{
"NDC": [
{
"NDCCode": "69901-523-08",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 BOX (69901-523-08) / 236 mL in 1 BOTTLE, PLASTIC",
"NDC11Code": "69901-0523-08",
"ProductNDC": "69901-523",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Vicks Vaposteam Lavender",
"NonProprietaryName": "Camphor, (-)-",
"DosageFormName": "INHALANT",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20250105",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "Kaz USA, Inc",
"SubstanceName": "CAMPHOR, (-)-",
"StrengthNumber": ".062",
"StrengthUnit": "g/mL",
"Status": "Active",
"LastUpdate": "2025-01-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250105",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves cough associated with a cold. temporarily helps you cough less. cough suppressant which temporarily controls the impulse to cough. temporarily helps to suppress the cough reflex that causes coughing. temporarily reduces the intensity of coughing. reduces your cough to help you rest."
},
{
"NDCCode": "69901-522-08",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (69901-522-08) / 236 mL in 1 BOTTLE, PLASTIC",
"NDC11Code": "69901-0522-08",
"ProductNDC": "69901-522",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Vicks Vaposteam",
"NonProprietaryName": "Camphor (synthetic)",
"DosageFormName": "LIQUID",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "19950228",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "Kaz USA, Inc",
"SubstanceName": "CAMPHOR (SYNTHETIC)",
"StrengthNumber": ".062",
"StrengthUnit": "g/mL",
"Status": "Active",
"LastUpdate": "2025-01-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19950228",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves cough associated with a cold."
},
{
"NDCCode": "62756-523-08",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (62756-523-08) ",
"NDC11Code": "62756-0523-08",
"ProductNDC": "62756-523",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Desloratadine",
"NonProprietaryName": "Desloratadine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20101124",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078359",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "DESLORATADINE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20101124",
"SamplePackage": "N",
"IndicationAndUsage": "Desloratadine is a histamine-1 (H1) receptor antagonist indicated for.",
"Description": "Desloratadine tablets are blue, circular, film-coated tablets containing 5 mg desloratadine, an antihistamine, to be administered orally. Desloratadine tablets also contain the following excipients: corn starch, microcrystalline cellulose, meglumine, pregelatinized maize starch, sodium starch glycolate and sodium stearyl fumarate, coating material consisting of hypromellose, titanium dioxide, polyethylene glycol, polysorbate 80 and FD&C Blue #2 Aluminum Lake. Desloratadine is a white to off-white powder that is slightly soluble in water, but very soluble in ethanol and propylene glycol. It has a molecular formula: C19H19ClN2 and a molecular weight of 310.8. The chemical name is 8-chloro-6,11-dihydro-11-(4-piperdinylidene)-5H-benzo[5,6]cyclohepta[1,2-b]pyridine and has the following structure."
},
{
"NDCCode": "71919-523-08",
"PackageDescription": "30 mL in 1 VIAL, GLASS (71919-523-08) ",
"NDC11Code": "71919-0523-08",
"ProductNDC": "71919-523",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Pecten",
"NonProprietaryName": "Giant Scallop",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20100203",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "GIANT SCALLOP",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/mL",
"Status": "Deprecated",
"LastUpdate": "2022-03-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20100203",
"SamplePackage": "N"
},
{
"NDCCode": "72189-523-08",
"PackageDescription": "8 TABLET in 1 BOTTLE (72189-523-08) ",
"NDC11Code": "72189-0523-08",
"ProductNDC": "72189-523",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dexamethasone",
"NonProprietaryName": "Dexamethasone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20231113",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217696",
"LabelerName": "Direct_Rx",
"SubstanceName": "DEXAMETHASONE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2026-02-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20231113",
"SamplePackage": "N",
"IndicationAndUsage": "Allergic States. Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, and serum sickness. Dermatologic Diseases. Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, and severe erythema multiforme (Stevens-Johnson syndrome). Endocrine Disorders. Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; may be used in conjunction with synthetic mineralocorticoid analogs where applicable; in infancy mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, and nonsuppurative thyroiditis. Gastrointestinal Diseases. To tide the patient over a critical period of the disease in regional enteritis and ulcerative colitis. Hematologic Disorders. Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond-Blackfan anemia), idiopathic thrombocytopenic purpura in adults, pure red cell aplasia, and selected cases of secondary thrombocytopenia. Miscellaneous. Diagnostic testing of adrenocortical hyperfunction, trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used with appropriate antituberculous chemotherapy. Neoplastic Diseases. For the palliative management of leukemias and lymphomas. Nervous System. Acute exacerbations of multiple sclerosis, cerebral edema associated with primary or metastatic brain tumor, craniotomy, or head injury. Ophthalmic Diseases. Sympathetic ophthalmia, temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical corticosteroids. Renal Diseases. To induce a diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus. Respiratory Diseases. Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. Rheumatic DisordersAs adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis, acute rheumatic carditis, ankylosing spondylitis, psoriatic arthritis, rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low- dose maintenance therapy). For the treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus.",
"Description": "Dexamethasone Tablets, USP for oral administration, are supplied in the following potencies, 0.5 mg, 0.75 mg, 1.5 mg, 2 mg, 4 mg and 6 mg. Inactive ingredients are Microcrystalline Cellulose, Lactose Anhydrous, Croscarmellose Sodium, Magnesium Stearate, FD&C Blue #1 Aluminum Lake (0.75 mg, 4 mg, 6 mg), D&C Red #27 Aluminum Lake (1.5 mg), FD&C Yellow #6 Aluminum Lake (0.5 mg), FD&C Red #40 Aluminum Lake (1.5 mg), D&C Yellow #10 Aluminum Lake (0.5 mg, 0.75 mg, 1.5 mg, 4 mg, 6 mg). The molecular weight for dexamethasone is 392.47. It is designated chemically as 9-fluoro-11β,17,21-trihydroxy-16α-methylpregna-1,4-diene-3,20-dione. The empirical formula is C22H29FO5 and the structural formula is. [structure]. Dexamethasone, a synthetic adrenocortical steroid, is a white to practically white, odorless, crystalline powder. It is stable in air. It is practically insoluble in water. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "79613-523-08",
"PackageDescription": "1 BOTTLE in 1 BOX (79613-523-08) > 236.6 mL in 1 BOTTLE",
"NDC11Code": "79613-0523-08",
"ProductNDC": "79613-523",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Simply Sanitizer Gel",
"NonProprietaryName": "Isopropyl Alcohol Gel",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200817",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "House of Chemicals, Inc",
"SubstanceName": "ISOPROPYL ALCOHOL",
"StrengthNumber": "75",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2021-01-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200817",
"SamplePackage": "N"
},
{
"NDCCode": "0006-5367-09",
"PackageDescription": "2 BOTTLE in 1 CARTON (0006-5367-09) / 7 TABLET, FILM COATED in 1 BOTTLE (0006-5367-08) ",
"NDC11Code": "00006-5367-09",
"ProductNDC": "0006-5367",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Steglujan",
"NonProprietaryName": "Ertugliflozin And Sitagliptin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20171219",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA209805",
"LabelerName": "Merck Sharp & Dohme LLC",
"SubstanceName": "ERTUGLIFLOZIN PIDOLATE; SITAGLIPTIN PHOSPHATE",
"StrengthNumber": "5; 100",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-06-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20171219",
"SamplePackage": "Y",
"IndicationAndUsage": "STEGLUJAN® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use: 1 Not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus [see Warnings and Precautions (5.1)]., 2 Has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using STEGLUJAN [see Warnings and Precautions (5.2)].",
"Description": "STEGLUJAN (ertugliflozin and sitagliptin) tablet for oral use contains ertugliflozin L-pyroglutamic acid, a SGLT2 inhibitor, and sitagliptin phosphate, a DPP-4 inhibitor. Ertugliflozin. The chemical name of ertugliflozin L-pyroglutamic acid is (1S,2S,3S,4R,5S)-5-(4-chloro-3-(4-ethoxybenzyl)phenyl)-1-(hydroxymethyl)-6,8-dioxabicyclo[3.2.1]octane-2,3,4-triol, compound with (2S)-5-oxopyrrolidine-2-carboxylic acid. The molecular formula is C27H32ClNO10 and the molecular weight is 566.00. The chemical structure is. Ertugliflozin L-pyroglutamic acid is a white to off-white powder that is soluble in ethyl alcohol and acetone, slightly soluble in ethyl acetate and acetonitrile and very slightly soluble in water. Sitagliptin. Sitagliptin phosphate monohydrate is described chemically as 7-[(3R)-3-amino-1-oxo-4-(2,4,5-trifluorophenyl)butyl]-5,6,7,8-tetrahydro-3-(trifluoromethyl)-1,2,4-triazolo[4,3-a]pyrazine phosphate (1:1) monohydrate. The empirical formula is C16H15F6N5O∙H3PO4∙H2O and the molecular weight is 523.32. The structural formula is. Sitagliptin phosphate monohydrate is a white to off-white, crystalline, non-hygroscopic powder. It is soluble in water and N,N-dimethyl formamide; slightly soluble in methanol; very slightly soluble in ethanol, acetone, and acetonitrile; and insoluble in isopropanol and isopropyl acetate. STEGLUJAN is available for oral use as film-coated tablets containing: 1 6.48 mg ertugliflozin L-pyroglutamic acid equivalent to 5 mg of ertugliflozin and 128.5 mg sitagliptin phosphate monohydrate equivalent to 100 mg sitagliptin (STEGLUJAN 5/100), 2 19.43 mg ertugliflozin L-pyroglutamic acid equivalent to 15 mg of ertugliflozin and 128.5 mg sitagliptin phosphate monohydrate equivalent to 100 mg sitagliptin (STEGLUJAN 15/100)."
