra Lifting Firming Fresh Serum 24h",
"NonProprietaryName": "Glycerin",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20150811",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part347",
"LabelerName": "CASMARA COSMETICS, SA",
"SubstanceName": "GLYCERIN",
"StrengthNumber": "8",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2017-03-03"
},
{
"NDCCode": "35356-062-05",
"PackageDescription": "5 PATCH in 1 CARTON (35356-062-05) > 72 h in 1 PATCH",
"NDC11Code": "35356-0062-05",
"ProductNDC": "35356-062",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fentanyl",
"NonProprietaryName": "Fentanyl",
"DosageFormName": "PATCH",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20130109",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076258",
"LabelerName": "Lake Erie Medical DBA Quality Care Products LLC",
"SubstanceName": "FENTANYL",
"StrengthNumber": "12",
"StrengthUnit": "ug/h",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20130109",
"SamplePackage": "N",
"IndicationAndUsage": "Fentanyl transdermal system is a transdermal formulation of fentanyl indicated for the management of persistent, moderate to severe chronic pain in opioid-tolerant patients 2 years of age and older when a continuous, around-the-clock opioid analgesic is required for an extended period of time, and the patient cannot be managed by other means such as non-steroidal analgesics, opioid combination products, or immediate-release opioids. Patients considered opioid-tolerant are those who are taking at least 60 mg of morphine daily, or at least 30 mg of oral oxycodone daily, or at least 8 mg of oral hydromorphone daily, or an equianalgesic dose of another opioid for a week or longer.",
"Description": "Fentanyl transdermal system is a transdermal system containing fentanyl. The chemical name is N-Phenyl-N-(1-(2-phenylethyl)-4-piperidinyl) propanamide. The structural formula is. The molecular weight of fentanyl base is 336.5, and the molecular formula is C22H28N2O. The n-octanol:water partition coefficient is 860:1. The pKa is 8.4. System Components and Structure. The amount of fentanyl released from each system per hour is proportional to the surface area (25 mcg/hr per 6.25 cm2). The composition per unit area of all system sizes is identical. Fentanyl transdermal system is a transparent rectangular patch with rounded corners comprising a protective liner and two functional layers. Proceeding from the outer surface toward the surface adhering to skin, these layers are. 1) a backing layer of polyolefin film; 2) a drug-in-adhesive layer. Before use, a protective liner covering the adhesive layer is removed and discarded. Fentanyl transdermal systems are packaged with additional pieces of protective film above and below the system within each pouch. These are discarded at the time of use."
},
{
"NDCCode": "41163-062-08",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (41163-062-08) > 8 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "41163-0062-08",
"ProductNDC": "41163-062",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Heartburn Relief",
"ProprietaryNameSuffix": "Maximum Strength",
"NonProprietaryName": "Ranitidine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20130615",
"EndMarketingDate": "20180715",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200536",
"LabelerName": "SUPERVALU INC.",
"SubstanceName": "RANITIDINE HYDROCHLORIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2018-07-16",
"ProductNdcExcludeFlag": "N"
},
{
"NDCCode": "41520-062-60",
"PackageDescription": "1 BOTTLE in 1 BOX (41520-062-60) > 30 TABLET in 1 BOTTLE",
"NDC11Code": "41520-0062-60",
"ProductNDC": "41520-062",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Senna S",
"NonProprietaryName": "Docusate Sodium, Sennosides",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150630",
"EndMarketingDate": "20200630",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part334",
"LabelerName": "Care One (American Sales Company)",
"SubstanceName": "DOCUSATE SODIUM; SENNOSIDES",
"StrengthNumber": "50; 8.6",
"StrengthUnit": "mg/1; mg/1",
"Status": "Deprecated",
"LastUpdate": "2020-07-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20150630",
"EndMarketingDatePackage": "20200630",
"SamplePackage": "N"
},
{
"NDCCode": "42254-062-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE, PLASTIC (42254-062-30)",
"NDC11Code": "42254-0062-30",
"ProductNDC": "42254-062",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Piroxicam",
"NonProprietaryName": "Piroxicam",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20100105",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074118",
"LabelerName": "Rebel Distributors Corp",
"SubstanceName": "PIROXICAM",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of Piroxicam Capsules USP and other treatment options before deciding to use Piroxicam Capsules USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Piroxicam Capsules USP is indicated: 1 For relief of the signs and symptoms of osteoarthritis., 2 For relief of the signs and symptoms of rheumatoid arthritis.",
"Description": "Piroxicam Capsules USP contains piroxicam which is a member of the oxicam group of nonsteroidal anti-inflammatory drugs (NSAIDs). Each ivory opaque/Swedish orange opaque capsule contains 10 mg piroxicam; each Swedish orange opaque/Swedish orange opaque capsule contains 20 mg piroxicam for oral administration. The chemical name for piroxicam is 4-hydroxyl-2-methyl-N-2-pyridinyl-2H-1,2,-benzothiazine-3-carboxamide 1,1-dioxide. Piroxicam occurs as a white crystalline solid, sparingly soluble in water, dilute acid and most organic solvents. It is slightly soluble in alcohol and in aqueous solutions. It exhibits a weakly acidic 4-hydroxy proton (pKa 5.1) and a weakly basic pyridyl nitrogen (pKa 1.8). The molecular weight of piroxicam is 331.35. Its molecular formula is C15H13N3O4S and it has the following structural formula. The inactive ingredients in Piroxicam Capsules USP include: hard gelatin capsules (which may contain FD&C Blue1, FD&C Red 40, D&C Yellow 10, titanium dioxide and gelatin inactive ingredients), corn starch, lactose, magnesium stearate and sodium lauryl sulfate."