},
{
"NDCCode": "0006-5368-09",
"PackageDescription": "2 BOTTLE in 1 CARTON (0006-5368-09) / 7 TABLET, FILM COATED in 1 BOTTLE (0006-5368-08) ",
"NDC11Code": "00006-5368-09",
"ProductNDC": "0006-5368",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Steglujan",
"NonProprietaryName": "Ertugliflozin And Sitagliptin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20171219",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA209805",
"LabelerName": "Merck Sharp & Dohme LLC",
"SubstanceName": "ERTUGLIFLOZIN PIDOLATE; SITAGLIPTIN PHOSPHATE",
"StrengthNumber": "15; 100",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-06-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20171219",
"SamplePackage": "Y",
"IndicationAndUsage": "STEGLUJAN® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use: 1 Not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus [see Warnings and Precautions (5.1)]., 2 Has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using STEGLUJAN [see Warnings and Precautions (5.2)].",
"Description": "STEGLUJAN (ertugliflozin and sitagliptin) tablet for oral use contains ertugliflozin L-pyroglutamic acid, a SGLT2 inhibitor, and sitagliptin phosphate, a DPP-4 inhibitor. Ertugliflozin. The chemical name of ertugliflozin L-pyroglutamic acid is (1S,2S,3S,4R,5S)-5-(4-chloro-3-(4-ethoxybenzyl)phenyl)-1-(hydroxymethyl)-6,8-dioxabicyclo[3.2.1]octane-2,3,4-triol, compound with (2S)-5-oxopyrrolidine-2-carboxylic acid. The molecular formula is C27H32ClNO10 and the molecular weight is 566.00. The chemical structure is. Ertugliflozin L-pyroglutamic acid is a white to off-white powder that is soluble in ethyl alcohol and acetone, slightly soluble in ethyl acetate and acetonitrile and very slightly soluble in water. Sitagliptin. Sitagliptin phosphate monohydrate is described chemically as 7-[(3R)-3-amino-1-oxo-4-(2,4,5-trifluorophenyl)butyl]-5,6,7,8-tetrahydro-3-(trifluoromethyl)-1,2,4-triazolo[4,3-a]pyrazine phosphate (1:1) monohydrate. The empirical formula is C16H15F6N5O∙H3PO4∙H2O and the molecular weight is 523.32. The structural formula is. Sitagliptin phosphate monohydrate is a white to off-white, crystalline, non-hygroscopic powder. It is soluble in water and N,N-dimethyl formamide; slightly soluble in methanol; very slightly soluble in ethanol, acetone, and acetonitrile; and insoluble in isopropanol and isopropyl acetate. STEGLUJAN is available for oral use as film-coated tablets containing: 1 6.48 mg ertugliflozin L-pyroglutamic acid equivalent to 5 mg of ertugliflozin and 128.5 mg sitagliptin phosphate monohydrate equivalent to 100 mg sitagliptin (STEGLUJAN 5/100), 2 19.43 mg ertugliflozin L-pyroglutamic acid equivalent to 15 mg of ertugliflozin and 128.5 mg sitagliptin phosphate monohydrate equivalent to 100 mg sitagliptin (STEGLUJAN 15/100)."
},
{
"NDCCode": "16714-523-01",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (16714-523-01) ",
"NDC11Code": "16714-0523-01",
"ProductNDC": "16714-523",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diltiazem Hydrochloride",
"NonProprietaryName": "Diltiazem Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20220222",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074943",
"LabelerName": "NORTHSTAR RX LLC",
"SubstanceName": "DILTIAZEM HYDROCHLORIDE",
"StrengthNumber": "120",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220222",
"SamplePackage": "N",
"IndicationAndUsage": "Diltiazem Hydrochloride Extended-Release Capsules, USP (Once-a-day dosage) are indicated for the treatment of hypertension. Diltiazem hydrochloride may be used alone or in combination with other antihypertensive medications, such as diuretics. Diltiazem Hydrochloride Extended-Release Capsules, USP (Once-a-day dosage) are indicated for the management of chronic stable angina.",
"Description": "Diltiazem hydrochloride is a calcium ion influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)one, 3-(acetyloxy)-5-[2-(dimethylamino)ethyl]-2,3-dihydro-2-(4-methoxyphenyl) monohydrochloride, (+)-cis-. Its molecular formula is C22H26N2O4S HCl and its molecular weight is 450.99. Its structural formula is as follows. Diltiazem hydrochloride is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol and chloroform. Diltiazem Hydrochloride Extended-Release Capsules, USP (Once-a-day dosage) complies with USP Drug Release Test #2. Diltiazem Hydrochloride Extended-Release Capsules, USP (Once-a-day dosage) contain multiple units of diltiazem HCI extended-release 60 mg, resulting in 120 mg, 180 mg, or 240 mg dosage strengths allowing for the controlled release of diltiazem HCI over a 24-hour period."
},
{
"NDCCode": "16714-523-02",
"PackageDescription": "500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (16714-523-02) ",
"NDC11Code": "16714-0523-02",
"ProductNDC": "16714-523",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diltiazem Hydrochloride",
"NonProprietaryName": "Diltiazem Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20220222",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074943",
"LabelerName": "NORTHSTAR RX LLC",
"SubstanceName": "DILTIAZEM HYDROCHLORIDE",
"StrengthNumber": "120",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220222",
"SamplePackage": "N",
"IndicationAndUsage": "Diltiazem Hydrochloride Extended-Release Capsules, USP (Once-a-day dosage) are indicated for the treatment of hypertension. Diltiazem hydrochloride may be used alone or in combination with other antihypertensive medications, such as diuretics. Diltiazem Hydrochloride Extended-Release Capsules, USP (Once-a-day dosage) are indicated for the management of chronic stable angina.",
"Description": "Diltiazem hydrochloride is a calcium ion influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)one, 3-(acetyloxy)-5-[2-(dimethylamino)ethyl]-2,3-dihydro-2-(4-methoxyphenyl) monohydrochloride, (+)-cis-. Its molecular formula is C22H26N2O4S HCl and its molecular weight is 450.99. Its structural formula is as follows. Diltiazem hydrochloride is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol and chloroform. Diltiazem Hydrochloride Extended-Release Capsules, USP (Once-a-day dosage) complies with USP Drug Release Test #2. Diltiazem Hydrochloride Extended-Release Capsules, USP (Once-a-day dosage) contain multiple units of diltiazem HCI extended-release 60 mg, resulting in 120 mg, 180 mg, or 240 mg dosage strengths allowing for the controlled release of diltiazem HCI over a 24-hour period."
},
{
"NDCCode": "55154-5040-8",
"PackageDescription": "2340 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55154-5040-8) ",
"NDC11Code": "55154-5040-08",
"ProductNDC": "55154-5040",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Januvia",
"NonProprietaryName": "Sitagliptin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20061016",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021995",
"LabelerName": "Cardinal Health 107, LLC",
"SubstanceName": "SITAGLIPTIN PHOSPHATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-11-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20061016",
"SamplePackage": "N",
"IndicationAndUsage": "JANUVIA® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.",
"Description": "JANUVIA Tablets contain sitagliptin phosphate, an orally-active inhibitor of the dipeptidyl peptidase-4 (DPP-4) enzyme. Sitagliptin phosphate monohydrate is described chemically as 7-[(3R)-3-amino-1-oxo-4-(2,4,5-trifluorophenyl)butyl]-5,6,7,8-tetrahydro-3-(trifluoromethyl)-1,2,4-triazolo[4,3-a]pyrazine phosphate (1:1) monohydrate. The empirical formula is C16H15F6N5OH3PO4H2O and the molecular weight is 523.32. The structural formula is:. Sitagliptin phosphate monohydrate is a white to off-white, crystalline, non-hygroscopic powder. It is soluble in water and N,N-dimethyl formamide; slightly soluble in methanol; very slightly soluble in ethanol, acetone, and acetonitrile; and insoluble in isopropanol and isopropyl acetate. Each film-coated tablet of JANUVIA contains 32.13, 64.25, or 128.5 mg of sitagliptin phosphate monohydrate, which is equivalent to 25, 50, or 100 mg, respectively, of free base and the following inactive ingredients: microcrystalline cellulose, anhydrous dibasic calcium phosphate, croscarmellose sodium, magnesium stearate, sodium stearyl fumarate, and propyl gallate. In addition, the film coating contains the following inactive ingredients: polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, red iron oxide, and yellow iron oxide."
},
{
"NDCCode": "55154-5042-8",
"PackageDescription": "1350 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55154-5042-8) ",
"NDC11Code": "55154-5042-08",
"ProductNDC": "55154-5042",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Januvia",
"NonProprietaryName": "Sitagliptin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20061016",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021995",
"LabelerName": "Cardinal Health 107, LLC",
"SubstanceName": "SITAGLIPTIN PHOSPHATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-11-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20061016",
"SamplePackage": "N",
"IndicationAndUsage": "JANUVIA® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.",
"Description": "JANUVIA Tablets contain sitagliptin phosphate, an orally-active inhibitor of the dipeptidyl peptidase-4 (DPP-4) enzyme. Sitagliptin phosphate monohydrate is described chemically as 7-[(3R)-3-amino-1-oxo-4-(2,4,5-trifluorophenyl)butyl]-5,6,7,8-tetrahydro-3-(trifluoromethyl)-1,2,4-triazolo[4,3-a]pyrazine phosphate (1:1) monohydrate. The empirical formula is C16H15F6N5OH3PO4H2O and the molecular weight is 523.32. The structural formula is:. Sitagliptin phosphate monohydrate is a white to off-white, crystalline, non-hygroscopic powder. It is soluble in water and N,N-dimethyl formamide; slightly soluble in methanol; very slightly soluble in ethanol, acetone, and acetonitrile; and insoluble in isopropanol and isopropyl acetate. Each film-coated tablet of JANUVIA contains 32.13, 64.25, or 128.5 mg of sitagliptin phosphate monohydrate, which is equivalent to 25, 50, or 100 mg, respectively, of free base and the following inactive ingredients: microcrystalline cellulose, anhydrous dibasic calcium phosphate, croscarmellose sodium, magnesium stearate, sodium stearyl fumarate, and propyl gallate. In addition, the film coating contains the following inactive ingredients: polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, red iron oxide, and yellow iron oxide."
},
{
"NDCCode": "55533-523-01",
"PackageDescription": "473 mL in 1 BOTTLE, PLASTIC (55533-523-01) ",
"NDC11Code": "55533-0523-01",
"ProductNDC": "55533-523",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Alcohol Antiseptic 80% Topical Solution",
"NonProprietaryName": "Alcohol",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200515",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "NCH Corporation",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "80",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-08-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20200515",
"SamplePackage": "N"
},
{
"NDCCode": "60923-523-32",
"PackageDescription": "1 KIT in 1 CARTON (60923-523-32) * 10 mL in 1 VIAL, SINGLE-USE (60923-562-01) * 32 POUCH in 1 BOX / 1 SWAB in 1 POUCH",
"NDC11Code": "60923-0523-32",
"ProductNDC": "60923-523",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Elevidys",
"NonProprietaryName": "Delandistrogene Moxeparvovec-rokl",
"DosageFormName": "KIT",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20230622",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125781",
"LabelerName": "Sarepta Therapeutics, Inc.",
"Status": "Active",
"LastUpdate": "2026-08-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230622",
"SamplePackage": "N",
"IndicationAndUsage": "ELEVIDYS is indicated for the treatment of patients 4 years of age and older with Duchenne muscular dystrophy (DMD), who are ambulatory and have a confirmed mutation in the DMD gene [see Clinical Pharmacology (12.2), Clinical Studies (14)].",
"Description": "ELEVIDYS (delandistrogene moxeparvovec-rokl) is a recombinant gene therapy designed to deliver the gene encoding the ELEVIDYS micro-dystrophin protein. ELEVIDYS is a non-replicating, recombinant, adeno-associated virus serotype rh74 (AAVrh74) based vector containing the ELEVIDYS micro-dystrophin transgene under the control of the MHCK7 promoter. The genome within the ELEVIDYS AAVrh74 vector contains no viral genes and consequently is incapable of replication or reversion to a replicating form. The micro-dystrophin protein expressed by ELEVIDYS is a shortened version (138 kDa, compared to 427 kDa size of dystrophin expressed in normal muscle cells) that contains selected domains of dystrophin expressed in normal muscle cells. ELEVIDYS is a preservative-free, sterile, clear, colorless liquid that may have some opalescence and may contain white to off-white particles. ELEVIDYS is a suspension for intravenous infusion with a nominal concentration of 1.33 ×1013 vg/mL and supplied in a single-dose 10 mL vial. Each vial contains an extractable volume of 10 mL and the following excipients: 200mM sodium chloride, 13 mM tromethamine HCl, 7 mM tromethamine, 1mM magnesium chloride, 0.001% poloxamer 188, with a pH of 8.0 ± 0.3."
},
{
"NDCCode": "62559-523-01",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62559-523-01) ",
"NDC11Code": "62559-0523-01",
"ProductNDC": "62559-523",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Inderal",
"ProprietaryNameSuffix": "La",
"NonProprietaryName": "Propranolol Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20170428",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018553",
"LabelerName": "ANI Pharmaceuticals, Inc.",
"SubstanceName": "PROPRANOLOL HYDROCHLORIDE",
"StrengthNumber": "160",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170428",
"SamplePackage": "N",
"IndicationAndUsage": "Inderal LA is indicated in the management of hypertension. It may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Inderal LA is not indicated in the management of hypertensive emergencies.",
"Description": "Inderal® LA (propranolol hydrochloride) is a synthetic beta-adrenergic receptor-blocking agent chemically described as 2-Propanol, 1-[(1-methylethyl)amino]-3-(1-naphthalenyloxy)-, hydrochloride,(±)-. Its molecular and structural formulae are. C16H21NO2 · HCl. Propranolol hydrochloride USP is a stable, white, crystalline solid which is readily soluble in water and ethanol. Its molecular weight is 295.80. Inderal LA is formulated to provide a sustained release of propranolol hydrochloride USP. Inderal LA is available as 60 mg, 80 mg, 120 mg, and 160 mg capsules for oral administration. : 1 Each Inderal LA 60 mg capsule contains 60 mg propranolol hydrochloride USP (equivalent to 52.60 mg of propranolol)., 2 Each Inderal LA 80 mg capsule contains 80 mg propranolol hydrochloride USP (equivalent to 70.14 mg of propranolol)., 3 Each Inderal LA 120 mg capsule contains 120 mg propranolol hydrochloride USP (equivalent to 105.21 mg of propranolol)., 4 Each Inderal LA 160 mg capsule contains 160 mg propranolol hydrochloride USP (equivalent to 140.28 mg of propranolol)."
},
{
"NDCCode": "62559-523-30",
"PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62559-523-30) ",
"NDC11Code": "62559-0523-30",
"ProductNDC": "62559-523",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Inderal",
"ProprietaryNameSuffix": "La",
"NonProprietaryName": "Propranolol Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20170428",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018553",
"LabelerName": "ANI Pharmaceuticals, Inc.",
"SubstanceName": "PROPRANOLOL HYDROCHLORIDE",
"StrengthNumber": "160",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240805",
"SamplePackage": "N",
"IndicationAndUsage": "Inderal LA is indicated in the management of hypertension. It may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Inderal LA is not indicated in the management of hypertensive emergencies.",
"Description": "Inderal® LA (propranolol hydrochloride) is a synthetic beta-adrenergic receptor-blocking agent chemically described as 2-Propanol, 1-[(1-methylethyl)amino]-3-(1-naphthalenyloxy)-, hydrochloride,(±)-. Its molecular and structural formulae are. C16H21NO2 · HCl. Propranolol hydrochloride USP is a stable, white, crystalline solid which is readily soluble in water and ethanol. Its molecular weight is 295.80. Inderal LA is formulated to provide a sustained release of propranolol hydrochloride USP. Inderal LA is available as 60 mg, 80 mg, 120 mg, and 160 mg capsules for oral administration. : 1 Each Inderal LA 60 mg capsule contains 60 mg propranolol hydrochloride USP (equivalent to 52.60 mg of propranolol)., 2 Each Inderal LA 80 mg capsule contains 80 mg propranolol hydrochloride USP (equivalent to 70.14 mg of propranolol)., 3 Each Inderal LA 120 mg capsule contains 120 mg propranolol hydrochloride USP (equivalent to 105.21 mg of propranolol)., 4 Each Inderal LA 160 mg capsule contains 160 mg propranolol hydrochloride USP (equivalent to 140.28 mg of propranolol)."
},
{
"NDCCode": "63187-523-15",
"PackageDescription": "15 mL in 1 BOTTLE, DROPPER (63187-523-15)",
"NDC11Code": "63187-0523-15",
"ProductNDC": "63187-523",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acella Antipyrine And Benzocaine Otic",
"NonProprietaryName": "Antipyrine, Benzocaine",
"DosageFormName": "SOLUTION",
"RouteName": "AURICULAR (OTIC)",
"StartMarketingDate": "20101109",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "ANTIPYRINE; BENZOCAINE",
"StrengthNumber": "54; 14",
"StrengthUnit": "mg/mL; mg/mL",
"Pharm_Classes": "Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2016-01-08"
},
{
"NDCCode": "63776-523-11",
"PackageDescription": ".5 mL in 1 AMPULE (63776-523-11) ",
"NDC11Code": "63776-0523-11",
"ProductNDC": "63776-523",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Viatrexx-tone",
"NonProprietaryName": "Calcarea Fluorica, Centella Asiatica, Copper, Embryo, Fumaric Acid, Funiculus, Graphites, Hamamelis, Kalium Aspariticum, Muscle, Natrum Oxalaceticum, Natrum Pyruvicum, Placenta, Plasma, Quinhydrone, Silicea, Succinic Acid, Vitamin B5, Zinc",
"DosageFormName": "SPRAY",
"RouteName": "ORAL; TOPICAL",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "BEEF; BOS TAURUS PLACENTA; BOS TAURUS UMBILICAL CORD; CALCIUM FLUORIDE; CENTELLA ASIATICA; COPPER; FUMARIC ACID; GRAPHITE; HUMAN EMBRYO TISSUE; HUMAN PLACENTAL TISSUE; HUMAN PLASMA; PANTOTHENIC ACID; PORK; POTASSIUM ASPARTATE; QUINHYDRONE; SILICON DIOXIDE; SODIUM DIETHYL OXALACETATE; SODIUM PYRUVATE; SUCCINIC ACID; SUS SCROFA EMBRYO; SUS SCROFA PLACENTA; SUS SCROFA UMBILICAL CORD; WITCH HAZEL; ZINC",
"StrengthNumber": "200; 30; 200; 30; 30; 30; 30; 30; 30; 30; 30; 30; 200; 30; 30; 30; 30; 30; 30; 30; 30; 200; 30; 30",
"StrengthUnit": "[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Depigmenting Activity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Inhibit Ovum Fertilization [PE], Meat Proteins [EXT], Meat Proteins [EXT], Melanin Synthesis Inhibitor [EPC], Melanin Synthesis Inhibitors [MoA], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20210419",
"SamplePackage": "N",
"IndicationAndUsage": "Soft tissue regeneration.",
"Description": "Viatrexx-Tone is a homeopathic product composed of physiological (low dose and low low dose) natural micro nutrients. These nano particles are designed to nourish the system."