},
{
"NDCCode": "43742-0062-1",
"PackageDescription": "30 mL in 1 BOTTLE, DROPPER (43742-0062-1)",
"NDC11Code": "43742-0062-01",
"ProductNDC": "43742-0062",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Detox",
"ProprietaryNameSuffix": "Iii",
"NonProprietaryName": "Conium Maculatum, Dulcamara, Echinacea, Aesculus Hippocastanum, Antimonium Tartaricum, Ascorbicum Acidum, Coccus Cacti, Galium Aparine, Gentiana Lutea, Geranium Robertianum, Lymph (suis), Sulphur, Glandula Suprarenalis Suis, Phenylalanine, Calcarea Phosphorica, Ferrum Phosphoricum, Hepar Suis, Hypothalamus (suis), Spleen (suis) Cortisone Aceticum, Mercurius Solubilis, Baryta Carbonica, Funiculus Umbilicalis Suis, Tonsil (suis), Gaertner Bach, Triiodothyronine, Medulla Ossis Suis, Mutabile Bach",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20120628",
"EndMarketingDate": "20171003",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Deseret Biologicals, Inc.",
"SubstanceName": "CONIUM MACULATUM FLOWERING TOP; SOLANUM DULCAMARA TOP; ECHINACEA, UNSPECIFIED; HORSE CHESTNUT; ANTIMONY POTASSIUM TARTRATE; ASCORBIC ACID; PROTORTONIA CACTI; GALIUM APARINE; GENTIANA LUTEA ROOT; GERANIUM ROBERTIANUM; PULSATILLA VULGARIS; LACTIC ACID, L-; SUS SCROFA LYMPH; SULFUR; SUS SCROFA ADRENAL GLAND; PHENYLALANINE; TRIBASIC CALCIUM PHOSPHATE; FERROSOFERRIC PHOSPHATE; PORK LIVER; SUS SCROFA HYPOTHALAMUS; SUS SCROFA SPLEEN; CORTISONE ACETATE; MERCURIUS SOLUBILIS; BARIUM CARBONATE; SUS SCROFA UMBILICAL CORD; SUS SCROFA TONSIL; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS; LIOTHYRONINE; SUS SCROFA BONE MARROW; ESCHERICHIA COLI",
"StrengthNumber": "4; 4; 4; 6; 6; 6; 6; 6; 6; 6; 6; 6; 8; 8; 8; 8; 10; 10; 10; 10; 10; 13; 13; 28; 6; 6; 9; 10; 12; 30",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL",
"Status": "Deprecated",
"LastUpdate": "2017-10-05"
},
{
"NDCCode": "43857-0062-1",
"PackageDescription": "30 mL in 1 BOTTLE, DROPPER (43857-0062-1) ",
"NDC11Code": "43857-0062-01",
"ProductNDC": "43857-0062",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Scrofularoforce",
"NonProprietaryName": "Juniperus Virginiana, Rumex Crispus, Scrophularia Nodosa, Xanthoxylum Fraxineum, Lymph Node, Baryta Carbonica, Baryta Muriatica, Belladonna, Calcarea Carbonica, Conium Maculatum, Helleborus Niger, Iodium, Kali Phosphoricum, Lachesis Mutus, Natrum Phosphoricum, Silicea",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20130125",
"EndMarketingDate": "20210914",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "BioActive Nutritional, Inc.",
"SubstanceName": "JUNIPERUS VIRGINIANA TWIG; RUMEX CRISPUS ROOT; SCROPHULARIA NODOSA; ZANTHOXYLUM AMERICANUM BARK; SUS SCROFA LYMPH; BARIUM CARBONATE; BARIUM CHLORIDE DIHYDRATE; ATROPA BELLADONNA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CONIUM MACULATUM FLOWERING TOP; HELLEBORUS NIGER ROOT; IODINE; POTASSIUM PHOSPHATE, DIBASIC; LACHESIS MUTA VENOM; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SILICON DIOXIDE",
"StrengthNumber": "3; 3; 3; 3; 8; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Status": "Deprecated",
"LastUpdate": "2021-09-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20160816",
"EndMarketingDatePackage": "20210914",
"SamplePackage": "N"
},
{
"NDCCode": "49348-062-10",
"PackageDescription": "1 BOTTLE in 1 BOX (49348-062-10) > 100 TABLET in 1 BOTTLE",
"NDC11Code": "49348-0062-10",
"ProductNDC": "49348-062",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Senna Laxative",
"ProprietaryNameSuffix": "Natural Vegetable Laxative",
"NonProprietaryName": "Sennosides",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130220",
"EndMarketingDate": "20190331",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part334",
"LabelerName": "McKesson (Sunmark)",
"SubstanceName": "SENNOSIDES",
"StrengthNumber": "8.6",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2019-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20130220",
"EndMarketingDatePackage": "20190331",
"SamplePackage": "N"
},
{
"NDCCode": "49354-062-15",
"PackageDescription": "15 mL in 1 TUBE (49354-062-15) ",
"NDC11Code": "49354-0062-15",
"ProductNDC": "49354-062",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Titanium Dioxide, Zinc Oxide",
"DosageFormName": "CREAM",
"StartMarketingDate": "20190701",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "HK Kolmar Canada, Inc",
"SubstanceName": "TITANIUM DIOXIDE; ZINC OXIDE",
"StrengthNumber": "75; 62.8",
"StrengthUnit": "mg/mL; mg/mL",
"Status": "Unfinished",
"LastUpdate": "2022-07-14",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "01-JUL-19"
},
{
"NDCCode": "49738-062-08",
"PackageDescription": "8 BLISTER PACK in 1 CARTON (49738-062-08) > 1 TABLET in 1 BLISTER PACK",
"NDC11Code": "49738-0062-08",
"ProductNDC": "49738-062",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Motion Sickness Relief",
"ProprietaryNameSuffix": "Less Drowsy",
"NonProprietaryName": "Meclizine Hcl",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140228",
"EndMarketingDate": "20181231",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part336",
"LabelerName": "SMART SENSE (Kmart)",
"SubstanceName": "MECLIZINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2019-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20140228",
"EndMarketingDatePackage": "20181231",
"SamplePackage": "N"
},
{
"NDCCode": "49781-062-51",
"PackageDescription": "1 BOTTLE in 1 CARTON (49781-062-51) > 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE",
"NDC11Code": "49781-0062-51",
"ProductNDC": "49781-062",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Leader Pain Relief",
"ProprietaryNameSuffix": "8 Hr",
"NonProprietaryName": "Acetaminophen",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20140123",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075077",
"LabelerName": "Cardinal Health",
"SubstanceName": "ACETAMINOPHEN",
"StrengthNumber": "650",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2019-02-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
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}
]
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<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Baclofen</ProprietaryName>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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<LastUpdate>2026-05-15</LastUpdate>
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<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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<IndicationAndUsage>Ergocalciferol is indicated for use in the treatment of hypoparathyroidism, refractory rickets, also known as vitamin D resistant rickets, and familial hypophosphatemia.</IndicationAndUsage>
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<IndicationAndUsage>Ergocalciferol is indicated for use in the treatment of hypoparathyroidism, refractory rickets, also known as vitamin D resistant rickets, and familial hypophosphatemia.</IndicationAndUsage>
<Description>ERGOCALCIFEROL CAPSULES, USP, is a synthetic calcium regulator for oral administration. Ergocalciferol is a white, colorless crystal, insoluble in water, soluble in organic solvents, and slightly soluble in vegetable oils. It is affected by air and by light. Ergosterol or provitamin D 2is found in plants and yeast and has no antirachitic activity. There are more than 10 substances belonging to a group of steroid compounds, classified as having vitamin D or antirachitic activity. One USP Unit of vitamin D 2is equivalent to one International Unit (IU), and 1 mcg of vitamin D 2is equal to 40 IU. Each softgel, for oral administration, contains Ergocalciferol, USP 1,250 mcg (equivalent to 50,000 USP units of Vitamin D), in an edible vegetable oil. Ergocalciferol, also called vitamin D 2, is 9,10-secoergosta-5,7,10(19),22-tetraen-3-ol,(3 β,5 Z,7 E,22 E)-; (C 28H 44O) with a molecular weight of 396.65, and has the following structural formula:. Inactive Ingredients:Refined soybean oil, gelatin, glycerin, purified water, D&C Yellow #10, and FD&C Blue #1.</Description>
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<NDC11Code>71335-0062-04</NDC11Code>
<ProductNDC>71335-0062</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ergocalciferol</ProprietaryName>
<NonProprietaryName>Ergocalciferol</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160615</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA080704</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>ERGOCALCIFEROL</SubstanceName>
<StrengthNumber>1.25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Ergocalciferols [CS], Provitamin D2 Compound [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180220</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ergocalciferol is indicated for use in the treatment of hypoparathyroidism, refractory rickets, also known as vitamin D resistant rickets, and familial hypophosphatemia.</IndicationAndUsage>
<Description>ERGOCALCIFEROL CAPSULES, USP, is a synthetic calcium regulator for oral administration. Ergocalciferol is a white, colorless crystal, insoluble in water, soluble in organic solvents, and slightly soluble in vegetable oils. It is affected by air and by light. Ergosterol or provitamin D 2is found in plants and yeast and has no antirachitic activity. There are more than 10 substances belonging to a group of steroid compounds, classified as having vitamin D or antirachitic activity. One USP Unit of vitamin D 2is equivalent to one International Unit (IU), and 1 mcg of vitamin D 2is equal to 40 IU. Each softgel, for oral administration, contains Ergocalciferol, USP 1,250 mcg (equivalent to 50,000 USP units of Vitamin D), in an edible vegetable oil. Ergocalciferol, also called vitamin D 2, is 9,10-secoergosta-5,7,10(19),22-tetraen-3-ol,(3 β,5 Z,7 E,22 E)-; (C 28H 44O) with a molecular weight of 396.65, and has the following structural formula:. Inactive Ingredients:Refined soybean oil, gelatin, glycerin, purified water, D&C Yellow #10, and FD&C Blue #1.</Description>
</NDC>
<NDC>
<NDCCode>71335-0062-5</NDCCode>
<PackageDescription>20 CAPSULE, LIQUID FILLED in 1 BOTTLE (71335-0062-5) </PackageDescription>
<NDC11Code>71335-0062-05</NDC11Code>
<ProductNDC>71335-0062</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ergocalciferol</ProprietaryName>
<NonProprietaryName>Ergocalciferol</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160615</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA080704</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>ERGOCALCIFEROL</SubstanceName>
<StrengthNumber>1.25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Ergocalciferols [CS], Provitamin D2 Compound [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181107</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ergocalciferol is indicated for use in the treatment of hypoparathyroidism, refractory rickets, also known as vitamin D resistant rickets, and familial hypophosphatemia.</IndicationAndUsage>