},
{
"NDCCode": "63776-523-14",
"PackageDescription": "1 BOTTLE, SPRAY in 1 BOX (63776-523-14) > 30 mL in 1 BOTTLE, SPRAY",
"NDC11Code": "63776-0523-14",
"ProductNDC": "63776-523",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Viatrexx-tone",
"NonProprietaryName": "Calcarea Fluorica, Centella Asiatica, Copper, Embryo, Fumaric Acid, Funiculus, Graphites, Hamamelis, Kalium Aspariticum, Muscle, Natrum Oxalaceticum, Natrum Pyruvicum, Placenta, Plasma, Quinhydrone, Silicea, Succinic Acid, Vitamin B5, Zinc",
"DosageFormName": "SPRAY",
"RouteName": "ORAL; TOPICAL",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "BEEF; BOS TAURUS PLACENTA; BOS TAURUS UMBILICAL CORD; CALCIUM FLUORIDE; CENTELLA ASIATICA; COPPER; FUMARIC ACID; GRAPHITE; HUMAN EMBRYO TISSUE; HUMAN PLACENTAL TISSUE; HUMAN PLASMA; PANTOTHENIC ACID; PORK; POTASSIUM ASPARTATE; QUINHYDRONE; SILICON DIOXIDE; SODIUM DIETHYL OXALACETATE; SODIUM PYRUVATE; SUCCINIC ACID; SUS SCROFA EMBRYO; SUS SCROFA PLACENTA; SUS SCROFA UMBILICAL CORD; WITCH HAZEL; ZINC",
"StrengthNumber": "200; 30; 200; 30; 30; 30; 30; 30; 30; 30; 30; 30; 200; 30; 30; 30; 30; 30; 30; 30; 30; 200; 30; 30",
"StrengthUnit": "[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Depigmenting Activity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Inhibit Ovum Fertilization [PE], Meat Proteins [EXT], Meat Proteins [EXT], Melanin Synthesis Inhibitor [EPC], Melanin Synthesis Inhibitors [MoA], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20190718",
"SamplePackage": "N",
"IndicationAndUsage": "Soft tissue regeneration.",
"Description": "Viatrexx-Tone is a homeopathic product composed of physiological (low dose and low low dose) natural micro nutrients. These nano particles are designed to nourish the system."
},
{
"NDCCode": "63776-523-15",
"PackageDescription": "50 mL in 1 BOTTLE (63776-523-15) ",
"NDC11Code": "63776-0523-15",
"ProductNDC": "63776-523",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Viatrexx-tone",
"NonProprietaryName": "Calcarea Fluorica, Centella Asiatica, Copper, Embryo, Fumaric Acid, Funiculus, Graphites, Hamamelis, Kalium Aspariticum, Muscle, Natrum Oxalaceticum, Natrum Pyruvicum, Placenta, Plasma, Quinhydrone, Silicea, Succinic Acid, Vitamin B5, Zinc",
"DosageFormName": "SPRAY",
"RouteName": "ORAL; TOPICAL",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "BEEF; BOS TAURUS PLACENTA; BOS TAURUS UMBILICAL CORD; CALCIUM FLUORIDE; CENTELLA ASIATICA; COPPER; FUMARIC ACID; GRAPHITE; HUMAN EMBRYO TISSUE; HUMAN PLACENTAL TISSUE; HUMAN PLASMA; PANTOTHENIC ACID; PORK; POTASSIUM ASPARTATE; QUINHYDRONE; SILICON DIOXIDE; SODIUM DIETHYL OXALACETATE; SODIUM PYRUVATE; SUCCINIC ACID; SUS SCROFA EMBRYO; SUS SCROFA PLACENTA; SUS SCROFA UMBILICAL CORD; WITCH HAZEL; ZINC",
"StrengthNumber": "200; 30; 200; 30; 30; 30; 30; 30; 30; 30; 30; 30; 200; 30; 30; 30; 30; 30; 30; 30; 30; 200; 30; 30",
"StrengthUnit": "[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Depigmenting Activity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Inhibit Ovum Fertilization [PE], Meat Proteins [EXT], Meat Proteins [EXT], Melanin Synthesis Inhibitor [EPC], Melanin Synthesis Inhibitors [MoA], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20190718",
"SamplePackage": "N",
"IndicationAndUsage": "Soft tissue regeneration.",
"Description": "Viatrexx-Tone is a homeopathic product composed of physiological (low dose and low low dose) natural micro nutrients. These nano particles are designed to nourish the system."
},
{
"NDCCode": "63776-523-16",
"PackageDescription": "100 mL in 1 BOTTLE (63776-523-16) ",
"NDC11Code": "63776-0523-16",
"ProductNDC": "63776-523",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Viatrexx-tone",
"NonProprietaryName": "Calcarea Fluorica, Centella Asiatica, Copper, Embryo, Fumaric Acid, Funiculus, Graphites, Hamamelis, Kalium Aspariticum, Muscle, Natrum Oxalaceticum, Natrum Pyruvicum, Placenta, Plasma, Quinhydrone, Silicea, Succinic Acid, Vitamin B5, Zinc",
"DosageFormName": "SPRAY",
"RouteName": "ORAL; TOPICAL",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "BEEF; BOS TAURUS PLACENTA; BOS TAURUS UMBILICAL CORD; CALCIUM FLUORIDE; CENTELLA ASIATICA; COPPER; FUMARIC ACID; GRAPHITE; HUMAN EMBRYO TISSUE; HUMAN PLACENTAL TISSUE; HUMAN PLASMA; PANTOTHENIC ACID; PORK; POTASSIUM ASPARTATE; QUINHYDRONE; SILICON DIOXIDE; SODIUM DIETHYL OXALACETATE; SODIUM PYRUVATE; SUCCINIC ACID; SUS SCROFA EMBRYO; SUS SCROFA PLACENTA; SUS SCROFA UMBILICAL CORD; WITCH HAZEL; ZINC",
"StrengthNumber": "200; 30; 200; 30; 30; 30; 30; 30; 30; 30; 30; 30; 200; 30; 30; 30; 30; 30; 30; 30; 30; 200; 30; 30",
"StrengthUnit": "[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Depigmenting Activity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Inhibit Ovum Fertilization [PE], Meat Proteins [EXT], Meat Proteins [EXT], Melanin Synthesis Inhibitor [EPC], Melanin Synthesis Inhibitors [MoA], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20210419",
"SamplePackage": "N",
"IndicationAndUsage": "Soft tissue regeneration.",
"Description": "Viatrexx-Tone is a homeopathic product composed of physiological (low dose and low low dose) natural micro nutrients. These nano particles are designed to nourish the system."
},
{
"NDCCode": "63776-523-17",
"PackageDescription": "250 mL in 1 BOTTLE (63776-523-17) ",
"NDC11Code": "63776-0523-17",
"ProductNDC": "63776-523",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Viatrexx-tone",
"NonProprietaryName": "Calcarea Fluorica, Centella Asiatica, Copper, Embryo, Fumaric Acid, Funiculus, Graphites, Hamamelis, Kalium Aspariticum, Muscle, Natrum Oxalaceticum, Natrum Pyruvicum, Placenta, Plasma, Quinhydrone, Silicea, Succinic Acid, Vitamin B5, Zinc",
"DosageFormName": "SPRAY",
"RouteName": "ORAL; TOPICAL",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "BEEF; BOS TAURUS PLACENTA; BOS TAURUS UMBILICAL CORD; CALCIUM FLUORIDE; CENTELLA ASIATICA; COPPER; FUMARIC ACID; GRAPHITE; HUMAN EMBRYO TISSUE; HUMAN PLACENTAL TISSUE; HUMAN PLASMA; PANTOTHENIC ACID; PORK; POTASSIUM ASPARTATE; QUINHYDRONE; SILICON DIOXIDE; SODIUM DIETHYL OXALACETATE; SODIUM PYRUVATE; SUCCINIC ACID; SUS SCROFA EMBRYO; SUS SCROFA PLACENTA; SUS SCROFA UMBILICAL CORD; WITCH HAZEL; ZINC",
"StrengthNumber": "200; 30; 200; 30; 30; 30; 30; 30; 30; 30; 30; 30; 200; 30; 30; 30; 30; 30; 30; 30; 30; 200; 30; 30",
"StrengthUnit": "[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL",
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"Status": "Deprecated",
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},
{
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"Description": "Viatrexx-Tone is a homeopathic product composed of physiological (low dose and low low dose) natural micro nutrients. These nano particles are designed to nourish the system."
},
{
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{
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"ProductTypeName": "HUMAN OTC DRUG",
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"LabelerName": "KENDO HOLDINGS INC.",
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{
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"DosageFormName": "TABLET, FILM COATED",
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"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
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{
"NDCCode": "71610-523-53",
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<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100203</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>72189-523-08</NDCCode>
<PackageDescription>8 TABLET in 1 BOTTLE (72189-523-08) </PackageDescription>
<NDC11Code>72189-0523-08</NDC11Code>
<ProductNDC>72189-523</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dexamethasone</ProprietaryName>
<NonProprietaryName>Dexamethasone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20231113</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217696</ApplicationNumber>
<LabelerName>Direct_Rx</LabelerName>
<SubstanceName>DEXAMETHASONE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231113</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Allergic States. Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, and serum sickness. Dermatologic Diseases. Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, and severe erythema multiforme (Stevens-Johnson syndrome). Endocrine Disorders. Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; may be used in conjunction with synthetic mineralocorticoid analogs where applicable; in infancy mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, and nonsuppurative thyroiditis. Gastrointestinal Diseases. To tide the patient over a critical period of the disease in regional enteritis and ulcerative colitis. Hematologic Disorders. Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond-Blackfan anemia), idiopathic thrombocytopenic purpura in adults, pure red cell aplasia, and selected cases of secondary thrombocytopenia. Miscellaneous. Diagnostic testing of adrenocortical hyperfunction, trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used with appropriate antituberculous chemotherapy. Neoplastic Diseases. For the palliative management of leukemias and lymphomas. Nervous System. Acute exacerbations of multiple sclerosis, cerebral edema associated with primary or metastatic brain tumor, craniotomy, or head injury. Ophthalmic Diseases. Sympathetic ophthalmia, temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical corticosteroids. Renal Diseases. To induce a diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus. Respiratory Diseases. Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. Rheumatic DisordersAs adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis, acute rheumatic carditis, ankylosing spondylitis, psoriatic arthritis, rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low- dose maintenance therapy). For the treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus.</IndicationAndUsage>
<Description>Dexamethasone Tablets, USP for oral administration, are supplied in the following potencies, 0.5 mg, 0.75 mg, 1.5 mg, 2 mg, 4 mg and 6 mg. Inactive ingredients are Microcrystalline Cellulose, Lactose Anhydrous, Croscarmellose Sodium, Magnesium Stearate, FD&C Blue #1 Aluminum Lake (0.75 mg, 4 mg, 6 mg), D&C Red #27 Aluminum Lake (1.5 mg), FD&C Yellow #6 Aluminum Lake (0.5 mg), FD&C Red #40 Aluminum Lake (1.5 mg), D&C Yellow #10 Aluminum Lake (0.5 mg, 0.75 mg, 1.5 mg, 4 mg, 6 mg). The molecular weight for dexamethasone is 392.47. It is designated chemically as 9-fluoro-11β,17,21-trihydroxy-16α-methylpregna-1,4-diene-3,20-dione. The empirical formula is C22H29FO5 and the structural formula is. [structure]. Dexamethasone, a synthetic adrenocortical steroid, is a white to practically white, odorless, crystalline powder. It is stable in air. It is practically insoluble in water. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>79613-523-08</NDCCode>
<PackageDescription>1 BOTTLE in 1 BOX (79613-523-08) > 236.6 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>79613-0523-08</NDC11Code>
<ProductNDC>79613-523</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Simply Sanitizer Gel</ProprietaryName>
<NonProprietaryName>Isopropyl Alcohol Gel</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200817</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>House of Chemicals, Inc</LabelerName>
<SubstanceName>ISOPROPYL ALCOHOL</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-01-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200817</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<NDC>
<NDCCode>0006-5367-09</NDCCode>
<PackageDescription>2 BOTTLE in 1 CARTON (0006-5367-09) / 7 TABLET, FILM COATED in 1 BOTTLE (0006-5367-08) </PackageDescription>
<NDC11Code>00006-5367-09</NDC11Code>
<ProductNDC>0006-5367</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Steglujan</ProprietaryName>
<NonProprietaryName>Ertugliflozin And Sitagliptin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20171219</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA209805</ApplicationNumber>
<LabelerName>Merck Sharp & Dohme LLC</LabelerName>
<SubstanceName>ERTUGLIFLOZIN PIDOLATE; SITAGLIPTIN PHOSPHATE</SubstanceName>
<StrengthNumber>5; 100</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171219</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>STEGLUJAN® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use: 1 Not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus [see Warnings and Precautions (5.1)]., 2 Has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using STEGLUJAN [see Warnings and Precautions (5.2)].</IndicationAndUsage>
<Description>STEGLUJAN (ertugliflozin and sitagliptin) tablet for oral use contains ertugliflozin L-pyroglutamic acid, a SGLT2 inhibitor, and sitagliptin phosphate, a DPP-4 inhibitor. Ertugliflozin. The chemical name of ertugliflozin L-pyroglutamic acid is (1S,2S,3S,4R,5S)-5-(4-chloro-3-(4-ethoxybenzyl)phenyl)-1-(hydroxymethyl)-6,8-dioxabicyclo[3.2.1]octane-2,3,4-triol, compound with (2S)-5-oxopyrrolidine-2-carboxylic acid. The molecular formula is C27H32ClNO10 and the molecular weight is 566.00. The chemical structure is. Ertugliflozin L-pyroglutamic acid is a white to off-white powder that is soluble in ethyl alcohol and acetone, slightly soluble in ethyl acetate and acetonitrile and very slightly soluble in water. Sitagliptin. Sitagliptin phosphate monohydrate is described chemically as 7-[(3R)-3-amino-1-oxo-4-(2,4,5-trifluorophenyl)butyl]-5,6,7,8-tetrahydro-3-(trifluoromethyl)-1,2,4-triazolo[4,3-a]pyrazine phosphate (1:1) monohydrate. The empirical formula is C16H15F6N5O∙H3PO4∙H2O and the molecular weight is 523.32. The structural formula is. Sitagliptin phosphate monohydrate is a white to off-white, crystalline, non-hygroscopic powder. It is soluble in water and N,N-dimethyl formamide; slightly soluble in methanol; very slightly soluble in ethanol, acetone, and acetonitrile; and insoluble in isopropanol and isopropyl acetate. STEGLUJAN is available for oral use as film-coated tablets containing: 1 6.48 mg ertugliflozin L-pyroglutamic acid equivalent to 5 mg of ertugliflozin and 128.5 mg sitagliptin phosphate monohydrate equivalent to 100 mg sitagliptin (STEGLUJAN 5/100), 2 19.43 mg ertugliflozin L-pyroglutamic acid equivalent to 15 mg of ertugliflozin and 128.5 mg sitagliptin phosphate monohydrate equivalent to 100 mg sitagliptin (STEGLUJAN 15/100).</Description>
</NDC>
<NDC>
<NDCCode>0006-5368-09</NDCCode>
<PackageDescription>2 BOTTLE in 1 CARTON (0006-5368-09) / 7 TABLET, FILM COATED in 1 BOTTLE (0006-5368-08) </PackageDescription>
<NDC11Code>00006-5368-09</NDC11Code>
<ProductNDC>0006-5368</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Steglujan</ProprietaryName>
<NonProprietaryName>Ertugliflozin And Sitagliptin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20171219</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA209805</ApplicationNumber>
<LabelerName>Merck Sharp & Dohme LLC</LabelerName>
<SubstanceName>ERTUGLIFLOZIN PIDOLATE; SITAGLIPTIN PHOSPHATE</SubstanceName>
<StrengthNumber>15; 100</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171219</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>STEGLUJAN® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use: 1 Not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus [see Warnings and Precautions (5.1)]., 2 Has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using STEGLUJAN [see Warnings and Precautions (5.2)].</IndicationAndUsage>
<Description>STEGLUJAN (ertugliflozin and sitagliptin) tablet for oral use contains ertugliflozin L-pyroglutamic acid, a SGLT2 inhibitor, and sitagliptin phosphate, a DPP-4 inhibitor. Ertugliflozin. The chemical name of ertugliflozin L-pyroglutamic acid is (1S,2S,3S,4R,5S)-5-(4-chloro-3-(4-ethoxybenzyl)phenyl)-1-(hydroxymethyl)-6,8-dioxabicyclo[3.2.1]octane-2,3,4-triol, compound with (2S)-5-oxopyrrolidine-2-carboxylic acid. The molecular formula is C27H32ClNO10 and the molecular weight is 566.00. The chemical structure is. Ertugliflozin L-pyroglutamic acid is a white to off-white powder that is soluble in ethyl alcohol and acetone, slightly soluble in ethyl acetate and acetonitrile and very slightly soluble in water. Sitagliptin. Sitagliptin phosphate monohydrate is described chemically as 7-[(3R)-3-amino-1-oxo-4-(2,4,5-trifluorophenyl)butyl]-5,6,7,8-tetrahydro-3-(trifluoromethyl)-1,2,4-triazolo[4,3-a]pyrazine phosphate (1:1) monohydrate. The empirical formula is C16H15F6N5O∙H3PO4∙H2O and the molecular weight is 523.32. The structural formula is. Sitagliptin phosphate monohydrate is a white to off-white, crystalline, non-hygroscopic powder. It is soluble in water and N,N-dimethyl formamide; slightly soluble in methanol; very slightly soluble in ethanol, acetone, and acetonitrile; and insoluble in isopropanol and isopropyl acetate. STEGLUJAN is available for oral use as film-coated tablets containing: 1 6.48 mg ertugliflozin L-pyroglutamic acid equivalent to 5 mg of ertugliflozin and 128.5 mg sitagliptin phosphate monohydrate equivalent to 100 mg sitagliptin (STEGLUJAN 5/100), 2 19.43 mg ertugliflozin L-pyroglutamic acid equivalent to 15 mg of ertugliflozin and 128.5 mg sitagliptin phosphate monohydrate equivalent to 100 mg sitagliptin (STEGLUJAN 15/100).</Description>