<Description>ERGOCALCIFEROL CAPSULES, USP, is a synthetic calcium regulator for oral administration. Ergocalciferol is a white, colorless crystal, insoluble in water, soluble in organic solvents, and slightly soluble in vegetable oils. It is affected by air and by light. Ergosterol or provitamin D 2is found in plants and yeast and has no antirachitic activity. There are more than 10 substances belonging to a group of steroid compounds, classified as having vitamin D or antirachitic activity. One USP Unit of vitamin D 2is equivalent to one International Unit (IU), and 1 mcg of vitamin D 2is equal to 40 IU. Each softgel, for oral administration, contains Ergocalciferol, USP 1,250 mcg (equivalent to 50,000 USP units of Vitamin D), in an edible vegetable oil. Ergocalciferol, also called vitamin D 2, is 9,10-secoergosta-5,7,10(19),22-tetraen-3-ol,(3 β,5 Z,7 E,22 E)-; (C 28H 44O) with a molecular weight of 396.65, and has the following structural formula:. Inactive Ingredients:Refined soybean oil, gelatin, glycerin, purified water, D&C Yellow #10, and FD&C Blue #1.</Description>
</NDC>
<NDC>
<NDCCode>71335-0062-7</NDCCode>
<PackageDescription>15 CAPSULE, LIQUID FILLED in 1 BOTTLE (71335-0062-7) </PackageDescription>
<NDC11Code>71335-0062-07</NDC11Code>
<ProductNDC>71335-0062</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ergocalciferol</ProprietaryName>
<NonProprietaryName>Ergocalciferol</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160615</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA080704</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>ERGOCALCIFEROL</SubstanceName>
<StrengthNumber>1.25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Ergocalciferols [CS], Provitamin D2 Compound [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240219</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ergocalciferol is indicated for use in the treatment of hypoparathyroidism, refractory rickets, also known as vitamin D resistant rickets, and familial hypophosphatemia.</IndicationAndUsage>
<Description>ERGOCALCIFEROL CAPSULES, USP, is a synthetic calcium regulator for oral administration. Ergocalciferol is a white, colorless crystal, insoluble in water, soluble in organic solvents, and slightly soluble in vegetable oils. It is affected by air and by light. Ergosterol or provitamin D 2is found in plants and yeast and has no antirachitic activity. There are more than 10 substances belonging to a group of steroid compounds, classified as having vitamin D or antirachitic activity. One USP Unit of vitamin D 2is equivalent to one International Unit (IU), and 1 mcg of vitamin D 2is equal to 40 IU. Each softgel, for oral administration, contains Ergocalciferol, USP 1,250 mcg (equivalent to 50,000 USP units of Vitamin D), in an edible vegetable oil. Ergocalciferol, also called vitamin D 2, is 9,10-secoergosta-5,7,10(19),22-tetraen-3-ol,(3 β,5 Z,7 E,22 E)-; (C 28H 44O) with a molecular weight of 396.65, and has the following structural formula:. Inactive Ingredients:Refined soybean oil, gelatin, glycerin, purified water, D&C Yellow #10, and FD&C Blue #1.</Description>
</NDC>
<NDC>
<NDCCode>71335-0062-9</NDCCode>
<PackageDescription>60 CAPSULE, LIQUID FILLED in 1 BOTTLE (71335-0062-9) </PackageDescription>
<NDC11Code>71335-0062-09</NDC11Code>
<ProductNDC>71335-0062</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ergocalciferol</ProprietaryName>
<NonProprietaryName>Ergocalciferol</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160615</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA080704</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>ERGOCALCIFEROL</SubstanceName>
<StrengthNumber>1.25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Ergocalciferols [CS], Provitamin D2 Compound [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180816</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ergocalciferol is indicated for use in the treatment of hypoparathyroidism, refractory rickets, also known as vitamin D resistant rickets, and familial hypophosphatemia.</IndicationAndUsage>
<Description>ERGOCALCIFEROL CAPSULES, USP, is a synthetic calcium regulator for oral administration. Ergocalciferol is a white, colorless crystal, insoluble in water, soluble in organic solvents, and slightly soluble in vegetable oils. It is affected by air and by light. Ergosterol or provitamin D 2is found in plants and yeast and has no antirachitic activity. There are more than 10 substances belonging to a group of steroid compounds, classified as having vitamin D or antirachitic activity. One USP Unit of vitamin D 2is equivalent to one International Unit (IU), and 1 mcg of vitamin D 2is equal to 40 IU. Each softgel, for oral administration, contains Ergocalciferol, USP 1,250 mcg (equivalent to 50,000 USP units of Vitamin D), in an edible vegetable oil. Ergocalciferol, also called vitamin D 2, is 9,10-secoergosta-5,7,10(19),22-tetraen-3-ol,(3 β,5 Z,7 E,22 E)-; (C 28H 44O) with a molecular weight of 396.65, and has the following structural formula:. Inactive Ingredients:Refined soybean oil, gelatin, glycerin, purified water, D&C Yellow #10, and FD&C Blue #1.</Description>
</NDC>
<NDC>
<NDCCode>0054-0062-58</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (0054-0062-58) / 240 mL in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>00054-0062-58</NDC11Code>
<ProductNDC>0054-0062</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Citalopram</ProprietaryName>