</NDC>
<NDC>
<NDCCode>16714-523-01</NDCCode>
<PackageDescription>100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (16714-523-01) </PackageDescription>
<NDC11Code>16714-0523-01</NDC11Code>
<ProductNDC>16714-523</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diltiazem Hydrochloride</ProprietaryName>
<NonProprietaryName>Diltiazem Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220222</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074943</ApplicationNumber>
<LabelerName>NORTHSTAR RX LLC</LabelerName>
<SubstanceName>DILTIAZEM HYDROCHLORIDE</SubstanceName>
<StrengthNumber>120</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220222</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diltiazem Hydrochloride Extended-Release Capsules, USP (Once-a-day dosage) are indicated for the treatment of hypertension. Diltiazem hydrochloride may be used alone or in combination with other antihypertensive medications, such as diuretics. Diltiazem Hydrochloride Extended-Release Capsules, USP (Once-a-day dosage) are indicated for the management of chronic stable angina.</IndicationAndUsage>
<Description>Diltiazem hydrochloride is a calcium ion influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)one, 3-(acetyloxy)-5-[2-(dimethylamino)ethyl]-2,3-dihydro-2-(4-methoxyphenyl) monohydrochloride, (+)-cis-. Its molecular formula is C22H26N2O4S HCl and its molecular weight is 450.99. Its structural formula is as follows. Diltiazem hydrochloride is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol and chloroform. Diltiazem Hydrochloride Extended-Release Capsules, USP (Once-a-day dosage) complies with USP Drug Release Test #2. Diltiazem Hydrochloride Extended-Release Capsules, USP (Once-a-day dosage) contain multiple units of diltiazem HCI extended-release 60 mg, resulting in 120 mg, 180 mg, or 240 mg dosage strengths allowing for the controlled release of diltiazem HCI over a 24-hour period.</Description>
</NDC>
<NDC>
<NDCCode>16714-523-02</NDCCode>
<PackageDescription>500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (16714-523-02) </PackageDescription>
<NDC11Code>16714-0523-02</NDC11Code>
<ProductNDC>16714-523</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diltiazem Hydrochloride</ProprietaryName>
<NonProprietaryName>Diltiazem Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220222</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074943</ApplicationNumber>
<LabelerName>NORTHSTAR RX LLC</LabelerName>
<SubstanceName>DILTIAZEM HYDROCHLORIDE</SubstanceName>
<StrengthNumber>120</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220222</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diltiazem Hydrochloride Extended-Release Capsules, USP (Once-a-day dosage) are indicated for the treatment of hypertension. Diltiazem hydrochloride may be used alone or in combination with other antihypertensive medications, such as diuretics. Diltiazem Hydrochloride Extended-Release Capsules, USP (Once-a-day dosage) are indicated for the management of chronic stable angina.</IndicationAndUsage>
<Description>Diltiazem hydrochloride is a calcium ion influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)one, 3-(acetyloxy)-5-[2-(dimethylamino)ethyl]-2,3-dihydro-2-(4-methoxyphenyl) monohydrochloride, (+)-cis-. Its molecular formula is C22H26N2O4S HCl and its molecular weight is 450.99. Its structural formula is as follows. Diltiazem hydrochloride is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol and chloroform. Diltiazem Hydrochloride Extended-Release Capsules, USP (Once-a-day dosage) complies with USP Drug Release Test #2. Diltiazem Hydrochloride Extended-Release Capsules, USP (Once-a-day dosage) contain multiple units of diltiazem HCI extended-release 60 mg, resulting in 120 mg, 180 mg, or 240 mg dosage strengths allowing for the controlled release of diltiazem HCI over a 24-hour period.</Description>
</NDC>
<NDC>
<NDCCode>55154-5040-8</NDCCode>
<PackageDescription>2340 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55154-5040-8) </PackageDescription>
<NDC11Code>55154-5040-08</NDC11Code>
<ProductNDC>55154-5040</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Januvia</ProprietaryName>
<NonProprietaryName>Sitagliptin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20061016</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021995</ApplicationNumber>
<LabelerName>Cardinal Health 107, LLC</LabelerName>
<SubstanceName>SITAGLIPTIN PHOSPHATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20061016</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>JANUVIA® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.</IndicationAndUsage>
<Description>JANUVIA Tablets contain sitagliptin phosphate, an orally-active inhibitor of the dipeptidyl peptidase-4 (DPP-4) enzyme. Sitagliptin phosphate monohydrate is described chemically as 7-[(3R)-3-amino-1-oxo-4-(2,4,5-trifluorophenyl)butyl]-5,6,7,8-tetrahydro-3-(trifluoromethyl)-1,2,4-triazolo[4,3-a]pyrazine phosphate (1:1) monohydrate. The empirical formula is C16H15F6N5OH3PO4H2O and the molecular weight is 523.32. The structural formula is:. Sitagliptin phosphate monohydrate is a white to off-white, crystalline, non-hygroscopic powder. It is soluble in water and N,N-dimethyl formamide; slightly soluble in methanol; very slightly soluble in ethanol, acetone, and acetonitrile; and insoluble in isopropanol and isopropyl acetate. Each film-coated tablet of JANUVIA contains 32.13, 64.25, or 128.5 mg of sitagliptin phosphate monohydrate, which is equivalent to 25, 50, or 100 mg, respectively, of free base and the following inactive ingredients: microcrystalline cellulose, anhydrous dibasic calcium phosphate, croscarmellose sodium, magnesium stearate, sodium stearyl fumarate, and propyl gallate. In addition, the film coating contains the following inactive ingredients: polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, red iron oxide, and yellow iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>55154-5042-8</NDCCode>
<PackageDescription>1350 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55154-5042-8) </PackageDescription>
<NDC11Code>55154-5042-08</NDC11Code>
<ProductNDC>55154-5042</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Januvia</ProprietaryName>
<NonProprietaryName>Sitagliptin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20061016</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021995</ApplicationNumber>
<LabelerName>Cardinal Health 107, LLC</LabelerName>
<SubstanceName>SITAGLIPTIN PHOSPHATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20061016</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>JANUVIA® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.</IndicationAndUsage>
<Description>JANUVIA Tablets contain sitagliptin phosphate, an orally-active inhibitor of the dipeptidyl peptidase-4 (DPP-4) enzyme. Sitagliptin phosphate monohydrate is described chemically as 7-[(3R)-3-amino-1-oxo-4-(2,4,5-trifluorophenyl)butyl]-5,6,7,8-tetrahydro-3-(trifluoromethyl)-1,2,4-triazolo[4,3-a]pyrazine phosphate (1:1) monohydrate. The empirical formula is C16H15F6N5OH3PO4H2O and the molecular weight is 523.32. The structural formula is:. Sitagliptin phosphate monohydrate is a white to off-white, crystalline, non-hygroscopic powder. It is soluble in water and N,N-dimethyl formamide; slightly soluble in methanol; very slightly soluble in ethanol, acetone, and acetonitrile; and insoluble in isopropanol and isopropyl acetate. Each film-coated tablet of JANUVIA contains 32.13, 64.25, or 128.5 mg of sitagliptin phosphate monohydrate, which is equivalent to 25, 50, or 100 mg, respectively, of free base and the following inactive ingredients: microcrystalline cellulose, anhydrous dibasic calcium phosphate, croscarmellose sodium, magnesium stearate, sodium stearyl fumarate, and propyl gallate. In addition, the film coating contains the following inactive ingredients: polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, red iron oxide, and yellow iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>55533-523-01</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE, PLASTIC (55533-523-01) </PackageDescription>
<NDC11Code>55533-0523-01</NDC11Code>
<ProductNDC>55533-523</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Alcohol Antiseptic 80% Topical Solution</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200515</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>NCH Corporation</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-08-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200515</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>60923-523-32</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (60923-523-32) * 10 mL in 1 VIAL, SINGLE-USE (60923-562-01) * 32 POUCH in 1 BOX / 1 SWAB in 1 POUCH</PackageDescription>
<NDC11Code>60923-0523-32</NDC11Code>
<ProductNDC>60923-523</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Elevidys</ProprietaryName>
<NonProprietaryName>Delandistrogene Moxeparvovec-rokl</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20230622</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125781</ApplicationNumber>
<LabelerName>Sarepta Therapeutics, Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-08-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230622</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ELEVIDYS is indicated for the treatment of patients 4 years of age and older with Duchenne muscular dystrophy (DMD), who are ambulatory and have a confirmed mutation in the DMD gene [see Clinical Pharmacology (12.2), Clinical Studies (14)].</IndicationAndUsage>