<NonProprietaryName>Citalopram</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20040525</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077043</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>CITALOPRAM HYDROBROMIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-08-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20040525</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Citalopram oral solution is indicated for the treatment of depression. The efficacy of citalopram oral solution in the treatment of depression was established in 4 to 6 week, controlled trials of outpatients whose diagnosis corresponded most closely to the DSM-III and DSM-III-R category of major depressive disorder (see CLINICAL PHARMACOLOGY). A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least five of the following nine symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation. The antidepressant action of citalopram oral solution in hospitalized depressed patients has not been adequately studied. The efficacy of citalopram oral solution in maintaining an antidepressant response for up to 24 weeks following 6 to 8 weeks of acute treatment was demonstrated in two placebo-controlled trials (see CLINICAL PHARMACOLOGY). Nevertheless, the physician who elects to use citalopram oral solution for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.</IndicationAndUsage>
<Description>Citalopram Oral Solution, USP is an orally administered selective serotonin reuptake inhibitor (SSRI) with a chemical structure unrelated to that of other SSRI's or of tricyclic, tetracyclic, or other available antidepressant agents. Citalopram hydrobromide is a racemic bicyclic phthalane derivative designated (±)-1-(3-dimethylaminopropyl)-1-(4-fluorophenyl)-1,3-dihydroisobenzofuran-5-carbonitrile, HBr with the following structural formula. The molecular formula is C20H22BrFN2O and its molecular weight is 405.30. Citalopram hydrobromide, USP occurs as a fine, white to off-white powder. Citalopram hydrobromide is sparingly soluble in water and soluble in ethanol. Citalopram is available as an oral solution. Citalopram Oral Solution, USP contains citalopram hydrobromide, USP equivalent to 2 mg/mL citalopram base. It also contains the following inactive ingredients: methylparaben, peppermint stick, propylene glycol, propylparaben, purified water, and sorbitol solution.</Description>
</NDC>
<NDC>
<NDCCode>0062-5356-01</NDCCode>
<PackageDescription>20 g in 1 TUBE, WITH APPLICATOR (0062-5356-01)</PackageDescription>
<NDC11Code>00062-5356-01</NDC11Code>
<ProductNDC>0062-5356</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Terazol 3</ProprietaryName>
<NonProprietaryName>Terconazole</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>VAGINAL</RouteName>
<StartMarketingDate>19910221</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019964</ApplicationNumber>
<LabelerName>Ortho-McNeil-Janssen Pharmaceutical</LabelerName>
<SubstanceName>TERCONAZOLE</SubstanceName>
<StrengthNumber>8</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC],Azoles [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>13630-0062-4</NDCCode>
<PackageDescription>177 mL in 1 CAN (13630-0062-4) </PackageDescription>
<NDC11Code>13630-0062-04</NDC11Code>
<ProductNDC>13630-0062</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Australian Gold</ProprietaryName>
<ProprietaryNameSuffix>Broad Spectrum Spf 30</ProprietaryNameSuffix>
<NonProprietaryName>Avobenzone, Homosalate, Octisalate, Octocrylene And Octobenzone</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20131215</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Prime Packaging, Inc.</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE</SubstanceName>
<StrengthNumber>24.8; 62.1; 41.4; 22.8; 16.6</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL; mg/mL; mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-04-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>17856-0062-1</NDCCode>
<PackageDescription>72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0062-1) > 10 mL in 1 CUP, UNIT-DOSE</PackageDescription>
<NDC11Code>17856-0062-01</NDC11Code>
<ProductNDC>17856-0062</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sucralfate</ProprietaryName>
<NonProprietaryName>Sucralfate Oral</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20191202</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209356</ApplicationNumber>
<LabelerName>ATLANTIC BIOLOGICALS CORP.</LabelerName>
<SubstanceName>SUCRALFATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/10mL</StrengthUnit>
<Pharm_Classes>Aluminum Complex [EPC], Organometallic Compounds [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210111</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sucralfate Oral Suspension is indicated in the short-term (up to 8 weeks) treatment of active duodenal ulcer.</IndicationAndUsage>
<Description>Sucralfate Oral Suspension contains sucralfate, USP and sucralfate is an α-D-glucopyranoside, β-D-fructofuranosyl-, octakis-(hydrogen sulfate), aluminum complex. Sucralfate Oral Suspension for oral administration contains 1 g of sucralfate, USP per 10 mL. Sucralfate Oral Suspension also contains: cherry flavor, colloidal silicon dioxide, FD&C Red #40, glycerin, methylcellulose, methylparaben, microcrystalline cellulose, purified water, simethicone emulsion, and sorbitol solution. Therapeutic category: antiulcer.</Description>
</NDC>
<NDC>
<NDCCode>20151-062-02</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 BOTTLE, PLASTIC (20151-062-02) > 50 mL in 1 BOTTLE, PLASTIC (20151-062-01)</PackageDescription>
<NDC11Code>20151-0062-02</NDC11Code>
<ProductNDC>20151-062</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hydra Lifting Firming Fresh Serum 24h</ProprietaryName>
<NonProprietaryName>Glycerin</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20150811</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part347</ApplicationNumber>
<LabelerName>CASMARA COSMETICS, SA</LabelerName>
<SubstanceName>GLYCERIN</SubstanceName>
<StrengthNumber>8</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-03-03</LastUpdate>
</NDC>
<NDC>
<NDCCode>35356-062-05</NDCCode>
<PackageDescription>5 PATCH in 1 CARTON (35356-062-05) > 72 h in 1 PATCH</PackageDescription>
<NDC11Code>35356-0062-05</NDC11Code>
<ProductNDC>35356-062</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fentanyl</ProprietaryName>
<NonProprietaryName>Fentanyl</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20130109</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076258</ApplicationNumber>
<LabelerName>Lake Erie Medical DBA Quality Care Products LLC</LabelerName>
<SubstanceName>FENTANYL</SubstanceName>
<StrengthNumber>12</StrengthNumber>
<StrengthUnit>ug/h</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130109</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fentanyl transdermal system is a transdermal formulation of fentanyl indicated for the management of persistent, moderate to severe chronic pain in opioid-tolerant patients 2 years of age and older when a continuous, around-the-clock opioid analgesic is required for an extended period of time, and the patient cannot be managed by other means such as non-steroidal analgesics, opioid combination products, or immediate-release opioids. Patients considered opioid-tolerant are those who are taking at least 60 mg of morphine daily, or at least 30 mg of oral oxycodone daily, or at least 8 mg of oral hydromorphone daily, or an equianalgesic dose of another opioid for a week or longer.</IndicationAndUsage>
<Description>Fentanyl transdermal system is a transdermal system containing fentanyl. The chemical name is N-Phenyl-N-(1-(2-phenylethyl)-4-piperidinyl) propanamide. The structural formula is. The molecular weight of fentanyl base is 336.5, and the molecular formula is C22H28N2O. The n-octanol:water partition coefficient is 860:1. The pKa is 8.4. System Components and Structure. The amount of fentanyl released from each system per hour is proportional to the surface area (25 mcg/hr per 6.25 cm2). The composition per unit area of all system sizes is identical. Fentanyl transdermal system is a transparent rectangular patch with rounded corners comprising a protective liner and two functional layers. Proceeding from the outer surface toward the surface adhering to skin, these layers are. 1) a backing layer of polyolefin film; 2) a drug-in-adhesive layer. Before use, a protective liner covering the adhesive layer is removed and discarded. Fentanyl transdermal systems are packaged with additional pieces of protective film above and below the system within each pouch. These are discarded at the time of use.</Description>
</NDC>
<NDC>
<NDCCode>41163-062-08</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (41163-062-08) > 8 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>41163-0062-08</NDC11Code>
<ProductNDC>41163-062</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Heartburn Relief</ProprietaryName>
<ProprietaryNameSuffix>Maximum Strength</ProprietaryNameSuffix>
<NonProprietaryName>Ranitidine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130615</StartMarketingDate>
<EndMarketingDate>20180715</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA200536</ApplicationNumber>
<LabelerName>SUPERVALU INC.</LabelerName>
<SubstanceName>RANITIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-07-16</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
</NDC>
<NDC>
<NDCCode>41520-062-60</NDCCode>
<PackageDescription>1 BOTTLE in 1 BOX (41520-062-60) > 30 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>41520-0062-60</NDC11Code>
<ProductNDC>41520-062</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Senna S</ProprietaryName>
<NonProprietaryName>Docusate Sodium, Sennosides</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150630</StartMarketingDate>
<EndMarketingDate>20200630</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part334</ApplicationNumber>
<LabelerName>Care One (American Sales Company)</LabelerName>
<SubstanceName>DOCUSATE SODIUM; SENNOSIDES</SubstanceName>
<StrengthNumber>50; 8.6</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-07-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20150630</StartMarketingDatePackage>
<EndMarketingDatePackage>20200630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>42254-062-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE, PLASTIC (42254-062-30)</PackageDescription>
<NDC11Code>42254-0062-30</NDC11Code>
<ProductNDC>42254-062</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Piroxicam</ProprietaryName>
<NonProprietaryName>Piroxicam</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100105</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074118</ApplicationNumber>
<LabelerName>Rebel Distributors Corp</LabelerName>
<SubstanceName>PIROXICAM</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Carefully consider the potential benefits and risks of Piroxicam Capsules USP and other treatment options before deciding to use Piroxicam Capsules USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Piroxicam Capsules USP is indicated: 1 For relief of the signs and symptoms of osteoarthritis., 2 For relief of the signs and symptoms of rheumatoid arthritis.</IndicationAndUsage>
<Description>Piroxicam Capsules USP contains piroxicam which is a member of the oxicam group of nonsteroidal anti-inflammatory drugs (NSAIDs). Each ivory opaque/Swedish orange opaque capsule contains 10 mg piroxicam; each Swedish orange opaque/Swedish orange opaque capsule contains 20 mg piroxicam for oral administration. The chemical name for piroxicam is 4-hydroxyl-2-methyl-N-2-pyridinyl-2H-1,2,-benzothiazine-3-carboxamide 1,1-dioxide. Piroxicam occurs as a white crystalline solid, sparingly soluble in water, dilute acid and most organic solvents. It is slightly soluble in alcohol and in aqueous solutions. It exhibits a weakly acidic 4-hydroxy proton (pKa 5.1) and a weakly basic pyridyl nitrogen (pKa 1.8). The molecular weight of piroxicam is 331.35. Its molecular formula is C15H13N3O4S and it has the following structural formula. The inactive ingredients in Piroxicam Capsules USP include: hard gelatin capsules (which may contain FD&C Blue1, FD&C Red 40, D&C Yellow 10, titanium dioxide and gelatin inactive ingredients), corn starch, lactose, magnesium stearate and sodium lauryl sulfate.</Description>