<Description>ELEVIDYS (delandistrogene moxeparvovec-rokl) is a recombinant gene therapy designed to deliver the gene encoding the ELEVIDYS micro-dystrophin protein. ELEVIDYS is a non-replicating, recombinant, adeno-associated virus serotype rh74 (AAVrh74) based vector containing the ELEVIDYS micro-dystrophin transgene under the control of the MHCK7 promoter. The genome within the ELEVIDYS AAVrh74 vector contains no viral genes and consequently is incapable of replication or reversion to a replicating form. The micro-dystrophin protein expressed by ELEVIDYS is a shortened version (138 kDa, compared to 427 kDa size of dystrophin expressed in normal muscle cells) that contains selected domains of dystrophin expressed in normal muscle cells. ELEVIDYS is a preservative-free, sterile, clear, colorless liquid that may have some opalescence and may contain white to off-white particles. ELEVIDYS is a suspension for intravenous infusion with a nominal concentration of 1.33 ×1013 vg/mL and supplied in a single-dose 10 mL vial. Each vial contains an extractable volume of 10 mL and the following excipients: 200mM sodium chloride, 13 mM tromethamine HCl, 7 mM tromethamine, 1mM magnesium chloride, 0.001% poloxamer 188, with a pH of 8.0 ± 0.3.</Description>
</NDC>
<NDC>
<NDCCode>62559-523-01</NDCCode>
<PackageDescription>100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62559-523-01) </PackageDescription>
<NDC11Code>62559-0523-01</NDC11Code>
<ProductNDC>62559-523</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Inderal</ProprietaryName>
<ProprietaryNameSuffix>La</ProprietaryNameSuffix>
<NonProprietaryName>Propranolol Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170428</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018553</ApplicationNumber>
<LabelerName>ANI Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>PROPRANOLOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>160</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170428</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Inderal LA is indicated in the management of hypertension. It may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Inderal LA is not indicated in the management of hypertensive emergencies.</IndicationAndUsage>
<Description>Inderal® LA (propranolol hydrochloride) is a synthetic beta-adrenergic receptor-blocking agent chemically described as 2-Propanol, 1-[(1-methylethyl)amino]-3-(1-naphthalenyloxy)-, hydrochloride,(±)-. Its molecular and structural formulae are. C16H21NO2 · HCl. Propranolol hydrochloride USP is a stable, white, crystalline solid which is readily soluble in water and ethanol. Its molecular weight is 295.80. Inderal LA is formulated to provide a sustained release of propranolol hydrochloride USP. Inderal LA is available as 60 mg, 80 mg, 120 mg, and 160 mg capsules for oral administration. : 1 Each Inderal LA 60 mg capsule contains 60 mg propranolol hydrochloride USP (equivalent to 52.60 mg of propranolol)., 2 Each Inderal LA 80 mg capsule contains 80 mg propranolol hydrochloride USP (equivalent to 70.14 mg of propranolol)., 3 Each Inderal LA 120 mg capsule contains 120 mg propranolol hydrochloride USP (equivalent to 105.21 mg of propranolol)., 4 Each Inderal LA 160 mg capsule contains 160 mg propranolol hydrochloride USP (equivalent to 140.28 mg of propranolol).</Description>
</NDC>
<NDC>
<NDCCode>62559-523-30</NDCCode>
<PackageDescription>30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62559-523-30) </PackageDescription>
<NDC11Code>62559-0523-30</NDC11Code>
<ProductNDC>62559-523</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Inderal</ProprietaryName>
<ProprietaryNameSuffix>La</ProprietaryNameSuffix>
<NonProprietaryName>Propranolol Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170428</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018553</ApplicationNumber>
<LabelerName>ANI Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>PROPRANOLOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>160</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240805</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Inderal LA is indicated in the management of hypertension. It may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Inderal LA is not indicated in the management of hypertensive emergencies.</IndicationAndUsage>
<Description>Inderal® LA (propranolol hydrochloride) is a synthetic beta-adrenergic receptor-blocking agent chemically described as 2-Propanol, 1-[(1-methylethyl)amino]-3-(1-naphthalenyloxy)-, hydrochloride,(±)-. Its molecular and structural formulae are. C16H21NO2 · HCl. Propranolol hydrochloride USP is a stable, white, crystalline solid which is readily soluble in water and ethanol. Its molecular weight is 295.80. Inderal LA is formulated to provide a sustained release of propranolol hydrochloride USP. Inderal LA is available as 60 mg, 80 mg, 120 mg, and 160 mg capsules for oral administration. : 1 Each Inderal LA 60 mg capsule contains 60 mg propranolol hydrochloride USP (equivalent to 52.60 mg of propranolol)., 2 Each Inderal LA 80 mg capsule contains 80 mg propranolol hydrochloride USP (equivalent to 70.14 mg of propranolol)., 3 Each Inderal LA 120 mg capsule contains 120 mg propranolol hydrochloride USP (equivalent to 105.21 mg of propranolol)., 4 Each Inderal LA 160 mg capsule contains 160 mg propranolol hydrochloride USP (equivalent to 140.28 mg of propranolol).</Description>
</NDC>
<NDC>
<NDCCode>63187-523-15</NDCCode>
<PackageDescription>15 mL in 1 BOTTLE, DROPPER (63187-523-15)</PackageDescription>
<NDC11Code>63187-0523-15</NDC11Code>
<ProductNDC>63187-523</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acella Antipyrine And Benzocaine Otic</ProprietaryName>
<NonProprietaryName>Antipyrine, Benzocaine</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>AURICULAR (OTIC)</RouteName>
<StartMarketingDate>20101109</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>ANTIPYRINE; BENZOCAINE</SubstanceName>
<StrengthNumber>54; 14</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-01-08</LastUpdate>
</NDC>
<NDC>
<NDCCode>63776-523-11</NDCCode>
<PackageDescription>.5 mL in 1 AMPULE (63776-523-11) </PackageDescription>
<NDC11Code>63776-0523-11</NDC11Code>
<ProductNDC>63776-523</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-tone</ProprietaryName>
<NonProprietaryName>Calcarea Fluorica, Centella Asiatica, Copper, Embryo, Fumaric Acid, Funiculus, Graphites, Hamamelis, Kalium Aspariticum, Muscle, Natrum Oxalaceticum, Natrum Pyruvicum, Placenta, Plasma, Quinhydrone, Silicea, Succinic Acid, Vitamin B5, Zinc</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL; TOPICAL</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>BEEF; BOS TAURUS PLACENTA; BOS TAURUS UMBILICAL CORD; CALCIUM FLUORIDE; CENTELLA ASIATICA; COPPER; FUMARIC ACID; GRAPHITE; HUMAN EMBRYO TISSUE; HUMAN PLACENTAL TISSUE; HUMAN PLASMA; PANTOTHENIC ACID; PORK; POTASSIUM ASPARTATE; QUINHYDRONE; SILICON DIOXIDE; SODIUM DIETHYL OXALACETATE; SODIUM PYRUVATE; SUCCINIC ACID; SUS SCROFA EMBRYO; SUS SCROFA PLACENTA; SUS SCROFA UMBILICAL CORD; WITCH HAZEL; ZINC</SubstanceName>
<StrengthNumber>200; 30; 200; 30; 30; 30; 30; 30; 30; 30; 30; 30; 200; 30; 30; 30; 30; 30; 30; 30; 30; 200; 30; 30</StrengthNumber>
<StrengthUnit>[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Depigmenting Activity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Inhibit Ovum Fertilization [PE], Meat Proteins [EXT], Meat Proteins [EXT], Melanin Synthesis Inhibitor [EPC], Melanin Synthesis Inhibitors [MoA], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210419</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Soft tissue regeneration.</IndicationAndUsage>
<Description>Viatrexx-Tone is a homeopathic product composed of physiological (low dose and low low dose) natural micro nutrients. These nano particles are designed to nourish the system.</Description>
</NDC>
<NDC>
<NDCCode>63776-523-14</NDCCode>
<PackageDescription>1 BOTTLE, SPRAY in 1 BOX (63776-523-14) > 30 mL in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>63776-0523-14</NDC11Code>
<ProductNDC>63776-523</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-tone</ProprietaryName>
<NonProprietaryName>Calcarea Fluorica, Centella Asiatica, Copper, Embryo, Fumaric Acid, Funiculus, Graphites, Hamamelis, Kalium Aspariticum, Muscle, Natrum Oxalaceticum, Natrum Pyruvicum, Placenta, Plasma, Quinhydrone, Silicea, Succinic Acid, Vitamin B5, Zinc</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL; TOPICAL</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>BEEF; BOS TAURUS PLACENTA; BOS TAURUS UMBILICAL CORD; CALCIUM FLUORIDE; CENTELLA ASIATICA; COPPER; FUMARIC ACID; GRAPHITE; HUMAN EMBRYO TISSUE; HUMAN PLACENTAL TISSUE; HUMAN PLASMA; PANTOTHENIC ACID; PORK; POTASSIUM ASPARTATE; QUINHYDRONE; SILICON DIOXIDE; SODIUM DIETHYL OXALACETATE; SODIUM PYRUVATE; SUCCINIC ACID; SUS SCROFA EMBRYO; SUS SCROFA PLACENTA; SUS SCROFA UMBILICAL CORD; WITCH HAZEL; ZINC</SubstanceName>
<StrengthNumber>200; 30; 200; 30; 30; 30; 30; 30; 30; 30; 30; 30; 200; 30; 30; 30; 30; 30; 30; 30; 30; 200; 30; 30</StrengthNumber>
<StrengthUnit>[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Depigmenting Activity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Inhibit Ovum Fertilization [PE], Meat Proteins [EXT], Meat Proteins [EXT], Melanin Synthesis Inhibitor [EPC], Melanin Synthesis Inhibitors [MoA], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190718</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Soft tissue regeneration.</IndicationAndUsage>
<Description>Viatrexx-Tone is a homeopathic product composed of physiological (low dose and low low dose) natural micro nutrients. These nano particles are designed to nourish the system.</Description>
</NDC>
<NDC>
<NDCCode>63776-523-15</NDCCode>