</NDC>
<NDC>
<NDCCode>43742-0062-1</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, DROPPER (43742-0062-1)</PackageDescription>
<NDC11Code>43742-0062-01</NDC11Code>
<ProductNDC>43742-0062</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Detox</ProprietaryName>
<ProprietaryNameSuffix>Iii</ProprietaryNameSuffix>
<NonProprietaryName>Conium Maculatum, Dulcamara, Echinacea, Aesculus Hippocastanum, Antimonium Tartaricum, Ascorbicum Acidum, Coccus Cacti, Galium Aparine, Gentiana Lutea, Geranium Robertianum, Lymph (suis), Sulphur, Glandula Suprarenalis Suis, Phenylalanine, Calcarea Phosphorica, Ferrum Phosphoricum, Hepar Suis, Hypothalamus (suis), Spleen (suis) Cortisone Aceticum, Mercurius Solubilis, Baryta Carbonica, Funiculus Umbilicalis Suis, Tonsil (suis), Gaertner Bach, Triiodothyronine, Medulla Ossis Suis, Mutabile Bach</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120628</StartMarketingDate>
<EndMarketingDate>20171003</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Deseret Biologicals, Inc.</LabelerName>
<SubstanceName>CONIUM MACULATUM FLOWERING TOP; SOLANUM DULCAMARA TOP; ECHINACEA, UNSPECIFIED; HORSE CHESTNUT; ANTIMONY POTASSIUM TARTRATE; ASCORBIC ACID; PROTORTONIA CACTI; GALIUM APARINE; GENTIANA LUTEA ROOT; GERANIUM ROBERTIANUM; PULSATILLA VULGARIS; LACTIC ACID, L-; SUS SCROFA LYMPH; SULFUR; SUS SCROFA ADRENAL GLAND; PHENYLALANINE; TRIBASIC CALCIUM PHOSPHATE; FERROSOFERRIC PHOSPHATE; PORK LIVER; SUS SCROFA HYPOTHALAMUS; SUS SCROFA SPLEEN; CORTISONE ACETATE; MERCURIUS SOLUBILIS; BARIUM CARBONATE; SUS SCROFA UMBILICAL CORD; SUS SCROFA TONSIL; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS; LIOTHYRONINE; SUS SCROFA BONE MARROW; ESCHERICHIA COLI</SubstanceName>
<StrengthNumber>4; 4; 4; 6; 6; 6; 6; 6; 6; 6; 6; 6; 8; 8; 8; 8; 10; 10; 10; 10; 10; 13; 13; 28; 6; 6; 9; 10; 12; 30</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-10-05</LastUpdate>
</NDC>
<NDC>
<NDCCode>43857-0062-1</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, DROPPER (43857-0062-1) </PackageDescription>
<NDC11Code>43857-0062-01</NDC11Code>
<ProductNDC>43857-0062</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Scrofularoforce</ProprietaryName>
<NonProprietaryName>Juniperus Virginiana, Rumex Crispus, Scrophularia Nodosa, Xanthoxylum Fraxineum, Lymph Node, Baryta Carbonica, Baryta Muriatica, Belladonna, Calcarea Carbonica, Conium Maculatum, Helleborus Niger, Iodium, Kali Phosphoricum, Lachesis Mutus, Natrum Phosphoricum, Silicea</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130125</StartMarketingDate>
<EndMarketingDate>20210914</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>BioActive Nutritional, Inc.</LabelerName>
<SubstanceName>JUNIPERUS VIRGINIANA TWIG; RUMEX CRISPUS ROOT; SCROPHULARIA NODOSA; ZANTHOXYLUM AMERICANUM BARK; SUS SCROFA LYMPH; BARIUM CARBONATE; BARIUM CHLORIDE DIHYDRATE; ATROPA BELLADONNA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CONIUM MACULATUM FLOWERING TOP; HELLEBORUS NIGER ROOT; IODINE; POTASSIUM PHOSPHATE, DIBASIC; LACHESIS MUTA VENOM; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SILICON DIOXIDE</SubstanceName>
<StrengthNumber>3; 3; 3; 3; 8; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-09-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20160816</StartMarketingDatePackage>
<EndMarketingDatePackage>20210914</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>49348-062-10</NDCCode>
<PackageDescription>1 BOTTLE in 1 BOX (49348-062-10) > 100 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>49348-0062-10</NDC11Code>
<ProductNDC>49348-062</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Senna Laxative</ProprietaryName>
<ProprietaryNameSuffix>Natural Vegetable Laxative</ProprietaryNameSuffix>
<NonProprietaryName>Sennosides</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130220</StartMarketingDate>
<EndMarketingDate>20190331</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part334</ApplicationNumber>
<LabelerName>McKesson (Sunmark)</LabelerName>
<SubstanceName>SENNOSIDES</SubstanceName>
<StrengthNumber>8.6</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20130220</StartMarketingDatePackage>
<EndMarketingDatePackage>20190331</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>49354-062-15</NDCCode>
<PackageDescription>15 mL in 1 TUBE (49354-062-15) </PackageDescription>
<NDC11Code>49354-0062-15</NDC11Code>
<ProductNDC>49354-062</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Titanium Dioxide, Zinc Oxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<StartMarketingDate>20190701</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>HK Kolmar Canada, Inc</LabelerName>
<SubstanceName>TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
<StrengthNumber>75; 62.8</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2022-07-14</LastUpdate>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>01-JUL-19</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>49738-062-08</NDCCode>
<PackageDescription>8 BLISTER PACK in 1 CARTON (49738-062-08) > 1 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>49738-0062-08</NDC11Code>
<ProductNDC>49738-062</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Motion Sickness Relief</ProprietaryName>