<PackageDescription>50 mL in 1 BOTTLE (63776-523-15) </PackageDescription>
<NDC11Code>63776-0523-15</NDC11Code>
<ProductNDC>63776-523</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-tone</ProprietaryName>
<NonProprietaryName>Calcarea Fluorica, Centella Asiatica, Copper, Embryo, Fumaric Acid, Funiculus, Graphites, Hamamelis, Kalium Aspariticum, Muscle, Natrum Oxalaceticum, Natrum Pyruvicum, Placenta, Plasma, Quinhydrone, Silicea, Succinic Acid, Vitamin B5, Zinc</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL; TOPICAL</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>BEEF; BOS TAURUS PLACENTA; BOS TAURUS UMBILICAL CORD; CALCIUM FLUORIDE; CENTELLA ASIATICA; COPPER; FUMARIC ACID; GRAPHITE; HUMAN EMBRYO TISSUE; HUMAN PLACENTAL TISSUE; HUMAN PLASMA; PANTOTHENIC ACID; PORK; POTASSIUM ASPARTATE; QUINHYDRONE; SILICON DIOXIDE; SODIUM DIETHYL OXALACETATE; SODIUM PYRUVATE; SUCCINIC ACID; SUS SCROFA EMBRYO; SUS SCROFA PLACENTA; SUS SCROFA UMBILICAL CORD; WITCH HAZEL; ZINC</SubstanceName>
<StrengthNumber>200; 30; 200; 30; 30; 30; 30; 30; 30; 30; 30; 30; 200; 30; 30; 30; 30; 30; 30; 30; 30; 200; 30; 30</StrengthNumber>
<StrengthUnit>[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Depigmenting Activity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Inhibit Ovum Fertilization [PE], Meat Proteins [EXT], Meat Proteins [EXT], Melanin Synthesis Inhibitor [EPC], Melanin Synthesis Inhibitors [MoA], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190718</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Soft tissue regeneration.</IndicationAndUsage>
<Description>Viatrexx-Tone is a homeopathic product composed of physiological (low dose and low low dose) natural micro nutrients. These nano particles are designed to nourish the system.</Description>
</NDC>
<NDC>
<NDCCode>63776-523-16</NDCCode>
<PackageDescription>100 mL in 1 BOTTLE (63776-523-16) </PackageDescription>
<NDC11Code>63776-0523-16</NDC11Code>
<ProductNDC>63776-523</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-tone</ProprietaryName>
<NonProprietaryName>Calcarea Fluorica, Centella Asiatica, Copper, Embryo, Fumaric Acid, Funiculus, Graphites, Hamamelis, Kalium Aspariticum, Muscle, Natrum Oxalaceticum, Natrum Pyruvicum, Placenta, Plasma, Quinhydrone, Silicea, Succinic Acid, Vitamin B5, Zinc</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL; TOPICAL</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>BEEF; BOS TAURUS PLACENTA; BOS TAURUS UMBILICAL CORD; CALCIUM FLUORIDE; CENTELLA ASIATICA; COPPER; FUMARIC ACID; GRAPHITE; HUMAN EMBRYO TISSUE; HUMAN PLACENTAL TISSUE; HUMAN PLASMA; PANTOTHENIC ACID; PORK; POTASSIUM ASPARTATE; QUINHYDRONE; SILICON DIOXIDE; SODIUM DIETHYL OXALACETATE; SODIUM PYRUVATE; SUCCINIC ACID; SUS SCROFA EMBRYO; SUS SCROFA PLACENTA; SUS SCROFA UMBILICAL CORD; WITCH HAZEL; ZINC</SubstanceName>
<StrengthNumber>200; 30; 200; 30; 30; 30; 30; 30; 30; 30; 30; 30; 200; 30; 30; 30; 30; 30; 30; 30; 30; 200; 30; 30</StrengthNumber>
<StrengthUnit>[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Depigmenting Activity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Inhibit Ovum Fertilization [PE], Meat Proteins [EXT], Meat Proteins [EXT], Melanin Synthesis Inhibitor [EPC], Melanin Synthesis Inhibitors [MoA], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210419</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Soft tissue regeneration.</IndicationAndUsage>
<Description>Viatrexx-Tone is a homeopathic product composed of physiological (low dose and low low dose) natural micro nutrients. These nano particles are designed to nourish the system.</Description>
</NDC>
<NDC>
<NDCCode>63776-523-17</NDCCode>
<PackageDescription>250 mL in 1 BOTTLE (63776-523-17) </PackageDescription>
<NDC11Code>63776-0523-17</NDC11Code>
<ProductNDC>63776-523</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-tone</ProprietaryName>
<NonProprietaryName>Calcarea Fluorica, Centella Asiatica, Copper, Embryo, Fumaric Acid, Funiculus, Graphites, Hamamelis, Kalium Aspariticum, Muscle, Natrum Oxalaceticum, Natrum Pyruvicum, Placenta, Plasma, Quinhydrone, Silicea, Succinic Acid, Vitamin B5, Zinc</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL; TOPICAL</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>BEEF; BOS TAURUS PLACENTA; BOS TAURUS UMBILICAL CORD; CALCIUM FLUORIDE; CENTELLA ASIATICA; COPPER; FUMARIC ACID; GRAPHITE; HUMAN EMBRYO TISSUE; HUMAN PLACENTAL TISSUE; HUMAN PLASMA; PANTOTHENIC ACID; PORK; POTASSIUM ASPARTATE; QUINHYDRONE; SILICON DIOXIDE; SODIUM DIETHYL OXALACETATE; SODIUM PYRUVATE; SUCCINIC ACID; SUS SCROFA EMBRYO; SUS SCROFA PLACENTA; SUS SCROFA UMBILICAL CORD; WITCH HAZEL; ZINC</SubstanceName>
<StrengthNumber>200; 30; 200; 30; 30; 30; 30; 30; 30; 30; 30; 30; 200; 30; 30; 30; 30; 30; 30; 30; 30; 200; 30; 30</StrengthNumber>
<StrengthUnit>[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL</StrengthUnit>
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<Description>Viatrexx-Tone is a homeopathic product composed of physiological (low dose and low low dose) natural micro nutrients. These nano particles are designed to nourish the system.</Description>
</NDC>
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<SamplePackage>N</SamplePackage>
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<Description>Viatrexx-Tone is a homeopathic product composed of physiological (low dose and low low dose) natural micro nutrients. These nano particles are designed to nourish the system.</Description>
</NDC>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<SamplePackage>N</SamplePackage>
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<Description>Viatrexx-Tone is a homeopathic product composed of physiological (low dose and low low dose) natural micro nutrients. These nano particles are designed to nourish the system.</Description>
</NDC>
<NDC>
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<ProprietaryName>Piperacillin And Tazobactam</ProprietaryName>
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<Pharm_Classes>Penicillin-class Antibacterial [EPC],Penicillins [CS],beta Lactamase Inhibitors [MoA],beta Lactamase Inhibitor [EPC]</Pharm_Classes>
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<SamplePackage>N</SamplePackage>
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<ProprietaryName>Detox Drops Acne Toner</ProprietaryName>
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<SamplePackage>N</SamplePackage>
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<SamplePackage>N</SamplePackage>
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</NDC>
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<SamplePackage>N</SamplePackage>
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<Description>Mirtazapine tablets, USP contain mirtazapine. Mirtazapine has a tetracyclic chemical structure and belongs to the piperazino-azepine group of compounds. It is designated 1,2,3,4,10,14b-Hexahydro-2-methylpyrazino[2,1-a]pyrido[2,3-c]benzazepine and has the molecular formula of C 17H 19N 3. Its molecular weight is 265.36. The structural formula is the following and it is the racemic mixture:. Mirtazapine, USP is a white to creamy white crystalline powder which is slightly soluble in water. Mirtazapine tablets are available for oral administration as scored film-coated tablets containing 15 or 30 mg of mirtazapine, and unscored film-coated tablets containing 45 mg of mirtazapine. Each tablet also contains anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, FD&C Blue No. 2 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, pregelatinized starch (corn), sodium lauryl sulfate, titanium dioxide and triacetin.</Description>
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<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Mirtazapine tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)] .</IndicationAndUsage>
<Description>Mirtazapine tablets, USP contain mirtazapine. Mirtazapine has a tetracyclic chemical structure and belongs to the piperazino-azepine group of compounds. It is designated 1,2,3,4,10,14b-Hexahydro-2-methylpyrazino[2,1-a]pyrido[2,3-c]benzazepine and has the molecular formula of C 17H 19N 3. Its molecular weight is 265.36. The structural formula is the following and it is the racemic mixture:. Mirtazapine, USP is a white to creamy white crystalline powder which is slightly soluble in water. Mirtazapine tablets are available for oral administration as scored film-coated tablets containing 15 or 30 mg of mirtazapine, and unscored film-coated tablets containing 45 mg of mirtazapine. Each tablet also contains anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, FD&C Blue No. 2 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, pregelatinized starch (corn), sodium lauryl sulfate, titanium dioxide and triacetin.</Description>
</NDC>
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<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210804</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<Description>Mirtazapine tablets, USP contain mirtazapine. Mirtazapine has a tetracyclic chemical structure and belongs to the piperazino-azepine group of compounds. It is designated 1,2,3,4,10,14b-Hexahydro-2-methylpyrazino[2,1-a]pyrido[2,3-c]benzazepine and has the molecular formula of C 17H 19N 3. Its molecular weight is 265.36. The structural formula is the following and it is the racemic mixture:. Mirtazapine, USP is a white to creamy white crystalline powder which is slightly soluble in water. Mirtazapine tablets are available for oral administration as scored film-coated tablets containing 15 or 30 mg of mirtazapine, and unscored film-coated tablets containing 45 mg of mirtazapine. Each tablet also contains anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, FD&C Blue No. 2 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, pregelatinized starch (corn), sodium lauryl sulfate, titanium dioxide and triacetin.</Description>
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