<ProprietaryNameSuffix>Less Drowsy</ProprietaryNameSuffix>
<NonProprietaryName>Meclizine Hcl</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140228</StartMarketingDate>
<EndMarketingDate>20181231</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part336</ApplicationNumber>
<LabelerName>SMART SENSE (Kmart)</LabelerName>
<SubstanceName>MECLIZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20140228</StartMarketingDatePackage>
<EndMarketingDatePackage>20181231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>49781-062-51</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (49781-062-51) > 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE</PackageDescription>
<NDC11Code>49781-0062-51</NDC11Code>
<ProductNDC>49781-062</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Leader Pain Relief</ProprietaryName>
<ProprietaryNameSuffix>8 Hr</ProprietaryNameSuffix>
<NonProprietaryName>Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140123</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075077</ApplicationNumber>
<LabelerName>Cardinal Health</LabelerName>
<SubstanceName>ACETAMINOPHEN</SubstanceName>
<StrengthNumber>650</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-02-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>50181-0062-1</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, DROPPER (50181-0062-1) </PackageDescription>
<NDC11Code>50181-0062-01</NDC11Code>
<ProductNDC>50181-0062</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Biotox</ProprietaryName>
<ProprietaryNameSuffix>Vi</ProprietaryNameSuffix>
<NonProprietaryName>Cochlearia Armoracia, Spleen (bovine), Thymus Gland (bovine), Influenzinum (2019-2020), Mycoplasma Pneumoniae, Cytomegalovirus Nosode, Human Papilloma Nosode, Coxsackie B1 Nosode, Coxsackie B4 Nosode, Pneumococcinum, Carcinosin</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200309</StartMarketingDate>
<EndMarketingDate>20251004</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>The Wellness Center for Research and Education, Inc.</LabelerName>
<SubstanceName>BOS TAURUS SPLEEN; BOS TAURUS THYMUS; HORSERADISH; HUMAN BREAST TUMOR CELL; HUMAN COXSACKIEVIRUS B1; HUMAN COXSACKIEVIRUS B4; HUMAN HERPESVIRUS 5; HUMAN PAPILLOMAVIRUS; INFLUENZA A VIRUS A/BRISBANE/02/2018 IVR-190 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/KANSAS/14/2017 X-327 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MARYLAND/15/2016 ANTIGEN (FORMALDEHYDE INACTIVATED); MYCOPLASMA PNEUMONIAE; STREPTOCOCCUS PNEUMONIAE</SubstanceName>
<StrengthNumber>8; 8; 3; 30; 8; 8; 12; 12; 10; 10; 10; 12; 30</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-10-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20200309</StartMarketingDatePackage>
<EndMarketingDatePackage>20251004</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fatigue, fever, cough, flu-like symptoms, heart palpitations, virus, pain, swelling and stiffness of limbs.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>51655-062-52</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-062-52) </PackageDescription>
<NDC11Code>51655-0062-52</NDC11Code>
<ProductNDC>51655-062</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rosuvastatin Calcium</ProprietaryName>
<NonProprietaryName>Rosuvastatin Calcium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220927</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208898</ApplicationNumber>
<LabelerName>Northwind Health Company, LLC</LabelerName>
<SubstanceName>ROSUVASTATIN CALCIUM</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220927</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Rosuvastatin tablets are indicated. To reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults without established coronary heart disease who are at increased risk of CV disease based on age, high-sensitivity C-reactive protein (hsCRP) ≥2 mg/L, and at least one additional CV risk factor. As an adjunct to diet to:. o Reduce low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia. o Reduce LDL-C and slow the progression of atherosclerosis in adults. o Reduce LDL-C in adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 7 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: o Primary dysbetalipoproteinemia. o Hypertriglyceridemia.</IndicationAndUsage>
<Description>Rosuvastatin calcium, USP is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor. The chemical name for rosuvastatin calcium is bis [(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2 [methyl (methylsulfonyl) amino] pyrimidin-5-yl] (3R, 5S)-3, 5-dihydroxyhept-6-enoic acid] calcium salt with the following structural formula:. The molecular formula for rosuvastatin calcium, USP is (C 22H 27FN 3O 6S) 2Ca and the molecular weight is 1,001.14. Rosuvastatin calcium is a white amorphous powder that is sparingly soluble in water and methanol, and slightly soluble in ethanol. Rosuvastatin calcium is a hydrophilic compound with a partition coefficient (octanol/water) of 0.13 at pH of 7.0. Rosuvastatin tablets, USP for oral use contain rosuvastatin 5 mg, 10 mg, 20 mg, or 40 mg (equivalent to 5.2 mg, 10.4 mg, 20.8 mg, and 41.6 mg rosuvastatin calcium) and the following inactive ingredients: crospovidone, hypromellose, lactose monohydrate, magnesium stearate, mannitol, meglumine, microcrystalline cellulose, pregelatinized starch, titanium dioxide and triacetin. Additionally, 10 mg, 20 mg and 40 mg tablets contain FD&C red No. 40/allura red AC aluminum lake, FD&C blue No. 2/indigo carmine aluminum lake and FD&C yellow No.6/sunset yellow FCF aluminum lake. Meets USP Dissolution Test 2.</Description>
</NDC>
</NDCList>